Prescription medicine
Mitapivat Brand names: Pyrukynd, Aqvesme
Mitapivat (Aqvesme) is a prescription medicine with an FDA approval on record since 2022. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the mitapivat FDA label on DailyMed (effective June 30, 2026, Agios Pharmaceuticals, Inc.); the NDA 216196 record on Drugs@FDA; every mitapivat label on DailyMed.
Highlights of the record
FDA label of June 30, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usagePYRUKYND is indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency.
Forms and strengths
- 5 mg
- 20 mg
- 50 mg
- 100 mg
Film-coated tablet; kit.
On the market
- Earliest approval on file
- February 17, 2022 Pyrukynd, Agios Pharms Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- July 31, 2041 Pyrukynd tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,017 through July 30, 2026
What is mitapivat used for?
From the label: indications and usagePYRUKYND is indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency. PYRUKYND is a pyruvate kinase activator indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency.
Conditions named in the indications of mitapivat's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Pyruvate Kinase Activator.
Source: FDA drug label (PYRUKYND), Agios Pharmaceuticals, Inc., effective June 30, 2026 (SPL set 4ccee896-e313-4c6c-9674-b4746ada0a90), via openFDA; the full label on DailyMed
Is there a generic for mitapivat (Aqvesme)?
No generic mitapivat is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 9 patents for Pyrukynd tablets: the compound patent runs to November 21, 2038, and the last listed entry to July 31, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2022 earliest approval on file
- 2041 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for mitapivat?
The FDA Adverse Event Reporting System holds 1,017 reports that list mitapivat among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6 are coded as a death and 90 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as mitapivat?
6 other medicines are given the same way (oral) and in the same FDA class as mitapivat or labeled mainly for the same use (anemia), the same class first. Anemia lists all 25 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Eltrombopag | Anemia | 13 labelers | $25.85 per tablet 50 mg tablet | No current entry |
| Prednisolone | Anemia | 23 labelers | $0.568 per mL 15 mg/5 mL solution | No current entry |
| Daprodustat | Anemia | none listed | n/a | No current entry |
| Vadadustat | Anemia | none listed | n/a | No current entry |
| Tetraferric tricitrate decahydrate | Anemia | none listed | $6.28 per tablet 210 mg tablet | No current entry |
| Ferric citrate | Anemia | 1 labeler | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Mitapivat side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other