Mitapivat
As of the edition of 20 October 2026, Mitapivat is a small molecule: marketed, first approved in 2022 (US); acts on PKLR; US protection ends in 2038.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Small molecule
- Brand name
- Pyrukynd
- First approved
- 17 February 2022 (US)
- Approvals on record
- 5 in 2 regions
- Holder of the most recent approval
- Agios Pharmaceuticals; 2 holders in all
- Registered trials
- 29, 1 stopped early
- Disease areas
- Blood and lymph; Inherited and neonatal; Nutrition and metabolism; Pregnancy and women's health; Urinary and reproductive
US protection
US protection ends in 2038.
The last listed US drug-substance patent ends in 2038. The application that gives this date is held by Agios Pharmaceuticals.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product17 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Mitapivat.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| PKLR | Pyruvate kinase PKLR | P30613 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 11 | 11 | 0 | 0 |
| Phase 2 | 6 | 1 | 4 | 1 |
| Phase 3 | 11 | 3 | 8 | 0 |
| Phase 4 | 1 | 0 | 1 | 0 |
| All trials | 29 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Agios Pharmaceuticals | Originator, Applicant and Lead sponsor of trials | 2014 to now |