What it is
SS-31 is a small synthetic peptide designed to interact with the inner mitochondrial membrane.
What the research says
- Published human studies of elamipretide have been in rare mitochondrial disease [1]. There are no published human studies of compounded SS-31 for general use.
Regulatory status
One elamipretide product has accelerated approval for Barth syndrome only [2]. Compounded SS-31 is not that product and is not FDA approved. Where prescribed, compounded versions are prepared by state-licensed 503A compounding pharmacies.
Safety and side effects
The approved use is narrow, and we found no published human studies of compounded SS-31, so its side effects in general use are unknown. A licensed healthcare provider should review your history and medications before deciding anything.
Is it right for you?
Only a licensed healthcare provider can decide whether any treatment is appropriate for you.
Frequently asked questions
Is compounded SS-31 approved by FDA?
No. Compounded SS-31 is not FDA approved. A separate elamipretide product has accelerated approval for Barth syndrome only [2].
Do I need a prescription for SS-31?
Yes. Prescription only, requires evaluation by a licensed provider. A provider decides whether it is appropriate for you.
Sources
- Reid Thompson W, et al. Genet Med, 2021. https://pmc.ncbi.nlm.nih.gov/articles/PMC7935714/
- FDA press announcement: FDA grants accelerated approval to first treatment for Barth syndrome. https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-first-treatment-barth-syndrome
SS-31 content on this page is for education. Compounded medications are not FDA approved. Prescription only, requires evaluation by a licensed provider. Educational content only, not medical advice.