SS-31 (Elamipretide): Evidence, Side Effects, and Regulatory Status (2026)
SS-31 (Elamipretide) is Investigational (Phase 3 trials completed). Evidence grade: preliminary. This page is clinically reviewed.
TL;DR / Quick Facts
SS-31 (Elamipretide) is SS-31 (elamipretide) is a mitochondria-targeted tetrapeptide studied in Barth syndrome, primary mitochondrial myopathy, and heart failure. Phase 3 trials completed. Not FDA-approved in 2026. FDA status: Investigational (Phase 3 trials completed). Typical use cases: longevity, eye health, mitochondrial. Evidence grade: preliminary. Dosing is not established (no FDA-approved protocol). Common side effects: see below. Medriva editorial stance: this compound has limited human evidence; consult a licensed clinician.
What it is
SS-31 (Elamipretide) is a member of the Mitochondria-targeted peptide (SS-31 / MTP-131) class. SS-31 binds cardiolipin on the inner mitochondrial membrane, stabilizing cristae structure and reducing ROS production.
What the evidence says
Evidence for SS-31 (Elamipretide) is preliminary. The bulk of the evidence is from pre-clinical models and small or uncontrolled human studies. Well-controlled phase 3 trials are limited or absent.
[Detailed evidence breakdown in the corresponding claim or pillar pages is linked at the bottom of this page.]
What it's used for
Commonly discussed uses of SS-31 (Elamipretide):
- Longevity — preliminary evidence.
- Additional uses listed in the linked use-case hubs; evidence varies by indication.
For the full list, see the linked use-case hubs below.
Dosing is unestablished
No FDA-approved dosing protocol exists for SS 31. Published research and clinic-marketed protocols are not interchangeable with medical guidance. Medriva does not publish dosing instructions for research-use or non-approved compounds. Review quality controls with a licensed clinician and use the vendor evaluation framework and COA explainer before considering any source.
Side effects and risks
- Common: Side effects vary by compound and indication; review the approved label or profile-specific safety data with a clinician.
- Serious: Seek urgent care for severe allergic symptoms, chest pain, severe abdominal pain, persistent vomiting, or other severe reactions.
- Long-term unknowns: For non-approved or research-use compounds, long-term human safety data may be limited.
Regulatory status
- FDA-approved use(s): None. Investigational; NDA submission pending/under review.
- Compounded availability: see 503A vs 503B explainer
- Research-use-only (RUO) availability: yes
- Banned in sport: see WADA & sports explainer
Cost and access
SS-31 (Elamipretide) is available primarily via telehealth platforms and 503A compounding pharmacies. For pricing, see our cost pages or the GLP-1 price/supply tracker where applicable.
Who it might be appropriate for
Adults with a relevant diagnosed condition or clinical goal, under the supervision of a licensed clinician, who have no contraindications. SS-31 (Elamipretide) is not for self-experimentation.
Who should not use it
Contraindications vary by compound, indication, pregnancy status, comorbidities, and current medications. For the full list, see the contraindications checklist and discuss with your clinician.
Medriva editorial stance
We describe the literature. We do not promote SS-31 (Elamipretide) as a cure, treatment, or performance enhancer. We do not recommend it for self-experimentation. We do recommend that readers (a) understand the evidence grade (preliminary), (b) understand the regulatory status (Investigational (Phase 3 trials completed)), and (c) discuss with a licensed clinician before acting.
How to talk to a clinician
See our guide on how to talk to a clinician for a templated conversation.
Frequently Asked Questions
Is SS-31 (Elamipretide) FDA-approved?
Investigational (Phase 3 trials completed). Compounded and RUO versions are not FDA-approved as finished products.
Does SS-31 (Elamipretide) work for longevity?
Evidence is preliminary. See the linked use-case hub for the full breakdown.
What are the side effects?
See the side effects section above. Discuss with your clinician.
How much does SS-31 (Elamipretide) cost?
See the cost pages or the GLP-1 price/supply tracker where applicable.
Can I buy SS-31 (Elamipretide) online?
Only via prescription from a 503A compounding pharmacy or a licensed telehealth platform. Medriva does not sell peptides and does not endorse RUO vendors.
Author + Clinical reviewer
Author: Daniel Arora, MPH Clinical reviewer: Jonathan Reeves, MD Last reviewed: 2026-06-05
Next steps
- Review the evidence grade and regulatory status before making decisions about SS 31.
- Bring this page to a licensed clinician if you are discussing benefits, risks, or alternatives.
- Subscribe to the Medriva Peptide Brief for evidence and regulatory updates.
Related use-case hubs
Related comparisons
Editorial process
This page follows the Medriva Editorial Policy and the Clinical Review Methodology. Page last reviewed: 2026-06-05. Author: Daniel Arora, MPH. Clinical reviewer: Jonathan Reeves, MD.
Current source updates
For new regulator actions, compounding-policy changes, warning letters, shortage updates, and sports-rule changes, review the Peptide Tracker before relying on older summaries.
