What it is
This is a compounded preparation that combines three ingredients: SS-31, MOTS-c and tesamorelin. SS-31 is a small synthetic peptide designed to interact with the inner mitochondrial membrane. MOTS-c is a short peptide encoded in mitochondrial DNA. Tesamorelin is a synthetic analog of growth hormone-releasing hormone (GHRH).
What the research says
- SS-31: published human studies of elamipretide have been in rare mitochondrial disease. There are no published human studies of compounded SS-31 for general use [1].
- MOTS-c: the published studies we reviewed are in mice and cells [2][3]. We did not find published human effectiveness or safety studies.
- Tesamorelin: the approved tesamorelin product's label states it is not indicated for weight loss management as it has a weight neutral effect [4].
- We did not find any published study of these three ingredients together.
Regulatory status
This blend is not FDA approved, and FDA has not reviewed it for safety, effectiveness or quality [5]. FDA has approved separate tesamorelin and elamipretide products, each for a specific, narrow use [4][6]. This blend is not either of those products. FDA has not approved any MOTS-c product. Where prescribed, compounded versions are prepared by state-licensed 503A compounding pharmacies.
Safety and side effects
The approved tesamorelin label warns of an increased risk of neoplasms (any prior cancer must be inactive and its treatment complete before starting), elevated IGF-1 levels with unknown long-term effects, fluid retention (including edema, arthralgia and carpal tunnel syndrome), glucose intolerance or diabetes, hypersensitivity reactions, and increased mortality in patients with acute critical illness. It is contraindicated in pregnancy, in active cancer, and in people with disruption of the hypothalamic-pituitary axis [4]. We found no published human safety data for MOTS-c or for compounded SS-31. Because the combination has not been studied, how the ingredients interact and what side effects the blend may cause are unknown. A licensed provider reviews every ingredient against your history, medications and labs, including blood glucose.
Is it right for you?
Only a licensed healthcare provider can decide whether any treatment is appropriate for you.
Frequently asked questions
Has the blend been studied as a combination?
We did not find any published study of these three ingredients together. Each ingredient has its own separate and limited evidence base [1][2][3].
What are the safety considerations?
The approved tesamorelin label warns of increased risk of neoplasms, elevated IGF-1, fluid retention, glucose intolerance or diabetes, hypersensitivity reactions, and increased mortality in acute critical illness, and it is contraindicated in pregnancy and active cancer [4]. Human safety data for MOTS-c and compounded SS-31 are lacking, and the combination has not been studied.
Is this blend approved by FDA?
No. The blend is not FDA approved. Compounded blends are not reviewed by FDA for safety, effectiveness or quality [5].
Do I need a prescription for the SS-31 + MOTS-c + Tesamorelin Blend?
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 (elamipretide in rare mitochondrial disease). https://pmc.ncbi.nlm.nih.gov/articles/PMC7935714/
- Lee C, et al. Cell Metab, 2015 (mouse study). https://www.sciencedirect.com/science/article/pii/S1550413115000613
- Reynolds JC, et al. Nat Commun, 2021 (mouse study). https://www.nature.com/articles/s41467-020-20790-0
- FDA prescribing information, EGRIFTA WR (tesamorelin), revised 3/2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022505s020lbl.pdf
- FDA: Compounding and the FDA, questions and answers. https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers
- 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 + MOTS-c + Tesamorelin Blend 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.