CJC-1295: FDA status, evidence and safety
As of October 15, 2026, CJC-1295 is not FDA-approved, is not on the 503A bulks list and sits in no interim compounding category after its Category 2 nomination was withdrawn in April 2026, so a U.S. pharmacy has no established federal route to compound it. FDA has noted serious adverse events, including increased heart rate, and limited clinical data.
Status at a glance
| Check | Status as of October 15, 2026 | Source · read date |
|---|---|---|
| FDA approval | Not approved. | FDA · read October 15, 2026 |
| 503A interim category | In no interim category; listed as nominated but withdrawn from Category 2 (page current as of April 22, 2026; categories PDF updated May 14, 2026). | FDA · read October 15, 2026; FDA categories PDF |
| FDA advisory committee (PCAC) | Not on the July 23–24, 2026 agenda; no PCAC date found. | FDA · read October 15, 2026 |
| WADA 2026 Prohibited List | S2.2.4, named as a growth-hormone-releasing hormone (GHRH) analogue. Prohibited at all times. | World Anti-Doping Agency · read October 15, 2026 |
| FDA warning letters, 2026 | None found naming CJC-1295. | FDA warning letters · read October 15, 2026 |
| WADA 2027 list | Entry unchanged on the 2027 list (approved September 10, published September 21, in force January 1, 2027). | World Anti-Doping Agency · read October 15, 2026 |
What CJC-1295 is
CJC-1295 is a synthetic analogue of growth-hormone-releasing hormone (GHRH), the signal that tells the pituitary gland to release growth hormone. WADA lists it alongside sermorelin and tesamorelin in that class. Clinics market it for body composition, recovery and sleep, usually in combination with ipamorelin (see CJC-1295 / ipamorelin).
Human evidence
FDA’s own assessment is that “available clinical data are limited” (FDA). We did not find controlled trials showing that CJC-1295 improves body composition, recovery or sleep in healthy adults, and we have not re-read the clinical literature for this update, so we cite no trial. Raising a hormone level in a blood test is not the same as showing a health benefit.
Animal and laboratory evidence
Much of the rationale for GHRH analogues comes from physiology and animal work on the growth-hormone axis. That explains the mechanism; it does not show that the marketed outcomes happen in people.
Risks
FDA states: “FDA has identified serious adverse events associated with CJC-1295 including increased heart rate and systemic vasodilatory reaction” (FDA). A vasodilatory reaction means blood vessels widen, which can cause flushing and a drop in blood pressure. Products from research websites add unknown purity, sterility and dose.
Legal sourcing: who can supply it
With no approval, no bulks-list entry and no category, CJC-1295 has no established federal compounding route as of October 15, 2026. If a clinic offers it, ask what legal basis its pharmacy relies on, and see the peptide legality guide.
The lawful route for a prescription peptide in the United States is a licensed clinician who examines you and writes a prescription, filled by a state-licensed 503A pharmacy or an FDA-registered 503B outsourcing facility that is allowed to use that substance. Websites that sell peptides “for research use only” or “not for human consumption” are not a lawful source of medicine for people. On August 24, 2026, FDA sent warning letters to five such sellers — Peptide Partners, Peak Performance Peptides, Royal Peptides, NuScience Peptides and Tex Peptides — calling their products unapproved new drugs. FDA wrote that the research-use labels did not change its view because the websites showed the products were meant for human use.
October 2026: what changed
- April 2026 — Category 2 withdrawals. FDA moved BPC-157, TB-500, CJC-1295, ipamorelin, AOD-9604, injectable GHK-Cu and other peptides off its Category 2 list after the nominators withdrew them. FDA lists them as “nominated but withdrawn” (page current as of April 22, 2026). They were not moved into Category 1.
- July 23–24, 2026 — advisory committee. FDA’s Pharmacy Compounding Advisory Committee reviewed BPC-157, KPV, TB-500, MOTs-C, emideltide (DSIP), Semax and Epitalon. FDA staff proposed not adding BPC-157 or TB-500. A law-firm account reports the committee voted 8–6 (one abstention) to recommend BPC-157, KPV and TB-500 (McDermott, July 27, 2026). A vote is advice; FDA has taken no final action.
- October 14–15, 2026 — interim access policy under White House review. The OIRA review site lists “Interim Access Policy for Compounding Using Certain Peptides” from HHS/FDA (RIN 0910-ZD94, stage: Notice), received October 14, 2026 and pending review; no text has been published (reginfo.gov). Reuters reported the filing on October 15 (Reuters), and the AP, citing two people, said it would let pharmacies make some popular peptides, including BPC-157. Which peptides, on what terms and from when are not public. Our running table: peptide legal status 2026.
For CJC-1295: it left Category 2 in April but was not on the July advisory agenda, and no PCAC date has been announced. Whether the interim policy will include it is unknown. Compare the other growth-hormone peptides on sermorelin and tesamorelin.
Frequently asked questions
Is CJC-1295 FDA-approved?
No. CJC-1295 is not an approved drug, and as of October 15, 2026 it is not on the 503A bulks list or in any of FDA’s interim compounding categories. Its April 2026 removal from Category 2 happened because the nomination was withdrawn, not because FDA cleared it.
What safety problems has FDA reported with CJC-1295?
FDA says it has identified serious adverse events associated with CJC-1295, including increased heart rate and systemic vasodilatory reaction, and that available clinical data are limited. That is FDA’s summary; we found no controlled trials in healthy adults that settle the question.
Is CJC-1295 banned in sport?
Yes. The 2026 WADA Prohibited List names CJC-1295 under S2.2.4 as a growth-hormone-releasing hormone analogue. It is prohibited at all times, in and out of competition.
Can a telehealth clinic legally prescribe CJC-1295?
A clinician can write a prescription, but a pharmacy needs a lawful basis to compound it, and CJC-1295 has none of the usual ones as of October 15, 2026. Research-use-only sellers are not a lawful source either.
Sources
- FDA — Certain bulk drug substances for use in compounding that may present significant safety risks (page current as of April 22, 2026) (read October 15, 2026)
- FDA — Interim policy categories for 503A and 503B bulk drug substances (PDF, updated May 14, 2026) (read October 15, 2026)
- FDA — Bulk drug substances used in compounding under section 503A (page current as of May 14, 2026) (read October 15, 2026)
- FDA — July 23–24, 2026 meeting of the Pharmacy Compounding Advisory Committee (page current as of August 6, 2026) (read October 15, 2026)
- World Anti-Doping Agency — Prohibited List (2026 list in force) (read October 15, 2026)
- FDA warning letter — Royal Peptides LLC, 734884 (August 24, 2026) (read October 15, 2026)
- OIRA (reginfo.gov) — Interim Access Policy for Compounding Using Certain Peptides, RIN 0910-ZD94 (pending EO 12866 review) (read October 15, 2026)
- Reuters via Yahoo News — FDA takes step to change peptide compounding access (October 15, 2026) (read October 15, 2026)
- World Anti-Doping Agency — 2027 Prohibited List (published September 21, 2026; in force January 1, 2027) (read October 15, 2026)