FDA's advisory committee voted 0 to 12, with 1 abstention, against ipamorelin in October 2024 [2]. Sermorelin was the active ingredient in Geref, an FDA-approved drug for children with growth hormone deficiency whose approval was withdrawn in 2009 at the maker's request [4]. Neither has an FDA-approved product today, and human evidence for both is thin.
Ipamorelin is a growth hormone secretagogue and sermorelin a growth hormone releasing hormone analog; both are meant to make the body release more of its own growth hormone [6].
At a glance
A pharmacy may not compound ipamorelin. Sermorelin's status is not confirmed by FDA [1] [5].
Side by sideThe largest ipamorelin trial we found, in 114 surgery patients, showed no significant benefit over placebo [7].
What the research showsSermorelin studies in older adults were small and short, with 10 to 19 people [8] [9].
What the research shows
Quick answer
If you are deciding between the two, the legal gap matters more than the biology. Ipamorelin was reviewed by FDA's advisers and voted down, and it cannot be compounded under 503A [2] [1]. Sermorelin was never reviewed by that committee, is not on any of FDA's 503A category lists, and is sold by telehealth companies as a compounded drug [1]. Compounded drugs are not FDA-approved, and FDA does not review them for safety, effectiveness or quality before they are sold [15]. No study we found compares ipamorelin with sermorelin directly.

Side by side
| Ipamorelin | Sermorelin | |
|---|---|---|
| What it is | Growth hormone secretagogue [6] | Growth hormone releasing hormone (GHRH) analog [6] |
| FDA-approved product | None found [1] | None today. Geref was approved, then withdrawn effective June 18, 2009 at the maker's request [4] |
| Legal to compound | No. Not in Category 1 or on the 503A bulks list [1] | Not confirmed. Not on any 503A list, and FDA has not said whether its old approval counts [1] [5] |
| FDA committee review | 0-12-1 against, Oct 29, 2024 [2] | None found |
| Human evidence | One 114-patient surgery trial, no significant benefit [7] | Small studies of 10 to 19 older adults over 2 to 16 weeks [8] [9] |
| Safety findings FDA posted | Serious adverse events including death in a published study of IV use [3] | FDA found Geref was not withdrawn for safety or effectiveness reasons [4] |
| Sports (WADA) | Banned at all times, class S2 [6] | Banned at all times, class S2 [6] |
| How to get it legally | No legal route [1] | Prescription for a compounded product; legal basis not confirmed [5] |
| Price | No legal price [1] | $119 to $179 a month at two sellers, checked Oct 25, 2026 [10] [11] |
Legal status
FDA placed ipamorelin acetate in Category 2, its significant-safety-risk group, on Sept 29, 2023 [14] and brought it to the Pharmacy Compounding Advisory Committee on Oct 29, 2024. The vote was 0 yes, 12 no and 1 abstain on both ipamorelin and ipamorelin acetate [2]. Members cited "a lack of information supporting safety and efficacy" [2]. FDA now lists it as nominated but withdrawn, and ipamorelin acetate is still in Category 2 for 503B outsourcing facilities [3]. The full record is on our CJC-1295 and ipamorelin page.
Sermorelin's history is different. Geref vials were approved on Sept 26, 1997 "for the treatment of idiopathic growth hormone deficiency (GHD) in children with growth failure," and an ampule version was approved in 1990 for testing whether the pituitary can release growth hormone [4]. The maker, EMD Serono, stopped selling both, and FDA withdrew approval effective June 18, 2009 [4]. In 2013, FDA determined both were "not withdrawn for reasons of safety or effectiveness" [4]. Under 503A, a pharmacy may compound with a bulk substance that is a component of an FDA-approved drug, but FDA's page does not say whether that covers a drug whose approval was withdrawn [5]. Our sermorelin page follows that question.
Legal status of Ipamorelin
Not allowed in compoundingIpamorelin cannot be legally compounded [1]. An FDA advisory committee voted against it in October 2024 [2], and we found no new review scheduled [16].
- FDA status
- FDA placed it in Category 2 on Sept 29, 2023 [14]. FDA now lists it as "nominated but withdrawn," which is outside every category [3]. We could not confirm when the nomination was withdrawn. It was not one of the 12 peptides FDA removed from Category 2 in April 2026 [17]. It is not in Category 1 and is not on the 503A bulks list, so a 503A pharmacy may not lawfully compound it today [1]. Ipamorelin acetate is also still in Category 2 for 503B outsourcing facilities [3]. FDA says a published study identified serious adverse events, including death, when ipamorelin was given intravenously [3].
- Advisory committee
- On Oct 29, 2024, the committee voted 0 yes, 12 no and 1 abstain on both ipamorelin and ipamorelin acetate [2].
- FDA-approved products
- None. We found no FDA-approved drug that contains Ipamorelin.
- Sports (WADA)
- Prohibited under class S2 as a growth hormone secretagogue. Ipamorelin is named [6].
Checked against FDA sources on . We update this box when FDA acts. Report a change: [email protected].
Legal status of Sermorelin
Not confirmedSermorelin was the active ingredient in Geref, an FDA-approved drug whose approval FDA withdrew in 2009 at the maker's request [4]. We could not find an FDA statement on whether pharmacies may compound it, so its status is not confirmed [1].
- FDA status
- Sermorelin is not on any of FDA's 503A category lists [1]. It was the active ingredient in Geref. The maker stopped selling Geref, and FDA withdrew its approval at the maker's request, effective June 18, 2009 [4]. In 2013, FDA determined that Geref was not withdrawn from sale for reasons of safety or effectiveness [4]. Under 503A, a pharmacy may compound with a bulk substance that is a component of an FDA-approved drug when no USP or NF monograph exists [5]. FDA's 503A page does not say whether a drug whose approval was withdrawn counts [5]. We found no FDA statement applying this rule to sermorelin, so we list its status as not confirmed.
- Advisory committee
- We found no advisory committee review of sermorelin.
- FDA-approved products
- None. Geref was FDA-approved, but FDA withdrew its approval in 2009 after the maker stopped selling it [4].
- Sports (WADA)
- Prohibited under class S2 as a growth hormone releasing hormone analog. Sermorelin is named [6].
- What happens next
- FDA would need to state whether sermorelin qualifies as a component of an approved drug, or act on it another way. We found no pending FDA action.
Checked against FDA sources on . We update this box when FDA acts. Report a change: [email protected].
What the research shows
Ipamorelin
The largest human trial we found tested intravenous ipamorelin in 117 adults after bowel surgery, with 114 in the main analysis. Median time to the first solid meal people could keep down was 25.3 hours on ipamorelin and 32.6 hours on placebo, a gap that was not statistically significant (p = 0.15) [7]. Side effects of any kind were reported by 87.5% on ipamorelin and 94.8% on placebo [7]. That trial says nothing about the uses ipamorelin is sold for online, such as muscle, fat loss or sleep, and we found no controlled trial of those uses.
Sermorelin
Studies in older adults were small and short. In a 1992 study, 10 healthy older men (average age 68) took GHRH-(1-29) for 14 days; the higher dose raised growth hormone and IGF-1 to levels like those of young men, and the study did not measure body composition [8]. A 1997 study gave a modified form, [Nle27]GHRH-(1-29), to 19 adults aged 55 to 71 for 16 weeks. Lean body mass rose in the men only, skin thickness rose in both sexes, and transient high blood fats were reported [9]. Neither study tested strength, longevity or long-term safety, and neither used the compounded products sold today.
Known risks
- Ipamorelin: FDA says a published study "identified serious adverse events including death" when ipamorelin was given intravenously [3]. No large controlled trial gives side effect rates for the products sold online.
- Sermorelin: FDA found Geref was not withdrawn for safety reasons [4], but compounded sermorelin is not FDA-approved and is not the same product as Geref. In the 1997 study, transient high blood fats were reported [9].
- Both: Banned at all times for tested athletes under WADA class S2 [6].
When to get help
Hives, swelling of the face, lips or throat, or trouble breathing after an injection need emergency care. Call 911. Tell your doctor about any peptide you use, including where it came from.
Price
Ipamorelin has no legal price, because no pharmacy may compound it [1] and we found no approved drug that contains it. Compounded sermorelin was listed at $119 a month on a 12-month plan ($1,428 upfront) to $159 month to month at PlexusDx [10], and $149 a month on a 3-month plan ($447 upfront) or $179 for a single month at Rx.com, which names Manifest Pharmacy as its dispenser, checked Oct 25, 2026 [11]. Those prices are for a product whose legal basis FDA has not confirmed. More prices and their caveats: legal peptide price tracker.
"Research use only" vials of either peptide are not a legal workaround; FDA rejected that label in a 2025 warning letter [12]. We do not link to those sellers.
The approved drug in this family
Tesamorelin, sold as Egrifta WR, is an FDA-approved GHRH analog, but only to reduce excess abdominal fat in adults with HIV who have lipodystrophy; its label says it is not for weight loss [13]. See tesamorelin. For growth hormone itself, see sermorelin vs HGH, and for every peptide's status, the peptide FDA status tracker.
How we check
Legal status comes from FDA's 503A categories document, its safety-risk page and committee minutes, through our peptide status file. Study results come from the published abstracts. Prices come from the sellers' own pages on Oct 25, 2026; listing a price is not an endorsement. Our method: editorial standards.
Questions people ask
Is ipamorelin better than sermorelin?
No trial we found compares them. Ipamorelin was voted down 0-12-1 by FDA's advisory committee on Oct 29, 2024 and cannot be compounded [2] [1]; its largest trial, in 114 surgery patients, showed no significant benefit [7]. Sermorelin was once FDA-approved as Geref for children with growth hormone deficiency [4].
Is ipamorelin legal in the US?
Not as a drug. As of Oct 25, 2026, ipamorelin is not in FDA's Category 1 or on the 503A bulks list, so a pharmacy may not compound it, and no FDA-approved drug contains it [1].
Is sermorelin legal?
How much does sermorelin cost compared with ipamorelin?
What are the side effects of ipamorelin vs sermorelin?
Are ipamorelin and sermorelin banned in sports?
Yes. The 2026 WADA Prohibited List names both under class S2, banned at all times: ipamorelin as a growth hormone secretagogue and sermorelin as a GHRH analog [6].
Medical review: pending. A licensed clinician has not yet reviewed this page.
Sources
18 cited
- Bulk drug substances nominated for use in compounding under section 503A (categories document). FDA, May 14, 2026.
- Pharmacy Compounding Advisory Committee minutes, Oct 29, 2024. FDA, Oct 29, 2024.
- Certain bulk drug substances for use in compounding that may present significant safety risks. FDA, Apr 22, 2026.
- Determination that Geref (sermorelin acetate) products were not withdrawn from sale for reasons of safety or effectiveness. FDA (Federal Register), Mar 4, 2013.
- Bulk drug substances used in compounding under section 503A of the FD&C Act. FDA, May 14, 2026.
- 2026 Prohibited List. World Anti-Doping Agency (copy hosted by Asia Rugby), Sep 2025.
- Prospective, randomized, controlled, proof-of-concept study of the ghrelin mimetic ipamorelin for the management of postoperative ileus in bowel resection patients (Beck et al., Int J Colorectal Dis 2014;29(12):1527-1534). Uniformed Services University (publication record), Nov 15, 2014.
- Growth hormone-releasing hormone-(1-29) twice daily reverses the decreased GH and IGF-I levels in old men (Corpas et al., J Clin Endocrinol Metab 1992;75(2):530-535). PubMed, Aug 1992.
- Endocrine and metabolic effects of long-term administration of [Nle27]GHRH-(1-29)-NH2 in age-advanced men and women (Khorram et al., J Clin Endocrinol Metab 1997;82(5):1472-1479). PubMed, May 1997.
- Sermorelin. PlexusDx, Oct 25, 2026.
- Sermorelin. Rx.com (Rx Platform LLC), Oct 25, 2026.
- Warning letter: USApeptide.com. FDA, Feb 26, 2025.
- Egrifta WR (tesamorelin) prescribing information. FDA, Mar 2025.
- 503A categories update, September 2023. FDA (hosted by Alliance for Pharmacy Compounding), Sep 29, 2023.
- Compounding and the FDA: questions and answers. FDA, 2025-09-16 (accessed 2026-10-25).
- FDA's peptide rally: what compounders and industry need to know (post 1 of 2). Hyman, Phelps & McNamara (FDA Law Blog), Apr 21, 2026.
- FDA peptides do-not-compound list update (2026). Frier Levitt, Apr 16, 2026.
- July 23-24, 2026 Meeting of the Pharmacy Compounding Advisory Committee. FDA, Jul 23, 2026.
This page is general information, not medical advice. Talk with a licensed clinician about your own care.