C32H49N9O5 · 639.8 g/mol · PubChem CID 11764719 ↗
SS-31
also known as Elamipretide, Bendavia, MTP-131
Synthetic four-amino-acid peptide that selectively localises to the inner mitochondrial membrane by binding cardiolipin. Stabilises cristae structure, preserves electron transport chain efficiency, and reduces ROS generation in stressed mitochondria. Other indications studied in Phase 2/3 trials — including ischemia-reperfusion and dry AMD — remain investigational, and research-grade SS-31 is not an approved product. Approval applies to the specific product Forzinity (elamipretide hydrochloride), granted US FDA accelerated approval on 19 September 2025 to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg, with continued approval potentially contingent on confirmatory benefit. [fda-forzinity-label-2025]
- Class
- Mitochondrial-targeted tetrapeptide
- Evidence level
- FDA-approved
- Regulatory status
- FDA-approved (US)
SQ · Abdomen · Once daily
Primary target — Cardiolipin in inner mitochondrial membrane [szeto-2014].
Pathway — Cardiolipin binding → cristae stabilisation → ETC integrity → reduced ROS + preserved ATP synthesis [szeto-2014][szilagyi-2009].
Downstream effect — Mitochondrial bioenergetic preservation; cardio-, neuro-, and reno-protective effects in animal + clinical studies [szeto-2014].
Origin — Synthetic tetrapeptide D-Arg-Dmt-Lys-Phe-NH₂; cell-permeable, mitochondrial-selective [szeto-2014].
| Parameter | Value |
|---|---|
| Standard dose | 40 mg / day SQ (clinical trials)Anecdotal community range 5-10 mg/day. Phase 3 trials use 40 mg. |
| Frequency | Once daily |
| Lower / starter dose | 5 mg / day (anecdotal) |
| Evidence basis | Accelerated approval (Forzinity) for Barth syndrome; AMD and ischemia-reperfusion remain investigational [fda-forzinity-label-2025] |
| Duration | Indefinite for mitochondrial disease; cycled for healthspan use |
| Reconstitution | Bacteriostatic water |
| Timing | Morning fasted preferred; pre-workout for exercise-induced mitochondrial stress |
| Half-life | ~3 h plasma; tissue uptake longer |
Reconstitution
A pure mass-to-volume utility. Enter what you have in the vial; the atlas computes the volume per dose. No prescription information.
- — Pregnancy / breastfeeding
- — Hypersensitivity to peptide
- — None established
- 01Reconstitution
Add bacteriostatic water per label. Light-protected handling.
- 02Injection site
SQ — abdomen or thigh. Rotate sites.
- 03Timing
Morning fasted; pre-workout for exercise-augmented mitochondrial stress.
- 04Storage
Lyophilised: refrigerate, light-protected. Reconstituted: refrigerate ≤30 days.
- 05Needle
29–31G, 4–8 mm insulin syringe.
Frequently asked
How does SS-31 work?
SS-31 acts on Cardiolipin in inner mitochondrial membrane, signalling via Cardiolipin binding → cristae stabilisation → ETC integrity → reduced ROS + preserved ATP synthesis. [szeto-2014][szeto-2014][szilagyi-2009]
Is SS-31 FDA-approved?
Yes — SS-31 is approved by the US FDA.
Sources
of 43 rendered claims carry a resolvable citation.
- [fda-forzinity-label-2025]FORZINITY (elamipretide) injec 2025 — FORZINITY (elamipretide) injection prescribing information
fda-label, 2025
NDA 215244. Accelerated approval 2025-09-19 to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg. - [szeto-2014]Szeto 2014 — First-in-class cardiolipin-protective compound as a therapeutic agent to restore mitochondrial bioenergetics
Br J Pharmacol, 2014
SS-31 cardiolipin-binding mechanism review. - [szilagyi-2009]Szilagyi 2009 — SS-31 protects mitochondria during ischemia-reperfusion
Stroke, 2009
Foundational SS-31 (Bendavia/Elamipretide) cardio-protective mechanism paper.