Home / Peptides / CJC-1295 and Ipamorelin: Status, Trials and What's Unknown
CJC-1295 and Ipamorelin: Status, Trials and What's Unknown
Neither is FDA-approved. The full trial registry, why they were developed, and how 503A, 503B, FDA's advisory committee and HHS's policy treat each.
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Quick facts
Fact sheet
- U.S. status
- Strongest evidence
- Limited human data
- Status verified
CJC-1295 and ipamorelin are usually sold together. This guide is about what is on the record: which trials exist, why each was developed, and how FDA and HHS treat them as compounding ingredients. For the question of whether they build muscle, see our guide to peptides for muscle growth.
Key takeaways
- Neither CJC-1295 nor ipamorelin is approved by FDA for any use.
- We found no published or registered clinical trial of CJC-1295 and ipamorelin taken together.
- The registry holds three trials in all: two of ipamorelin and one of CJC-1295. None of these trials has reported results on what the two drugs are promoted for.
- HHS’s October 2026 interim compounding policy does not include CJC-1295 or ipamorelin.
- The World Anti-Doping Agency prohibits both at all times.
- Reports of “reinstated” status do not match FDA’s lists.
Are CJC-1295 and ipamorelin FDA-approved?
Neither CJC-1295 nor ipamorelin is approved by FDA for any use. A search of Drugs@FDA and FDA labels on Nov. 9, 2026 found no product listed as ipamorelin, CJC-1295 or “CJC 1295.” That search shows approved products, not pending applications.
A name caution. FDA evaluated “CJC-1295” and “CJC-1295 DAC” (with “drug affinity complex”) as separate substances (FDA minutes). Data on one should not be assumed for the other. The 2006 trial described below studied a long-acting analogue developed by ConjuChem; its abstract does not use the word “DAC,” so we do not say which product sold today it corresponds to.
What does the full trial registry show?
We searched ClinicalTrials.gov and Europe PMC on Nov. 9, 2026. There are three registered trials in all, and none tests the combination. One search result for ipamorelin is an observational study of veterans in which ipamorelin only appears in a list of supplements; it is not a trial of ipamorelin, and we do not count it.
| Study | Drug | What it was | What was found |
|---|---|---|---|
| Teichman 2006 | CJC-1295 (ConjuChem’s long-acting analogue) | Two placebo-controlled, dose-escalation trials in healthy adults aged 21 to 61; 28 and 49 days | Growth hormone rose 2- to 10-fold for six days or more, and IGF-I 1.5- to 3-fold for 9 to 11 days. “No serious adverse reactions were reported.” The trials measured hormone levels only, not muscle, fat, strength, sleep or recovery |
| NCT00267527, ConjuChem | CJC-1295 | Phase 2 in HIV for visceral fat, 120 planned, 2005 to 2006 | Terminated. The registry gives no reason and no results, and we found no publication. We do not speculate about why |
| Beck 2014 (NCT00672074), Helsinn | Ipamorelin, intravenous | Phase 2, double-blind, placebo-controlled, after bowel resection; 117 enrolled, 114 analyzed | No significant difference in the time until patients tolerated a solid meal (25.3 vs 32.6 hours, p=0.15). The authors call it “well tolerated” |
| NCT01280344, Helsinn | Ipamorelin, intravenous | Phase 2, quadruple-blind, gastrointestinal function after surgery; 320 participants; ended in May 2014 | No results in the registry, and we found no publication. A 2017 review cites it, which we did not read |
In two small trials in healthy adults, CJC-1295 raised growth hormone and IGF-I levels. Those trials measured hormone levels, not muscle, fat, strength or recovery. Ipamorelin was tested intravenously after bowel surgery; in the published phase 2 trial of 117 patients, it did not significantly shorten the time until patients could eat a solid meal.
We found no active registered trial of either drug. No study in people has reported results on muscle, body fat, performance, sleep, skin or aging; the CJC-1295 trial in visceral fat was terminated without results. Both drugs were tested in settings that differ from how they are promoted: intravenously in hospital after surgery for ipamorelin, and in hormone-marker studies in healthy volunteers for CJC-1295.
Why were they developed?
The registry shows what each was tested for:
- CJC-1295 was tested by ConjuChem for excess abdominal fat in people with HIV, in a phase 2 trial that was terminated.
- Ipamorelin was tested by Helsinn for recovery of gut function after bowel surgery. One trial did not show a significant difference, and a second, larger one has no published results.
Neither drug was approved. That is what the registrations show; we do not know why development stopped, and we do not say.
What about the two deaths in the ipamorelin trial?
In a small trial of intravenous ipamorelin after bowel surgery, two patients who received ipamorelin died after complications of the surgery. FDA says it is unclear whether the deaths were related to ipamorelin, but that, together with higher rates of low potassium and high blood sugar in the ipamorelin group, they raise safety concerns (FDA briefing).
FDA’s briefing says the two patients had bowel resection for colon cancer and developed postoperative complications from an anastomotic leak. The trial’s authors describe the drug as well tolerated. We report both readings.
That setting was intravenous, in hospital, after cancer surgery. It is a different context from how ipamorelin is promoted, and the trial does not tell us about other routes. FDA also says it “has not identified safety-related information regarding ipamorelin acetate via certain other injectable routes of administration” (FDA), so the absence of that information does not show safety.
How do FDA and HHS treat them for compounding?
The picture differs by type of compounder. Compounded drugs are not FDA-approved, and FDA does not review them for safety, effectiveness or quality before they are marketed. We give no legal conclusion about any product. For how 503A and 503B work, see 503A compounding of peptides.
| CJC-1295 | Ipamorelin | |
|---|---|---|
| FDA’s 503A categories list (updated May 14, 2026) | Not listed | Not listed |
| 503A, Category 2 page (FDA) | The page, updated April 22, 2026, lists the nomination as withdrawn | The page, updated April 22, 2026, lists the nomination as withdrawn |
| 503B list (updated March 21, 2025) | Not on it | In Category 2 for outsourcing facilities, since Sept. 29, 2023 |
| FDA’s advisory committee | Voted against it on Dec. 4, 2024: free base 0 to 13, acetate 1 to 12, DAC forms 0 to 13 (minutes) | Voted against it on Oct. 29, 2024: free base 0 to 12 with 1 abstention, acetate 0 to 12 with 1 abstention (minutes) |
| HHS’s Oct. 30, 2026 policy | Not included | Not included |
FDA’s advisory committee voted against adding either peptide to the list of substances pharmacies may use for compounding in 2024.
FDA keeps ipamorelin in Category 2, substances that may pose significant safety risks, for outsourcing facilities. The nominations of both peptides for regular compounding pharmacies were withdrawn; that did not make them eligible for compounding.
So “ipamorelin is in FDA’s Category 2” is exact only for 503B, which covers outsourcing facilities. For regular compounding pharmacies, FDA’s page lists the nomination as withdrawn, and it does not show a path to compounding. Websites that say the peptides were “reinstated” or moved to “Category 1” do not match FDA’s lists.
What about HHS’s policy?
HHS’s October 2026 interim compounding policy does not include CJC-1295 or ipamorelin. It names six other peptides: BPC-157, TB-500, epitalon, semax, KPV and MOTS-c (HHS policy). Some commenters on the policy’s public docket asked HHS to reconsider ipamorelin; when we searched on Nov. 9, 2026, we did not find a comment that mentions CJC-1295. The docket is a nonrulemaking one, and comments do not by themselves add a substance to the policy. We did not count or read all comments, so we do not describe them as support.
What are the known risks?
- CJC-1295. FDA’s Category 2 page says FDA “has identified serious adverse events associated with CJC-1295 including increased heart rate and systemic vasodilatory reaction,” and that clinical data are limited. It also names a risk of immune reactions and impurities.
- Ipamorelin. FDA names a risk of immune reactions, and notes that it contains unnatural amino acids, which add to the complexity of characterizing it. The intravenous trial described above is the other concern FDA cites.
- Growth hormone and IGF-I. Raising them in people without a deficiency has no established long-term safety record with these products. For context only, the label of tesamorelin, a different approved drug, warns of neoplasms, elevated IGF-1, fluid retention and glucose intolerance; those are that label’s warnings, not findings about these peptides. See our tesamorelin guide.
- Quality of gray-market products. A preprint that has not been peer-reviewed (Mendias and Awan, April 2026) analyzed 6,441 samples of 14 gray-market peptides, including these two, from public independent laboratory data. Depending on the criterion, 41.6% to 71.1% failed basic quality criteria, and 15% had measurable endotoxin. The abstract does not give figures for each peptide, so we do not attribute them to CJC-1295 or ipamorelin (preprint).
- FDA letters. In a letter dated Aug. 24, 2026 (FDA), FDA cited a product named “Tesamorelin Ipamorelin Blend” as an unapproved new drug. A warning letter states FDA’s position on one company; it is not a court ruling, and we do not link to sellers.
Are they allowed in sport?
No. The World Anti-Doping Agency prohibits both at all times. CJC-1295 is listed as an analogue of growth-hormone-releasing hormone and ipamorelin as a growth hormone secretagogue, under section S2.2.4, in both the 2026 and 2027 lists. See our guide to peptides and sports bans.
Which claims are not supported?
- “The CJC-1295 and ipamorelin stack builds muscle and burns fat.” We found no trial of the combination, and no study of either has reported results on muscle or fat.
- “More growth hormone means better results.” A hormone level is a marker, not a result.
- “HHS’s decision means they can now be compounded.” HHS’s policy does not include them.
- “They were reinstated.” Not according to FDA’s lists.
- “Ipamorelin is selective, so it is safe.” FDA says it lacks safety information for certain other injectable routes.
- “There are clinical trials underway.” We found no active registered trial of either drug.
What should you ask your doctor?
- What is behind the goal that makes me interested in these peptides (muscle, sleep, recovery, aging), and what evidence-based options exist?
- If one of them is suggested, what human evidence supports it for that goal, given that no study has reported these outcomes?
- Would it be a compounded product, who would make it, and is it prescribed for me by name?
- Do I compete in a tested sport?
We do not give doses, cycles or preparation instructions, and we do not recommend sellers. For a broader look at the evidence on these peptides and muscle, see our guide to peptides for muscle growth, and for the legal picture, are peptides legal in the US.
Frequently asked questions
Are CJC-1295 and ipamorelin FDA-approved?
No. Neither CJC-1295 nor ipamorelin is approved by FDA for any use.
Is there a trial of CJC-1295 and ipamorelin together?
We found no published or registered clinical trial of CJC-1295 and ipamorelin taken together.
Do CJC-1295 and ipamorelin build muscle?
No study of either has reported results on muscle. In two small trials in healthy adults, CJC-1295 raised growth hormone and IGF-I levels, and those trials measured hormone levels, not muscle, fat, strength or recovery.
Are they covered by the HHS policy?
HHS’s October 2026 interim compounding policy does not include CJC-1295 or ipamorelin.
Why is ipamorelin in Category 2?
FDA keeps ipamorelin in Category 2 for outsourcing facilities. It cites immune-reaction risk and a published study with serious adverse events, including deaths, when ipamorelin was given intravenously; FDA says it is unclear whether the deaths were related to the drug.
Are CJC-1295 and ipamorelin banned in sport?
The World Anti-Doping Agency prohibits both at all times.
From Best Peptides Today
Sources we checked
- FDA: bulk drug substances that may present significant safety risks (Category 2)FDA. Accessed .
- FDA: bulk drug substances nominated under section 503A, by category (updated May 14, 2026)FDA. Accessed .
- FDA: bulk drug substances nominated under section 503B, by category (updated March 21, 2025)FDA. Accessed .
- FDA briefing document on ipamorelin for the Pharmacy Compounding Advisory Committee (Oct. 29, 2024)FDA. Accessed .
- FDA Pharmacy Compounding Advisory Committee minutes (Oct. 29, 2024)FDA. Accessed .
- FDA Pharmacy Compounding Advisory Committee minutes (Dec. 4, 2024)FDA. Accessed .
- Drugs@FDA and FDA labels (searched Nov. 9, 2026; no product listed as ipamorelin or CJC-1295)FDA. Accessed .
- Federal Register: HHS enforcement discretion policy on 503A peptide compounding (Oct. 30, 2026)Other. Accessed .
- HHS: Enforcement Discretion Policy, with Appendices A and BOther. Accessed .
- Regulations.gov docket HHS-OASH-2026-0496Other. Accessed .
- CJC-1295 in healthy adults, Teichman 2006 (PubMed)PubMed. Accessed .
- Intravenous ipamorelin after bowel resection, Beck 2014 (PubMed)PubMed. Accessed .
- ClinicalTrials.gov NCT00267527 (CJC-1295, visceral fat in HIV, phase 2, terminated)ClinicalTrials.gov. Accessed .
- ClinicalTrials.gov NCT00672074 (ipamorelin after bowel resection, phase 2)ClinicalTrials.gov. Accessed .
- ClinicalTrials.gov NCT01280344 (ipamorelin, gastrointestinal function after surgery, phase 2)ClinicalTrials.gov. Accessed .
- Peptide Supplements and Their Therapeutic Applications in Sports Medicine, Am J Sports Med 2026 (PubMed)PubMed. Accessed .
- Quality of gray-market peptide samples, Mendias and Awan, Preprints.org, April 2026 (not peer-reviewed)Other. Accessed .
- FDA Warning Letter 733652 (Aug. 24, 2026)FDA. Accessed .
- WADA 2026 Prohibited ListOther. Accessed .
- WADA 2027 Prohibited List (in force from Jan. 1, 2027)Other. Accessed .
Written and maintained by the Best Peptides For Editorial Team. How we rate evidence.