Podcast episode 90 (in German)
SS-31 (elamipretide) – the first approval that proves the opposite
September 28, 2026
SS-31, also called elamipretide, received in September 2025 the first approval this field has ever seen. Even so, it is no evidence for anti-aging — quite the opposite. The episode does the math on why.
What it is about
SS-31 is a very short peptide that migrates to the inner mitochondrial membrane and binds there to the lipid cardiolipin. Cardiolipin holds together the tight folding of this membrane, on whose surface energy is generated; it breaks down with age and in certain diseases. Unlike most substances in this series, there is a named target structure here and a phase 3 trial in humans. The episode goes through MMPOWER-3, through the post-hoc analysis by genotype and through the approval for Barth syndrome — a disease that about 150 people in the US live with. And it sorts out what remains of all this for someone who is healthy and wants to prevent disease.
Key points
- SS-31 binds to cardiolipin in the inner mitochondrial membrane — a named target structure that is detectable in humans, and not a general promise about cellular energy.
- The phase 3 trial MMPOWER-3 tested 2 co-primary endpoints against placebo over 24 weeks, the 6-minute walking distance and a fatigue questionnaire; both were missed.
- Only a post-hoc split by genotype showed, in patients with defects in the nuclear genome, 25 meters more walking distance versus practically zero, and in a narrower group 37 meters versus a deterioration of 8 meters.
- Instead of selling this finding as a result, the company set up a new trial, NuPower, that tests exactly this group — which is rare in this field.
- The September 2025 approval applies to Barth syndrome and is based on an open-label study without placebo with 10 patients, 8 of whom completed it.
- About 150 people in the US live with this disease, which affects around 1 in 350,000; a post-approval study with 48 participants is ongoing.
- The episode gives human evidence 5 with a mixed direction, plus safety 6, use 3 and hype 2 — a high evidence number measures how much something has been studied, not whether it works.
Where the data stop
There is no study in healthy people, not a single one. What exists is a phase 3 trial in a muscle disease that missed its primary endpoint, a post-hoc subgroup that is still being tested, and an ultra-rare hereditary disease. The marketing jumps from there to protection against aging, and this leap has no basis: replacing something that is missing is different from topping up something that is sufficient. A program in age-related macular degeneration is underway, but older people with a disease are, once again, not the same as healthy people who want to prevent disease.
The safety data also have a limit. They come from studies with a product manufactured under regulatory requirements and given under medical supervision, and the side effects there were mostly mild to moderate. They do not apply to a vial from an unclear source: the safety of a substance and the safety of a product are two different things.
Listen (in German)
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Published on September 28, 2026.
The topic in the database
- A mitochondria-targeted peptide that binds to cardiolipin and stabilizes the cellular power plants – and one of the few with real clinical …SS-31 (Elamipretide)
Information only, not medical advice and not a usage or dosage recommendation. Prescription-only and unapproved substances belong in the hands of a physician. Last updated: 2026-09-19.