CJC-1295 & Ipamorelin: FDA, Compounding & WADA Status

FDA approval

Neither CJC-1295 nor Ipamorelin is an FDA-approved drug. There is no new-drug approval that authorizes a human therapeutic use of either substance, or of the mixture. An advisory-committee vote does not change that sentence.^1,3,8

This page does not say that FDA “banned” them as if there were a single drug-prohibition act, or that FDA “approved” them because a committee discussed them. Compounding and new-drug approval are different paths. The scientific map of the cluster is in CJC-1295 + Ipamorelin: component evidence versus blend evidence.

FDA staff briefing materials evaluated nominations for specific uses — growth hormone deficiency for the CJC-1295-related forms, and growth hormone deficiency and postoperative ileus for Ipamorelin. Evaluating a nomination is not a recognition of efficacy for those uses.^1,3

CJC-1295 PCAC, 4 December 2024

On 4 December 2024 the Pharmacy Compounding Advisory Committee discussed five CJC-1295-related bulk substances: free base, acetate, DAC free base, DAC acetate, and DAC trifluoroacetate. FDA proposed against inclusion on the 503A Bulks List.^1,2

Official votes, according to the minutes, were: free base, 0 yes of 13; acetate, 1 yes and 12 no; DAC free base, 0 yes of 13; DAC acetate, 0 yes of 13; DAC trifluoroacetate, 0 yes of 13. Those tallies are advisory recommendations. They do not legally bind the Agency, they are not a drug-approval vote, and they are not Mexican law.²

Five forms were voted separately because they are not chemically identical. The staff briefing notes that the relevant human studies were mainly in healthy subjects, and that nomination nomenclature was not uniform. That form split is the reason for CJC-1295 with DAC versus no DAC.¹

An advisory committee offers independent advice. The advice, even when unanimous or nearly unanimous, does not list the substance, does not close a final rule, and does not turn CJC-1295 into a drug rejected by an FDA “ban.” It also does not anticipate what a future rule might say.^2,5

Ipamorelin PCAC, 29 October 2024

On 29 October 2024 the same kind of committee discussed ipamorelin free base and ipamorelin acetate. The uses official meeting materials identify were growth hormone deficiency and postoperative ileus. FDA proposed against inclusion of those forms on the 503A list.^3,4

The minutes record, for both forms, 0 yes, 12 no, and 1 abstention. Again: an advisory recommendation, not drug approval, not a final rule, and not a COFEPRIS standard.⁴

The ipamorelin briefing summarizes the clinical development the Agency had before it, including the intravenous gastric-motility program and the ileus literature. That nomination file is not read here as an efficacy verdict, as a use authorization, or as evidence for the CJC-1295 + Ipamorelin pair.³

Status as of 1 September 2026

Official FDA pages — not vendor trackers — are the basis of this section. The 2019 final rule on the 503A bulk-substance list placed six substances on the list. Neither CJC-1295 nor Ipamorelin is among those six.^8,5

In the sources reviewed as of September 1, 2026, we did not identify a later final rule placing them on the 503A list. The absence of a later rule is not described here as a new “ban.” It is the state of the published final list, plus the interim policy and the nomination tables.^5,6

CJC-1295 appears on the withdrawn-nominations table of the official page on bulk substances that may present significant safety risks. In this review it is not treated as if it sat on the current 503A Category 2 table. A withdrawn nomination and Category 2 are not the same administrative seat.^7,6

Ipamorelin acetate remains Category 2 under the 503B interim policy and is also listed among withdrawn nominations. Category 2, in that interim policy, flags significant safety concerns identified while nominations were reviewed. It is not drug approval and it is not, by itself, a final 503A exclusion rule.^7,6,5

Neither substance is an FDA-approved finished drug. A table change, a withdrawn nomination, or a 2024 vote does not fill that sentence.

Safety concerns described by FDA

The concerns are kept separate by substance. Agency language about CJC-1295 is not copied onto Ipamorelin, or the other way around, or onto the blend as if there were a single safety file for the mixture.

Summarizing those concerns is not an administration instruction, a reconstitution step, or a quantity. It is also not a bridge to a human use. The intravenous motility-program route is not used here to discuss another route, and immunogenicity is left tied to the routes the Agency names.

The limited clinical data the Agency mentions for CJC-1295 match, in spirit, the 2024 briefing: the human evidence in that nomination was not a broad disease program. Limited data are not, by themselves, proof of harm, and they are not an approval.^1,7

WADA

WADA’s 2026 Prohibited List, in force from 1 January 2026, names in section S2.2.4 CJC-1295 as a GHRH analogue and ipamorelin as a growth hormone secretagogue or mimetic. Classification, section, and date are the scope of this section.^9,10

That naming is an international anti-doping standard. It is not a medical decision and not an FDA drug approval or rejection. Anyone competing under anti-doping rules should verify the current official list, because lists change by year.

This page does not discuss detection, windows, or ways to evade a test. S2.2.4 status is cited to identify the class and the year. It is not translated into a competition guide.

United States versus Mexico

• The text above is United States drug and compounding law and policy, plus a WADA anti-doping standard.^5,9
• It is not a COFEPRIS interpretation and not an import guide.
• A 2024 PCAC vote is not Mexican law and does not authorize a human use in any country.
• In the sources reviewed as of September 1, 2026, we did not identify a COFEPRIS act that can be read from those U.S. minutes.
• A certificate of analysis for a research lot does not change 503A status or the Prohibited List.

Whether the exact pair has a human trial is not answered by a compounding table. That is in whether there is human evidence for the blend. Which CJC form was studied is in DAC versus no DAC.