CJC-1295 FDA Status: Nominations, Review and Votes

CJC-1295 FDA status has two parts: it is not FDA-approved, and it is absent from the federal 503A compounding list. A compounded medication, prepared by a pharmacy for a patient, is different from an FDA-approved product.

The record includes two withdrawn nominations and five advisory votes against listing. Those are separate events, and neither approves a medication.

CJC-1295 FDA status began with a nomination

A nomination asks FDA to consider an ingredient for its 503A Bulks List. That is a federal ingredient list for traditional pharmacy compounding when other ingredient pathways do not apply. A nomination starts consideration; it does not put anything on the list. Our 503A Bulks List guide explains the broader rules.

FDA received a November 2018 nomination from LDT Health Solutions. It acted for the International Peptide Society, according to FDA's meeting introduction. A compounding pharmacy submitted another nomination in November 2020.

Both submissions concerned CJC-1295, but the names did not consistently identify the ingredient. FDA therefore examined five forms. Some had DAC, short for drug affinity complex, a chemical attachment that binds to albumin, a carrier protein in blood. Others lacked that attachment. The name on a vial cannot tell you whether its ingredient matches the FDA review or a published study.

Category 2 and the withdrawn nominations

CJC-1295 was formerly in Category 2. That category means FDA identified significant safety concerns during its ingredient review. For Category 1 ingredients, FDA generally doesn't take action against compounding if its stated conditions are met. Category 2 doesn't get that policy.

The pharmacy's withdrawal reached FDA on September 18, 2024. LDT's withdrawal arrived September 19, 2024.

Withdrawal means the nominators pulled their requests. It does not mean FDA resolved the safety concerns or moved the ingredient into Category 1. The CJC-1295/ipamorelin blend pairs two ingredients studied for growth hormone release. Each ingredient still needs its own assessment in a prescribed formulation. A list entry for one substance cannot establish eligibility for an entire blend.

What FDA staff found in November 2024

FDA continued reviewing CJC-1295 on its own initiative after the withdrawals. Its staff assessment, dated November 15, 2024, recommended against listing all five forms for growth hormone deficiency, meaning too little growth hormone.

Reviewers found gaps in ingredient identity, purity and evidence of effectiveness. They also discussed immunogenicity, the potential to trigger an unwanted immune response. The available human studies used the long-acting DAC form in healthy adults, rather than patients with the condition under review.

FDA's assessment described increases in heart rate and systemic vasodilation, meaning blood vessels widen throughout the body. Some reported reactions included temporary drops in blood pressure. Those concerns helped explain the recommendation; the nomination withdrawals had not erased the clinical questions.

The early studies and ConjuChem's halted program

Teichman and colleagues' 2006 Journal of Clinical Endocrinology & Metabolism paper compared CJC-1295 with an inactive injection. The two trials lasted 28 and 49 days. Participants were healthy adults aged 21–61. After one injection, average growth hormone rose 2–10 times for at least six days. IGF-1, a hormone involved in growth, rose 1.5–3 times for 9–11 days. These were hormone measurements, not recovery or muscle-building outcomes.

Ionescu and Frohman's 2006 paper in the same journal found that growth hormone pulses, its bursts of release, persisted while levels between pulses increased. That study also used long-acting CJC-1295. Its findings cannot simply be assigned to a form without DAC.

FDA's December 2024 presentation recounts ConjuChem's later trial in people with HIV-associated changes in body fat. It stopped in 2006 after a participant died following a heart attack. The account says the treating physician pointed to underlying coronary disease. FDA described the reports as anecdotal; the trial results were not published. The record does not establish that CJC-1295 caused the death.

December 4, 2024: five separate votes

The Pharmacy Compounding Advisory Committee, a panel that advises FDA, did consider CJC-1295. FDA physician Marianne San Antonio and scientist Mai Tu presented the review. Five public speakers addressed the CJC-1295 topic.

The official minutes record these votes on whether each ingredient should join the 503A Bulks List. Free base means the molecule without a salt partner; acetate and trifluoroacetate are distinct salt forms.

All five recommendations opposed listing; four were unanimous. These were ingredient votes, not a review of a finished CJC-1295/ipamorelin prescription.

Where the record stands today

As of September 30, 2026, the day this article was written, FDA's safety page places CJC-1295 under “Bulk drug substances nominated but withdrawn.” Its “Content current as of” date is 04/22/2026. That is the page's update date, not the date the nominations were withdrawn.

The nominations PDF says “Updated May 14, 2026”. CJC-1295 appears in none of its three categories. FDA's 503A overview is current as of 05/14/2026. The final regulation, displayed as up to date on 9/28/2026, includes no CJC-1295 entry. Committee advice and a final regulation are separate steps.

As of September 30, 2026, the day this article was written, FDA's July 23–24, 2026 slides again name CJC-1295 as an example of different forms sold under one name. That discussion reinforces the ingredient-identity issue; it is not a new CJC-1295 listing decision.

As of September 30, 2026, the day this article was written, an August 11, 2026 sports-medicine review adds perspective on the evidence. It mapped studies of six compounds, including CJC-1295 and ipamorelin. The authors found that current human trials do not substantiate the claimed recovery and performance benefits. This was a review of existing studies, not a new treatment trial.

What this means for CJC-1295 compounding

A licensed provider may still prescribe a compounded formulation; that decision is between the patient and the doctor.

FDA's 2024 assessment found no applicable official drug-quality monograph, a written ingredient standard, for the five forms. None was a component of an approved U.S. drug. They also remain absent from the final 503A list and Category 1 policy.

Promise offers an injectable CJC-1295/ipamorelin blend by prescription, after a licensed provider reviews your request. Our CJC-1295 and ipamorelin guide explains the two ingredients. The FDA ingredient review does not demonstrate that a compounded blend will produce the same hormone response as the early single-compound studies.

What a visit can clarify

The useful questions are specific: Which CJC-1295 form is being considered? What evidence applies to that form and your treatment goal? What will be measured, and who reviews changes or side effects?

The provider can explain how a lab result would affect the plan, what would prompt a pause and how to report a reaction. The pharmacy can identify the ingredient and batch supplied. These are practical questions about a particular medication, separate from a committee vote on its raw ingredient.

A visit also gives the provider your medical history and medication list. Hormone changes in healthy volunteers cannot settle whether a particular treatment makes sense for you. The exact formulation, the reason for considering it and the follow-up plan belong in that discussion. A clear plan names the person responsible for follow-up and when the next review happens.

At Promise, a licensed provider reviews every request and not everyone qualifies.