Elamipretide (SS-31)

Main evidence: Human clinical trials. Updated 2026-10-28.

What research and users report, not a recommendation or medical advice. Many of these products are not approved for human use. Ask your doctor. Packs report what sources say, each with its evidence label. A claim labelled community, educator, manufacturer or animal has not been validated in humans.

Summary

This pack organizes cited evidence, protocol context, safety cautions, and Australian legal status for the compound.

What the sources say

A published combination study of elamipretide (SS-31) plus sacubitril/valsartan reported better cardiac outcomes than either treatment alone in a doxorubicin-induced rat cardiomyopathy model; this is animal evidence and does not establish human combination benefit. (Animal studies; "Early treatment with combination of SS31 and entresto effectively preserved the heart function in doxorubicin-induced dilated cardiomyopathic rat", 2021-08-10)
A Reddit user with self-described ME/CFS reported perceived energy and executive-function improvement and also described insomnia, agitation, constipation, sedation and anxiety during self-experimentation; the report cannot verify diagnosis, product, dose, causality or safety. (Community reports; Reddit, "My Experience Treating my ME/CFS with mitochondrial peptide SS-31" (undated post; accessed 2026-10-28), 2026-10-28)
Elamipretide (SS-31) is a mitochondrial cardiolipin-binding peptide; the U.S. FDA approved Forzinity for a narrow Barth syndrome indication, while controlled studies in other conditions have not consistently shown clinical benefit. (Educator material (not peer reviewed); FDA, "FDA Grants Accelerated Approval to First Treatment for Barth Syndrome", 2025-09-19)
The U.S. FDA granted accelerated approval for Forzinity to improve muscle strength in adults and children with Barth syndrome weighing at least 30 kg; confirmatory evidence is required. This U.S. authorization does not confer Australian approval. (Educator material (not peer reviewed); FDA, "FDA Grants Accelerated Approval to First Treatment for Barth Syndrome", 2025-09-19)
Evidence is indication-specific: the randomized Barth syndrome primary endpoints were negative, the open-label extension had no placebo control, and the larger phase 3 primary mitochondrial myopathy trial was negative. (Human clinical trials; Thompson et al., "A phase 2/3 randomized clinical trial followed by an open-label extension to evaluate the effectiveness of elamipretide in Barth syndrome, a genetic disorder of mitochondrial cardiolipin metabolism", 2020-10-20)
The FDA label reports local administration reactions in all 12 elamipretide-treated participants in the small Barth syndrome safety population, compared with 8 of 12 on placebo; it also warns of serious hypersensitivity reactions and reports eosinophil increases with longer exposure. (Educator material (not peer reviewed); FDA, "FORZINITY (elamipretide) injection, for subcutaneous use — Prescribing Information" (label revised 2025-09; exact day not stated; accessed 2026-10-28), 2026-10-28)
No Australian TGA approval or ARTG entry for elamipretide/Forzinity was identified in the public-register sources checked on 2026-10-28; FDA approval in the United States is not Australian registration. (Educator material (not peer reviewed); TGA, "Searching the Australian Register of Therapeutic Goods (ARTG)" (public search checked 2026-10-28; page last updated 2021-06-22), 2026-10-28)
The TGA describes possible pathways for some unapproved therapeutic goods, including SAS, Authorised Prescriber and clinical-trial mechanisms, each subject to its rules; their existence does not establish that a particular patient or product qualifies. (Educator material (not peer reviewed); TGA, "Access pathways for unapproved therapeutic goods" (undated page; accessed 2026-10-28), 2026-10-28)

Sources

Dosing, stacking and protocol details are not published here.