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Guide

How is ipamorelin dosed?

Ipamorelin has no approved product and no completed Phase 3 trial. One published pharmacokinetic study and one published Phase 2 randomized trial exist — both intravenous, in a hospital or clinical-research setting, testing a different use than the subcutaneous dosing community sources describe. This page reads all three trials directly and states that distinction plainly.

Topic: Reading ipamorelin’s actual trial evidence, and why it describes a different route than community use

Audience: Anyone comparing an ipamorelin dose figure against what was actually studied

Reading time: 8–10 minutes

No approved product; every trial used IV administration

Ipamorelin has not been approved by the FDA, EMA, or any regulatory body. The two registered Phase 2 trials studied intravenous ipamorelin for postoperative ileus — a hospital-inpatient indication treating GI paralysis after bowel surgery — and the one published pharmacokinetic study also used IV infusion, in healthy volunteers. None used subcutaneous injection. Every figure on this page is a fact about a specific study — not a recommendation.

On this page
  1. 1.What ipamorelin is, and what's actually been tested
  2. 2.What the trials administered — all of them IV
  3. 3.Is there a community-reported dose?
  4. 4.Regulatory position: 503B Category 2 and a warning letter
  5. 5.Related pages
  6. 6.FAQ
  7. 7.References

What ipamorelin is, and what’s actually been tested

Ipamorelin is a synthetic pentapeptide developed by Novo Nordisk as a selective ghrelin receptor (GHSR-1a) agonist, intended to stimulate growth hormone release. It has no approved product anywhere and has not completed a Phase 3 trial. The ipamorelin profile covers the mechanism and broader research context; this page exists specifically to read every trial’s own dosing directly.

The evidence below is ordered the way the site’s own convention places it: published trial data first, graded by design, then community-reported practice last, attributed and marked unverified. All of the trial data here is intravenous, administered in a clinical or hospital setting — a materially different use than the subcutaneous self-injection community sources describe, and this page keeps that distinction visible throughout rather than presenting one dose figure as if it covered both.

What the trials administered — all of them IV

Three studies exist. Each is graded against Prof. Peptide’s standing citation convention — a claim is attributed when it resolves to a named, checkable source. Two grade as attributed, published, peer-reviewed studies; the third is a registered, completed trial with no published or posted result, reported here as that absence rather than left out entirely.

Gobburu et al. 1999 — Pharmacokinetic/Pharmacodynamic Study

Gobburu JV, Agersø H, Jusko WJ, Ynddal L. Pharm Res. 1999;16(9):1412–1416. PMID 10496658.

Design: Dose-escalation pharmacokinetic/pharmacodynamic study in healthy male volunteers. No efficacy or safety endpoint — the study characterizes disposition and GH response, not an indication.

Arms: 40 participants (8 healthy male subjects at each of 5 dose levels), IV infusion over 15 minutes at 4.21, 14.02, 42.13, 84.27, or 140.45 nmol/kg.

Endpoint reported: Dose-proportional pharmacokinetics: terminal half-life 2 hours, clearance 0.078 L/h/kg, volume of distribution at steady-state 0.22 L/kg. A single episode of GH release peaked at 0.67 hours post-infusion at every dose tested, with concentration for half-maximal GH stimulation (SC50) of 214 nmol/L.

Adverse events reported: No adverse-event data reported — safety was not a stated endpoint of this pharmacokinetic study.

Attributed — verbatim PubMed abstract read directly, registered pharmacokinetic study. Characterizes disposition and GH response only; not evidence for any therapeutic dose.

Beck, Sweeney & McCarter 2014 — Postoperative Ileus (Phase 2 RCT)

NCT00672074

Beck DE, Sweeney WB, McCarter MD; Ipamorelin 201 Study Group. Int J Colorectal Dis. 2014;29(12):1527–1534. PMID 25331030.

Design: Multicenter, randomized, double-blind, placebo-controlled Phase 2 trial in hospital inpatients undergoing small or large bowel resection by open or laparoscopic surgery. Proof-of-concept design for postoperative ileus.

Arms: 117 patients enrolled (114 in the safety and modified intent-to-treat populations), randomized to IV ipamorelin 0.03 mg/kg or placebo, twice daily, from postoperative day 1 to 7 or hospital discharge.

Endpoint reported: Primary efficacy endpoint (time to tolerance of a standardized solid meal): 25.3 hours (ipamorelin) versus 32.6 hours (placebo), p=0.15 — not statistically significant. The paper's own conclusion states no significant differences between ipamorelin and placebo in the key or secondary efficacy analyses.

Adverse events reported: Any treatment-emergent adverse event: 87.5% (ipamorelin) versus 94.8% (placebo) — a lower rate on ipamorelin, per the paper's own reported figures.

Attributed — verbatim PubMed abstract read directly, registered with a checkable NCT number independently confirmed against ClinicalTrials.gov (Phase 2, COMPLETED, actual enrollment 117). This is a completed, peer-reviewed, randomized controlled trial — the strongest single piece of human evidence on this page — but a hospital IV study that missed its primary endpoint, not a subcutaneous dosing study.

Ipamorelin Compared to Placebo for GI Function Recovery (Phase 2, Unpublished)

NCT01280344

ClinicalTrials.gov registry record only — no peer-reviewed publication or posted results found.

Design: Phase 2, randomized, double-blind, placebo-controlled dose-finding trial in patients following small or large bowel resection with primary anastomosis, for gastrointestinal dysmotility.

Arms: 320 participants (actual enrollment per the registry) randomized to IV ipamorelin 0.03 mg/kg twice daily, 0.06 mg/kg twice daily, 0.06 mg/kg three times daily, or matching placebo.

Endpoint reported: No results were ever posted to the ClinicalTrials.gov registry, and no peer-reviewed publication was found for this page. The registry marks the study COMPLETED with no results.

Adverse events reported: Not reported — no results exist to cite.

Topline absent — registered, completed, but with no published or posted outcome of any kind. Reported here as an absence: a 320-patient trial exists and ran to completion, but neither its efficacy nor its safety findings are available to attribute to anything.

The ipamorelin reconstitution calculator performs the arithmetic of converting a vial and reconstitution volume into syringe units for a given milligram or microgram figure; it does not set a schedule.

Is there a community-reported dose?

Yes — 200–300 mcg subcutaneously per injection, one to three times daily, most commonly at bedtime, is the figure consistently reported across vendor and blog dosing pages and already documented on the ipamorelin profile. It is reported here, below the trial evidence above, as observed practice attributed to where it circulates — not a studied dose.

It diverges from every trial on this page in two ways at once: route (subcutaneous versus every trial’s intravenous administration) and how the dose is specified (a fixed 200–300 microgram amount per injection, versus a body-weight-based milligram dose — 0.03 or 0.06 mg/kg — in the trials). No source was found deriving the community figure from either the Gobburu pharmacokinetic data or the ileus trials’ dosing.

Regulatory position: 503B Category 2 and a warning letter

Ipamorelin acetate is on FDA’s active 503B Category 2 list, and separately withdrawn from 503A consideration.

Checked directly against FDA’s own published bulk-substance safety-risk page: “Ipamorelin acetate” was added to the active 503B Category 2 list on September 29, 2023, with the stated concern that “compounded drugs containing Ipamorelin acetate may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation or peptide-related impurities.” The same substance and the same language also appear in the 503A “bulk drug substances nominated but withdrawn” table — meaning it is not on the active 503A list either.

A specific FDA warning letter does name a compounded ipamorelin product: on January 26, 2022, FDA sent a warning letter (624782) to Innoveix Pharmaceuticals Inc., referencing a compounded “Semorelin/Ipamorelin 3 mg for subcutaneous or intramuscular injection” product the firm had voluntarily recalled. The letter’s stated concern is sterility assurance — deficient sterile drug-production practices at that specific firm — not a 503A or 503B eligibility finding about ipamorelin as a substance, and this page keeps that distinction intact rather than treating the two as the same kind of regulatory action.

Research-grade ipamorelin, of the kind sold by the vendors Prof. Peptide tracks elsewhere on this site, is neither an approved product nor a verified lawfully compounded one under the current regulatory position above. It is sold labeled for laboratory research use, not for human administration, and it is not dispensed against a prescription.

FAQ

Is there an FDA-approved ipamorelin product?
No. Ipamorelin has not been approved by the FDA, EMA, or any regulatory body, for any indication. It has never completed a Phase 3 trial. The strongest evidence that exists is one published pharmacokinetic study and one published Phase 2 randomized trial, both using intravenous administration, neither leading to an approval.
What dose did the ipamorelin trials use?
All three studies used intravenous administration. Gobburu et al. 1999 used five ascending IV infusion doses from 4.21 to 140.45 nmol/kg over 15 minutes, in healthy volunteers, to characterize pharmacokinetics — not an indication or a recommended dose. Beck et al. 2014 (NCT00672074) used 0.03 mg/kg IV twice daily for up to 7 days, in hospital patients recovering from bowel surgery, to treat postoperative ileus. NCT01280344 tested 0.03 mg/kg IV twice daily, 0.06 mg/kg IV twice daily, and 0.06 mg/kg IV three times daily against placebo, for the same hospital indication, but never published results.
Were any of the trials done with subcutaneous injection?
No. All three used intravenous infusion — the two Phase 2 trials in a hospital-inpatient setting treating postoperative ileus, the pharmacokinetic study in a clinical research setting in healthy volunteers. None of them tested the subcutaneous route that community-reported ipamorelin use describes. This page states that distinction directly rather than presenting the IV trial doses as if they described subcutaneous use.
Did the postoperative ileus trial work?
No, not on its primary endpoint. Beck et al. 2014 reported median time to first tolerated meal was 25.3 hours with ipamorelin versus 32.6 hours with placebo — a numeric difference, but not statistically significant (p=0.15). The paper's own conclusion states there were no significant differences between ipamorelin and placebo in the key and secondary efficacy analyses.
What adverse events were reported in the trials?
In Beck et al. 2014, any treatment-emergent adverse event occurred in 87.5% of the ipamorelin group and 94.8% of the placebo group — a lower rate on ipamorelin, reported here precisely rather than described as comparable. The paper concludes the 0.03 mg/kg IV twice-daily dose was well tolerated over up to 7 days. Neither the Gobburu 1999 PK study nor NCT01280344 has published adverse-event data for Prof. Peptide to cite — NCT01280344 completed but never posted results.
Is there a commonly reported ipamorelin dosing protocol?
Yes — 200–300 mcg subcutaneously per injection, one to three times daily, most commonly at bedtime, is the figure the ipamorelin profile and vendor/blog sources consistently report. This diverges from every trial on this page in both route (subcutaneous versus IV) and magnitude (roughly 200–300 micrograms per dose community-side, versus a weight-based milligram dose — 0.03 or 0.06 mg/kg — in the trials). No source was found deriving the community figure from either trial.
What is ipamorelin's current FDA compounding status?
Restricted, and flagged for safety concerns FDA has not resolved. Ipamorelin acetate is on FDA's active 503B Category 2 list (added September 29, 2023), citing immunogenicity risk from potential aggregation or peptide-related impurities — checked directly against FDA's own published list. It also appears in the 503A "nominated but withdrawn" table with the same language, meaning it is not on the active 503A list either. A separate FDA warning letter (Innoveix Pharmaceuticals, 2022) names a compounded Sermorelin/Ipamorelin product, but its stated concern was sterility assurance in that firm's sterile-compounding practices — not a 503A/503B eligibility finding about ipamorelin itself.

References

  1. Gobburu JV, Agersø H, Jusko WJ, Ynddal L. Pharmacokinetic-pharmacodynamic modeling of ipamorelin, a growth hormone releasing peptide, in human volunteers. Pharm Res. 1999;16(9):1412–1416. PMID 10496658. https://pubmed.ncbi.nlm.nih.gov/10496658/
  2. Beck DE, Sweeney WB, McCarter MD; Ipamorelin 201 Study Group. Prospective, randomized, controlled, proof-of-concept study of the Ghrelin mimetic ipamorelin for the management of postoperative ileus in bowel resection patients. Int J Colorectal Dis. 2014;29(12):1527–1534. PMID 25331030. ClinicalTrials.gov NCT00672074. https://clinicaltrials.gov/study/NCT00672074
  3. ClinicalTrials.gov. Safety and Efficacy of Ipamorelin Compared to Placebo for the Recovery of Gastrointestinal Function, NCT01280344. https://clinicaltrials.gov/study/NCT01280344
  4. U.S. Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
  5. U.S. Food and Drug Administration. Warning Letter: Innoveix Pharmaceuticals Inc., reference 624782, 2022-01-26. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/innoveix-pharmaceuticals-inc-624782-01262022

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