Ipamorelin (NNC 26-0161)
Synthetic pentapeptide ghrelin receptor (GHS-R1a) agonist and growth hormone secretagogue. Developed by Novo Nordisk; selectively stimulates pituitary growth hormone release without significant elevations in ACTH, cortisol, or prolactin. Lacks FDA approval for any clinical indication.
60-Second Scientific Briefing
Ipamorelin is a synthetic pentapeptide that acts as a selective agonist at the ghrelin/growth hormone secretagogue receptor (GHSR-1a). Unlike older secretagogues, it stimulates GH secretion with minimal effect on ACTH, cortisol, or prolactin. It was evaluated in early trials for postoperative ileus but was never approved by the US FDA.
What is Ipamorelin?
Pharmacological Classification & Molecular IdentitySynthetic pentapeptide growth hormone secretagogue containing non-proteinogenic amino acids (Aib and D-2-Nal).
Verified Chemical & Regulatory Registry Identifiers
Mechanism of Action & Receptor Targets
Biological Pathway and Target BindingBiological pathway and target receptor binding mechanism.
Receptor Selectivity: Selectively binds and activates pituitary GHSR-1a, mimicking ghrelin to provoke episodic growth hormone release without significantly elevating plasma ACTH, cortisol, or prolactin.
Regulatory & FDA Approval Status
Legal and Regulatory ClassificationsNot approved by the US FDA for human therapy. Classified under FDA 503A Category 2 with safety concerns. Prohibited at all times by WADA under S2 (Peptide Hormones, Growth Factors).
Ipamorelin is not approved for commercial sale, prescription therapy, or compounded medication distribution. It exists strictly within authorized scientific and clinical research frameworks.
Human Evidence & Clinical Trials
Clinical Study Readouts and Evidence SynthesesInvestigated in Phase 1 and Phase 2 trials for postoperative bowel recovery (ileus) in the 2000s; trials did not demonstrate sufficient efficacy for approval and commercial development was halted.
Clinical Evidence
Investigated in Phase 1 and Phase 2 trials for postoperative bowel recovery (ileus) in the 2000s; trials did not demonstrate sufficient efficacy for approval and commercial development was halted.
Safety Profile & Clinical Limitations
Documented Adverse Events and Known UncertaintiesDocumented effects in early trials include headache, lightheadedness, transient flushing, and mild water retention. Uncontrolled long-term safety profile is unestablished.
Effects on insulin resistance, IGF-1 elevation and long-term neoplastic risks outside clinical supervision.
Dose Approval Status
Commercial Dosing Status and Policy DirectivesNOT ESTABLISHED. No approved medical dosing protocol exists.
Under Egypt Peptides medical governance policies, no personal dosages, titration intervals, cycles, stacking recommendations, or self-injection instructions may be provided for unapproved investigational compounds. Clinical study protocols represent controlled experimental research parameters exclusively.
What is Known vs. What is Unknown
Evidence Comparison and Clinical Evidence Boundaries✓ Confirmed Scientific Evidence
- Synthetic pentapeptide growth hormone secretagogue containing non-proteinogenic amino acids (Aib and D-2-Nal).
- Targets & Selectivity: Selectively binds and activates pituitary GHSR-1a, mimicking ghrelin to provoke episodic growth hormone release without significantly elevating plasma ACTH, cortisol, or prolactin.
- Investigated in Phase 1 and Phase 2 trials for postoperative bowel recovery (ileus) in the 2000s; trials did not demonstrate sufficient efficacy for approval and commercial development was halted.
- Safety considerations: Documented effects in early trials include headache, lightheadedness, transient flushing, and mild water retention. Uncontrolled long-term safety profile is unestablished.
? Unknown / Under Ongoing Investigation
- Effects on insulin resistance, IGF-1 elevation and long-term neoplastic risks outside clinical supervision.
Verified Questions & Answers
10 Verified scientific answers with permanent anchor keysIpamorelin is classified as a Growth Hormone Secretagogue Receptor (GHSR) Agonist. Molecular structure: Synthetic pentapeptide growth hormone secretagogue containing non-proteinogenic amino acids (Aib and D-2-Nal)..
Pharmacological classification and molecular integrity are documented in verified regulatory and scientific literature.
- Ipamorelin, the first selective growth hormone secretagogue (European Journal of Endocrinology, 1998-11-01)
Ipamorelin exerts biological activity via Selectively binds and activates pituitary GHSR-1a, mimicking ghrelin to provoke episodic growth hormone release without significantly elevating plasma ACTH, cortisol, or prolactin..
Receptor binding affinity and selectivity dictate the physiological response observed in laboratory and clinical trials.
- Ipamorelin, the first selective growth hormone secretagogue (European Journal of Endocrinology, 1998-11-01)
Regulatory status: Not approved by the US FDA for human therapy. Classified under FDA 503A Category 2 with safety concerns. Prohibited at all times by WADA under S2 (Peptide Hormones, Growth Factors).
Investigational and research-only compounds cannot be legally distributed or marketed as prescription drugs.
- World Anti-Doping Agency (WADA) Prohibited List: Non-Approved Substances (S0) and Peptide Hormones (S2) (World Anti-Doping Agency, 2024-01-01)
- FDA Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (Category 2 Safety Evaluation) (U.S. Food and Drug Administration, 2023-09-29)
Clinical evaluation status: Investigated in Phase 1 and Phase 2 trials for postoperative bowel recovery (ileus) in the 2000s; trials did not demonstrate sufficient efficacy for approval and commercial development was halted.
Clinical trial readouts and systematic analyses establish the boundary between demonstrated findings and experimental hypotheses.
- FDA Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (Category 2 Safety Evaluation) (U.S. Food and Drug Administration, 2023-09-29)
- Ipamorelin, the first selective growth hormone secretagogue (European Journal of Endocrinology, 1998-11-01)
Reported safety profile: Documented effects in early trials include headache, lightheadedness, transient flushing, and mild water retention. Uncontrolled long-term safety profile is unestablished.
Adverse reaction monitoring and contraindications are critical parameters in pharmacological risk-benefit evaluation.
- Ipamorelin, the first selective growth hormone secretagogue (European Journal of Endocrinology, 1998-11-01)
Key scientific uncertainties: Effects on insulin resistance, IGF-1 elevation and long-term neoplastic risks outside clinical supervision.
Egypt Peptides enforces strict transparency regarding scientific limitations and gaps in longitudinal clinical data.
- FDA Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (Category 2 Safety Evaluation) (U.S. Food and Drug Administration, 2023-09-29)
NOT ESTABLISHED. No approved medical dosing protocol exists.
Under medical governance mandates, clinical study dosages represent strictly controlled experimental parameters and must never be interpreted as individual therapeutic advice.
- FDA Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (Category 2 Safety Evaluation) (U.S. Food and Drug Administration, 2023-09-29)
Storage status: NOT ESTABLISHED. Research materials require laboratory refrigeration.
Peptide integrity degrades rapidly when exposed to elevated temperatures, repeated freeze-thaw cycles, or direct UV light exposure.
- FDA Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (Category 2 Safety Evaluation) (U.S. Food and Drug Administration, 2023-09-29)
Yes. Unapproved pharmacological substances are strictly prohibited at all times in competitive sports under WADA Category S0 (Non-approved substances) or Category S2.
Athletes subject to drug testing face strict liability and multi-year competition bans upon detection of prohibited peptides or their metabolites.
- World Anti-Doping Agency (WADA) Prohibited List: Non-Approved Substances (S0) and Peptide Hormones (S2) (World Anti-Doping Agency, 2024-01-01)
- FDA Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (Category 2 Safety Evaluation) (U.S. Food and Drug Administration, 2023-09-29)
Egypt Peptides provides peer-reviewed scientific reference monographs for research documentation. We strictly prohibit individual medical consultations, reconstitution guides, stacking recipes, or off-label use instructions.
All scientific claims must link to verified authoritative sources (FDA, PubMed, ClinicalTrials.gov) with zero tolerance for ungrounded marketing claims.
- Ipamorelin, the first selective growth hormone secretagogue (European Journal of Endocrinology, 1998-11-01)
Authoritative Sources & Literature Registry
Regulatory dossiers, clinical trial registries, and peer-reviewed studiesWorld Anti-Doping Agency (WADA) Prohibited List: Non-Approved Substances (S0) and Peptide Hormones (S2) ↗
https://www.wada-ama.org/en/prohibited-list
FDA Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (Category 2 Safety Evaluation) ↗
https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act
Ipamorelin, the first selective growth hormone secretagogue ↗
https://doi.org/10.1530/eje.0.1390552