Mitapivat and Omaveloxolone: Interaction Details
AI-assisted, pharmacist-reviewed · Source data updated Aug 8, 2026 · Sources: FDA labeling, DDInter 2.0, cited literature
Omaveloxolone
Mitapivat
How we grade severity & evidence
Severity levels
- Contraindicated: These should generally not be used together.
- Major: Potentially serious — often needs a change or close monitoring.
- Moderate: Can be significant — usually manageable with monitoring.
- Minor: Usually limited clinical impact.
Evidence grades
- Established: Well documented — supported by controlled studies or strong clinical data.
- Probable: Good supporting evidence, though not definitively proven.
- Suspected: Some evidence suggests this interaction, but it is not well established.
- Possible: Limited or conflicting evidence; the interaction may occur.
- Theoretical: Predicted from the drugs' pharmacology; not yet confirmed in people.
Ratings come from the documented interaction literature and are reviewed by a pharmacist. They describe the documented risk of the combination, not what will necessarily happen to you — your dose, timing, and health picture all matter.
What happens
Reduced omaveloxolone exposure, reduced efficacy of omaveloxolone, reduced CYP3A4 substrate exposure and reduced efficacy of CYP3A4 substrate
Interaction Deep Dive
Avoid concomitant use of omaveloxolone with drugs that are strong or moderate CYP3A4 inducers and CYP3A4 substrates. Concomitant use may significantly decreases the exposure of both the drugs, which may reduce the effectiveness of both the drugs. If used concomitantly, monitor for lack of efficacy of concomitant treatment1.
Why it happens (mechanism)
Induction of CYP3A-mediated metabolism of omaveloxolone; induction of CYP3A4 substrate metabolism by omaveloxolone
Literature reports
2 reports — tap to read
a) In a drug interaction study, omaveloxolone when coadministered with midazolam decreased the AUC of midazolam (CYP3A4 substrate) by approximately 45% 1.
b) In a drug interaction study, after single dose administration, omaveloxolone Cmax and AUC decreased 38% and 48%, respectively, following concomitant use with efavirenz (moderate CYP3A4 inducer) 1.
Common questions
Can I take Mitapivat and Omaveloxolone together?
Reduced omaveloxolone exposure, reduced efficacy of omaveloxolone, reduced CYP3A4 substrate exposure and reduced efficacy of CYP3A4 substrate Always confirm with your pharmacist or prescriber before making any change.
How serious is the Mitapivat and Omaveloxolone interaction?
It is rated major. Potentially serious — often needs a change or close monitoring.
How quickly could this interaction happen?
The documented onset is "unspecified". The timing of this interaction is not well characterized.
How strong is the evidence for this interaction?
The evidence is graded "theoretical". Predicted from the drugs' pharmacology; not yet confirmed in people.
Questions for your pharmacist
- Does my dose of Mitapivat or Omaveloxolone need adjusting while I take them together?
- What symptoms should prompt me to call you or my prescriber right away?
- Does the timing of my doses matter for this combination?
- Is there a safer alternative to one of these medications for me?
References (1)
- Product Information: Skyclarys® oral capsules, omaveloxolone oral capsules. Biogen U.S. Corporation, Cambridge, MA, 2026. DailyMed
Keep reading about Omaveloxolone
Keep reading about Mitapivat
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Prescription drugs aren't the whole picture — herbal and dietary supplements can interact with them too. From the evidence-graded Natural Medicines database:
major · moderate · minor — check everything you take with our drug–supplement interaction checker.
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