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Peptide profile

Ipamorelin: FDA Status, Research and Uses

By Living+. Updated October 25, 2026.

Key takeaway

Ipamorelin is a lab-made 5 amino acid peptide that triggers growth hormone release through the ghrelin receptor. It is not FDA approved. It was studied for bowel recovery after surgery and showed no clear benefit over placebo. FDA lists it as a compounding safety concern, and WADA bans it [1, 2, 7, 9].

At a glance

Where it stands

Checked

  • FDA approvedNoNo approved product
  • Pharmacy compounding (503A)Withdrawn503A nominations withdrawn September 19, 2024; FDA lists it as nominated but withdrawn from category 2. Not in any 503A category on the May 14, 2026 list. PCAC voted 0-12-1 against inclusion on October 29, 2024.
  • Outsourcing facilities (503B)Category 2Ipamorelin acetate is in 503B category 2 (significant safety risks) since September 29, 2023 (list updated March 21, 2025).
  • WADA (sport)ProhibitedS2.2.4 Growth hormone secretagogues (GHS)
Same data as the Status Tracker. Checked against 10 sources

Key facts

Class
Growth hormone secretagogue (ghrelin receptor agonist) [5, 7]
Length
5 amino acids (pentapeptide) with non-natural amino acids [5, 2]
Half-life
About 2 hours after IV infusion (healthy men) [6]
Route in studies
Intravenous in human trials; FDA also reviewed compounded subcutaneous and nasal products [6, 7, 2]
First studied
1998 [5, 2]

How it works

Growth hormone release is controlled by more than one signal. One of them is the ghrelin receptor, also called the growth hormone secretagogue receptor. Ipamorelin is a lab-made peptide of 5 amino acids that binds this receptor. Researchers at Novo Nordisk found it in a series of compounds based on an older peptide called GHRP-1 [5, 2].

In lab and animal tests, ipamorelin released growth hormone about as strongly as GHRP-6. Unlike GHRP-6 and GHRP-2, it did not raise the stress hormones ACTH and cortisol in pigs, even at doses more than 200 times the amount needed for growth hormone release. The authors called it the first selective growth hormone secretagogue [5].

In healthy men given IV infusions, ipamorelin caused a single burst of growth hormone that peaked at about 0.67 hours, then faded. Its half-life was about 2 hours [6].

Ghrelin receptor activity also speeds up gut movement, which is why ipamorelin was tested for bowel recovery after surgery [7]. FDA notes that drugs in this class depend on a working pituitary. People with complete growth hormone deficiency are not expected to respond [2].

What the research shows

3 human trials1 animal study

  1. 2014Human trial

    Beck et al., Ipamorelin 201 Study Group

    Studied for postoperative ileus

    117 adults after bowel resection (114 analyzed) Phase 2, randomized, double-blind, placebo-controlled, multicenter, up to 7 days

    Median time to first tolerated meal was 25.3 hours vs 32.6 hours on placebo, not a significant difference (p = 0.15) [7]

    Read the study
  2. 2011Human trial

    Helsinn phase 2 dose-finding trial (NCT01280344)

    320 adults after bowel resection (actual enrollment) Phase 2, double-blind, placebo-controlled, dose finding

    Completed. Listed by FDA as a study of ipamorelin acetate for bowel recovery after bowel resection [8, 2]

    Read the study
  3. 1999Human trial

    Gobburu et al., healthy volunteer PK study

    Healthy men, 8 per dose level at 5 dose levels Dose escalation, 15-minute IV infusions

    Half-life was about 2 hours. Each dose caused one growth hormone peak at about 0.67 hours [6]

    Read the study
  4. 1998Animal study

    Raun et al., discovery study

    Rat pituitary cells, rats and pigs Lab and animal pharmacology tests

    Released growth hormone with potency similar to GHRP-6, without raising ACTH or cortisol in pigs [5]

    Read the study

Doses used in studies

In the bowel surgery trial, patients received 0.03 mg/kg by IV infusion twice daily for up to 7 days [7]. In the healthy volunteer study, 15-minute IV infusions ranged from 4.21 to 140.45 nmol/kg [6].

FDA found no data supporting ipamorelin for diagnosing or treating growth hormone deficiency in children or adults [2].

Dosing is set by a licensed provider.

Side effects and safety

FDA lists ipamorelin acetate on its compounding safety risks page. It says compounded ipamorelin may pose a risk of immune reactions and contains non-natural amino acids that make it harder to characterize. FDA cites a published study with serious adverse events, including death, when ipamorelin was given by IV for gut motility [1].

In that bowel surgery trial, low blood potassium (12.5% vs 3.4%), insomnia (10.7% vs 5.2%) and high blood sugar at discharge (14.3% vs 8.6%) were more common on ipamorelin than placebo. Two people on ipamorelin died after complications of colon cancer surgery. FDA says it is unclear if the deaths were related to the drug [2].

FDA's adverse event database had two non-serious reports for compounded ipamorelin through September 30, 2023 [2]. FDA found no safety data for ipamorelin given by certain other injection routes [1].

Common questions

Is ipamorelin FDA approved?

No. FDA says ipamorelin is not a component of any FDA-approved drug and has no USP monograph [2].

Is ipamorelin legal to compound?

FDA's advisers voted against adding it to the 503A Bulks List in 2024 [3], and it is not in any 503A category [10]. For outsourcing facilities, ipamorelin acetate is in 503B category 2 for safety risks [11, 1].

How is ipamorelin different from GHRP-6 and GHRP-2?

In animal tests it released growth hormone like GHRP-6 but did not raise ACTH or cortisol, while GHRP-6 and GHRP-2 did [5].

Did ipamorelin help bowel recovery after surgery?

In a phase 2 trial of 114 patients, time to first tolerated meal did not differ significantly from placebo [7].

Is ipamorelin banned in sports?

Yes. The WADA 2026 Prohibited List names ipamorelin under S2.2.4, banned in and out of competition [9].

Why is ipamorelin often paired with CJC-1295?

FDA's review notes reports of this pairing in practice. It found no data on whether ipamorelin, with or without CJC-1295, improved growth hormone deficiency [2].

How long does ipamorelin last in the body?

In healthy men given IV infusions, its half-life was about 2 hours [6].

What side effects were seen with ipamorelin?

In the surgery trial, low potassium, insomnia and high blood sugar were more common than on placebo [2]. FDA also flags a risk of immune reactions [1].

Sources

  1. FDA: Certain bulk drug substances for use in compounding that may present significant safety risks
  2. FDA: PCAC briefing document, ipamorelin-related bulk drug substances, October 29, 2024
  3. FDA: PCAC minutes, October 29, 2024
  4. FDA: PCAC transcript (PM session), October 29, 2024
  5. Raun et al. 1998, Eur J Endocrinol (PubMed)
  6. Gobburu et al. 1999, Pharm Res (PubMed)
  7. Beck et al. 2014, Int J Colorectal Dis (PubMed)
  8. ClinicalTrials.gov: NCT01280344
  9. WADA: 2026 Prohibited List
  10. FDA: Bulk drug substances nominated under section 503A (categories, updated May 14, 2026)
  11. FDA: Bulk drug substances nominated under section 503B (categories, updated March 21, 2025)

Updated October 25, 2026. Educational information, not medical advice.