Peptides · Longevity & Cellular Health

SS-31

Elamipretide · Bendavia

FDA-approved for Barth syndrome (2025)

The clinical heavyweight of this list: a mitochondria-targeting peptide developed by Stealth BioTherapeutics that won FDA accelerated approval in September 2025 (as Forzinity) for the ultra-rare Barth syndrome — while its larger trials in other mitochondrial diseases have produced mixed results.

At a glance

  • Targets cardiolipin in the inner mitochondrial membrane
  • Multiple randomised human trials — a rarity in this space
  • FDA accelerated approval as Forzinity for Barth syndrome, Sep 2025
  • Phase 3 in mitochondrial myopathy missed both endpoints

How it works

SS-31 binds cardiolipin, a lipid unique to the inner mitochondrial membrane, stabilising the membrane and improving the efficiency of cellular energy production — a mechanism aimed at diseases driven by mitochondrial dysfunction.

What the research shows

Elamipretide has real randomised trial data across Barth syndrome, primary mitochondrial myopathy, heart failure and dry age-related macular degeneration — with genuinely mixed results: its phase 3 in primary mitochondrial myopathy missed both endpoints, while the Barth syndrome programme ultimately earned approval. It is a real pharmaceutical, not a supplement.

Regulatory status

Australia

Not registered on the ARTG; available in Australia only through clinical trials if any are recruiting.

Worldwide

FDA-approved via the accelerated pathway on 19 September 2025 (brand name Forzinity) for Barth syndrome in patients weighing at least 30 kg — after an advisory committee vote and an earlier complete response letter. Development continues in retinal and other mitochondrial disease.

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This is general information, not medical advice. retatrutide.net.au is an independent publication. Unless stated otherwise above, this compound is not an approved medicine in Australia, and this page does not endorse or facilitate its use. Speak to a registered health practitioner about any treatment decision.

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SS-31 — Research, Evidence & Australian Status | Retatrutide Australia