Molecule
Elamipretide
- Presentations
- 1
- Brands
- 1
- Manufacturers
- 1
- Available from stock
- 0
Elamipretide is a medicine. MedsAcross lists 1 presentations of it from 1 manufacturers, with brand names, strengths, packs and regulatory status for each. It is available for export supply from India to licensed hospitals, importers and physicians, with the documents the destination country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Key facts
- US FDA first approval
- 19 September 2025
- EU status
- Not recorded
- Orphan designation
- Yes
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Subcutaneous
- Dosage forms
- Injection
- Identifiers
- UNII 87GWG91S09CAS 736992-21-5DrugBank DB11981Q27269822
All presentations
1 presentations of Elamipretide, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Forzinity 280 mg/3.5 mL injectionSubcutaneous | Stealth Biotherapeutics | US FDA | Available on request |
Brands by market
1 brand names across 1 markets.
United States
Manufacturers
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 19 September 2025 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Questions and answers
Is Elamipretide available for export from India?
Yes, on request. MedsAcross lists 1 presentations of Elamipretide and sources them for licensed hospitals, importers and physicians against valid import documents.
What brand names does Elamipretide have?
The catalogue lists 1 brand names for Elamipretide, including Forzinity.
Is Elamipretide approved by the US FDA?
Yes. The US FDA first approved Elamipretide on 19 September 2025, according to Drugs@FDA.
Does Elamipretide need cold chain shipping?
No listed presentation of Elamipretide is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Request Elamipretide for export supply
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.