Elamipretide
As of the edition of 20 October 2026, Elamipretide is a protein: marketed, first approved in 2025 (US); US protection ends in 2032.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Protein
- Brand name
- Forzinity
- First approved
- 19 September 2025 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Stealth BioTherapeutics
- Registered trials
- 25, 3 stopped early
- Disease areas
- Heart and blood vessels; Nutrition and metabolism; Eye; Nervous system; Inherited and neonatal; Bones, joints and muscles
US protection
US protection ends in 2032.
The last listed US exclusivity ends in 2032. The application that gives this date is held by Stealth BioTherapeutics.
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 product3 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 3 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 0 | 0 |
| Phase 1 | 9 | 8 | 0 | 1 |
| Phase 2 | 12 | 10 | 0 | 2 |
| Phase 3 | 3 | 2 | 1 | 0 |
| All trials | 25 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Stealth BioTherapeutics | Originator and Lead sponsor of trials | 2022 to now |