At a glance
- Elamipretide (SS-31) is an FDA-approved drug, marketed as Forzinity (first approval: September 19, 2025).
- PubMed lists 473 publications mentioning it, including 19 randomized controlled trials and 170 animal-only studies.
- ClinicalTrials.gov lists 30 registered studies testing it (3 active).
- FDA’s adverse event system (FAERS) has no reports mentioning it.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
| Application | Product | Status | First approval | Sponsor |
|---|---|---|---|---|
| NDA215244 | FORZINITY | Approved, marketed | September 19, 2025 | STEALTH BIOTHERAPS |
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Report from the 2026 Barth Syndrome Foundation International Scientific, Medical & Family Conference: Advances in Barth Syndrome Research, Therapy Development, and Clinical Care.
- Mitochondria-targeted peptide elamipretide alleviates cisplatin-induced ovarian failure by activating the nuclear factor erythroid 2-related factor 2/heme oxygenase-1 pathway.
- Mitochondrial Quality Control in Degenerative Musculoskeletal Diseases: Signaling Networks and Therapeutic Landscapes.
- Elamipretide Rejuvenates Oocyte Quality and Restores Female Fertility During Reproductive Aging.
- Mitochondrial Quality Control in Inherited Mitochondrial Cardiomyopathy: Convergent Pathobiology and a Testable Therapeutic Framework.
- The Oxidative-Mitochondrial-Inflammatory Axis in Retinitis Pigmentosa: Extracellular mtDNA as Biomarker and Therapeutic Read-Out.
- Engineered Mitochondria-Targeted Biomimetic Hybrid Nanovesicles Ameliorate Rheumatoid Arthritis via Regulating Macrophage Autophagy and cGAS-STING Signaling.
- Targeting Mitochondria in MASLD: Comparative Evaluation of MitoQ and SS-31 (Elamipretide) in Aged Female Mice under Nutritional Stress.
- Reactive oxygen species and antioxidant strategies in human sperm cryodamage.
- Oral Colon- and Mitochondria-Targeted Nanoparticles Alleviate Ulcerative Colitis by Reeducating Macrophage Polarization via SIRT3/FOXO3a-Mediated Mitochondrial Restoration.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 30
- Active
- 3
- With posted results
- 14
Conditions studied
Show 20 more studies
All 30 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
No FAERS reports mention this peptide.
FDA prescribing information
Official US prescribing information. Dosing sections are intentionally not shown.
Source: DailyMed / openFDA
Change history
No changes since monitoring began on October 30, 2026.