SS-31
Elamipretide (SS-31) • Also called Elamipretide, Elamipretide Acetate, SS 31
SS-31, also called elamipretide, is a prominent mitochondrial peptide in biohacking circles, but FDA has identified elamipretide acetate as ineligible for use in human drug compounding under section 503A.
Current status
Restricted
Mitochondrial and energy interest, with current federal compounding constraints still in play.
FDA category
Not on 503A bulks list
Can pharmacies compound this?
No
Reclassification expected?
Unclear
Interest is strong, but the current federal signal is a direct 503A ineligibility problem rather than a favorable review pathway.
Primary Use
Mitochondrial and energy interest
Also searched as
Elamipretide, Elamipretide Acetate, SS 31
Regulatory Timeline
Feb 27, 2026
Political pressure and market expectations increased around a future peptide reclassification review.
Dec 8, 2025
Current status signal recorded: FDA warning-letter posture identifies elamipretide (SS-31) acetate as ineligible for use in human drug compounding under section 503A..
Mar 15, 2023
FDA peptide compounding scrutiny intensified across 503A and 503B channels.
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State-specific notes
Florida
Demand in longevity circles does not create a compliant compounding basis.