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Icotyde icotrokinra 200 mg Tablet, Film Coated, 7-count — NDC 57894-0201-07 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Icotyde icotrokinra 200 mg Tablet, Film Coated, 7-count — NDC 57894-201-07 (Billing 57894-0201-07)

by Janssen Biotech, Inc. · 1 BLISTER PACK in 1 CARTON / 7 TABLET, FILM COATED in 1 BLISTER PACK

This is a package of 7 tablets of Icotyde icotrokinra 200 mg Tablet, Film Coated from Janssen Biotech, Inc., marketed since Mar 2026 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 57894-0201-07
🏷️ FDA NDC (as labeled) 57894-201-07 billing pads the product segment with a zero
This package
Contains7-count Pack sizes2 compare ↓
Main listing for product 57894-201 · Also comes in: 30 tablets 57894-201-30
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 57894-201-07 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
57894 labeler · 201 product · 07 package
Package marketed since
Mar 17, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
7 EA per package
Barcode (UPC-A, from the NDC)
3 5789420107 6
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 57894-201-07
Product NDC 57894-201
11-digit billing NDC 57894020107
NCPDP billing unit EA — each (per item)
RxCUI 2739036, 2739042
UNII MUW8FP7HNZ
Application # NDA220149
SPL Set ID aee3c963-edc0-4252-8769-cdf6c7cdc21a
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-03-17
Route ORAL
Dosage form TABLET, FILM COATED
Substance ICOTROKINRA

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90250550200340
GCN Seq No 088771
GCN 58933
HICL code 051213
Ingredient (HICL) Icotrokinra Hcl
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L1
Therapeutic class — intermediate (HIC2) Drugs To Treat Specific Top Diseases (Systemic)
HIC3 code L1A
Therapeutic class — specific (HIC3) Antipsoriatic Agents,Systemic
AHFS code 84:06.28.00
AHFS class Immunomodulatory Agents (84:06)
FDB label name ICOTYDE 200 MG TABLET
FDB brand name Icotyde
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 088771
  • GCN: 58933
  • GPI-14 (Medi-Span): 90250550200340
  • HICL (First Databank): 051213
  • AHFS class code: 84:06.28.00
  • RxCUI (RxNorm): 2739036
Why two NDCs? The FDA registers this code as 57894-201-07 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 57894-0201-07. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name ICOTYDE 200 MG TABLET Ingredient Icotrokinra Hcl

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 30 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
57894-0201-07 You're viewing this Main listing 1 BLISTER PACK in 1 CARTON / 7 TABLET, FILM COATED in 1 BLISTER PACK 2026-03-17 — Active
57894-0201-30 57894-201-30 1 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE 2026-03-17 — Active

Pack size FAQ

What quantity is in this package?
This is a 7-count package — 1 blister pack in 1 carton / 7 tablet, film coated in 1 blister pack.
How does this package differ from NDC 57894-0201-30?
Both are Icotyde icotrokinra 200 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 7-count one, while NDC 57894-0201-30 is the 30 tablets package.
What NDC number is used to bill for this package of Icotyde icotrokinra 200 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Icotyde 200 mgthis 57894-0201-07 Janssen 7 tablets — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2026
First FDA approval
Mar 2026
📍
2026
Currently FDA-listed
listed with the FDA
🛡️
2041
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Nov 2041. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Mar 17, 2026 RLD RS ⏳ ~15.1 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 11939361 — method of use (U-4447)
US 11845808 — drug substance (U-4447)
US 12552836 — drug substance
Exclusivity NCE
2026 2028 2030 2032 2034 2036 2038 2040 2042
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (3)
PatentTypeUse codeExpires
US 11939361 ↗ Method of use U-4447 Nov 19, 2041
US 11845808 ↗ Drug substance U-4447 Jan 14, 2041
US 12552836 ↗ Drug substance — Jul 12, 2039
FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)Mar 17, 2031
Common questions
Is there a generic version of ICOTYDE 200 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for ICOTYDE 200 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Nov 2041 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color yellow
ShapeOval
Imprint200;JNJ
Size19 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII G7515SW10N
    A waxy liquid derived from vegetable oil and fatty acids. It works as an emulsifier and solubilizer to help blend oil and water-based ingredients together and improve how the medicine dissolves and is absorbed in the body.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 23ZQ42JZZH
    A synthetic polymer made by chemically linking polyvinyl alcohol to polyethylene glycol. It acts as a binder and film-former to hold tablet ingredients together and create smooth coatings on capsules or tablets.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII GRV5BG8C5N
    A plant-based filler and binder made from cellulose combined with silica. It helps hold tablet ingredients together, improves flowability during manufacturing, and ensures consistent tablet density and shape.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

10 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerJanssen Biotech, Inc.
Application holderJANSSEN BIOTECH INC
FDA applicationNDA220149 (NDA)
Labeler code57894
First marketedMar 2026
Product typeHuman Prescription Drug
Portfolio36 products on file

More NDCs from Janssen Biotech, Inc. labeler code 57894

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 82 words ▾

1 INDICATIONS AND USAGE ICOTYDE is indicated for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. ICOTYDE is an interleukin-23 (IL-23) receptor antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. ( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION See the full prescribing information for recommended evaluation and immunizations prior to treatment. ( 2.1 ) Recommended dosage is 200 mg orally once daily. ( 2.2 ) Administer ICOTYDE on an empty stomach with water upon waking. ( 2.2 ) Wait at least 30 minutes after taking ICOTYDE before eating food. ( 2.2 ) For patients who have difficulty swallowing tablets, ICOTYDE can be dispersed in water. ( 2.3 )

2.1Recommended Evaluation and Immunizations Prior to Treatment Initiation Consider evaluating patients for tuberculosis (TB) infection prior to initiating treatment with ICOTYDE based on clinical judgment [see Warnings and Precautions (5.2) ] . Complete all age-appropriate vaccinations according to current immunization guidelines [see Warnings and Precautions (5.3) ] .

2.2Recommended Dosage and Administration Instructions The recommended dosage of ICOTYDE is 200 mg administered orally once daily. Administer ICOTYDE upon waking on an empty stomach with water. Wait at least 30 minutes after taking ICOTYDE before eating food.

Swallow ICOTYDE whole. Do not crush, split, or chew tablets [see Clinical Pharmacology (12.3) ] . If a patient misses a dose, instruct patients to take the missed dose as soon as possible with a return to normal dosing schedule the following day.

2.3Alternative Preparation and Administration Instructions for Patients Who Have Difficulty Swallowing Tablets ICOTYDE 200 mg tablet can also be dispersed in water using the following instructions: Place one ICOTYDE tablet in a cup containing at least 120 mL (4 ounces) of water. It may take a few minutes for the tablet to disperse. The tablet may not completely disperse.

The mixture may look yellow, milky, or cloudy, and small pieces may be seen in the water which are safe to swallow. Gently swirl the cup before drinking and swallowing the full mixture. Add at least 120 mL (4 ounces) of additional water to the cup and completely swallow the contents to make sure the whole dose is taken.

Complete administration of ICOTYDE within 15 minutes of dispersion in water.

💊 Dosage Forms and Strengths 36 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: 200 mg of icotrokinra, yellowish orange to yellowish brown, oval, film-coated tablets debossed with '200' on one side and 'JNJ' on the other side. Tablets: 200 mg ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Infections : Avoid treatment with ICOTYDE in patients with any clinically important active infection until the infection resolves or is adequately treated. If such an infection develops, discontinue ICOTYDE until the infection resolves. ( 5.1 ) Tuberculosis (TB) : Consider evaluating for TB prior to initiating treatment with ICOTYDE based on clinical judgment.

Monitor patients for signs and symptoms of active TB during and after treatment with ICOTYDE. ( 5.2 ) Immunizations : Avoid use of live vaccines during treatment with ICOTYDE. ( 5.3 )

5.1Infections Medicines that interact with the immune system may increase the risk of infection. In the 16-week placebo-controlled trials in subjects with moderate-to-severe plaque psoriasis, the rate of serious infections for ICOTYDE-treated subjects was 0.2% compared to 0.4% of subjects who received placebo. Avoid treatment with ICOTYDE in patients with any clinically important active infection until the infection resolves or is adequately treated.

In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing ICOTYDE. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection and/or is not responding to standard therapy, monitor the patient closely and discontinue ICOTYDE until the infection resolves.

5.2Tuberculosis Consider evaluating patients for tuberculosis (TB) infection prior to initiating treatment with ICOTYDE based on clinical judgment. Consider anti-TB therapy prior to initiating ICOTYDE in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after ICOTYDE treatment.

Avoid administering ICOTYDE to patients with active TB.

5.3Immunizations Avoid use of live vaccines in patients during treatment with ICOTYDE. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating therapy with ICOTYDE, complete immunizations according to current immunization guidelines. No data are available on the response to live or inactive vaccines.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions (≥1%) are headache, nausea, cough, fungal infection, and fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at 1-800-526-7736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ICOTYDE was evaluated in two placebo-controlled trials (Trial PSO-3 and Trial PSO-4) and two placebo- and active-controlled trials (Trial PSO-1 and Trial PSO-2) [see Clinical Studies (14) ] . A total of 2367 adults and pediatric subjects 12 years of age and older who weigh at least 40 kg with moderate-to-severe plaque psoriasis received ICOTYDE 200 mg orally once daily.

Of these, 648 subjects were treated with ICOTYDE for at least one year. Data from these four trials were pooled to evaluate the safety of ICOTYDE compared to placebo for 16 weeks. Adverse Reactions Weeks 0 to 16 Table 1: Adverse Reactions that Occurred in ≥1% of Subjects in the ICOTYDE Group and More Frequently than in the Placebo Group in Trials PSO-1, PSO-2, PSO-3, and PSO-4 through Week 16 percentages based on Cochran-Mantel-Haenszel (CMH) adjusted proportions.

Adverse Reactions ICOTYDE N=1296 n (%) Placebo N=568 n (%) Headache 51 (4.1) 19 (3.3) Nausea 15 (1.2) 3 (0.5) Cough 15 (1.2) 1 (0.2) Fungal Infection Fungal infection includes tinea pedis (n=4), tinea versicolor (n=2), oral candidiasis (n=2), onychomycosis (n=1), skin candida (n=1), urinary tract candidiasis (n=1), vulvovaginal candidiasis (n=1), fungal skin infection (n=1), genital infection fungal (n=1), ear infection fungal (n=1), laryngitis fungal (n=1). Two subjects experienced more than 1 event. 14 (1.1) 0 (0) Fatigue 15 (1.0) 3 (0.5) Adverse reactions that occurred in < 1% of subjects in the ICOTYDE group and at a higher rate than in the placebo group through Week 16 in Trials PSO-1, PSO-2, PSO-3, and PSO-4 were: gastritis, abdominal discomfort, and one fatal case involving upper gastrointestinal bleeding in a subject with underlying risk factors.

A relationship of this event to ICOTYDE is not established. Adverse Reactions in Pediatric Subjects 12 Years of Age and Older The safety of ICOTYDE was evaluated in pediatric subjects 12 years of age and older who weigh at least 40 kg with moderate-to-severe plaque psoriasis in two placebo-controlled trials (Trial PSO-3 and Trial PSO-4). A total of 72 pediatric subjects were treated with ICOTYDE 200 mg orally once daily.

Of these, 45 subjects were treated with ICOTYDE for at least one year. The adverse reactions observed in pediatric subjects were consistent with the most common adverse reactions (≥ 1%) observed in the overall population.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Moderate or Severe Renal Impairment: Monitor for potential adverse reactions when ICOTYDE is used in patients with eGFR <60 mL/min. ( 8.6 )

8.1Pregnancy Risk Summary The available data on the use of ICOTYDE during pregnancy are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In an animal reproduction study in rabbits, oral administration of icotrokinra to pregnant rabbits during the period of organogenesis at a dose 157 times the maximum recommended human dose (MRHD) based on AUC comparison resulted in maternal body weight loss, low food consumption, late pregnancy loss, and an increased fetal incidence of fused ribs (see Data ) .

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, and other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

There is a pregnancy safety study for ICOTYDE. If a patient becomes pregnant while receiving ICOTYDE, healthcare providers can report ICOTYDE exposure by calling 1-800-526-7736 or visiting www.ICOTYDE.com. Data Animal Data In an embryo-fetal development study, icotrokinra was administered to pregnant rats during the period of organogenesis at oral doses of 70, 200, and 1000 mg/kg/day.

No maternal or embryo-fetal toxicity was observed at doses up to 1000 mg/kg/day (297 times the MRHD based on AUC comparison). In another embryo-fetal development study, icotrokinra was administered to pregnant rabbits during the period of organogenesis at oral doses of 50, 200, and 500 mg/kg/day. Maternal body weight loss, low food consumption, late pregnancy loss, and an increased fetal incidence of fused ribs were observed at 500 mg/kg/day (157 times the MRHD based on AUC comparison).

No maternal or embryo-fetal toxicity was noted at doses up to 200 mg/kg/day in rabbits (27 times the MRHD based on AUC comparison). In a pre- and post-natal development study in rats, icotrokinra was administered to pregnant rats during pregnancy and lactation periods at oral doses of 20, 70, and 200 mg/kg/day. No maternal or developmental toxicity was noted in doses up to 200 mg/kg/day (127 times the MRHD based on AUC comparison).

8.2Lactation Risk Summary There are no data on the presence of icotrokinra in human milk, the effects on the breastfed infant, or the effects on milk production. When administered to lactating rats, icotrokinra was detected in the plasma of nursing pups (see Data ) . When a drug is present in animal milk, it is likely that the drug will be present in human milk.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ICOTYDE and any potential adverse effects on the breastfed infant from ICOTYDE or from the underlying maternal condition. Data In a pre- and post-natal development study in rats, icotrokinra was administered orally to pregnant rats during pregnancy and lactation periods at doses up to 200 mg/kg/day (127 times the MRHD based on AUC comparison). Although not directly measured in rat milk, icotrokinra was detected in the plasma of nursing rat pups.

No adverse developmental effects were observed in the nursing pups.

8.4Pediatric Use The safety and effectiveness of ICOTYDE have been established in pediatric patients 12 years of age and older who weigh at least 40 kg with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Use of ICOTYDE for this indication is supported by evidence from two multi-center, randomized 52-week trials (Trial PSO-3 and Trial PSO-4) conducted in adults and pediatric subjects, including 72 pediatric subjects 12 years of age and older treated with ICOTYDE [see Adverse Reactions (6.1) and Clinical… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary The available data on the use of ICOTYDE during pregnancy are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In an animal reproduction study in rabbits, oral administration of icotrokinra to pregnant rabbits during the period of organogenesis at a dose 157 times the maximum recommended human dose (MRHD) based on AUC comparison resulted in maternal body weight loss, low food consumption, late pregnancy loss, and an increased fetal incidence of fused ribs (see Data ) .

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, and other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

There is a pregnancy safety study for ICOTYDE. If a patient becomes pregnant while receiving ICOTYDE, healthcare providers can report ICOTYDE exposure by calling 1-800-526-7736 or visiting www.ICOTYDE.com. Data Animal Data In an embryo-fetal development study, icotrokinra was administered to pregnant rats during the period of organogenesis at oral doses of 70, 200, and 1000 mg/kg/day.

No maternal or embryo-fetal toxicity was observed at doses up to 1000 mg/kg/day (297 times the MRHD based on AUC comparison). In another embryo-fetal development study, icotrokinra was administered to pregnant rabbits during the period of organogenesis at oral doses of 50, 200, and 500 mg/kg/day. Maternal body weight loss, low food consumption, late pregnancy loss, and an increased fetal incidence of fused ribs were observed at 500 mg/kg/day (157 times the MRHD based on AUC comparison).

No maternal or embryo-fetal toxicity was noted at doses up to 200 mg/kg/day in rabbits (27 times the MRHD based on AUC comparison). In a pre- and post-natal development study in rats, icotrokinra was administered to pregnant rats during pregnancy and lactation periods at oral doses of 20, 70, and 200 mg/kg/day. No maternal or developmental toxicity was noted in doses up to 200 mg/kg/day (127 times the MRHD based on AUC comparison).

🧒 Pediatric Use 114 words ▾

8.4Pediatric Use The safety and effectiveness of ICOTYDE have been established in pediatric patients 12 years of age and older who weigh at least 40 kg with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Use of ICOTYDE for this indication is supported by evidence from two multi-center, randomized 52-week trials (Trial PSO-3 and Trial PSO-4) conducted in adults and pediatric subjects, including 72 pediatric subjects 12 years of age and older treated with ICOTYDE [see Adverse Reactions (6.1) and Clinical Studies (14) ].

The safety and effectiveness of ICOTYDE in pediatric patients younger than 12 years of age or who weigh less than 40 kg have not been established.

🧓 Geriatric Use 66 words ▾

8.5Geriatric Use Of the 2367 subjects exposed to ICOTYDE in clinical trials for moderate-to-severe plaque psoriasis, 240 (10.1%) were 65 years of age and older, and 36 (1.5%) were 75 years of age and older. No overall differences in safety and effectiveness of ICOTYDE have been observed between subjects 65 years of age and older and younger adult subjects [see Clinical Studies (14) ] .

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Icotrokinra is a peptide that selectively binds to the IL-23 receptor (IL-23R) with a dissociation constant of 7 pM and antagonizes the binding of IL-23. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses. Icotrokinra inhibits the IL-23/IL-23R-dependent release of proinflammatory cytokines.

12.2Pharmacodynamics Icotrokinra reduced serum levels of proinflammatory cytokines, IL-17A, IL-17F, IL-19, IL-22 and β-defensin-2, relative to pretreatment levels in evaluated subjects with moderate-to-severe plaque psoriasis based on exploratory analysis of the pharmacodynamic markers. A decrease from baseline was observed in the expression of mRNA related to IL-23/Th17 pathway and psoriasis, including molecular targets IL17A , IL17F , IL19 , IL22 , IL23A , and DEFB4A , in lesional skin biopsies up to 24 weeks post treatment in an exploratory analysis of subjects with moderate-to-severe plaque psoriasis.

The relationship between these pharmacodynamic markers and the mechanism(s) by which icotrokinra exerts its clinical effects is not fully understood. Cardiac Electrophysiology At 5 times the maximum recommended dose of ICOTYDE, clinically significant QTc interval prolongation was not observed.

12.3Pharmacokinetics Following the administration of icotrokinra 200 mg, the mean (standard deviation) maximum concentration (C max ) is 3.62 (1.48) ng/mL and total systemic exposure (AUC inf ) is 44.8 (11.4) ng*h/mL. Icotrokinra C max and AUC increase in a dose-proportional manner between 0.05 to 5 times the recommended dosage in healthy subjects. Following multiple dose administration accumulation for C max was up to 1.6-fold and for AUC was up to 1.5-fold.

Icotrokinra steady state is reached in approximately 3 days. No clinically relevant differences in icotrokinra pharmacokinetics were observed between healthy subjects and patients with moderate-to-severe plaque psoriasis. Absorption Icotrokinra median (min, max) time to maximum plasma concentration (T max ) is 2 (0.25, 8) hours.

Effect of Food Icotrokinra AUC decreased by 43% and C max decreased by 59% following administration with a high-fat meal (1000 calories, 50% fat) [see Dosage and Administration (2.2) ]. No clinically significant differences in icotrokinra pharmacokinetics were observed following administration of caffeine. Distribution Icotrokinra is 52% bound to plasma protein.

Blood to plasma partition ratio is 0.53. Icotrokinra steady state apparent (oral) volume of distribution is 92800 L. Elimination Icotrokinra median elimination half-life is 12 hours with an apparent (oral) clearance of 6550 L/h.

Metabolism Icotrokinra is a peptide and it is metabolized by peptide catabolism into smaller peptides. Excretion Following oral administration of icotrokinra to healthy subjects, approximately 37% to 81% of the dose was recovered in feces within 24 hours as unchanged icotrokinra, and 0.001% of the dose was recovered in urine as unchanged icotrokinra. Specific Populations No clinically significant differences in the pharmacokinetics of icotrokinra were observed based on age (range: 12 to 87 years), body weight (range: 39 to 211 kg), sex, race (76% White, 20.1% Asian, 1.7% Black), ethnicity, immunogenicity, mild (eGFR ≥60 to <90 mL/min, [calculated according to Chronic Kidney Disease Epidemiology Collaboration]) renal impairment.

The effect of mild (Child-Pugh Class A) to severe (Child-Pugh Class C) hepatic impairment on icotrokinra pharmacokinetics is unknown. Hepatic impairment is unlikely to affect icotrokinra elimination since the drug is not metabolized hepatically. However, patients with severe hepatic impairment were not studied in clinical trials.

Pediatric Patients No clinically relevant differences in icotrokinra pharmacokinetics were observed in pediatric patients with moderate-to-severe plaque psoriasis 12 years of age and older who weigh at least 40 kg compared to adults. Patients wit… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 51 words ▾

12.1Mechanism of Action Icotrokinra is a peptide that selectively binds to the IL-23 receptor (IL-23R) with a dissociation constant of 7 pM and antagonizes the binding of IL-23. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses. Icotrokinra inhibits the IL-23/IL-23R-dependent release of proinflammatory cytokines.

📦 How Supplied / Storage and Handling 97 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ICOTYDE™ (icotrokinra) tablets: 200 mg, yellowish orange to yellowish brown, oval, film-coated tablets debossed with '200' on one side and 'JNJ' on the other side. ICOTYDE is supplied in bottles of 30 tablets (NDC Number: 57894-201-30), with a silica gel desiccant and a child-resistant closure. Storage and Handling Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted between 15 °C to 30 °C (59 °F to 86 °F) [see USP Controlled Room Temperature].

Store in original package to protect from moisture. Do not discard desiccant.

📦 Storage and Handling 45 words ▾

Storage and Handling Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted between 15 °C to 30 °C (59 °F to 86 °F) [see USP Controlled Room Temperature]. Store in original package to protect from moisture. Do not discard desiccant.

📋 Description 171 words ▾

11 DESCRIPTION Icotrokinra is an IL-23 receptor antagonist, in the form of a hydrochloride salt. Icotrokinra is a 13-amino acid peptide. The molecular formula for icotrokinra is C 90 H 120 N 20 O 22 S 2 and its molecular weight is 1898.17.

The chemical name for icotrokinra is (4S)-4-[([4-[(2S)-2-[(2S)-2-[([(4R,7S,10S,13S,16S,19R)-19-acetamido-7-(4-acetamidobutyl)-16-(2-amino-2-oxoethyl)-13-[(1R)-1-hydroxyethyl]-3,3,20,20-tetramethyl-10-[(7-methyl-1H-indol-3-yl)methyl]6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentaazacycloicosan-4-yl]carbonyl)amino]-3-[4-(2-aminoethoxy)phenyl]propanamido]-3-(2-naphthyl)propanamido]tetrahydro-2H-pyran-4-yl]carbonyl)amino]-5-[[(2S)-4-amino-1-[[(2S)-1-[(2-amino-2-oxoethyl)(methyl)amino]-1-oxo-3-(pyridin-3-yl)propan-2-yl]amino]-1,4-dioxobutan-2-yl]amino]-5-oxopentanoic acid.

The structural formula for icotrokinra hydrochloride is: Icotrokinra hydrochloride is a white to almost white powder. It is freely soluble below pH 2, very slightly soluble at pH 5, practically insoluble at pH 9, and freely soluble above pH 11. The isoelectric point (pI) of the compound is 7.15.

ICOTYDE™ (icotrokinra) tablets are supplied as 200 mg film-coated tablets for oral administration. Each tablet of ICOTYDE contains 200 mg icotrokinra (equivalent to 201.6–202.8 mg of icotrokinra hydrochloride) and the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, and silicified microcrystalline cellulose. The film coating contains the following inactive ingredients: glyceryl monocaprylocaprate, iron oxide yellow, macrogol polyvinyl alcohol graft polymer, polyvinyl alcohol partially hydrolyzed, talc, and titanium dioxide.

Chemical Structure

💬 Information for Patients 203 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Infections Instruct patients of the importance of communicating any history of infections to the healthcare provider and contacting their healthcare provider if they develop any symptoms of an infection [see Warnings and Precautions (5.1) ] . Tuberculosis Advise patients to contact their healthcare provider if they experience symptoms suggestive of TB (e.g., unexplained fever, cough, or difficulty breathing) [see Warnings and Precautions (5.2) ] .

Immunizations Instruct patients to inform their healthcare provider that they are taking ICOTYDE prior to a potential vaccination [see Warnings and Precautions (5.3) ] . Dosage and Administration Instruct patients to take ICOTYDE once daily upon waking on an empty stomach with water. Instruct patients to wait at least 30 minutes after taking ICOTYDE before eating food [see Dosage and Administration (2.2) ] .

Instruct patients who have trouble swallowing tablets to disperse the tablet in water [see Dosage and Administration (2.3) ] . Pregnancy Advise pregnant women that there is a pregnancy safety study that monitors pregnancy outcomes in women exposed to ICOTYDE during pregnancy, and they can be enrolled by calling 1-800-526-7736 or www.ICOTYDE.com [see Use in Specific Populations (8.1) ].

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE ICOTYDE™ (ai-koh-tide) (icotrokinra) tablets, for oral use This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 3/2026 What is the most important information I should know about ICOTYDE?

Infections. Medicines that interact with the immune system, such as ICOTYDE, may lower your ability to fight infections and may increase your risk of infections. Your healthcare provider may check you for infections and tuberculosis (TB) before starting treatment and may treat you for TB before you begin treatment with ICOTYDE if you have a history of TB or have active TB.

Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with ICOTYDE. Tell your healthcare provider right away if you have any infection or have symptoms of an infection, including: fever, sweat, or chills cough shortness of breath blood in your mucus (phlegm) muscle aches warm, red, or painful skin or sores on your body different from your psoriasis weight loss diarrhea or stomach pain burning when you urinate or urinating more often than normal See "What are the possible side effects of ICOTYDE?" for more information about side effects.

What is ICOTYDE? ICOTYDE is a prescription medicine used to treat moderate-to-severe plaque psoriasis in adults and children 12 years of age and older who weigh at least 88 pounds (40 kg), who may benefit from taking injections or medicines by mouth (systemic therapy) or treatment using ultraviolet or UV light (phototherapy). It is not known if ICOTYDE is safe and effective in children under 12 years of age or who weigh less than 88 pounds (40 kg).

Before taking ICOTYDE, tell your healthcare provider about all of your medical conditions, including if you: have an infection that does not go away or that keeps coming back. have tuberculosis (TB) or have been in close contact with someone with TB. have recently received or are scheduled to receive an immunization (vaccine). Avoid receiving live vaccines during treatment with ICOTYDE. have kidney problems. are pregnant or plan to become pregnant. It is not known if ICOTYDE can harm your unborn baby.

Pregnancy Safety Study. There is a pregnancy safety study for women who take ICOTYDE during pregnancy. The purpose of this study is to collect information about the health of you and your baby.

If you are pregnant or become pregnant during treatment with ICOTYDE, you can report your pregnancy by calling 1-800-526-7736 or visiting www.ICOTYDE.com. are breastfeeding or plan to breastfeed. It is not known if ICOTYDE passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with ICOTYDE.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I take ICOTYDE? Take ICOTYDE exactly as your healthcare provider tells you to take it.

Take ICOTYDE 1 time a day. Take ICOTYDE when you wake up on an empty stomach with water. Wait at least 30 minutes after taking ICOTYDE before eating food.

Swallow ICOTYDE tablets whole. Do not crush, split, or chew ICOTYDE tablets. If you cannot swallow ICOTYDE tablets whole: Place 1 ICOTYDE tablet in a cup containing at least 120 mL (4 ounces) of water.

Wait a few minutes for the tablet to break up (disperse) in the water. The tablet may not completely disperse. The mixture may look yellow, milky, or cloudy.

Small pieces may be seen in the water, which are safe to swallow. Gently swirl the cup before swallowing the mixture. Add at least 120 mL (4 ounces) of additional water to the cup and completely swallow all of the mixture to make sure that you take your full dose of ICOTYDE.

Take the ICOTYDE and water mixture within 15 minutes of preparation. If you miss a dose of ICOTYDE, take the dose as soon as you remember and go back to your regular schedule the next day. What are the possible side effects of ICOTYDE?

IC… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Following the administration of icotrokinra 200 mg, the mean (standard deviation) maximum concentration (C max ) is 3.62 (1.48) ng/mL and total systemic exposure (AUC inf ) is 44.8 (11.4) ng*h/mL. Icotrokinra C max and AUC increase in a dose-proportional manner between 0.05 to 5 times the recommended dosage in healthy subjects. Following multiple dose administration accumulation for C max was up to 1.6-fold and for AUC was up to 1.5-fold.

Icotrokinra steady state is reached in approximately 3 days. No clinically relevant differences in icotrokinra pharmacokinetics were observed between healthy subjects and patients with moderate-to-severe plaque psoriasis. Absorption Icotrokinra median (min, max) time to maximum plasma concentration (T max ) is 2 (0.25, 8) hours.

Effect of Food Icotrokinra AUC decreased by 43% and C max decreased by 59% following administration with a high-fat meal (1000 calories, 50% fat) [see Dosage and Administration (2.2) ]. No clinically significant differences in icotrokinra pharmacokinetics were observed following administration of caffeine. Distribution Icotrokinra is 52% bound to plasma protein.

Blood to plasma partition ratio is 0.53. Icotrokinra steady state apparent (oral) volume of distribution is 92800 L. Elimination Icotrokinra median elimination half-life is 12 hours with an apparent (oral) clearance of 6550 L/h.

Metabolism Icotrokinra is a peptide and it is metabolized by peptide catabolism into smaller peptides. Excretion Following oral administration of icotrokinra to healthy subjects, approximately 37% to 81% of the dose was recovered in feces within 24 hours as unchanged icotrokinra, and 0.001% of the dose was recovered in urine as unchanged icotrokinra. Specific Populations No clinically significant differences in the pharmacokinetics of icotrokinra were observed based on age (range: 12 to 87 years), body weight (range: 39 to 211 kg), sex, race (76% White, 20.1% Asian, 1.7% Black), ethnicity, immunogenicity, mild (eGFR ≥60 to <90 mL/min, [calculated according to Chronic Kidney Disease Epidemiology Collaboration]) renal impairment.

The effect of mild (Child-Pugh Class A) to severe (Child-Pugh Class C) hepatic impairment on icotrokinra pharmacokinetics is unknown. Hepatic impairment is unlikely to affect icotrokinra elimination since the drug is not metabolized hepatically. However, patients with severe hepatic impairment were not studied in clinical trials.

Pediatric Patients No clinically relevant differences in icotrokinra pharmacokinetics were observed in pediatric patients with moderate-to-severe plaque psoriasis 12 years of age and older who weigh at least 40 kg compared to adults. Patients with Renal Impairment Icotrokinra AUC increased by 2.47-fold in patients with moderate (eGFR ≥30 to <60 mL/min, [calculated according to Chronic Kidney Disease Epidemiology Collaboration]) and 2.78-fold in severe (eGFR ≥15 to <30 mL/min) renal impairment. No clinically significant differences in the pharmacokinetics of icotrokinra were observed in patients with mild renal impairment (eGFR ≥60 to <90 mL/min) based on population pharmacokinetic analysis.

Drug Interaction Studies Clinical Studies No formal drug-drug interaction studies have been conducted with icotrokinra. No clinically significant drug interactions have been identified. In Vitro Studies CYP450 Enzymes: Icotrokinra does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4.

Icotrokinra does not induce CYP1A2, CYP2B6, and CYP3A4. Transporter systems: Icotrokinra is not a substrate of P-gp, BCRP, OATP1B1, OATP1B3, OAT1, OAT3, OCT2, MATE1, and MATE2-K. Icotrokinra does not inhibit P-gp, BCRP, OATP1B1, OATP1B3, OAT1, OAT3, OCT2, MATE1, MATE2-K, and BSEP.

🧬 Pharmacodynamics 126 words ▾

12.2Pharmacodynamics Icotrokinra reduced serum levels of proinflammatory cytokines, IL-17A, IL-17F, IL-19, IL-22 and β-defensin-2, relative to pretreatment levels in evaluated subjects with moderate-to-severe plaque psoriasis based on exploratory analysis of the pharmacodynamic markers. A decrease from baseline was observed in the expression of mRNA related to IL-23/Th17 pathway and psoriasis, including molecular targets IL17A , IL17F , IL19 , IL22 , IL23A , and DEFB4A , in lesional skin biopsies up to 24 weeks post treatment in an exploratory analysis of subjects with moderate-to-severe plaque psoriasis.

The relationship between these pharmacodynamic markers and the mechanism(s) by which icotrokinra exerts its clinical effects is not fully understood. Cardiac Electrophysiology At 5 times the maximum recommended dose of ICOTYDE, clinically significant QTc interval prolongation was not observed.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The efficacy of ICOTYDE was evaluated in four multi-center, randomized, double-blind, placebo and/or active comparator-controlled trials (Trial PSO-1 [NCT06143878], Trial PSO-2 [NCT06220604], Trial PSO-3 [NCT06095115], and Trial PSO-4 [NCT06095102]) that included 2500 subjects (2428 adults and 72 pediatric subjects 12 years and older who weigh at least 40 kg) with moderate-to-severe plaque psoriasis who were eligible for systemic therapy or phototherapy. Adults with Moderate-to-Severe Plaque Psoriasis (Trials PSO-1 and PSO-2) Trial Design Trial PSO-1 and Trial PSO-2 enrolled 1505 adults with moderate-to-severe plaque psoriasis defined as Investigator's Global Assessment (IGA) score ≥3, a Psoriasis Area and Severity Index (PASI) score ≥12, and body surface area (BSA) involvement ≥10%.

Subjects were randomized to either ICOTYDE 200 mg orally once daily, deucravacitinib 6 mg orally once daily or placebo. At Week 16, subjects originally randomized to placebo received ICOTYDE 200 mg orally once daily thereafter. At Week 24, subjects originally randomized to deucravacitinib received ICOTYDE 200 mg orally once daily thereafter.

Baseline Characteristics Baseline characteristics were consistent across both trials. In Trial PSO-1 and Trial PSO-2, 68% of subjects were male, 78% of subjects were White, 2% of subjects were Black, and 18% of subjects were Asian; for ethnicity, 16% identified as Hispanic or Latino. The mean age was 46 (range: 18 to 86) years, and the mean baseline weight was 88 kg.

At baseline, subjects had a median affected BSA of 21%, a median PASI score of 18, and 14% had a history of psoriatic arthritis. The proportion of subjects with a baseline IGA score of 4 (severe) was 20%. At baseline, 72% had received prior systemic therapy, 33% of subjects had received prior phototherapy, and 26% had received prior biologic therapy.

Clinical Response Trial PSO-1 and Trial PSO-2 assessed responses at Week 16 for ICOTYDE compared to placebo for two co-primary endpoints: the proportion of subjects who achieved IGA 0/1 response (defined as IGA score of 0 [cleared] or 1 [minimal] with a ≥2-grade improvement from baseline) the proportion of subjects who achieved at least a 90% improvement in PASI scores from baseline (PASI 90). Other evaluated outcomes for ICOTYDE compared to placebo included IGA 0, PASI 75, PASI 100, Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score of 0, and PSSD Itch Score improvement from baseline (≥4-point reduction).

Other comparisons between ICOTYDE and deucravacitinib that were secondary endpoints included: the proportion of subjects who achieved IGA 0/1 score with at least 2-grade improvement from baseline, IGA 0 score, PASI 75, PASI 90, and PASI 100 at Week 16 and Week 24 the proportion of subjects who achieved PSSD Symptom Score of 0 at Week 16. Tables 2 and 3 present the efficacy results in adults with moderate-to-severe plaque psoriasis for Trial PSO-1 and Trial PSO-2. Table 2: Efficacy Results in Adults with Moderate-to-Severe Plaque Psoriasis (Trial PSO-1) Endpoint ICOTYDE (N=311) n (%) Placebo (N=156) n (%) Deucravacitinib (N=307) n (%) Difference, % (95% CI) Difference from Placebo Difference from Deucravacitinib CI = Confidence interval; PASI = Psoriasis Area and Severity Index; IGA = Investigator's Global Assessment; PSSD = Psoriasis Symptoms and Signs Diary IGA 0 or 1 ("cleared" or "minimal") and a ≥2-grade improvement from baseline) Week 16 Co-primary endpoints comparing ICOTYDE to placebo.

213 (68) 17 (11) 154 (50) 58 (50, 64) 18 (11, 26) Week 24 230 (74) - 161 (52) - 22 (14, 29) IGA 0 ("cleared") Week 16 114 (37) 3 (2) 48 (16) 35 (29, 41) 21 (14, 28) Week 24 150 (48) - 63 (21) - 28 (21, 35) PASI 75 Week 16 231 (74) 18 (12) 176 (57) 63 (55, 69) 17 (10, 24) Week 24 254 (82) - 196 (64) - 18 (11, 25) PASI 90 Week 16 171 (55) 6 (4) 91 (30) 51 (44, 57) 25 (18, 33) Week 24 205 (66) - 127 (41) - 25 (17, 32) PASI 100 Week 16 97 (31) 2 (1) 34 (11) 30 (24, 36) 20 (14, 26) Week 24 1… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 160 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 6-month transgenic rasH2 mouse study, no drug-related tumors were observed at oral doses of icotrokinra up to 500 mg/kg/day (76 times the MRHD based on AUC comparison). In a 2-year rat carcinogenicity study, no drug-related tumors were observed at oral doses of 20 mg/kg/day (16 times the MRHD based on AUC comparison). Icotrokinra was not genotoxic in an in vitro bacterial reverse mutation assay (the Ames test), an in vitro human lymphocyte chromosomal aberration assay, or an in vivo rat micronucleus and Comet assays.

In male rats, icotrokinra had no adverse effect on mating, fertility or early embryonic development of their offspring at oral doses up to 20 mg/kg/day (114 times the MRHD based on AUC comparison). In female rats, icotrokinra had no adverse effect on estrous cyclicity, mating, fertility, or early embryonic parameters at oral doses up to 70 mg/kg/day (335 times the MRHD based on AUC comparison).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 157 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 6-month transgenic rasH2 mouse study, no drug-related tumors were observed at oral doses of icotrokinra up to 500 mg/kg/day (76 times the MRHD based on AUC comparison). In a 2-year rat carcinogenicity study, no drug-related tumors were observed at oral doses of 20 mg/kg/day (16 times the MRHD based on AUC comparison). Icotrokinra was not genotoxic in an in vitro bacterial reverse mutation assay (the Ames test), an in vitro human lymphocyte chromosomal aberration assay, or an in vivo rat micronucleus and Comet assays.

In male rats, icotrokinra had no adverse effect on mating, fertility or early embryonic development of their offspring at oral doses up to 20 mg/kg/day (114 times the MRHD based on AUC comparison). In female rats, icotrokinra had no adverse effect on estrous cyclicity, mating, fertility, or early embryonic parameters at oral doses up to 70 mg/kg/day (335 times the MRHD based on AUC comparison).

📄 Package Label / Principal Display Panel 43 words ▾

PRINCIPAL DISPLAY PANEL - 200 mg Tablet Bottle Carton Rx only NDC 57894-201-30 ICOTYDE™ (icotrokinra) tablets 200 mg oral use Attention: Dispense the enclosed Medication Guide to each patient. 30 film-coated tablets Johnson &Johnson PRINCIPAL DISPLAY PANEL - 200 mg Tablet Bottle Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Janssen Biotech, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 30 tablets (57894-0201-30). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Janssen Biotech, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.