FDA 2026 COMPOUNDING REVIEW

MOTS-c

A central mitochondrial and metabolic wellness signal with a substantial gap between biological interest and clinical validation.

Record version 1.0Last verified 5 September 2026Evidence grade CRegulatory surveillance cohort

FDA STATUS

Not FDA approved; advisory review is not drug approval

MHRA / UK LICENCE

No UK marketing authorisation identified

NICE STATUS

No NICE recommendation identified

NHS ACCESS

No routine NHS access

PRIVATE LAWFUL USE CONTEXT

Research market presence is not licensed clinical use

EVIDENCE MATURITY

Mechanistic and early human interest without authorised therapeutic use

DEVELOPMENT PHASE

Regulatory surveillance cohort

MARKET EXPOSURE

High research market

PROFESSIONAL RELEVANCE

Track human trials, regulatory development and combination exposure without extrapolating from unrelated authorised peptides.

Product, formulation and indication

No authorised product is represented for this investigational or surveillance record. Product level data will be added only when a sourceable regulated product exists.

Status history

5 September 2026

Production baseline verification recorded.

FDA PCAC reviewed 503A bulk substance nominations in July 2026

Future material changes will be appended with their previous status and source; they will not be silently overwritten.

Verify this record

Source labels identify what each link can prove. Sponsor material is used for time sensitive development claims only.