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AMIRAVOResearch Library

Tesamorelin vs CJC-1295 (no DAC)

Tesamorelin and CJC-1295 without DAC are both growth hormone-releasing hormone (GHRH) analogues, but they sit at opposite ends of the evidence spectrum 1,5. Tesamorelin is FDA-approved (initial US approval 2010) for reducing excess abdominal fat in adults with HIV and lipodystrophy, with two phase 3 placebo-controlled trials behind it 1,3. CJC-1295 without DAC is a GHRH(1-29) analogue that FDA reviewers describe as first referenced in the literature in 2010 through an unidentified preparation seized by Norwegian authorities, with no nonclinical or clinical data to assess it 5. It has never been approved and appears on the FDA's compounding page of substances that may present significant safety risks, current as of 22 April 2026 7.

Unbranded reference vial illustrating Tesamorelin; not an actual product
Tesamorelin
FDA-approved
Unbranded reference vial illustrating CJC-1295 (no DAC); not an actual product
CJC-1295 (no DAC)
Not approved — research use only

Side by side

FieldTesamorelinCJC-1295 (no DAC)
ClassGHRH (growth hormone-releasing factor) analogue 1GHRH(1-29) analogue without the albumin-binding drug affinity complex 5
Origin and structureThe 44-amino-acid sequence of human GRF with a trans-3-hexenoyl group attached at the N-terminal tyrosine; prepared as an acetate salt 1A 29-amino-acid GHRH analogue (Tyr-D-Ala-Asp-Ala-Ile-Phe-Thr-Gln-Ser-Tyr-Arg-Lys-Val-Leu-Ala-Gln-Leu-Ser-Ala-Arg-Lys-Leu-Leu-Gln-Asp-Ile-Leu-Ser-Arg-NH2) per FDA's characterisation 5
Proposed mechanismBinds and stimulates human GRF receptors with potency similar to endogenous GRF, causing pulsatile release of endogenous growth hormone 1Presumed GHRH receptor agonism by analogy; FDA states it did not identify pharmacological studies of CJC-1295 free base or acetate and that it is unknown whether these forms are pharmacologically active 5
Half-lifeAbout 11 minutes in healthy subjects after subcutaneous administration, per the US label 1Not located for this form; unmodified GHRH(1-29)-NH2 had a disappearance half-time of about 4 minutes in healthy men, and the DAC modification was created specifically to overcome that short half-life 5,9
Highest human trial phaseApproved product; two phase 3 placebo-controlled trials 1,3,10No human study of this form located; FDA states there are no nonclinical or clinical data for CJC-1295 free base or acetate 5
FDA statusFDA-approved; initial US approval 2010, EGRIFTA WR label revised 03/2025 1Never approved; CJC-1295 appears on the FDA compounding page among substances that may present significant safety risks (nomination withdrawn), as of 22 April 2026 7
Published human outcomesVisceral fat fell 15.2% versus a 5.0% rise with placebo in a 412-patient trial 2; a pooled analysis of two phase 3 trials (806 patients) reported a 15.4% treatment effect 3; liver fat fell more than placebo in a 61-patient trial 4None located for the non-DAC form; the published human pharmacokinetic and growth hormone studies used a DAC-containing form, and FDA notes the salt forms were not specified 5,6
Safety signalsLabel warnings include neoplasm risk, elevated IGF-1, fluid retention, glucose intolerance, hypersensitivity and increased mortality in acute critical illness 1No safety data for this form; FDA cites immunogenicity and characterisation concerns, limited water solubility, and notes genotoxicity signals and injection-site findings for DAC-containing forms in animals 5,7
WADA statusNamed under S2.2.4 (GHRH analogues); prohibited at all times (2026 List) 11CJC-1295 is named under S2.2.4 (GHRH analogues); prohibited at all times (2026 List) 11
Who funded the evidencePhase 3 registration sponsored by Theratechnologies 10; later liver-fat trials funded by the US NIH 4No sponsored research located; the available assessment is FDA's own review of nominated compounding substances 5,6

Tesamorelin: what the data says

Tesamorelin is approved in the US for reducing excess abdominal fat in HIV-infected adults with lipodystrophy; the label states that long-term cardiovascular safety has not been established and that the product is not indicated for body-weight management 1.

  • In a 412-patient randomized trial (humans), visceral adipose tissue decreased by 15.2% with tesamorelin and increased by 5.0% with placebo over 26 weeks, with IGF-I rising by 81% 2.
  • A pooled analysis of two phase 3 trials (806 patients) reported a 15.4% treatment effect on visceral fat and no significant change in subcutaneous abdominal fat 3.
  • In a 61-patient NIH-funded trial in HIV with non-alcoholic fatty liver disease (humans), hepatic fat fraction fell more than with placebo over 12 months 4.

CJC-1295 (no DAC): what the data says

FDA's 2024 review of CJC-1295-related substances separates the DAC-containing forms, which have published human pharmacokinetic studies, from CJC-1295 without DAC, which does not 5.

  • FDA states that CJC-1295 without DAC was first referenced in the literature in 2010, in the identification of an unknown pharmaceutical preparation seized by Norwegian police and customs 5.
  • FDA concluded there is no nonclinical or clinical data to assess CJC-1295 free base or acetate, and that it is unknown whether these forms are pharmacologically active 5.
  • FDA also concluded the substances are not well characterised, citing missing impurity, aggregate and endotoxin data, and noted limited water solubility for the free base 5.
  • The DAC modification was introduced in 2005 specifically to overcome the short half-life of GHRH(1-29), so a non-DAC analogue would not be expected to share the long duration measured for DAC forms 5,8.

Key research differences

  • Approval: tesamorelin is an FDA-approved product; CJC-1295 in any form has never been approved 1,7.
  • Human data: tesamorelin has two phase 3 trials with over 800 participants combined 3, while FDA found no clinical data at all for CJC-1295 without DAC 5.
  • Characterisation: tesamorelin's identity and composition are set out in an approved label 1; FDA judged CJC-1295 substances not well characterised 5.
  • Expected duration: the albumin-binding DAC unit, absent here, was what extended the molecule's time in circulation 5,8.

Where the evidence is limited

These two compounds cannot be compared on outcomes, because only one has human outcome data. Tesamorelin's results come from trials in adults with HIV-associated abdominal fat and are specific to that population and endpoint 2,3. For CJC-1295 without DAC, FDA states there are no nonclinical or clinical data, and that published studies carrying the CJC-1295 name used DAC-containing material of unspecified salt form 5,6. Any inference from the DAC literature to the non-DAC form is therefore unsupported 5.

Frequently asked questions

What is the difference between CJC-1295 with and without DAC?
The DAC is a maleimidopropionamide-lysine unit that binds serum albumin and was added to overcome the short half-life of GHRH(1-29) 5,8. FDA found no pharmacological studies of the non-DAC forms and says it is unknown whether they are active 5.
Is tesamorelin FDA-approved?
Yes. Tesamorelin is approved for reducing excess abdominal fat in HIV-infected adults with lipodystrophy, with initial US approval in 2010 1.
Can tesamorelin and CJC-1295 (no DAC) be compared directly?
No. Tesamorelin has phase 3 trial data, while FDA states there are no nonclinical or clinical data for CJC-1295 free base or acetate 3,5.
Are both named on the WADA list?
Yes. WADA's 2026 Prohibited List names tesamorelin and CJC-1295 under S2.2.4, growth hormone releasing factors, prohibited at all times 11.

References

  1. EGRIFTA WR (tesamorelin) for injection, prescribing information (revised 03/2025) DailyMed (NLM). 2025
  2. Metabolic effects of a growth hormone-releasing factor in patients with HIV New England Journal of Medicine. 2007
  3. Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in HIV-infected patients with excess abdominal fat: a pooled analysis of two phase 3 trials with safety extension data Journal of Clinical Endocrinology and Metabolism. 2010
  4. Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial Lancet HIV. 2019
  5. Pharmacy Compounding Advisory Committee, 4 December 2024: FDA presentation slides on CJC-1295-related bulk drug substances FDA. 2024
  6. FDA Briefing Document, Pharmacy Compounding Advisory Committee, 4 December 2024 (CJC-1295-, AOD-9604- and thymosin alpha-1-related bulk drug substances) FDA. 2024
  7. 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
  8. 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
  9. 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
  10. TH9507 in Patients With HIV-Associated Lipodystrophy (NCT00123253) ClinicalTrials.gov. 2013
  11. Prohibited List 2026 (in force 1 January 2026) World Anti-Doping Agency. 2026

For research use only. Not for human or veterinary use. Not a drug, food, or dietary supplement. This page compares published research and is not medical advice or a recommendation.