Ipamorelin: where it stands with the FDA, and what it costs
Often prescribed together with CJC-1295. No FDA-approved drug contains it.
Go to clinicLowest per monthIpamorelin injection
Pepti · $239/mo (≈ $256 per 30 days with its fees)
Where Ipamorelin stands today
No FDA-approved drug contains ipamorelin. FDA put ipamorelin acetate in 503A Category 2 (significant safety risks) in September 2023 and removed it in September 2024 because the nominations were withdrawn; on October 29, 2024 FDA's Pharmacy Compounding Advisory Committee voted 0 to 12 (1 abstention) against adding either form to the 503A bulks list. No final rule has followed. For outsourcing facilities it remains in 503B Category 2. It is not among the six peptides in HHS's October 2026 interim policy.
For pharmacies compounding one patient's prescription (section 503A)
Not in any 503A category and not on the 503A bulks list. Removed from Category 2 in September 2024 after its nominations were withdrawn; the advisory committee voted against listing it (Oct 29, 2024); no final rule yet. Not in HHS's Oct 2026 interim policy.
“Bulk drug substances nominated but withdrawn ... Ipamorelin acetate , which also appears in the table above because it is in category 2 under the 503B interim policy”
““Ipamorelin acetate” has been removed from Category 2 because the nominations were withdrawn by the nominators.”
FDA interim 503A bulks policy: a substance outside Category 1 gets no interim enforcement discretion
“Drug products compounded using a bulk drug substance for which each of the above circumstances are not present are not within the scope of the policy described in this guidance.”
For outsourcing facilities (section 503B)
503B Category 2 (Bulk Drug Substances that Raise Significant Safety Risks), added September 29, 2023.
“Ipamorelin acetate 503B September 29, 2023 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.”
“503B Category 2: Bulk Drug Substances that Raise Significant Safety Risks ... Ipamorelin Acetate”
The FDA's compounding advisory committee
29 October 2024: Should ipamorelin (free base) be placed on the 503A bulks list? Should ipamorelin acetate? (uses FDA reviewed: growth hormone deficiency and postoperative ileus). Vote: Free base: Yes 0, No 12, Abstain 1. Acetate: Yes 0, No 12, Abstain 1.. Committee advised against listing; FDA has published no rule since
“VOTE: FDA is proposing that Ipamorelin (free base) NOT be included on the 503A Bulks List. Should Ipamorelin (free base) be placed on the list? Vote Result: Yes: 0 No: 12 Abstain: 1 Committee Discussion: The majority of the Committee members voted against placing Ipamorelin (free base) on the 503A Bulks List.”
FDA warnings, recalls and letters
24 August 2026: Five warning letters dated 24 Aug 2026 to research-peptide sellers; each names PT-141 (bremelanotide) and tesamorelin as unapproved new drugs (the sellers' products have no approved application); NuScience also sold a tesamorelin/ipamorelin blend. (NuScience Peptides LLC (online 'research peptide' seller); same-day letters to Royal Peptides, Peak Performance Peptides, Peptide Partners and TXP Innovations dba Tex Peptides name PT-141 and tesamorelin too).
“Based on our review, “GLP-2 Tirz Peptide,” “GLP-1 Sema Research Peptide,” “GLP-3 RT (Retatrutide) Research Peptide,” “Survodutide,” “Mazdutide,” “PT-141 Peptide (Bremelanotide),” “Tesamorelin Research Peptide,” “Tesamorelin Ipamorelin Blend,” and “Bacteriostatic water for Peptides (BAC Water)” are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a).”
For athletes who are tested
Prohibited at all times (in and out of competition) (World Anti-Doping Agency, 2026 Prohibited List (in force 1 Jan 2026; WADA approved a 2027 list in Sept 2026, effective 1 Jan 2027, not read here)).
“growth hormone secretagogues (GHS) and their mimetics [e.g. anamorelin, capromorelin, ibutamoren (MK-677), ipamorelin”
Our reading
Ipamorelin has no current route to lawful 503A compounding (no monograph, no approved-drug component, not on the bulks list, not in Category 1 or the HHS policy), and 503B facilities are told it raises significant safety risks. A pharmacy compounding it does so outside FDA's enforcement policies.
Every source above was checked again on 14 November 2026.
What 3 clinics charge
- PeptiIpamorelin injection$239/mo≈ $256 per 30 days with its fees
What Ipamorelin is
- What it is
- Growth hormone secretagogue (ghrelin receptor agonist)
- How it works
- A five-amino-acid peptide that acts on the ghrelin receptor to prompt growth hormone release.
- How it is given
- Subcutaneous injection
Ipamorelin side by side
About Ipamorelin
Is Ipamorelin FDA-approved?
No. No FDA-approved drug contains Ipamorelin. What clinics sell is compounded by a pharmacy for a prescription, and the FDA does not review compounded products before they are sold.
Is Ipamorelin legal in the US?
Whether a pharmacy may compound it for your prescription is what decides it. No FDA-approved drug contains ipamorelin. FDA put ipamorelin acetate in 503A Category 2 (significant safety risks) in September 2023 and removed it in September 2024 because the nominations were withdrawn; on October 29, 2024 FDA's Pharmacy Compounding Advisory Committee voted 0 to 12 (1 abstention) against adding either form to the 503A bulks list. No final rule has followed. For outsourcing facilities it remains in 503B Category 2. It is not among the six peptides in HHS's October 2026 interim policy.
How much does Ipamorelin cost?
3 clinics publish a price. The lowest that compares per month is $239/mo at Pepti. What a month buys differs by clinic, so each price lists what it includes. every Ipamorelin price