NDASUBCUTANEOUSSOLUTIONPriority Review
Approved
Sep 2025
Lifecycle
Launch
Competitive Pressure
0/100
Data completeness
4/8 — Partial
Priority Review
FORZINITY (elamipretide hydrochloride) by Stealth BioTherapeutics is 12. Approved for muscle strength in adult. First approved in 2025.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FORZINITY (elamipretide hydrochloride) is a small-molecule mitochondrial cardiolipin binder administered via subcutaneous injection that improves mitochondrial morphology and function. It is indicated to improve muscle strength in adults with mitochondrial myopathy. The drug localizes to the inner mitochondrial membrane, targeting the underlying cellular dysfunction in muscle disorders.
Growth7.8 years to LOE
Early-stage launch with no direct competitors creates significant opportunity for commercial team expansion and market development leadership.
Mechanism of Action
12.1 Mechanism of Action FORZINITY is a mitochondrial cardiolipin binder that localizes to the inner mitochondrial membrane and improves mitochondrial morphology and function. 12.2 Pharmacodynamics Effects on QTc Interval Cardiac electrophysiology Clinically significant QTc interval prolongation…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.