SS-31
Also known as: Elamipretide, Bendavia, MTP-131, FORZINITY
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Key Facts: SS-31
- Category
- Anti-Aging
- FDA Status
- FDA Approved
- Clinical Status
- FDA Accelerated Approval (Sept 2025) - Barth syndrome (FORZINITY, first FDA-approved mitochondria-targeted therapeutic). Confirmatory trials required. Phase 3 for other indications.
- Administration
- Subcutaneous injection or IV infusion
- Typical Dose
- 40 mg subcutaneous daily
- Frequency
- Once daily
- Duration
- Variable by condition
Mechanism of Action
SS-31 is a cell-permeable, mitochondria-targeted peptide that concentrates in the inner mitochondrial membrane and binds tightly to cardiolipin. Cardiolipin is essential for keeping the membrane's folded cristae structure intact and for organizing the proteins of the electron transport chain that generate ATP. By stabilizing cardiolipin, SS-31 helps preserve cristae shape, reduces the electron leakage that produces reactive oxygen species, and supports more efficient ATP production. Studies also suggest it modulates the membrane's surface electrostatics and can limit opening of the mitochondrial permeability transition pore, a trigger for cell death, though the full mechanistic picture is still being worked out.
Research Summary
Unlike most peptides in this space, SS-31 has been through extensive human trials, with a mixed but consequential record. In TAZPOWER, a randomized placebo-controlled crossover study in Barth syndrome, elamipretide improved skeletal muscle strength and cardiac stroke volume, and the long open-label extension showed sustained benefit, which ultimately supported FDA accelerated approval in September 2025 as the first treatment for that ultra-rare disease. It has also failed prominently: the Phase 3 MMPOWER-3 trial in primary mitochondrial myopathy missed its primary endpoints on the six-minute walk test, the ReCLAIM trial in dry age-related macular degeneration did not hit its primary endpoints, and a heart-failure trial (PROGRESS-HF) also missed its primary endpoint. Across these studies the drug was generally well tolerated, with mostly mild effects such as injection-site reactions, headache and nausea. The accurate summary is that SS-31 is a validated mitochondrial-targeting peptide with one approved indication and a string of negative trials elsewhere, so its benefit appears to depend heavily on the specific disease.
Dosing Information
Typical Dosingⓘ
Community experience
40 mg subcutaneous daily
40 mg daily
Once daily
FDA approved as FORZINITY for Barth syndrome. Subcutaneous injection for patients weighing at least 30 kg.
Research Dosingⓘ
Scientific studies
Doses from clinical trials
Doses from Studies
40 mg IV or subcutaneous
Clinical trial doses vary by indication
Duration
Variable by condition
Administration
Subcutaneous injection or IV infusion
Timing & Administration
Best Time to Take
Morning
Once daily
Food Recommendation
With or without food
Why This Timing?
SS-31 (Elamipretide) targets mitochondria. Morning use supports daytime energy production.
Possible Side Effects
Not everyone experiences these effects. Individual responses vary based on dosage, duration, and personal factors.
- ●Injection site reactions (very common - 80%)
- ●Headache
- ●Dizziness
- ●Nausea
- ●May trigger histamine release - use caution with MCAS or histamine sensitivity
- ●No serious adverse events in trials
- ●FDA approved September 2025
References
- https://pmc.ncbi.nlm.nih.gov/articles/PMC11816484/
- https://pmc.ncbi.nlm.nih.gov/articles/PMC7247319/
- https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-first-treatment-barth-syndrome
- https://www.neurology.org/doi/10.1212/WNL.0000000000207402
- https://pubmed.ncbi.nlm.nih.gov/41260682/
Research This Peptide Further
Buy in shop
SS-31 from $92/kit
5 verified vendors, ≥99% purity, COAs included.
Frequently Asked Questions
What does SS-31 do?
SS-31 (sequence D-Arg-Dmt-Lys-Phe-NH2), known generically as elamipretide and sold as FORZINITY, is a synthetic tetrapeptide that homes in on the energy-producing machinery inside your cells. It works by binding cardiolipin, a fat unique to the inner mitochondrial membrane, to help mitochondria run cleaner and make more ATP with less oxidative damage. This is the rare research peptide with a real regulatory finish line: the FDA granted it accelerated approval in September 2025 for Barth syndrome, though it has failed several other major trials.
How does SS-31 work?
SS-31 is a cell-permeable, mitochondria-targeted peptide that concentrates in the inner mitochondrial membrane and binds tightly to cardiolipin. Cardiolipin is essential for keeping the membrane's folded cristae structure intact and for organizing the proteins of the electron transport chain that generate ATP. By stabilizing cardiolipin, SS-31 helps preserve cristae shape, reduces the electron leakage that produces reactive oxygen species, and supports more efficient ATP production. Studies also suggest it modulates the membrane's surface electrostatics and can limit opening of the mitochondrial permeability transition pore, a trigger for cell death, though the full mechanistic picture is still being worked out.
Is SS-31 FDA approved?
Yes, SS-31 is FDA approved. FDA Accelerated Approval (Sept 2025) - Barth syndrome (FORZINITY, first FDA-approved mitochondria-targeted therapeutic). Confirmatory trials required. Phase 3 for other indications.
What are the side effects of SS-31?
Reported side effects include: Injection site reactions (very common - 80%), Headache, Dizziness, Nausea, May trigger histamine release - use caution with MCAS or histamine sensitivity. Individual responses vary based on dosage, duration, and personal health factors.
What is the typical dose of SS-31?
Community-reported common dose: 40 mg subcutaneous daily (Once daily). Range: 40 mg daily. Administration: Subcutaneous injection or IV infusion. Prescription required. Consult healthcare provider.
Related Peptides
Peptides commonly compared with SS-31 or used in similar applications.
Humanin
PreclinicalHumanin is a 24-amino-acid peptide encoded inside mitochondrial DNA (in the 16S rRNA gene), discovered in 2001 and named for its ability to protect human neurons from Alzheimer-related cell death. It was the first member of the mitochondrial-derived peptide family and is studied mainly for neuroprotection, cell survival, and metabolic and age-related disease. The honest status: it has the deepest preclinical evidence base of any mitochondrial peptide, but human therapeutic trials are essentially absent.
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Anti-AgingDSIP
Clinical TrialsDSIP, or delta sleep-inducing peptide, is a small naturally occurring nonapeptide (sequence Trp-Ala-Gly-Gly-Asp-Ala-Ser-Gly-Glu) first isolated in the 1970s from the blood of sleeping rabbits. As the name suggests, it was named for its ability to promote delta-wave (deep, slow-wave) sleep in animals. Despite five decades of study it has no regulatory approval and the human evidence for it as a sleep aid is weak and inconsistent.
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Anti-AgingFOXO4-DRI
PreclinicalFOXO4-DRI is an experimental senolytic peptide, meaning it is designed to kill off worn-out 'zombie' cells (senescent cells) while leaving healthy ones alone. It comes from a single influential 2017 mouse study and is engineered with a clever stability trick. It has never been tested in a human clinical trial, so anything beyond 'promising in mice' is speculation.
Anti-AgingVesilute
PreclinicalVesilute is marketed as a Khavinson-style short peptide bioregulator aimed at the urinary bladder and lower urinary tract. Vendor sources cannot even agree on its sequence: some list a Glu-Asp dipeptide, others a Lys-Glu-Asp tripeptide. There are no approvals and, importantly, no peer-reviewed studies published specifically on a peptide called Vesilute, so almost everything written about it is extrapolated from the broader bioregulator family rather than direct evidence.
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