Understand the source comparison
SS-31 FDA Approved Status Comparison — Clinical vs Research Contexts
Stealth BioTherapeutics Clinical Trials Investigational New Drug (IND) under FDA oversight cGMP manufacturing with full batch documentation Human use in FDA-approved clinical protocols only Complete chain-of-custody from synthesis to administration The only co
No winner is assigned.
This page preserves a source comparison for education. It does not add a rating, recommendation or clinical judgment.
- Stealth BioTherapeutics Clinical Trials
- Investigational New Drug (IND) under FDA oversight
- cGMP manufacturing with full batch documentation
- Human use in FDA-approved clinical protocols only
- Complete chain-of-custody from synthesis to administration
- The only context where SS-31 can be legally administered to humans. Requires IRB approval and patient informed consent
- Research-Grade Peptide (Licensed Supplier)
- Research chemical, not approved for human use
- GMP synthesis with HPLC purity ≥98%, verified by mass spec
- In vitro studies, animal research, mechanistic investigations
- Certificate of analysis provided per batch; no FDA submission
- Legitimate laboratory use. Identical molecular structure to clinical-grade SS-31 but without regulatory approval for therapeutic claims
- Compounded 'SS-31' from Non-Licensed Source
- Unregulated; no FDA oversight
- Unknown. No independent verification
- Illegal if marketed for human consumption
- None. Buyer assumes all risk
- High risk of impurity, incorrect dosing, or complete absence of active compound; no legal recourse if product is mislabelled
- FDA-Approved Mitochondrial Disease Drug (for comparison)
- NDA-approved therapeutic product
- cGMP with ongoing FDA inspections
- Prescribed therapeutic use in approved indications
- Full FDA traceability and adverse event reporting
- None exist as of 2026. SS-31 would be the first if approved, which underscores why its regulatory path has been so difficult
- The table underscores a critical point: SS-31's lack of FDA approval doesn't mean it's unavailable. It means the contexts in which it can be legally used are narrowly defined. Clinical researchers working under an active IND can administer it to patients. Laboratory researchers can purchase it for non-human studies. What's prohibited is marketing it as a therapeutic agent to consumers, which is why legitimate suppliers explicitly state 'for research use only' on every product listing.