PeptideTreatments
Reviewed by Peptide Treatments Medical Advisory Board (Medical Advisory Board)

SS-31: Regulatory Status

Current legal and regulatory status for SS-31 across jurisdictions. This page reflects the most recent verified information and is updated as regulatory actions occur.

Back to SS-31 overview

United States

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FDA Approved

Prescription required

FDA-approved as undefined (Barth syndrome — improve muscle strength in patients ≥30 kg, 2025). Compounding status: not compoundable (FDA-approved drug; not on shortage list). WADA: not listed. FDA approved Sept 2025 for Barth syndrome via accelerated approval. Stealth BioTherapeutics had financial difficulties; current commercialization status to be verified.

Last verified:

What This Means

Reclassification is not the same as FDA approval.

Even if SS-31 moves to Category 1, it remains an off-label therapeutic that requires physician supervision. Category 1 means it can be compounded under section 503A — it does not confer approved-drug status.

SS-31 Overview

Uses, benefits, evidence, and monitoring.

Contraindications

Safety profile and drug interactions.

Evidence Summary

Clinical trial data and evidence tiers.