FDA-approvedMitochondria-targeted tetrapeptideMitochondrial disease
SS-31 (elamipretide)
SS-31 (elamipretide) is a mitochondria-targeted tetrapeptide; FDA granted accelerated approval to elamipretide (Forzinity) for Barth syndrome in 2025.
What is SS-31?
SS-31 (elamipretide) is a mitochondria-targeted tetrapeptide; FDA granted accelerated approval to elamipretide (Forzinity) for Barth syndrome in 2025. SS-31 (elamipretide) is an FDA-approved prescription medicine (FORZINITY); "research use only" vials sold online are not the approved product.
Key takeaways
- SS-31 (elamipretide) is an FDA-approved prescription medicine (FORZINITY); "research use only" vials sold online are not the approved product.
- PubMed indexes 206 papers on SS-31 (15 tagged as clinical trials) as of October 19, 2026.
- ClinicalTrials.gov lists 21 registered studies using SS-31.
- 24 vendors in our directory listed SS-31 in their public catalog on October 19, 2026.
Structure
Regulatory & access status
SS-31 (elamipretide) is an FDA-approved prescription medicine (FORZINITY); "research use only" vials sold online are not the approved product.
- FORZINITY — STEALTH BIOTHERAPS, application NDA215244 (prescription). Drugs@FDA
Sellers that market unapproved peptides for human use can receive FDA warning letters; our vendor directory links any letter we found on fda.gov.
How much research exists on SS-31 (elamipretide)?
PubMed indexes 206 papers mentioning SS-31 (elamipretide) in the title or abstract, 155 of them from the last five years and 15 tagged as clinical trials (search run October 19, 2026; repeat the search).
Most relevant recent papers
- Elamipretide: A Review of Its Structure, Mechanism of Action, and Therapeutic Potential. — Int J Mol Sci, 2025 · review
- Efficacy and Safety of Elamipretide in Individuals With Primary Mitochondrial Myopathy: The MMPOWER-3 Randomized Clinical Trial. — Neurology, 2023 · clinical trial
- Elamipretide: First Approval. — Drugs, 2026 · review
- Elamipretide (SS-31) improves mitochondrial dysfunction, synaptic and memory impairment induced by lipopolysaccharide in mice. — J Neuroinflammation, 2019
- Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. — Sports Med, 2026 · review
- Genotype-specific effects of elamipretide in patients with primary mitochondrial myopathy: a post hoc analysis of the MMPOWER-3 trial. — Orphanet J Rare Dis, 2024 · clinical trial
Registered clinical studies
ClinicalTrials.gov lists 21 studies with SS-31 (elamipretide) as an intervention (see all). Most recent:
- A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for the Treatment of Fuchs' Corneal Endothelial Dystrophy (FCED) — NCT02653391 · Phase 1/Phase 2 · completed · started 2016-02
- A Trial to Evaluate Safety, Tolerability and Efficacy of Elamipretide in Subjects With Barth Syndrome — NCT03098797 · Phase 2/Phase 3 · completed · started 2017-07-05
- Study of Healthy Aging and Physical Function With Elamipretide — NCT07275424 · Phase 2 · recruiting · started 2025-11-26
- Safety, Tolerability, and Efficacy of MTP-131 for the Treatment of Mitochondrial Myopathy — NCT02367014 · Phase 1/Phase 2 · completed · started 2015-02
- Safety, Tolerability, Efficacy of MTP-131 for Treatment of Mitochondrial Disease in Subjects From the MMPOWER Study — NCT02805790 · Phase 2 · completed · started 2016-08-22
What the evidence does not show
- Paper counts measure research attention, not whether SS-31 works or is safe.
Research suppliers that list SS-31
24 vendors in our directory listed a product matching SS-31 in their public catalog on October 19, 2026. Listed alphabetically; a listing is not an endorsement. Research use only.
- Amino Amigos
- Ascension Peptides
- Atomik Labz
- Backroad Aminos
- Biocollex Research
- BioGenix Peptides
- Dynamic Peptide
- JetPeps
- Liberty Peptides
- Licensed Peptides
- LotusPeptide
- Peptide Crafters
- Peptide Partners
- Peptide.Express
- Pinnacle Peptide Labs
- Plum Labs Research
- Polaris Peptides
- Pure Lab Peptides
- Ramp Peptides
- Royal Peptides
- San Diego Peptides
- Sports Technology Labs
- Swiss Chems
- Voltera Sciences
Prices per mg, where we could verify them, are on our price comparison.
SS-31 reconstitution math
Lab arithmetic only, not dosing guidance: vial-by-vial concentration tables are on SS-31 10 mg vial math.
SS-31 FAQ
Is SS-31 FDA-approved?
SS-31 (elamipretide) is an FDA-approved prescription medicine (FORZINITY); "research use only" vials sold online are not the approved product.
Is SS-31 safe?
Safety data come from the published studies listed on this page; read them in full. Products sold as "research use only" have no FDA review of their purity, sterility or dose.
How much research is there on SS-31?
PubMed indexes 206 papers on SS-31 (15 tagged as clinical trials) as of October 19, 2026.
Who sells SS-31?
Amino Amigos, Ascension Peptides, Atomik Labz, Backroad Aminos, Biocollex Research, BioGenix Peptides and 18 more listed it on their public catalogs when we checked; a listing is not an endorsement.
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