Ipamorelin free base and ipamorelin acetate
No FDA-approved ipamorelin drug product. FDA's 2024 review recommended against adding either substance to the 503A Bulks List.
Current sourceIpamorelin
What limited human studies and FDA's compounding review actually show
Ipamorelin is an investigational growth-hormone secretagogue and ghrelin-receptor agonist, not an FDA-approved treatment. Human research is limited to early pharmacology work and a postoperative-ileus trial; it does not establish the body-composition, recovery, anti-aging, or wellness outcomes commonly promoted online.
Editorial status
This page aggregates regulatory documents and published human research. Its claims, citations, populations, and limitations received an independent editorial evidence check. Last editorial audit: .
It has not been medically reviewed by a clinician. It provides general education, not diagnosis, treatment, dosing instructions, or advice for an individual. Use the product-specific official information and consult a qualified clinician or pharmacist for personal decisions.
Product and regulatory distinctions
A compound name is not one interchangeable set of instructions. Product, formulation, indication, labeling, and jurisdiction matter.
Compounded injectable ipamorelin acetate
FDA identifies potential immunogenicity and characterization concerns and says available information is insufficient to know whether certain injectable routes would cause harm.
Current sourceClaim-by-claim evidence map
Each finding is tied to the population and product actually studied. Trial results are not personal predictions.
Intravenous ipamorelin caused a short-lived growth-hormone response in an early human pharmacology study.
- Population
- Forty healthy adult men in a dose-escalation study, eight at each infusion level.
- Finding
- Pharmacokinetic-pharmacodynamic modeling found a dose-related growth-hormone response after a 15-minute infusion.
- Limits
- This was a small, short pharmacology experiment in healthy men, not a trial of clinical benefit, chronic use, subcutaneous products, or combined peptide regimens.
A randomized phase 2 trial did not demonstrate a statistically significant improvement in its reported postoperative recovery outcome.
- Population
- Adults undergoing bowel resection in a prospective randomized, double-blind, placebo-controlled proof-of-concept study.
- Finding
- Median time to first tolerated meal was 25.3 hours with ipamorelin and 32.6 hours with placebo; the difference was not statistically significant (p=0.15).
- Limits
- The study concerned short-term intravenous use after surgery. It does not test or support physique, recovery, sleep, longevity, or outpatient wellness claims.
FDA found the evidence inadequate to establish safety for proposed compounded subcutaneous use.
- Population
- FDA review of the nominated bulk substances and available clinical and quality information.
- Finding
- FDA cited absent safety data for subcutaneous administration, immunogenicity concerns, incomplete impurity and aggregate characterization, and safety signals in intravenous development.
- Limits
- A regulatory evidence gap is not proof that every exposure causes harm; it means safety and effectiveness have not been established for the marketed use.
What this evidence does not answer
- No robust controlled trials establish muscle gain, fat loss, injury recovery, sleep improvement, or anti-aging benefit.
- Published intravenous studies cannot establish the safety, purity, exposure, or effectiveness of subcutaneous grey-market products.
- Evidence for ipamorelin alone cannot be transferred to CJC-1295/ipamorelin blends or other combinations.
Useful information to organize between visits
- Exact product label, named ingredients, route, and source
- Lot or batch identifier and any available dispensing documentation
- Symptoms with onset, severity, duration, and relationship to exposure
- Relevant laboratory results ordered and interpreted by a clinician
- Questions or suspected adverse events to discuss with a clinician or pharmacist
Questions to bring to a clinician or pharmacist
- 1.Is this an FDA-approved product, and what evidence supports the claimed purpose?
- 2.What product-quality and sterility information is actually available?
- 3.Could growth-hormone or IGF-1 effects conflict with my conditions, medicines, or laboratory results?
- 4.How should a suspected adverse event be evaluated and reported?
Primary sources
- FDA Briefing Document: IpamorelinU.S. Food and Drug Administration · Published 2024 · Accessed July 12, 2026
- Pharmacy Compounding Advisory Committee meeting transcriptU.S. Food and Drug Administration · Published 2024 · Accessed July 12, 2026
- Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety RisksU.S. Food and Drug Administration · Published 2023 · Accessed July 12, 2026
- Pharmacokinetic-pharmacodynamic modeling of ipamorelin in human volunteersPharmaceutical Research via PubMed · Published 1999 · Accessed July 12, 2026
- Prospective randomized controlled proof-of-concept study of ipamorelin for postoperative ileusInternational Journal of Colorectal Disease via PubMed · Published 2015 · Accessed July 12, 2026
- Safety and Efficacy of Ipamorelin for Management of Post-Operative Ileus (NCT00672074)ClinicalTrials.gov · Published 2008 · Accessed July 12, 2026
Turn scattered notes into a useful treatment history
Dosi organizes timing, locations, symptoms, reminders, and questions for your next appointment. It does not prescribe or replace your care team.
Start tracking free