Claimed effect · SS-31 (elamipretide)

Does SS-31 (elamipretide) help with dry age-related macular degeneration?

C
Grade C — weak human evidence1 phase 2 RCT (n=176) · effect size: small
Short answerWeak human evidence. 1 phase 2 RCT (n=176): enough to be interesting, not enough to count on. Where an effect is seen it is a small effect. ReCLAIM-2 missed its two primary endpoints; a slowing of ellipsoid-zone loss on OCT is a secondary signal the developer is carrying into phase 3.

What the studies show

ReCLAIM-2 missed its two primary endpoints; a slowing of ellipsoid-zone loss on OCT is a secondary signal the developer is carrying into phase 3.

“While the primary end points were not met in this phase II study, elamipretide treatment was associated with a slowing of progressive EZ degradation/loss, a surrogate for photoreceptor damage.”

Verbatim, from the abstractEhlers JP, et al. ReCLAIM-2: a randomized phase 2 clinical trial evaluating elamipretide in dry age-related macular degeneration. Ophthalmol Sci, 2025;5:100628

A few small or poorly-controlled human studies. Enough to be interesting; not enough to count on. Most of what gets called “clinically proven” online lives here.

  1. 1
    Ehlers JP, et al. ReCLAIM-2: a randomized phase 2 clinical trial evaluating elamipretide in dry age-related macular degeneration.Ophthalmol Sci, 2025;5:100628176 patients; primaries missed, ellipsoid-zone secondary signal.

In context

SS-31, developed as elamipretide, is a four-amino-acid peptide that concentrates in mitochondria and binds cardiolipin, a lipid of the inner membrane. After a decade of trials it was approved in the United States in September 2025 for Barth syndrome, an ultra-rare genetic disease — on the strength of an open-label extension, since its randomised crossover missed both primary endpoints. Larger randomised trials in primary mitochondrial myopathy and in heart failure were negative. It is a genuine, narrowly approved medicine, not a general 'mitochondrial' or anti-ageing treatment.

SS-31 (elamipretide) is approved (rx, us; barth syndrome only). Legal status differs by country — see the regulation section or the jurisdiction pages.

Questions

Is SS-31 (elamipretide) proven to help with dry age-related macular degeneration?
No. The human evidence is weak (1 phase 2 RCT (n=176)); LYO grades it C.
What studies are behind the grade?
ReCLAIM-2 missed its two primary endpoints; a slowing of ellipsoid-zone loss on OCT is a secondary signal the developer is carrying into phase 3.
Is SS-31 (elamipretide) approved for this?
SS-31 (elamipretide) is an approved medicine (Approved (Rx, US; Barth syndrome only)); whether this particular outcome is a licensed indication is stated on the compound page's regulation section.

Other outcomes for SS-31 (elamipretide)

Written and maintained by LYO Research — how pages are written and checked. Reviewed 3 September 2026. Grades count human evidence only; see how LYO grades. Not medical advice. Correct this page →