Mitochondrial cardiolipin-binding tetrapeptide
SS-31 is an earlier research name for elamipretide. The prescription product FORZINITY received accelerated FDA approval for one narrow Barth-syndrome indication. That approval does not establish general benefits for energy, recovery, performance, anti-aging, or other mitochondrial conditions.
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Depth and confidence summarize the research record—not effectiveness, safety, or a recommendation.
Elamipretide has controlled Phase 2 and Phase 3 trials, long-term extension data, pharmacology studies, and a current accelerated-approval program.
Research depth describes how large and mature the overall record is. It does not tell you whether the results were positive.
The approved Barth-syndrome endpoint is supported by a very small open-label extension, while several larger controlled programs did not meet their primary endpoints.
Confidence describes how reliable and consistent the conclusions are. It can be high for one outcome and low for another.
The strongest evidence type shows what the best-supported conclusions are actually based on.
Human findings are more directly relevant than animal or laboratory results, but they still apply only to the populations and outcomes studied.
Route-specific record
These are exposures used in cited research for a specific route and population—not a suggested amount.
Half-life describes how long it takes the measured amount in the body to fall by half. It is not a dosing recommendation.
Evidence can change by administration method. Findings from one route should not automatically be applied to another.
Evidence boundary: Approval is under the accelerated pathway for muscle strength in Barth syndrome patients weighing at least 30 kg. It does not establish general mitochondrial, exercise, heart, eye, or wellness benefit, and the ready-to-use preserved product is not interchangeable with powdered or vendor-supplied SS-31. Amounts shown describe cited research exposure—not a dosage recommendation.
Practical starting point
Common goals and questions—not recommendations or promises of benefit.
The overview, studies, and source ledger below explain what supports each label—and where the evidence stops.
What the evidence says
FDA accelerated approval for a genetically confirmed Barth-syndrome population weighing at least 30 kg, supported by a 12-person crossover trial and its very small long-term open-label extension. A randomized post-approval trial is required to verify clinical benefit.
This is the strongest supported conclusion in the current human evidence—not a summary of every claim made about the compound.
Whether the knee-strength change predicts meaningful functional benefit in Barth syndrome, plus long-term and rare safety and any efficacy outside the approved population.
Keeping the main uncertainty visible prevents an early or promising finding from looking more settled than it is.
The evidence story
Importance shows how much an item changes the evidence story. Quality shows how much confidence the design deserves. A strong negative study can score highly on both.
Importance and quality answer different questions. A rigorous study can be highly important even when it challenges a popular claim.
The trial was recruiting and had no posted outcome results by the July 25, 2026 evidence cutoff.
FDA approved FORZINITY for a narrowly defined Barth-syndrome population based on improvement in knee-extensor strength, while requiring confirmatory evidence to verify clinical benefit.
The trial did not meet either primary efficacy endpoint. Prespecified ellipsoid-zone imaging measures favored elamipretide, but they do not establish a proven visual or geographic-atrophy benefit.
The study was active but no longer recruiting and had no posted outcome results by the evidence cutoff.
Function, fatigue, cardiac measures, and knee extensor strength improved from open-label baseline over time. FDA used the knee-strength change as an intermediate endpoint reasonably likely to predict benefit.
Administration and handling
The September 2025 label describes FORZINITY 40 mg subcutaneously once daily for patients in the approved Barth-syndrome population weighing at least 30 kg, with a product-specific renal-impairment adjustment for certain adults. Published studies used their own protocol-defined routes and schedules. These details do not establish a consumer dose, cycle, or route for unapproved uses or unverified materials. The label also says not to mix FORZINITY with another product in the same syringe.
FORZINITY is an FDA-approved 80 mg/mL ready-to-use preserved solution, not a lyophilized vial. Its label specifies refrigerated storage at 2°C to 8°C, no freezing, and disposal of an opened single-patient-use vial after eight days; during that opened-vial period it may be refrigerated or held at 20°C to 25°C. Those instructions apply only to the named product. They do not validate the identity, sterility, reconstitution, stability, or storage of powdered or vendor-supplied materials sold as SS-31.
Primary-source ledger
2026-07-13 · NCT07531251
2025-09-19 · NCT03098797
2025-09-19
2024-10-09 · PMID 39605874 · NCT03891875 · DOI 10.1016/j.xops.2024.100628
2024-04-18 · NCT06373731
2024-04-10 · PMID 38602181 · NCT03098797 · DOI 10.1016/j.gim.2024.101138
2023-06-02 · PMID 37268435 · NCT03323749 · DOI 10.1212/WNL.0000000000207402
2020-10-20 · PMID 33077895 · NCT03098797 · DOI 10.1038/s41436-020-01006-8
2020-02-26 · PMID 32096613 · NCT02805790 · DOI 10.1002/jcsm.12559
2020-02-14 · PMID 32068002 · NCT02788747 · DOI 10.1016/j.cardfail.2020.02.001