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HealthRX.com · Printable question sheet

One-year MOTS-c claim check and dated record to show a clinician

Questions that sort a 12-month MOTS-c story into what was measured and what was assumed, plus a month-by-month record for anyone already using a MOTS-c-labelled product to bring to a clinician.

Companion to “MOTS-c Year-1 Outcomes: What Real Users Report After 12 Months” · healthrx.com/reviews-mots-c/year-1-outcomes · Facts checked 2026-10-19

What a one-year result would normally rest on

  • ICH E1 treats 100 people followed for at least one year as an acceptable part of a long-term safety database.[1]
  • If none of those 100 has a serious adverse event, a one-year incidence above 3% can reasonably be ruled out; smaller or untracked groups cannot do this.[1]
  • FDA's July 2026 review identified no clinical studies or human exposure data for MOTS-c by any route.[2]
  • FDA says it lacks important information on whether MOTS-c would cause harm if given to people.[3]

Before trusting a 12-month story

  • Who took the measurement (a lab, a DEXA scan, a clinician), and on what dates
  • What else changed in the same months: diet, training, sleep, other medicines
  • Whether the product's identity and amount were ever tested
  • Whether the change reversed or held after stopping
  • Whether it describes one person, or a counted group followed the whole year

Month-by-month record, if you already use a MOTS-c-labelled product

Record what happened; leave out amounts and schedules found online.

MonthProduct, seller and lotResults a clinician orderedReactions or symptomsOther changes that month

For your clinician

  1. Which of my results could be explained by diet, training or weight change rather than the product?
  2. Which symptoms, such as dizziness, shakiness or a hard lump at an injection site, should make me contact you?
  3. Given that no human study exists, what would make you advise stopping?
  4. Is there a registered trial I could ask about instead of using an untested product?
  5. Do any of my current medicines make an unstudied product riskier for me?
Sources for the facts on this sheet
  1. International Council for Harmonisation (ICH). ICH E1: The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions (Step 4, 27 October 1994). Accessed 2026-10-19. https://database.ich.org/sites/default/files/E1_Guideline.pdf
  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 2026-10-19. https://www.fda.gov/media/193347/download
  3. U.S. Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. Accessed 2026-10-19. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks

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