# CJC-1295: FDA Status, Research and Uses

> CJC-1295 (with and without DAC) FDA status, the 2024 compounding committee vote, WADA status, and the small human studies done so far.

- Canonical URL: https://livingpluspeptides.com/peptides/cjc-1295/
- Last updated: October 25, 2026
- Publisher: Living+

CJC-1295 is a lab-made analog of growth hormone-releasing hormone (GHRH). Its best studied form, CJC-1295 with DAC, binds albumin in the blood and lasts for days. It is not FDA approved. It was studied in small trials in healthy adults, and its developer stopped trials in 2006 after a death [2, 4].

## 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- 503A compounding: [Nomination withdrawn or removed](https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks). Nominations withdrawn; FDA lists CJC-1295 under 'nominated but withdrawn' from category 2 (page current as of April 22, 2026), with safety concerns stated. Not in any 503A category on the May 14, 2026 list. PCAC voted against inclusion on December 4, 2024.
- 503B bulks list: [Not nominated](https://www.fda.gov/media/94164/download). Not in any 503B category (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 releasing factors (GHRH analog))
- FDA drug shortage: [Not on the shortage list](https://api.fda.gov/drug/shortages.json?search=generic_name:%22CJC%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, CJC-1295, December 4, 2024](https://www.fda.gov/media/183819/download), [FDA: PCAC final summary minutes, December 4, 2024](https://www.fda.gov/media/185642/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: CJC (no matches)](https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22CJC%22), [openFDA drug shortages query: CJC](https://api.fda.gov/drug/shortages.json?search=generic_name:%22CJC%22), [DEA Diversion: Controlled Substances - Alphabetical Order](https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf)

## Key facts

- Class: Growth hormone-releasing hormone (GHRH) analog [2]
- Amino-acid length: 29 amino acids (the DAC form adds a reactive lysine group that binds albumin) [2, 6]
- Half-life: About 5.8 to 8.1 days for CJC-1295 with DAC (healthy adults) [4]
- Route used in studies: Subcutaneous injection in human studies [4]
- First studied: 2005 (first described, in rats); first human studies published in 2006 [6, 2]

## How it works

The brain makes growth hormone-releasing hormone, or GHRH. GHRH signals the pituitary gland to release growth hormone. CJC-1295 is a lab-made peptide based on the first 29 amino acids of human GHRH. Four of those amino acids, at positions 2, 8, 15 and 27, were swapped to make it more stable [2].

The name CJC-1295 covers two different substances. FDA treats CJC-1295 without DAC and CJC-1295 with DAC as two distinct active moieties [2]. DAC stands for drug affinity complex. It is a reactive lysine group that binds to albumin, a protein in the blood. In rats, this kept the peptide in the blood beyond 72 hours [6].

In healthy adults, one dose of CJC-1295 with DAC raised growth hormone 2- to 10-fold for 6 days or more and raised IGF-1 for 9 to 11 days. Its estimated half-life was 5.8 to 8.1 days [4]. Growth hormone still came in pulses, but the baseline level between pulses rose sharply [5].

FDA found no studies of any form of CJC-1295 in people with growth hormone deficiency, the use it was nominated for. All published human studies used the DAC form in healthy people [2].

## What the research shows

| Study | Year | Participants | Design | Result | Link |
| --- | --- | --- | --- | --- | --- |
| Human trial: Teichman et al., first human trials | 2006 | Healthy adults aged 21 to 61 (42 in study 1, 24 in study 2) | Two randomized, double-blind, placebo-controlled, ascending-dose trials lasting 28 and 49 days [4, 2] | After one dose, GH rose 2- to 10-fold for 6 days or more and IGF-1 rose 1.5- to 3-fold for 9 to 11 days. Estimated half-life was 5.8 to 8.1 days [4] | [Source](https://pubmed.ncbi.nlm.nih.gov/16352683/) |
| Human trial: Ionescu and Frohman, GH pulse study | 2006 | Healthy men aged 20 to 40 | Single dose of 60 or 90 mcg/kg, overnight GH sampling every 20 minutes before and 1 week after | Trough GH rose 7.5-fold, mean GH rose 46% and IGF-1 rose 45%. GH pulse frequency and size were unchanged [5] | [Source](https://pubmed.ncbi.nlm.nih.gov/17018654/) |
| Human trial: ConjuChem phase 2 trial in HIV (NCT00267527) | 2005 | People with HIV-associated visceral obesity (registry lists 120; FDA cites reports of 192 enrolled) | Phase 2, randomized, placebo-controlled, double-blind, 12 weeks | Terminated. FDA cites reports that one participant died after a heart attack and notes the data were never published [7, 2] | [Source](https://clinicaltrials.gov/study/NCT00267527) |
| Animal study: Jette et al., discovery study | 2005 | Rats and cultured rat pituitary cells | Lab and animal tests of GHRH 1-29 albumin conjugates | CJC-1295 gave a 4-fold larger GH response than GHRH 1-29 over 2 hours and was still in plasma beyond 72 hours [6] | [Source](https://pubmed.ncbi.nlm.nih.gov/15817669/) |

## Doses used in studies

In the first human trials, healthy adults received single subcutaneous doses from 30 to 250 mcg/kg. In a second trial, they received 2 or 3 doses of 20 to 60 mcg/kg given weekly or every 2 weeks [2, 4].

In the GH pulse study, healthy men received a single dose of 60 or 90 mcg/kg [5]. No dose has been tested or approved for any medical use [2].

**Dosing is set by a licensed provider.**

## Side effects and safety

FDA lists CJC-1295 on its compounding safety risks page. It says compounded CJC-1295 may pose a risk of immune reactions and that FDA has identified serious adverse events, including increased heart rate and systemic vasodilatory reactions. FDA adds that clinical data are limited [1].

In the first human trials, injection site reactions occurred in about 70% of people on CJC-1295. Headache occurred in 63% vs 14% on placebo, diarrhea in 43%, and flushing, warmth and brief low blood pressure in 30%. Most side effects were more common at the higher doses [2]. A dose-dependent rise in heart rate was reported in the GH pulse study [2].

In 2006 the developer withdrew CJC-1295 with DAC from clinical trials after a participant in a phase 2 trial died [2]. FDA cites reports that the person had chest discomfort 2 hours after the 11th weekly dose, and an ECG confirmed a heart attack. The attending physician linked it to underlying coronary artery disease [2]. No safety data exist in children [2].

## Legal and regulatory status

- 2026-05-14: FDA's 503A nominations list, updated May 14, 2026, does not list CJC-1295 in category 1, 2 or 3 [9]. [Source](https://www.fda.gov/media/94155/download)
- 2026-04-22: FDA's compounding safety risks page (current as of April 22, 2026) lists CJC-1295 under bulk drug substances nominated but withdrawn from category 2. Its safety concerns are still stated [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 CJC-1295 under S2.2.4 (GHRH and its analogs), banned at all times [8]. [Source](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf)
- 2024-12-04: FDA's Pharmacy Compounding Advisory Committee voted against adding CJC-1295 to the 503A Bulks List: 13 to 0 for the free base and the DAC forms, and 12 to 1 for the acetate [3]. [Source](https://www.fda.gov/media/185642/download)
- 2024-11-15: FDA's review for the committee recommended that none of the five CJC-1295 forms be placed on the 503A Bulks List. The original nominations had been withdrawn, and FDA reviewed them on its own [2]. [Source](https://www.fda.gov/media/183819/download)

See every peptide's status side by side in the [Peptide Status Tracker](https://livingpluspeptides.com/regulation/tracker/#row-cjc-1295).

## Frequently asked questions

### Is CJC-1295 FDA approved?

No. No form of CJC-1295 is FDA approved, and FDA says none is a component of an FDA-approved drug [2].

### Can pharmacies legally compound CJC-1295?

Under 503A, a bulk substance must have a USP monograph, be part of an approved drug, or be on the 503A Bulks List [10]. FDA says CJC-1295 has no monograph and is not part of an approved drug [2], and the advisory committee voted against listing it in 2024 [3].

### What is the difference between CJC-1295 with DAC and without DAC?

FDA treats them as two distinct active moieties. The DAC form has an added group that binds albumin, which made it last days in human studies [2, 4].

### Why did CJC-1295 trials stop?

The developer withdrew CJC-1295 with DAC from clinical trials in 2006 after a participant in a phase 2 HIV trial died [2, 7].

### Is CJC-1295 banned in sports?

Yes. The WADA 2026 Prohibited List names CJC-1295 under S2.2.4, banned in and out of competition [8].

### What side effects were reported with CJC-1295?

In healthy adults, injection site reactions, headache, diarrhea, flushing and brief low blood pressure were reported, and heart rate rose in one study [2].

### Is CJC-1295 the same as sermorelin?

No. Both are based on GHRH 1-29, but CJC-1295 has four swapped amino acids and, in the DAC form, an albumin-binding group [2]. WADA lists both as GHRH analogs [8].

### Has CJC-1295 been tested in people with growth hormone deficiency?

FDA found no studies of any form of CJC-1295 in people with growth hormone deficiency [2].

## 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. [Teichman et al. 2006, J Clin Endocrinol Metab (PubMed)](https://pubmed.ncbi.nlm.nih.gov/16352683/)
5. [Ionescu and Frohman 2006, J Clin Endocrinol Metab (PubMed)](https://pubmed.ncbi.nlm.nih.gov/17018654/)
6. [Jette et al. 2005, Endocrinology (PubMed)](https://pubmed.ncbi.nlm.nih.gov/15817669/)
7. [ClinicalTrials.gov: NCT00267527](https://clinicaltrials.gov/study/NCT00267527)
8. [WADA: 2026 Prohibited List](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf)
9. [FDA: Bulk drug substances nominated under section 503A (categories, updated May 14, 2026)](https://www.fda.gov/media/94155/download)
10. [Federal Register 2026-07361: PCAC meeting notice, July 2026 (FDA)](https://public-inspection.federalregister.gov/2026-07361.pdf)

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