# CJC-1295 vs Ipamorelin: FDA Status and Research

> CJC-1295 and ipamorelin compared: how each acts on growth hormone, FDA and compounding status, human studies, half-life and FDA safety concerns.

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- Last updated: October 25, 2026
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| | 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| FDA safety list | Listed as nominated but withdrawn from category 2, with safety concerns stated [1].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](/regulation/tracker/), the full [CJC-1295](/peptides/cjc-1295/) and [ipamorelin](/peptides/ipamorelin/) pages, and [503A vs 503B pharmacies](/regulation/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].

## 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, CJC-1295-related bulk drug substances, December 4, 2024](https://www.fda.gov/media/183819/download)
3. [FDA: PCAC final summary minutes, December 4, 2024](https://www.fda.gov/media/185642/download)
4. [FDA: PCAC briefing document, ipamorelin-related bulk drug substances, October 29, 2024](https://www.fda.gov/media/182088/download)
5. [FDA: PCAC final summary minutes, October 29, 2024](https://www.fda.gov/media/185412/download)
6. [Teichman et al. 2006, J Clin Endocrinol Metab (PubMed)](https://pubmed.ncbi.nlm.nih.gov/16352683/)
7. [Ionescu and Frohman 2006, J Clin Endocrinol Metab (PubMed)](https://pubmed.ncbi.nlm.nih.gov/17018654/)
8. [Gobburu et al. 1999, Pharm Res (PubMed)](https://pubmed.ncbi.nlm.nih.gov/10496658/)
9. [Beck et al. 2014, Int J Colorectal Dis (PubMed)](https://pubmed.ncbi.nlm.nih.gov/25331030/)
10. [FDA: Bulk drug substances used in compounding under section 503A](https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act)

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