Quick answers
- What is Mitapivat used for?
- The FDA-approved label (Pyrukynd, Agios Pharmaceuticals, Inc., June 30, 2026) says: “PYRUKYND 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.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Mitapivat have a boxed warning?
- The label we quote has no boxed warning, but 1 of 2 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Mitapivat?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Mitapivat been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Mitapivat?
- 1 company lists prescription products of Mitapivat in the FDA NDC Directory, including Agios Pharmaceuticals, Inc..
What Mitapivat is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
PYRUKYND 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.
— FDA label: Pyrukynd, Agios Pharmaceuticals, Inc., effective June 30, 2026. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
1 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Agios Pharmaceuticals, Inc.5 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA216196 AQVESME, PYRUKYND | Agios Pharms Inc | February 17, 2022 | 4, latest September 28, 2026 2026: Manufacturing (CMC) · 2026: Manufacturing (CMC) · 2025: Efficacy |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Pyrukynd, Agios Pharmaceuticals, Inc., effective June 30, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →