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.
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.
| Month | Product, seller and lot | Results a clinician ordered | Reactions or symptoms | Other changes that month |
|---|---|---|---|---|
For your clinician
- Which of my results could be explained by diet, training or weight change rather than the product?
- Which symptoms, such as dizziness, shakiness or a hard lump at an injection site, should make me contact you?
- Given that no human study exists, what would make you advise stopping?
- Is there a registered trial I could ask about instead of using an untested product?
- Do any of my current medicines make an unstudied product riskier for me?
Sources for the facts on this sheet
- 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
- 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
- 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.