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HealthRX.com · Printable question sheet

Young-adult MOTS-c record: the product, reproductive plans and questions for a clinician

Being young lowers baseline risk; it does not supply missing safety data. Fill in the product details and any pregnancy, fertility or hormone plans, then bring the sheet to a clinician, or keep it ready for a poison specialist if a dosing mistake is possible.

Companion to “MOTS-c Safety in Young Adults: The Missing Treatment Denominator” · healthrx.com/mots-c/young-adult-safety · Facts checked 2026-10-18

The product

Exact product name, and the seller or pharmacy
Lot number and stated concentration
Route, amount and time of each usefrom your own notes, not from a web schedule
How it has been stored since it arrived

Plans and context a clinician will ask about

Could you or a partner become pregnant in the coming year?
Current contraception, if any
Trying to conceive, fertility treatment, or sperm or egg banking
Hormone medicinesbirth control, testosterone, thyroid or others
Competitive sport with drug testing
Other medicines, supplements and alcohol use
Medical conditions you have been told about

Where the evidence stands for young adults

  • The healthy-men study that included ages 18 to 30 measured the body's own MOTS-c; nobody in it was given MOTS-c.[1]
  • FDA's July 2026 review identified no developmental and reproductive toxicity studies and no repeat-dose toxicity studies of MOTS-c.[2]
  • ICH M3(R2) describes a high level of concern about unintended exposure of an embryo or fetus when women who could become pregnant join drug trials.[3]
  • The registered MOTS-c trial enrolls ages 18 to 65 and excludes pregnancy, breastfeeding and planned pregnancy.[4]

Questions for the clinician

  1. If I am trying to conceive, or could become pregnant, what would you advise about a product with no reproductive safety data?
  2. Could any hormone or contraceptive medicine I take make a new symptom harder to read?
  3. Is there an approved option, studied in people my age, for the goal I have?
  4. Which symptoms would mean I should stop and contact you?
  5. If I think I used the wrong amount, whom should I call first?
Sources for the facts on this sheet
  1. D'Souza RF, Woodhead JST, Hedges CP, et al. Increased expression of the mitochondrial derived peptide, MOTS-c, in skeletal muscle of healthy aging men is associated with myofiber composition. Aging (Albany NY) 2020. PMID 32182209. https://pubmed.ncbi.nlm.nih.gov/32182209/
  2. U.S. Food and Drug Administration. FDA Briefing Document: MOTS-c-Related Bulk Drug Substances (MOTS-c (free base) and MOTS-c acetate), Pharmacy Compounding Advisory Committee, July 23-24, 2026. Accessed 2026-10-18. https://www.fda.gov/media/193347/download
  3. International Council for Harmonisation. ICH M3(R2): Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (Step 4, 11 June 2009). Accessed 2026-10-18. https://database.ich.org/sites/default/files/M3_R2__Guideline.pdf
  4. U.S. National Library of Medicine, ClinicalTrials.gov (API v2 record). NCT07505745: A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Pharmacodynamics of MOTS-c (a Mitochondrial-Derived Peptide) in Adults With Prediabetes and Overweight/Obesity. Accessed 2026-10-18. https://clinicaltrials.gov/api/v2/studies/NCT07505745

This sheet records information for a conversation with your prescriber or pharmacist. It does not replace their instructions or the medication's prescribing information.