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Nirogacestat

Nirogacestat is a gamma secretase inhibitor taken by mouth to treat adults with desmoid tumors that are growing and need systemic (whole-body) treatment.

Brand name Ogsiveo
Drug class Gamma Secretase Inhibitor
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Aug 13, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 6, 2026
Nirogacestat at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Nirogacestat (Ogsiveo) is a specialist medicine, on the U.S. market since about 2023 and the first approved for this use, for adults whose desmoid tumors (noncancerous but locally aggressive soft-tissue growths) keep growing and need whole-body treatment; it blocks the enzyme gamma secretase, which switches off Notch signaling that can drive tumor growth. Side effects are common, mainly diarrhea, which most people get, plus missed periods or menopause-like symptoms from its effect on the ovaries. Call your prescriber promptly if diarrhea turns severe or will not settle with anti-diarrheal medicine. Expect regular blood tests for liver enzymes, phosphate and potassium, plus skin checks for new skin cancers.

Clinical pearls

  • Skip stomach acid reducers such as omeprazole or famotidine; if needed, use an antacid taken 2 hours apart from Ogsiveo.
  • Avoid grapefruit, Seville oranges and starfruit, and have every new prescription checked, since many drugs shift nirogacestat levels.
  • Hormonal birth control may work less well; add a barrier method and continue contraception until 1 week after the last dose.
  • It can cause pregnancy loss, so men with partners who could conceive need contraception until 1 week after the last dose.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asTablet
Earliest FDA record2023
Companies listing it with the FDA1
FDA label last updatedSep 1, 2026
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Nirogacestat, written from its FDA label.

What Nirogacestat is used for

▾

Nirogacestat is used for one condition:

  • Adults with progressing desmoid tumors who require systemic treatment (Ogsiveo tablets).

How Nirogacestat works

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Nirogacestat is a gamma secretase inhibitor. It blocks the step that activates the Notch receptor, a signaling protein on cells. When Notch is out of balance, it can promote tumor growth, so blocking it helps target desmoid tumors.

Nirogacestat dosage

▾

Ogsiveo tablets are taken by mouth twice a day. You can take them with or without food.

  • Swallow tablets whole. Do not break, crush or chew.
  • If you vomit or miss a dose, take the next dose at its usual time.
  • Your prescriber may lower the dose or pause treatment if side effects are significant.

Follow your prescriber's directions and the label.

Dosing details from the FDA-approved label

From the Nirogacestat prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Recommended dosage (until disease progression or unacceptable toxicity)
    • 150 mg administered orally twice daily until disease progression or unacceptable toxicity
    • May be taken with or without food. Swallow tablets whole; do not break, crush, or chew. If a dose is vomited or missed, take the next dose at its scheduled time.
  • Dosage modification: diarrhea persisting for ≥ 3 days despite maximal medical therapy (Grades 3 or 4)
    • Withhold until resolved to Grade ≤ 1 or baseline, then restart at a dosage of 100 mg twice daily
  • Dosage modification: increased ALT or AST, Grade 2 (≥ 3 to 5 × ULN)
    • Withhold until ALT, AST, or both are resolved to < 3 × ULN or baseline, then restart at a dosage of 100 mg twice daily
  • Dosage modification: increased ALT or AST, Grades 3 or 4 (> 5 × ULN)
    • Permanently discontinue
  • Dosage modification: hypophosphatemia persisting for ≥ 3 days despite maximal replacement therapy (Grades 3 or 4)
    • Withhold until resolved to Grade ≤ 1 or baseline, then restart at a dosage of 100 mg twice daily
  • Dosage modification: hypokalemia despite maximal replacement therapy (Grades 3 or 4)
    • Withhold until resolved to Grade ≤ 1 or baseline, then restart at a dosage of 100 mg twice daily
  • Dosage modification: anaphylaxis or other severe hypersensitivity reaction (Grades 3 or 4)
    • Permanently discontinue
  • Other severe, life-threatening, or persistent intolerable Grade 2 adverse reactions
    • Withhold drug until resolved to Grade ≤ 1 or baseline
    • Only restart at a dosage of 100 mg twice daily after considering potential benefit and likelihood of recurrence
    • Permanently discontinue for recurrence of severe or life-threatening adverse reaction upon rechallenge at the reduced dose.
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION The recommended dosage is 150 mg orally twice daily until disease progression or unacceptable toxicity. ( 2.1 ) See Full Prescribing Information for dosage modifications due to adverse reactions. ( 2.2 ) 2.1 Recommended Dosage The recommended dosage of OGSIVEO is 150 mg administered orally twice daily until disease progression or unacceptable toxicity. OGSIVEO may be taken with or without food. Instruct patients to swallow OGSIVEO tablets whole and not to break, crush, or chew prior to swallowing. If a patient vomits or misses a dose, instruct the patient to take the next dose at its scheduled time. 2.2 Dos ag e Modifications for Adverse Reactions The recommended dose modifications for OGSIVEO for selected severe adverse reactions are summarized in Table 1 [ see Warnings and Precautions ( 5 ) , Adverse Reactions ( 6 ) ]. For other severe adverse reactions, life-threatening adverse reactions, or persistent intolerable Grade 2 adverse reactions, withhold drug until resolved to Grade ≤ 1 or baseline. Only restart at a dosage of 100 mg twice daily after considering the potential benefit and likelihood of recurrence of the adverse reaction. Permanently discontinue OGSIVEO for recurrence of severe or life-threatening adverse reaction upon rechallenge at the reduced dose. Table 1. Recommended Dose Modifications for Adverse Reactions Adverse Reaction Severity OGSIVEO Dosage Modifications Diarrhea persisting for ≥ 3 days despite maximal medical therapy [ see Warnings and Precautions ( 5.1 ) ] Grades 3 or 4 Withhold OGSIVEO until resolved to Grade ≤ 1 or baseline, then restart at a dosage of 100 mg twice daily. Increased ALT or AST [see Warnings and Precautions ( 5.3 ) ] Grade 2 (≥ 3 to 5 × ULN) Withhold OGSIVEO until ALT, AST, or both are resolved to < 3 × ULN or baseline, then restart at a dosage of 100 mg twice daily. Grades 3 or 4 (> 5 × ULN) Permanently discontinue. Hypophosphatemia persisting for ≥ 3 days despite maximal replacement therapy [see Warnings and Precautions ( 5.5 ) ] Grades 3 or 4 Withhold OGSIVEO until resolved to Grade ≤ 1 or baseline, then restart at a dosage of 100 mg twice daily. Hypokalemia despite maximal replacement therapy [see Warnings and Precautions ( 5.5 ) ] Grades 3 or 4 Withhold OGSIVEO until resolved to Grade ≤ 1 or baseline, then restart at a dosage of 100 mg twice daily.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Nirogacestat side effects

▾

Many people have side effects. The most common ones include:

Common side effects

  • Diarrhea
  • Ovarian toxicity (such as missed periods or early menopause)
  • Rash
  • Nausea
  • Fatigue
  • Mouth sores (stomatitis)
  • Headache
  • Stomach pain
  • Cough
  • Hair loss
  • Upper respiratory infection
  • Shortness of breath

When to get medical help

  • Call your doctor if diarrhea is severe or does not improve with anti-diarrheal medicine.
  • Tell your doctor about missed or irregular periods, hot flashes, night sweats or vaginal dryness.
  • Report signs of liver problems. Your doctor will check liver blood tests (AST and ALT) regularly.
  • Tell your doctor about new skin growths or changes. Skin cancers can occur.
  • Get help right away for signs of a severe allergic reaction.
  • Your doctor will monitor phosphate and potassium levels, which can drop.
  • Tell your doctor right away if you become pregnant.

Contact your doctor about severe diarrhea, menstrual changes, liver problems, skin changes or allergic reactions. Common lab changes include low phosphate, low potassium, and higher liver enzymes, urine glucose and urine protein.

Nirogacestat warnings and precautions

▾
  • Diarrhea: It can be severe. Anti-diarrheal medicine is used, and the dose may be changed.
  • Ovarian toxicity: Fertility and female reproductive function may be impaired. Watch for changes in periods and symptoms like hot flashes, night sweats and vaginal dryness.
  • Liver: AST and ALT can rise. Liver tests are done regularly.
  • Skin cancer: Non-melanoma skin cancers can occur. Skin exams are done before and during treatment.
  • Electrolytes: Phosphate and potassium can drop and are monitored.
  • Allergic reactions: Treatment may be paused or stopped permanently depending on severity.
  • Pregnancy: It can harm a fetus.

Nirogacestat interactions

▾

Several medicines and foods can change nirogacestat levels.

  • Strong or moderate CYP3A inhibitors, including grapefruit, Seville oranges and starfruit: raise levels and side effects.
  • Strong or moderate CYP3A inducers: lower levels and may reduce effectiveness.
  • Proton pump inhibitors and H2 blockers: may lower absorption. If needed, space Ogsiveo 2 hours from antacids.
  • Certain CYP3A substrates: nirogacestat can raise their levels.
  • Certain CYP2C19 substrates: nirogacestat can lower their levels and effect.

Interactions listed in the FDA-approved label

From the Nirogacestat prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Strong or moderate CYP3A inhibitors (including grapefruit products, Seville oranges, and starfruit): Nirogacestat is a CYP3A substrate; these inhibitors increase nirogacestat exposure, which may increase the risk of adverse reactions. Avoid concomitant use.
  • Strong or moderate CYP3A inducers: Nirogacestat is a CYP3A substrate; these inducers decrease serum nirogacestat exposure, which may reduce effectiveness. Avoid concomitant use.
  • Gastric acid reducing agents (proton pump inhibitors, H2 blockers): Nirogacestat is poorly soluble at pH ≥ 6; these agents may decrease serum nirogacestat exposure, which may reduce effectiveness. Avoid concomitant use with proton pump inhibitors and H2 blockers. If unavoidable, stagger OGSIVEO with antacids (e.g., administer 2 hours before or 2 hours after antacid use).
  • Certain CYP3A substrates: Nirogacestat increases exposure of CYP3A substrates, which may increase the risk of adverse reactions related to these substrates. Avoid concomitant use with CYP3A substrates where minimal concentration changes may lead to serious adverse reactions.
  • Certain CYP2C19 substrates: Nirogacestat decreases exposure of CYP2C19 substrates, which may decrease efficacy of these substrates. Avoid concomitant use where decreased concentrations of CYP2C19 substrates may lead to significant decreases in efficacy, unless otherwise recommended in the Prescribing Information for the CYP2C19 substrate.
Read the label’s full interactions text

7 DRUG INTERACTIONS Strong or moderate CYP3A inhibitors : Avoid concomitant use. ( 7.1 ) Strong or moderate CYP3A inducers : Avoid concomitant use. ( 7.1 ) Gastric acid reducing agents : Avoid concomitant use with proton pump inhibitors and H2-receptor antagonists. If concomitant use cannot be avoided, OGSIVEO administration can be staggered with antacids. ( 7.1 ) 7.1 Effect s of Other Drugs on OGSIVEO Table 4. Effects of Other Drugs on OGSIVEO Strong or Moderate CYP3A Inhibitors Prevention or Management Avoid concomitant use of OGSIVEO with strong or moderate CYP3A inhibitors including grapefruit products, Seville oranges, and starfruit. Clinical Effect Nirogacestat is a CYP3A substrate. Strong or moderate CYP3A inhibitors increase nirogacestat exposure [see Clinical Pharmacology ( 12.3 ) ], which may increase the risk of OGSIVEO adverse reactions . Strong or Moderate CYP3A Inducers Prevention or Management Avoid concomitant use of OGSIVEO with strong or moderate CYP3A inducers. Clinical Effect Nirogacestat is a CYP3A substrate. Strong or moderate CYP3A inducers decrease serum nirogacestat exposure [ see Clinical Pharmacology ( 12.3 ) ], which may reduce the effectiveness of OGSIVEO. Gastric Acid Reducing Agents Prevention or Management Avoid concomitant use with proton pump inhibitors and H2 blockers . If concomitant use cannot be avoided, OGSIVEO can be staggered with antacids (e.g., administer OGSIVEO 2 hours before or 2 hours after antacid use). Clinical Effect Nirogacestat is poorly soluble at pH ≥ 6. Gastric acid reducing agents may decrease serum nirogacestat exposure [ see Clinical Pharmacology ( 12.3 ) ], which may reduce the effectiveness of OGSIVEO. 7.2 Effects of OGSIVEO on Other Drugs Table 5. Effects of OGSIVEO on Other Drugs Certain CYP3ASubstrates Prevention or Management Avoid concomitant use with CYP3A substrates where minimal concentration changes may lead to serious adverse reactions .

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿168 supplements and herbs with documented Nirogacestat interactions, ranked by severity Check Nirogacestat against a supplement or herb →

Before taking Nirogacestat

▾
  • No contraindications are listed.
  • Pregnancy: can cause fetal harm. A pregnancy test is advised before starting.
  • Use effective contraception during treatment and for 1 week after. Add a barrier method if you use hormonal birth control.
  • Males with female partners who can become pregnant should also use contraception.
  • Do not breastfeed during treatment and for 1 week after the last dose.
  • Fertility may be affected in females and males.
  • Children: safety and effectiveness are not established, and growth plate changes have been reported.
  • Adults 65 and older: too few were studied to know if they respond differently.

Nirogacestat overdose

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The label notes that Ogsiveo is highly bound to proteins in the blood. Because of this, it is not expected to be removed by dialysis. If you take too much, seek medical help right away.

What Nirogacestat does in the body

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Higher nirogacestat exposure is linked to a greater risk of severe low phosphate. At the recommended dosage, no meaningful average increase in the QTc interval (a heart rhythm measurement) of more than 20 ms was seen.

How your body processes Nirogacestat

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Peak levels occur about 1.5 hours after a dose. Absolute bioavailability is about 19%, and food did not meaningfully change absorption. Steady state is reached in about 6 days.

The body clears it mainly through the liver enzyme CYP3A4, with smaller roles for CYP2C9, 2C19 and 2D6. The half-life is about 23 hours. Elimination is about 38% in feces and 17% in urine.

How to store Nirogacestat

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Store at 20°C to 25°C (68°F to 77°F).

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

168

Supplements & herbs that interact with Nirogacestat

168 supplements and herbal products have documented interactions with Nirogacestat in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 6
  • Moderate · 124
  • Minor · 38
ACTIVATED CHARCOAL Major BEER Major GRAPEFRUIT Major SIBERIAN COCKLEBUR Major ST. JOHN'S WORT Major WINE Major ACACIA RIGIDULA Moderate ADRAFINIL Moderate +160 more
Every supplement checked against Nirogacestat — ranked by severity The full interaction hub: 6 major · 124 moderate · 38 minor · every one linked to its full report. Check Nirogacestat against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Nirogacestat: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Nirogacestat — the kind of thing our pharmacy team would talk through with you at the counter.

What is this medicine for?

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Nirogacestat, sold as Ogsiveo, treats adults whose desmoid tumors are growing and need whole-body treatment. It works by blocking a signaling pathway called Notch that can drive tumor growth.

How do I take it?

▾
You take the tablet by mouth twice a day, with or without food. Swallow it whole and do not crush, chew or break it. If you miss a dose or vomit, skip it and take your next dose at the normal time.

What side effects should I expect?

▾
Diarrhea is the most common, so ask your doctor about anti-diarrheal medicine. Rash, nausea, fatigue, mouth sores, headache and stomach pain are also common. Call your doctor if diarrhea is severe or lingers.

Can this affect my periods or fertility?

▾
Yes. It can cause ovarian toxicity, such as missed periods or early menopause, and may impair fertility in females and males. Tell your doctor about period changes, hot flashes or night sweats.

Is it safe in pregnancy or while breastfeeding?

▾
No. It can harm a developing baby. Use effective contraception during treatment and for 1 week after your last dose, and add a barrier method if you use hormonal birth control. Do not breastfeed during that time either.

Are there foods or medicines I should avoid?

▾
Avoid grapefruit, Seville oranges and starfruit, since they raise drug levels. Acid reducers like proton pump inhibitors and H2 blockers can lower absorption. Check all your medicines with me before starting.

Is Nirogacestat available over the counter?

▾
No. Nirogacestat is a prescription medicine: every Nirogacestat product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Nirogacestat first available?

▾
The earliest FDA record we hold for Nirogacestat is from 2023: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Nirogacestat was first used.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Nirogacestat on HelloPharmacist

📊Nirogacestat supplement interactions168 checked — ranked by severity 🌿Drug & Supplement CheckerNirogacestat vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Nirogacestat NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Nirogacestat Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Nirogacestat forms and strengths (how it comes)

Nirogacestat is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Nirogacestat inactive ingredients by manufacturer.

Tablet

By mouth
Brands Ogsiveo
How this form is used
What it may be used for
  • Ogsiveo is used for adults with progressing desmoid tumors who require systemic treatment.
Important instructions
  • Ogsiveo is taken by mouth twice daily, with or without food.
  • Swallow Ogsiveo tablets whole. Do not break, crush or chew them.
  • If you vomit or miss a dose of Ogsiveo, take the next dose at its scheduled time.
Available strengths 2 strengths
100 mg 150 mg
8 FDA-listed product records ⓘ

Nirogacestat on the U.S. market: products, makers and brands

How Nirogacestat appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1 company lists 2 Nirogacestat product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2023. Brand names on the directory include Ogsiveo; the rest are generics.

1
Dose forms ⓘ
1
Labelers (makers, repackagers, distributors)
1
Brand names
2
FDA-listed product records ⓘ
2023
Earliest FDA record ⓘ

How widely Nirogacestat is used (Medicaid data)

A general measure of how commonly Nirogacestat is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Nirogacestat is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

611
Medicaid prescriptions filled (Q1–Q4 2025)
$17M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Nirogacestat prescribed? Of the 1,601 medications we measure, Nirogacestat ranks #1,344 by Medicaid prescriptions — more than 16% of them.

Where Nirogacestat ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,344 of 1,601
#1,339 Emtricitabine 625 Rx #1,340 Ertugliflozin / Sitagl... 620 Rx #1,341 Ropeginterferon alfa-2... 618 Rx #1,342 Flurandrenolide Topica... 615 Rx #1,343 Trabectedin Injection 614 Rx #1,344 Interferon Beta-1b Inj... 611 Rx #1,345 Nirogacestat 611 Rx #1,346 Corticotropin, Reposit... 609 Rx #1,347 Estrogen and Bazedoxif... 608 Rx #1,348 Molnupiravir 597 Rx #1,349 Amikacin Oral Inhalati... 597 Rx

Utilization by Nirogacestat product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

Other Nirogacestat products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

611 Medicaid prescriptions (Q1–Q4 2025) 100% of Nirogacestat prescriptions shown $17M gross reimbursement (before rebates) ≈ $27,876 per prescription (gross)

Summed across the 2 of 3 listed NDC products with Medicaid activity.

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Nirogacestat, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 3 listed Nirogacestat NDCs with Medicaid activity.

Compare Nirogacestat products

A representative set of FDA-listed product records for Nirogacestat — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Tablet
100 mg Oral SpringWorks Therapeutics, Inc. NDA View NDC →
150 mg Oral SpringWorks Therapeutics, Inc. NDA View NDC →

Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Nirogacestat NDCs →

Nirogacestat side effects reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Nirogacestat — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Nirogacestat are diarrhoea, nausea, fatigue; about 29% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

838
Reports mentioning it
29%
Reported as serious
12
Distinct effects shown
Most reported effects
Diarrhoea
305
Nausea
193
Fatigue
163
Rash
109
Headache
87
Vomiting
75
Stomatitis
59
Cough
47
Pruritus
44
Alopecia
42
Age groups
Adult · 56Elderly · 8Child · 3Adolescent · 2

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Nirogacestat in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Nirogacestat FDA approval history

How Nirogacestat went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Nirogacestat was first approved by the FDA in 2023 (Brand: OGSIVEO · Springworks). It remains available in U.S. pharmacies today.

2023
Brand approved
Brand: OGSIVEO · Springworks
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Nirogacestat recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Nirogacestat recalls since July 2021.

✅No Nirogacestat recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Nirogacestat RxCUI 2670631 1 dose form · 3 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 2670636 In current FDA listings
    Clinical drug / strength (SCD) 50 MG RxCUI 2670637 100 MG RxCUI 2680360 150 MG RxCUI 2680366

Look up RxCUI 2670631 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Nirogacestat brand names

Nirogacestat is sold under one brand name in the FDA directory — Ogsiveo. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Ogsiveo

Who makes Nirogacestat: manufacturers and labelers

One company lists Nirogacestat products with the FDA. By number of product records, the largest are SpringWorks Therapeutics, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

SpringWorks Therapeutics, Inc. 2

Nirogacestat drug class (RxNorm)

Nirogacestat belongs to the Gamma Secretase Inhibitor class.

Pharmacologic class Gamma Secretase Inhibitor
Drug family (ATC) Other antineoplastic agents
How it works Cytochrome P450 2C19 Inducers, Cytochrome P450 3A Inhibitors, Gamma Secretase Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Nirogacestat page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Sep 1, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Nirogacestat.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Nirogacestat after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
Finished products in the current FDA directory
2
Companies listing them (makers, repackagers, distributors)
1
FDA labeler codes behind them ⓘ
1
Linked representative label ⓘ
SpringWorks Therapeutics, Inc.
Linked label effective
Sep 1, 2026
Composite sections available
21
Linked SPL Set ID
f172e6ff-3190-41b0-b95a-58a7ef9e9e1e
Linked SPL Document ID
a20856d6-9ddc-4e6a-bd63-d19cdcec6a41
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. SpringWorks Therapeutics, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →