CJC-1295 (with DAC) vs Sermorelin
CJC-1295 with DAC and sermorelin are both based on the first 29 amino acids of growth hormone-releasing hormone (GHRH), but they differ in how long they persist in circulation and in regulatory history 1,7. CJC-1295 with DAC carries a maleimidopropionamide-lysine group that binds covalently to circulating albumin, and its estimated half-life in healthy adults was several days 2,5. Sermorelin is unmodified GHRH(1-29) amide, cleared within minutes, and was FDA-approved as GEREF, although both GEREF applications are now listed as discontinued 9,10. CJC-1295 has never been FDA-approved and appears on the FDA's compounding page of substances that may present significant safety risks, current as of 22 April 2026 6.


Side by side
| Field | CJC-1295 (with DAC) | Sermorelin |
|---|---|---|
| Class | Long-acting albumin-binding GHRH analogue (drug affinity complex) 1,5 | GHRH analogue 7 |
| Origin and structure | GHRH(1-29) with a maleimidopropionamide-lysine unit added at the C terminus, identified by ConjuChem 1,5 | 29-amino-acid analogue of human GHRH, described as the shortest synthetic peptide with full GHRH activity 7 |
| Proposed mechanism | Acts at the GHRH receptor; in rats it binds serum albumin, which extends its time in circulation 1. In healthy men, growth hormone pulsatility was preserved while trough levels rose 3 | Stimulates growth hormone secretion from the anterior pituitary 7 |
| Half-life | Estimated at 5.8 to 8.1 days in healthy adults 2; FDA slides cite a half-life of up to 8 days from the same work 5 | Disappearance half-time of about 4 minutes for GHRH(1-29)-NH2 infused intravenously in healthy men 9 |
| Highest human trial phase | Phase 2 in HIV-associated visceral obesity, terminated, no results posted 4 | Approved product; a multicentre study enrolled 110 children with growth hormone deficiency 8,10 |
| FDA status | Never FDA-approved; CJC-1295 is listed among bulk substances that may present significant safety risks (nomination withdrawn), as of 22 April 2026 6 | Approved as GEREF (NDA 019863, 1990; NDA 020443, 1997), both listed as discontinued in Drugs@FDA as of 24 October 2026 10; in 2013 FDA determined GEREF was not withdrawn for safety- or efficacy-related reasons 11 |
| Published human outcomes | In healthy adults, growth hormone and IGF-I rose for several days after a single injection; no trial in growth hormone deficiency was identified by FDA 2,5 | In growth hormone-deficient children, mean height velocity rose over 12 months in an open-label study 8; a review notes smaller increases than with somatropin 7 |
| Safety signals | FDA slides list injection-site reactions, systemic vasodilatory reactions, headache, gastrointestinal symptoms, dizziness and heart-rate increase in healthy-adult studies, and describe an unpublished phase 2 trial that was terminated after a participant died of myocardial infarction 5. The FDA compounding page cites immunogenicity and characterisation concerns 6 | No adverse biochemical or hormonal changes, and no change in fasting glucose, were reported in the 110-child study 8 |
| WADA status | CJC-1295 is named under S2.2.4 (growth hormone releasing factors); prohibited at all times (2026 List) 12 | Sermorelin is named under S2.2.4 (growth hormone releasing factors); prohibited at all times (2026 List) 12 |
| Who funded the evidence | Discovery work was done at ConjuChem 1; the healthy-adult pharmacokinetic study was authored from a pharmaceutical consultancy 2; the terminated phase 2 trial was sponsored by ConjuChem 4 | The paediatric study was run by the Geref International Study Group 8; the GEREF applications were held by EMD Serono 10 |
CJC-1295 (with DAC): what the data says
CJC-1295 was identified in rats as an albumin-binding GHRH(1-29) derivative with a longer presence in plasma than unmodified GHRH(1-29) (animal data) 1.
- In two randomized, placebo-controlled ascending-dose studies in healthy adults (humans), growth hormone and IGF-I rose for several days after injection, and the estimated half-life was 5.8 to 8.1 days 2.
- In healthy men (humans), growth hormone pulse frequency and magnitude were unchanged while trough levels and IGF-I rose 3.
- FDA reviewers reported that no article described outcomes in people with growth hormone deficiency, and that it is often unclear which chemical form was used in published studies 5.
- A phase 2 trial in HIV-associated visceral obesity was terminated and no results were posted 4; FDA slides describe a participant death from myocardial infarction in an unpublished trial of this type 5.
Sermorelin: what the data says
Sermorelin was developed for diagnosis and treatment of idiopathic growth hormone deficiency in children 7.
- In a multicentre open-label study of 110 previously untreated prepubertal children (humans), mean height velocity increased at 6 and 12 months, and 74% were considered good responders at 6 months 8.
- A review reports smaller height-velocity increases than with somatropin and notes that effects on final adult height were not determined 7.
- In healthy men, GHRH(1-29)-NH2 was cleared rapidly, with a disappearance half-time of about 4 minutes 9.
Key research differences
- Duration: the DAC modification binds albumin and extends the half-life to days 1,2, whereas unmodified GHRH(1-29) is cleared in minutes 9.
- Regulatory history: sermorelin was FDA-approved as GEREF, now discontinued 10,11; CJC-1295 has never been approved and is on the FDA's compounding risk page 6.
- Population studied: sermorelin's main published outcome data come from children with growth hormone deficiency 8; CJC-1295 human data come from healthy adults, with no growth hormone deficiency outcome data identified by FDA 5.
- Documented harms: FDA slides describe a terminated, unpublished phase 2 trial with a participant death for CJC-1295 5; the sermorelin paediatric study reported no adverse biochemical changes 8.
Where the evidence is limited
No head-to-head trial was located. The CJC-1295 human literature consists of short pharmacokinetic and pharmacodynamic studies in healthy adults, and FDA reviewers note that the exact substance used in those studies is unclear because several chemical forms share the name 5. Sermorelin's outcome data come from an open-label paediatric study without a placebo group 8. Half-life values were measured by different routes and methods 2,9, and the terminated phase 2 safety report for CJC-1295 is described only through FDA slides and unpublished sources 5.
Frequently asked questions
What does 'with DAC' mean?
Is either compound FDA-approved?
Can CJC-1295 with DAC and sermorelin be compared directly?
Are they prohibited in sport?
References
- Human growth hormone-releasing factor (hGRF)1-29-albumin bioconjugates activate the GRF receptor on the anterior pituitary in rats: identification of CJC-1295 as a long-lasting GRF analog Endocrinology. 2005
- Prolonged stimulation of growth hormone (GH) and insulin-like growth factor I secretion by CJC-1295, a long-acting analog of GH-releasing hormone, in healthy adults Journal of Clinical Endocrinology and Metabolism. 2006
- Pulsatile secretion of growth hormone (GH) persists during continuous stimulation by CJC-1295, a long-acting GH-releasing hormone analog Journal of Clinical Endocrinology and Metabolism. 2006
- A Study to Evaluate CJC 1295 in HIV Patients With Visceral Obesity (NCT00267527), phase 2, terminated ClinicalTrials.gov. 2006
- Pharmacy Compounding Advisory Committee, 4 December 2024: FDA presentation slides on CJC-1295-related bulk drug substances FDA. 2024
- Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (content current as of 04/22/2026) FDA (Human Drug Compounding). 2026
- Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency BioDrugs. 1999
- [...] subcutaneous growth hormone-releasing hormone therapy accelerates growth in growth hormone-deficient children during the first year of therapy. Geref International Study Group Journal of Clinical Endocrinology and Metabolism. 1996
- Incorporation of D-Ala2 in growth hormone-releasing hormone-(1-29)-NH2 increases the half-life and decreases metabolic clearance in normal men Journal of Clinical Endocrinology and Metabolism. 1994
- Drugs@FDA (openFDA) records for GEREF: NDA 019863 and NDA 020443, marketing status discontinued FDA openFDA. 2026
- Federal Register notice 2013-04827: determination that GEREF (sermorelin acetate) injection was not withdrawn from sale for safety- or efficacy-related reasons Federal Register (FDA). 2013
- Prohibited List 2026 (in force 1 January 2026) World Anti-Doping Agency. 2026
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