Compounds / SS-31

SS-31

Also known as: Elamipretide, Forzinity (brand), MTP-131, Bendavia

Established human clinical FDA accelerated approval 2025 (Barth syndrome only) Category: Longevity and Mitochondrial

The compounds described in this library are research-use-labeled chemicals and are not FDA-approved for human use. This content is factual scientific reference drawn from published literature. It is not medical, dosing, or purchasing advice. VialReport does not sell, supply, or distribute any compound.

Short summary

A mitochondria-targeted tetrapeptide that received FDA accelerated approval in 2025 under the brand name Forzinity as the first approved treatment for Barth syndrome. Its regulatory position is very different from most compounds in this library, though the approval dataset was unusually small and the approval is conditional.

Dive deeper

Origin and Development

Developed from research on mitochondria-targeted peptides, originally designated SS-31 and later developed as elamipretide by Stealth BioTherapeutics. It has also appeared in the literature under the names MTP-131 and Bendavia.

Mechanism as Understood in the Literature

Described as selectively targeting and stabilizing cardiolipin, a lipid of the inner mitochondrial membrane that is essential to mitochondrial structure and to the function of the electron transport chain. Cardiolipin abnormalities are central to Barth syndrome, which is the basis of the approved indication.

Research Status

The approval dataset deserves careful reading. Forzinity received accelerated approval based on an intermediate muscle-strength measure observed primarily during the open-label extension of a 12-patient study, and "first approved treatment for Barth syndrome" replaces any broader claim. The randomized portion of TAZPOWER did not meet its original primary efficacy endpoints. Continued approval is contingent on confirmatory evidence. Separately, the compound has been studied in several hundred patients across mitochondrial disease programs, including a Phase 3 trial (NuPower) in primary mitochondrial disease.

Regulatory status · approved

FDA-approved as a prescription medicine under several brand names.

Approved indications and formulations differ by brand.

Material sold outside the approved supply chain is not the approved product, regardless of how it is labeled.

Commonly Confused With

The research designation SS-31 and the approved drug name elamipretide refer to the same molecule, which causes confusion because the research-market listings and the pharmaceutical literature use different names. Also distinct from other mitochondria-directed compounds such as MOTS-c, which is a mitochondrial-derived peptide rather than a mitochondria-targeted synthetic one.

How This Compound Is Marketed

Vendor marketing for this compound typically references mitochondrial function, energy, and longevity, well beyond the narrow approved indication. VialReport does not evaluate or endorse these claims. See Research Status above for what the published literature actually establishes.

Analytical Profile

A tetrapeptide, sequence D-Arg-dimethylTyr-Lys-Phe-NH2, molecular weight approximately 640 Da. Contains non-standard residues including a dimethylated tyrosine, which gives a distinctive analytical signature.

Stability and Handling

The approved product has defined manufacturer storage requirements. Material outside that supply chain will not carry equivalent characterization.

Key Literature

  1. 01 Reid Thompson W, et al. A phase 2/3 randomized clinical trial followed by an open-label extension to evaluate the effectiveness of elamipretide in Barth syndrome (TAZPOWER). Genet Med. 2021;23(3):471-478.
  2. 02 Szeto HH. First-in-class cardiolipin-protective compound as a therapeutic agent to restore mitochondrial bioenergetics. Br J Pharmacol. 2014;171(8):2029-2050.
  3. 03 Stealth BioTherapeutics. FDA accelerated approval of Forzinity. 2025.

VialReport publishes factual reference information and independent test data. Nothing here is medical, dosing, or purchasing advice.

Published reports

Reports for SS-31

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