CJC-1295 regulatory status
Current status of CJC-1295 in the United States: Removed from Category 2 (Apr 2026). In sport: WADA prohibited. Details, sources, and the dated timeline follow.
By the PeptideAgent Editorial Team. Draft, pending editorial review. Last verified
What is the current status of CJC-1295?
- FDA and compounding
- Not FDA approved for any use and never approved anywhere; the developer's programs in HIV lipodystrophy and GH deficiency were discontinued in the late 2000s. FDA placed CJC-1295 on the 503A Category 2 list on September 29, 2023, citing limited clinical data, peptide related impurities, and serious adverse events including increased heart rate and a systemic vasodilatory reaction. The nomination was later withdrawn and FDA's April 2026 update lists CJC-1295 under nominated but withdrawn substances rather than Category 1 or the bulks list. It was not among the peptides the Pharmacy Compounding Advisory Committee reviewed in July 2026. With no active nomination, no bulks list entry, and no approved product, licensed 503A pharmacies and 503B facilities have no lawful basis to compound it. Products sold as CJC-1295 without DAC are a different molecule (modified GRF 1-29) with the same non-status.
- WADA
- WADA prohibited
- Access path
- Not legally available through a licensed pharmacy (withdrawn 503A nomination, not on the bulks list, not an approved drug).
- Clinics that still advertise compounded CJC-1295 are dispensing outside FDA's stated categories; ask what the legal basis is.
- Products labeled research use only are not lawful for human use.
Full CJC-1295 page: evidence, dosing in the literature, and sources
Is CJC-1295 FDA approved or legal? Questions and answers
Is CJC-1295 FDA approved?
No. CJC-1295 is not FDA approved for any use and has never been approved anywhere; the developer's clinical programs ended in the late 2000s. It was not among the peptides the Pharmacy Compounding Advisory Committee reviewed in July 2026, so no approval or compounding listing is pending. [1] [2]
What is the FDA status of CJC-1295 in 2026?
Removed from Category 2, but still blocked. FDA placed CJC-1295 on the 503A Category 2 list on September 29, 2023, citing limited clinical data, impurities, and serious adverse events. The nomination was withdrawn, and FDA's April 2026 update lists it as nominated but withdrawn, not on the bulks list. Products sold as CJC-1295 without DAC (modified GRF 1-29) have the same status. [2] [3]
Is CJC-1295 legal?
There is no lawful way to obtain CJC-1295 for human use in the United States. With no approved product, no active nomination, and no bulks list entry, licensed 503A pharmacies and 503B facilities have no lawful basis to compound it, and research use only products are not lawful for human use. [2] [3]
Is CJC-1295 banned by WADA?
Yes. CJC-1295 is named in section S2 of the WADA Prohibited List under growth hormone releasing hormone and its analogues, and is prohibited at all times. [4]
How has the status of CJC-1295 changed over time?
- WADA
WADA publishes the 2027 Prohibited List
WADA published the 2027 Prohibited List on September 21, 2026, and it takes effect January 1, 2027. The S2 peptide hormone and growth factor classes are unchanged. BPC-157 is still named under S0, and MOTS-c is still named under S4.4 as an activator of AMP-activated protein kinase. WADA added a note that many peptides without approval for human use fall under S0 or another section, and that a peptide not named on the list may still be prohibited. GLP-1 receptor agonists such as semaglutide and tirzepatide are still not on the list.
- FDA
FDA lists BPC-157 and 16 other peptides as withdrawn from 503A Category 2
FDA's Category 2 page, revised in April 2026 and current as of April 22, 2026, moved BPC-157, AOD-9604, CJC-1295, dihexa, DSIP, epitalon, injectable GHK-Cu, ipamorelin, KPV, LL-37, melanotan II, MOTS-c, PEG-MGF, selank, semax, thymosin alpha-1, and thymosin beta-4 fragment (TB-500) to a list of bulk drug substances nominated but withdrawn by their nominators. A withdrawn substance is no longer in 503A Category 2, but withdrawal is not an approval and does not place a substance on the 503A bulks list; a 503A pharmacy still needs a listing before it may compound it. Ipamorelin acetate remains in 503B Category 2. Seven of the withdrawn peptides (BPC-157, KPV, TB-500, MOTS-c, semax, epitalon, and DSIP) were taken to the Pharmacy Compounding Advisory Committee in July 2026.
- WADA
WADA 2026 Prohibited List takes effect
The 2026 WADA Prohibited List took effect on January 1, 2026 and continues to prohibit the S2 peptide hormone and growth factor classes (GHRH analogs, growth hormone secretagogues, GH fragments, IGF-1 and analogs, MGF, thymosin beta-4 and derivatives, hCG and GnRH-class releasing factors in males), myostatin inhibitors, insulin and the AMPK activator MOTS-c under S4, desmopressin under S5, and BPC-157 under S0. GLP-1 receptor agonists such as semaglutide and tirzepatide are not on the list.
- WADA
WADA 2025 Prohibited List keeps peptide hormones and growth factors banned at all times
The 2025 WADA Prohibited List took effect on January 1, 2025. Section S2 (peptide hormones, growth factors, related substances and mimetics) covers GHRH analogs such as CJC-1295, sermorelin, and tesamorelin, growth hormone secretagogues such as ipamorelin, GHRP-2, GHRP-6, hexarelin, and ibutamoren (MK-677), growth hormone fragments such as AOD-9604, growth factors including IGF-1 and its analogs, MGF, and thymosin beta-4 (TB-500), and chorionic gonadotropin and releasing factors such as gonadorelin and kisspeptin (prohibited in males). Myostatin inhibitors such as ACE-031 fall under S4, insulin under S4 metabolic modulators, desmopressin under S5, and BPC-157 remains an S0 non-approved substance.
- FDA
FDA places a batch of nominated peptides in 503A Category 2
In September 2023 FDA updated its 503A bulk drug substances category lists to place a group of nominated peptides in Category 2, which means FDA identified significant safety risks and the substances may not be used in 503A compounding while the evaluation continues. Kisspeptin-10 and ibutamoren (MK-677) were added on September 29, 2023 and remain in Category 2 on the FDA page current as of April 22, 2026. BPC-157, CJC-1295, ipamorelin, AOD-9604, dihexa, DSIP, epitalon, KPV, MOTS-c, selank, semax, melanotan II, LL-37, thymosin alpha-1, and thymosin beta-4 fragment (TB-500) were also placed in Category 2 under the 503A interim policy; that same page now lists them as nominated but withdrawn (see the April 2026 event). Hexarelin, PNC-27, and 5-amino-1MQ have never appeared on the FDA category lists.
Sources
Numbered citations in the answers above point here, followed by the regulatory sources on record for CJC-1295 and the source of each dated event.
- [1]FDA Pharmacy Compounding Advisory Committee meetings (July 2026 meeting on peptide nominations)FDA, 2026
- [2]FDA: Bulk drug substances used in compounding under section 503A of the FD&C Act (503A bulks list, Category 1, 2, and 3 lists, and withdrawn nominations)FDA, 2026
- [3]FDA: Certain bulk drug substances for use in compounding that may present significant safety risks (503A Category 2 list and nominated but withdrawn substances, current as of April 22, 2026)FDA, 2026
- [4]WADA Prohibited List, section S2 (growth hormone releasing hormone and its analogues, including CJC-1295)WADA, 2026
- [5]WADA 2027 Prohibited ListWADA, 2026
From the blog
- CJC-1295 side effects: what the human studies reported
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