# Ipamorelin: FDA Status, Research and Uses

> Ipamorelin FDA status, the 2024 compounding committee vote, its 503B category 2 listing, WADA status, and the human studies to date.

- Canonical URL: https://livingpluspeptides.com/peptides/ipamorelin/
- Last updated: October 25, 2026
- Publisher: Living+

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].

## Regulatory status

- FDA approved: No
- 503A compounding: [Nomination withdrawn or removed](https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks). 503A nominations withdrawn September 19, 2024; FDA lists it as nominated but withdrawn from category 2.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.
- 503B bulks list: [Category 2 (significant safety concerns)](https://www.fda.gov/media/94164/download). Ipamorelin acetate is in 503B category 2 (significant safety risks) since September 29, 2023 (list updated March 21, 2025).
- WADA prohibited: [Yes](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf) (S2.2.4 Growth hormone secretagogues (GHS))
- FDA drug shortage: [Not on the shortage list](https://api.fda.gov/drug/shortages.json?search=generic_name:%22ipamorelin%22)
- DEA schedule: [Not scheduled](https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf)
- Last verified: November 2, 2026

Checked against: [FDA: 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), [FDA: PCAC briefing document, ipamorelin, October 29, 2024](https://www.fda.gov/media/182088/download), [FDA: PCAC minutes, October 29, 2024](https://www.fda.gov/media/185412/download), [FDA: PCAC transcript (PM session), October 29, 2024](https://www.fda.gov/media/185414/download), [FDA: Bulk drug substances nominated for use in compounding under section 503A (updated May 14, 2026)](https://www.fda.gov/media/94155/download), [FDA: Bulk drug substances nominated for use in compounding under section 503B (updated March 21, 2025)](https://www.fda.gov/media/94164/download), [WADA: 2026 Prohibited List](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf), [openFDA Drugs@FDA query: ipamorelin (no matches)](https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22ipamorelin%22), [openFDA drug shortages query: ipamorelin](https://api.fda.gov/drug/shortages.json?search=generic_name:%22ipamorelin%22), [DEA Diversion: Controlled Substances - Alphabetical Order](https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf)

## Key facts

- Class: Growth hormone secretagogue (ghrelin receptor agonist) [5, 7]
- Amino-acid length: 5 amino acids (pentapeptide) with non-natural amino acids [5, 2]
- Half-life: About 2 hours after IV infusion (healthy men) [6]
- Route used 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

| Study | Year | Participants | Design | Result | Link |
| --- | --- | --- | --- | --- | --- |
| Human trial: Beck et al., Ipamorelin 201 Study Group | 2014 | 117 adults after bowel resection (114 analyzed) | Phase 2, randomized, double-blind, placebo-controlled, multicenter, up to 7 days | Studied for postoperative ileus. Median time to first tolerated meal was 25.3 hours vs 32.6 hours on placebo, not a significant difference (p = 0.15) [7] | [Source](https://pubmed.ncbi.nlm.nih.gov/25331030/) |
| Human trial: Helsinn phase 2 dose-finding trial (NCT01280344) | 2011 | 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] | [Source](https://clinicaltrials.gov/study/NCT01280344) |
| Human trial: Gobburu et al., healthy volunteer PK study | 1999 | 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] | [Source](https://pubmed.ncbi.nlm.nih.gov/10496658/) |
| Animal study: Raun et al., discovery study | 1998 | 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] | [Source](https://pubmed.ncbi.nlm.nih.gov/9849822/) |

## 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].

## Legal and regulatory status

- 2026-05-14: FDA's 503A nominations list, updated May 14, 2026, does not list ipamorelin in category 1, 2 or 3 [10]. [Source](https://www.fda.gov/media/94155/download)
- 2026-04-22: FDA's compounding safety risks page (current as of April 22, 2026) keeps ipamorelin acetate in 503B category 2 and also lists it as nominated but withdrawn [1]. [Source](https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks)
- 2026-01-01: The WADA 2026 Prohibited List took effect. It names ipamorelin under S2.2.4 (growth hormone secretagogues), banned at all times [9]. [Source](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf)
- 2024-10-29: FDA's Pharmacy Compounding Advisory Committee voted 0 yes, 12 no, 1 abstain on adding ipamorelin free base, and the same on ipamorelin acetate, to the 503A Bulks List [3]. [Source](https://www.fda.gov/media/185412/download)
- 2024-09-19: The 503A nominations for ipamorelin and ipamorelin acetate were withdrawn. FDA still presented its review to the committee [4]. [Source](https://www.fda.gov/media/185414/download)
- 2023-09-29: FDA added ipamorelin acetate to 503B category 2 (significant safety risks) [1]. [Source](https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks)

See every peptide's status side by side in the [Peptide Status Tracker](https://livingpluspeptides.com/regulation/tracker/#row-ipamorelin).

## Frequently asked 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](https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks)
2. [FDA: PCAC briefing document, ipamorelin-related bulk drug substances, October 29, 2024](https://www.fda.gov/media/182088/download)
3. [FDA: PCAC minutes, October 29, 2024](https://www.fda.gov/media/185412/download)
4. [FDA: PCAC transcript (PM session), October 29, 2024](https://www.fda.gov/media/185414/download)
5. [Raun et al. 1998, Eur J Endocrinol (PubMed)](https://pubmed.ncbi.nlm.nih.gov/9849822/)
6. [Gobburu et al. 1999, Pharm Res (PubMed)](https://pubmed.ncbi.nlm.nih.gov/10496658/)
7. [Beck et al. 2014, Int J Colorectal Dis (PubMed)](https://pubmed.ncbi.nlm.nih.gov/25331030/)
8. [ClinicalTrials.gov: NCT01280344](https://clinicaltrials.gov/study/NCT01280344)
9. [WADA: 2026 Prohibited List](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf)
10. [FDA: Bulk drug substances nominated under section 503A (categories, updated May 14, 2026)](https://www.fda.gov/media/94155/download)
11. [FDA: Bulk drug substances nominated under section 503B (categories, updated March 21, 2025)](https://www.fda.gov/media/94164/download)

Educational information, not medical advice. This site sells nothing.