MOTS-c

FDA's 2026 review did not identify any in-vivo human or animal pharmacokinetic study of MOTs-C, but noted a laboratory study reporting that MOTs-C was rapidly broken down into shorter fragments when incubated in human whole blood in vitro. FDA stated it remains unknown whether exogenously administered MOTs-C can reach pharmacologically active concentrations in the body over time.^[1]

• This describes FDA's characterization of a cited in-vitro blood-incubation experiment, not this batch's independent inspection of that primary paper, and not a human pharmacokinetic measurement.
• In-vitro degradation does not by itself establish the clinical effect, or lack of effect, of injected MOTs-C.

FDA’s July 2026 review did not identify human studies administering the exact MOTs-C free base or acetate preparations it evaluated. Measurements of naturally occurring MOTs-C and studies of modified analogues do not establish efficacy or pharmacokinetics of injected MOTs-C.^[1]

• This is the documented scope of the regulator’s review, not a claim that every possible report has been excluded.
• FDA's review states it found no clinical studies or human exposure data for MOTS-c via any route of administration, not only an absence of matching-preparation studies; see the separate record on the in-vitro blood-hydrolysis finding it also reported.