Last reviewed · How we verify
Forzinity (ELAMIPRETIDE)
Forzinity works by binding to a specific site on mitochondria to improve their function.
At a glance
| Generic name | ELAMIPRETIDE |
|---|---|
| Sponsor | Stealth Biotheraps |
| Modality | Recombinant protein |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
| First approval | 2025 |
Mechanism of action
FORZINITY is a mitochondrial cardiolipin binder that localizes to the inner mitochondrial membrane and improves mitochondrial morphology and function.
Approved indications
- Barth syndrome
- Barth syndrome
Common side effects
- Any local administration reaction
- Injection site erythema
- Injection site induration
- Injection site pruritus
- Injection site pain
- Injection site bruising
- Injection site urticaria
- Injection site hemorrhage
Key clinical trials
- FRDA Investigator Initiated Study (IIS) With Elamipretide (PHASE1,PHASE2)
- Study of Healthy Aging and Physical Function With Elamipretide (PHASE2)
- ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD) (PHASE3)
- Study to Evaluate Efficacy and Safety of Elamipretide in Subjects With Primary Mitochondrial Disease From Nuclear DNA Mutations (nPMD) (PHASE3)
- An Intermediate Size Expanded Access Protocol of Elamipretide
- ReCLAIM-2 Study to Evaluate Safety,Efficacy & Pharmacokinetics of Elamipretide in Subjects With AMD With Non-central GA (PHASE2)
- A Trial to Evaluate Safety, Tolerability and Efficacy of Elamipretide in Subjects With Barth Syndrome (PHASE2,PHASE3)
- A Trial to Evaluate Safety and Efficacy of Elamipretide Primary Mitochondrial Myopathy Followed by Open-Label Extension (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Forzinity CI brief — competitive landscape report
- Forzinity updates RSS · CI watch RSS
- Stealth Biotheraps portfolio CI