Active ingredient
Mitapivat
5 finished FDA listings contain Mitapivat as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- MITAPIVAT, MITAPIVAT SULFATE
- Dosage forms
- Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 1
- Strengths listed
- 100 mg/1 · 20 mg/1 · 5 mg/1 · 50 mg/1
- Brand names in FDA listings
- Aqvesme, Pyrukynd
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2594468
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 216196 | AGIOS PHARMS INC | 2022-02-17 | 5 |
Official labeling on DailyMed
- AQVESME (MITAPIVAT) TABLET, FILM COATED [AGIOS PHARMACEUTICALS, INC.] · version 6 · 2026-08-31
- PYRUKYND (MITAPIVAT) TABLET, FILM COATED PYRUKYND (MITAPIVAT) KIT [AGIOS PHARMACEUTICALS, INC.] · version 12 · 2026-07-06
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.