CJC-1295 vs Ipamorelin: FDA Status and Research

Q: Is CJC-1295 or ipamorelin FDA approved?

No. FDA says neither is a component of an FDA-approved drug.

	CJC-1295	Ipamorelin
FDA status	Not FDA approved and not part of any approved drug ^[2]. FDA advisers voted against adding it to the 503A Bulks List on Dec 4, 2024 ^[3].	Not FDA approved and not part of any approved drug ^[4]. FDA advisers voted against adding it to the 503A Bulks List on Oct 29, 2024 ^[5].
Studied for	Raising growth hormone and IGF-1 in healthy adults. FDA found no published studies in people with a disease ^{[2, 6]}.	Bowel recovery after surgery. A phase 2 trial found no significant gain over placebo ^[9].
Route	Subcutaneous injection in human studies ^[6].	IV infusion in human trials ^{[8, 9]}.
Key trials	Teichman et al. 2006 and Ionescu and Frohman 2006, both in healthy adults ^{[6, 7]}.	Gobburu et al. 1999 in healthy men and Beck et al. 2014 after bowel surgery ^{[8, 9]}.
How it acts	Growth hormone-releasing hormone (GHRH) analog ^[2].	Ghrelin receptor agonist (growth hormone secretagogue) ^{[9, 4]}.
Half-life	5.8 to 8.1 days for the DAC form ^[6].	About 2 hours after IV infusion ^[8].
FDA safety list	Listed as nominated but withdrawn from category 2, with safety concerns stated ^[1].	In 503B category 2 (significant safety risks) since Sep 29, 2023 ^[1].

CJC-1295 and ipamorelin both raise growth hormone, but by different routes. CJC-1295 copies the brain hormone GHRH, while ipamorelin acts on the ghrelin receptor ^{[2, 9]}. Neither is FDA approved, and FDA's advisers voted against letting pharmacies compound either one from bulk powder under section 503A ^{[3, 5]}.

Two different signals to the pituitary

CJC-1295 is a 29 amino acid peptide based on human GHRH. FDA treats the form with DAC, which binds albumin in the blood, and the form without DAC as two different active moieties ^[2]. In healthy adults, one shot of the DAC form raised growth hormone 2- to 10-fold for 6 days or more. Its estimated half-life was 5.8 to 8.1 days ^[6].

Ipamorelin is a 5 amino acid peptide first identified in 1998 ^[4]. It binds the ghrelin receptor ^[9]. In healthy men given IV infusions, it caused one burst of growth hormone that peaked at about 0.67 hours. Its half-life was about 2 hours ^[8]. So one lasts days and the other lasts hours.

FDA notes that drugs that trigger growth hormone release depend on a working pituitary. People with complete growth hormone deficiency will not respond to them ^{[2, 4]}.

What each was studied for

All published human studies of CJC-1295 used the DAC form in healthy people. FDA found no studies of any form in people with a disease or condition. A phase 2 trial in people with HIV was stopped ^[2]. One study found that growth hormone still came in pulses, while trough levels rose 7.5-fold ^[7].

Ipamorelin was tested for bowel recovery after surgery. In a phase 2 trial of 114 analyzed patients, median time to first tolerated meal was 25.3 hours vs 32.6 hours on placebo. That gap was not significant ^[9]. FDA found no data that ipamorelin helps diagnose or treat growth hormone deficiency ^[4].

Safety concerns FDA has raised

FDA's compounding safety page says compounded CJC-1295 may pose a risk of immune reactions. It cites serious adverse events, including faster heart rate and systemic vasodilatory reactions ^[1]. The developer withdrew CJC-1295 with DAC from trials in 2006 after a phase 2 participant died ^[2].

For ipamorelin acetate, FDA cites a risk of immune reactions and notes that its non-natural amino acids make it harder to characterize. FDA also cites a published study with serious adverse events, including death, when it was given by IV for gut motility ^[1]. FDA added ipamorelin acetate to 503B category 2 on Sep 29, 2023 ^[1].

Why they are often named together

FDA's reviews mention reports of a "trending" pairing of ipamorelin with CJC-1295 ^[4]. FDA found no data on whether ipamorelin, with or without CJC-1295, improved growth hormone deficiency ^[4]. Pairing them in practice is not the same as testing them together in a trial.

FDA also found no data supporting ipamorelin for bowel recovery after surgery ^[4]. For CJC-1295, FDA found no data on how well any form treats growth hormone deficiency ^[2].

Compounding rules for both

Under section 503A, a pharmacy may compound from a bulk substance only if it has a USP or NF monograph, is part of an approved drug, or is on FDA's 503A bulks list ^[10]. FDA says neither peptide has a monograph or is part of an approved drug ^{[2, 4]}. See the FDA Peptide Status Tracker, the full CJC-1295 and ipamorelin pages, and 503A vs 503B pharmacies for more ^[1].

Frequently asked questions

Is CJC-1295 or ipamorelin FDA approved?

No. FDA says neither is a component of an FDA-approved drug ^{[2, 4]}.

What is the main difference between CJC-1295 and ipamorelin?

CJC-1295 is a GHRH analog, while ipamorelin acts on the ghrelin receptor ^{[2, 9]}. The DAC form of CJC-1295 lasted days in studies, while ipamorelin's half-life was about 2 hours ^{[6, 8]}.

Has the CJC-1295 and ipamorelin combination been studied?

FDA's ipamorelin review notes reports of the pairing but found no data on whether it improved growth hormone deficiency ^[4].

Can pharmacies compound CJC-1295 or ipamorelin?

FDA advisers voted against adding either to the 503A Bulks List, in December and October 2024 ^{[3, 5]}. Ipamorelin acetate is also in 503B category 2 for safety risks ^[1].

Which one lasts longer in the body?

CJC-1295 with DAC had an estimated half-life of 5.8 to 8.1 days in healthy adults ^[6]. Ipamorelin's half-life was about 2 hours after IV infusion ^[8].

What safety issues has FDA flagged?

For CJC-1295, faster heart rate and vasodilatory reactions. For ipamorelin, serious adverse events including death when given by IV for gut motility ^[1].