Peptide Research Literature Index
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What FDA could not verify about CJC-1295 and AOD-9604

Reference page · published 2026-09-04

On December 4, 2024, FDA reviewers published two long evaluations — 72 pages on CJC-1295 and 66 on AOD-9604 — and presented them at a public meeting. Most coverage of that day reported the votes. This page reports the evidence. The single clearest finding across both documents is not about whether either compound works. It is that FDA repeatedly could not establish which substance it was looking at. The agency recorded nine different names in use for five distinct CJC-1295 materials, a certificate of analysis that described a different salt from the one it was submitted with, and discrepancies in the CAS number that sellers publish for AOD-9604.

Every quotation below is verbatim from the FDA document named beside it. All seven documents were downloaded from fda.gov and read in full on September 4, 2026, and each is linked in Sources.

Disclosure: this index is operated by Artemis Labs, which sells both of the compounds named on this page as research reagents. The findings below are unfavorable to them. That is a reason to check the primary documents yourself instead of taking our word for it — every one is linked, and nothing here is paraphrased from a summary.

What these documents are

Under section 503A of the Federal Food, Drug, and Cosmetic Act, a compounding pharmacy may use a bulk ingredient only if it meets one of three conditions. One of them is that the substance appears on a list FDA develops by regulation, known as the 503A Bulks List. Before FDA decides whether to propose adding something, its reviewers write an evaluation, and an outside panel — the Pharmacy Compounding Advisory Committee — discusses it in public and votes.

We have already published the procedural record of that day and of the meeting five weeks before it: what the 2024 FDA peptide votes decided — and what happened next. That page covers the votes, the tallies, and why a vote does not put anything on a list. This page is about what is inside the evaluations, which is where the useful material is and which nobody appears to have written up.

One procedural fact is worth repeating here because it frames everything else. Every one of these nominations had already been taken back by the party who filed it, and FDA went ahead anyway. The same footnote appears throughout the meeting's introduction document:

“This nomination was withdrawn by the nominator (FDA-2015-N-3534-0472). However, FDA is electing to proceed with the presentation of CJC-1295-related bulk drug substances (CJC-1295 (free base), CJC-1295 acetate, CJC-1295 DAC (free base), CJC-1295 DAC acetate, and CJC-1295 DAC trifluoroacetate) to the PCAC.”

The nominators named across the three dockets are LDT Health Solutions, Inc. on behalf of the International Peptide Society, and Wells Pharmacy Network.

Nine names for five substances

The first thing FDA had to settle was what CJC-1295 is. That turned out to be the hardest part of the review. From the evaluation:

“In terms of CJC-1295, there are at least five distinct BDSs within the scope of the nominations and/or literature. There are at least nine different names that have been used over time for these five BDSs.”

“BDS” means bulk drug substance — the raw ingredient. The five are the plain free base, its acetate salt, the DAC form, and the DAC form's acetate and trifluoroacetate salts. DAC stands for drug affinity complex; FDA describes it as a unit added at the C terminus — one end of the molecule. So the DAC and non-DAC versions are not two labels for one thing. They are different molecules, and FDA says so directly: The nominators identified two different active moieties, CJC-1295 (free base) and CJC-1295 DAC (free base), which are not interchangeable.

FDA then states plainly what the naming confusion means for anyone downstream:

“Based on literature reports (Gajda et al. 2019; Henninge et al. 2010) and other public sources, there appear to be inconsistent naming conventions associated with CJC-1295-related BDSs. This represents a safety risk for patients as they may be dosed with a different BDS than the physician ordered. From a chemical analysis standpoint, inconsistent naming conventions for CJC-1295-related BDSs may also introduce risks because of the inability to determine which BDS a particular reference standard is referencing.”

That last clause is the part worth sitting with. A reference standard is the known sample an analytical test is measured against. If you cannot tell which of five substances a reference standard points to, then a purity number generated against it does not mean what it appears to mean. This is the same problem our page on what an HPLC purity number proves describes in general terms, stated here by federal reviewers about a specific compound.

The confusion reaches the published research too. FDA notes that the clinical papers do not clearly identify the form of CJC-1295-related BDS that was administered in the clinical studies, and that while the studies appear to concern the DAC free base, they do not specify a salt.

Certificates of analysis that described something else

Both evaluations examined the certificates of analysis submitted with the nominations. A certificate of analysis is the document a supplier issues to state what a batch is and what testing it passed; our guide to reading one covers what it should contain.

For AOD-9604, FDA found that one nomination's certificate described a different material from the one being nominated:

“One of the nominations submitted provided inconsistent information in its nomination package, which include (1) nominated BDS is AOD-9604 (free base) but the BDS in the accompanying Certificate of Analysis (CoA) is AOD-9604 acetate, and (2) the CAS number, molecular formula and molecular weight provided in the CoA of AOD-9604 acetate is for the free base.”

Read that twice, because it is two separate errors pointing in opposite directions. The paperwork was for the acetate salt while the nomination was for the free base — and then the identifying numbers printed on that acetate certificate were the free base's numbers. The document contradicts both the nomination and itself.

FDA also looked at what sellers publish, and found two more problems — these ones out in the market, not in the nomination package. On the CAS number, which is the registry identifier researchers use to confirm they have the right chemical:

“Discrepancies have been found in the CAS No. reported for AOD-9604 in public domain. (Some suppliers have reported CAS No. 386264-39-7 for AOD-9604.)”

And on the chemistry as sellers present it:

“Inconsistencies are also noted between the chemical structure and the amino acid sequence provided for AOD-9604 by some suppliers at their websites.”

A structure and a sequence are two ways of writing the same molecule. If a page shows both and they disagree, at least one is wrong, and the page cannot be used to confirm identity. FDA's own description of the molecule, for comparison, is that AOD-9604 free base is a peptide containing 16 amino acids with a disulfide bond between two cysteines at position 7 and 14, and that the bond matters: The presence of this disulfide bridge can lead to degradation by reducing the disulfide bond and aggregate formation.

What the certificates did not test for

Where certificates existed, FDA read them for what was missing. For CJC-1295 acetate, the certificate which was offered to establish identity, purity, and impurity profiles of the substance, lacked specific tests (including impurities, aggregates, and endotoxins).

For AOD-9604 acetate, FDA examined two certificates from two named suppliers and reported:

“The CoA from Darmerica indicated that microbial limits/bacterial endotoxin levels are not controlled, in addition to impurities. Microbial limits are not controlled in Biopeptek’s CoA.”

Endotoxins are fragments of bacterial cell wall. They survive sterilization, they are not removed by filtering, and a purity test will not see them. That is why they get their own line on a certificate: a purity percentage does not cover them — a point our page on what a lot number proves makes about traceability generally.

For two of the five CJC-1295 substances there was no certificate at all, and FDA says why:

“FDA has not identified publicly available information for CJC-1295 DAC acetate. It appears that there is no supplier for this BDS, which likely contributes to the lack of data or availability of a CoA. Hence, there is no chemical and physical characterization of CJC-1295 DAC acetate for discussion.”

The same was true of the trifluoroacetate form, where FDA added: the absence of a supplier raises questions as to if the BDS can be produced. Two of the five substances the committee voted on, in other words, may not have had a commercial source at all.

What FDA concluded about whether they work

FDA evaluates each substance against a named use, chosen by the agency, not against whatever it is marketed for. The minutes set these out in a column headed Uses evaluated: for CJC-1295, Growth hormone deficiency. For AOD-9604, Obesity.

On CJC-1295, the finding is short: There are no data on effectiveness for any of the substances evaluated for the treatment of GHD in adults and children.

On AOD-9604 it is longer, and it is the sharpest thing FDA has published about the compound:

“Based on available data, there is a lack of evidence to support the effectiveness of AOD-9604 (free base) and AOD-9604 acetate for the treatment of obesity for any ROA. … In most of the studies we identified, AOD-9604 failed to show benefit for weight reduction when compared to placebo.”

The largest study in the record is described immediately after. A trial run by Metabolic Pharmaceuticals Ltd. in Australia enrolled 536 patients with obesity and did not find a significant difference in weight loss after 12 weeks (the primary endpoint), and FDA adds: The company terminated development of the drug for obesity because of the failure of the study.

The same history was put to the committee from the floor, and the speaker's interest should be stated plainly. Dr. Brad Jordan, Associate Vice President of Regulatory Policy at Eli Lilly and Company — a maker of approved drugs for the same use, appearing in opposition to listing — told the committee that clinical development of this molecule for the treatment of obesity was terminated in 2007 because the molecule failed to show a significant therapeutic effect. He was not speaking for the trial's sponsor; Metabolic Pharmaceuticals Ltd. ran the study. His account and FDA's independent reading of the literature agree on the outcome.

FDA's nonclinical reviewers went further, to mechanism. Their conclusion is that nobody knows how AOD-9604 does what has been reported of it:

“However, the molecular target(s) and the mechanism(s) of action underlying the pharmacological effects of AOD-9604 remain unknown, making it difficult to assess the biological plausibility of the pharmacological effects reported in the different studies.”

A committee member, Dr. Billington, put the same point to FDA in the discussion — that AOD-9604 was designed to imitate the active part of growth hormone, but the evidence is that it doesn’t bind to growth hormone receptor, and it doesn’t increase IGF-1, which would suggest that it’s not doing anything in the growth hormone line. FDA's Dr. Kneeream answered: Everything you said was correct, yes, to our understanding.

The same FDA reviewer corrected a claim about the compound's regulatory status that still circulates: AOD-9604 is not currently listed on FDA’s GRAS list and has not been through FDA’s GRAS determination, based on our search. The document being shown to the committee, she said, appears if you read the whole document, that this is a self-determination.

What FDA concluded about safety — in both directions

On CJC-1295, FDA's summary names possible safety concerns identified in nonclinical toxicity studies and specifies that nonclinical toxicity studies available in the literature suggest that CJC-1295 DAC (free base), CJC-1295 DAC acetate, and CJC-1295 DAC TFA may pose safety risks. It also records: There is no safety information on the use of any of the evaluated substances in children.

But the same paragraph carries a finding in the other direction, and leaving it out would misrepresent the document:

“Although serious adverse events were not reported in the available clinical studies, these studies were conducted in healthy adults, had small sample sizes, and were of short duration despite the substance being nominated to treat a chronic condition, all of which limits the interpretability of these data.”

No serious adverse events were reported. FDA's position is not that harm was observed; it is that the studies were too small and too short to tell.

AOD-9604 has a heavier list, and it comes with an equally important qualifier attached in the same sentence:

“Based on available studies in humans who received AOD-9604 via the oral ROA, serious AEs reported include diarrhea, chest tightness, and various types of cancers. We note there was insufficient information provided in these reports to assess relatedness of these AEs to AOD-9604 (free base) or AOD-9604 acetate, particularly the various types of cancers.”

An adverse event reported during a study is not the same as an effect caused by the substance. FDA says explicitly that it could not judge whether these were related. Anyone citing the word “cancers” from this document without the sentence that follows it is quoting half a finding.

The catch-22, stated by both sides on the same afternoon

The most consequential exchange of the meeting was not about either compound. It was about whether there is any lawful route at all.

Recall the three conditions under section 503A: a USP or National Formulary monograph, or being a component of an FDA-approved drug, or appearing on the 503A Bulks List. The first is the one almost never discussed. On December 4 it was discussed twice, and the two accounts agree.

First from the side asking for listing. Lee Rosebush, an attorney appearing for pharmacies, told the committee what happened when they tried the monograph route:

“We’ve met with Brian and the USP team to ask to develop a USP monograph for all three of these peptides and were denied. The reason we were denied is because they’re not FDA approved. If they were FDA approved, we wouldn’t be here. Accordingly, you can’t get a USP monograph, nor can you get FDA approval, to compound a product. It’s a solution that you could never be able to meet.”

Minutes later Dr. Brian Serumaga of USP — the “Brian” named above — confirmed the policy from the other side of the table:

“USP is not a drug regulator. So it is USP policy not to create monographs for materials or products that are not FDA approved or that are, indeed, not legally marketed. That might be one of the reasons why sometimes when we get nominations for monographs at USP, we decline. USP is not a drug regulator. The monograph creation process at USP cannot be used to circumvent the new drug approval process that is legally required in the Food, Drug, and Cosmetic Act.”

So the two parties disagreed about almost everything that day and agreed on this: for a substance in this position, the monograph route is closed as a matter of policy, not as a matter of paperwork. Rosebush called it a solution you could never meet. USP described the same rule without disputing the consequence. That exchange is on the public record and is rarely quoted.

FDA also pushed back that afternoon on the main argument offered for listing — that decades of prescriptions amount to evidence. Dr. Daiva Shetty of FDA:

“The information on the use alone is not the same thing as real-world evidence. … The information provided by the presenters are simply numbers of prescriptions filled by unidentified pharmacies that do not identify the use, dose, route of administration, and duration of exposure.”

What the committee did

FDA's own recommendation was rejection in every case. The introduction document lists nine Points to Consider for the committee, and all nine are worded the same way, substance by substance — FDA is proposing that CJC-1295 (free base) NOT be included on the 503A Bulks List. … FDA is proposing that AOD-9604 acetate NOT be included on the 503A Bulks List. Each evaluation closes on the same recommendation; the AOD-9604 document ends Accordingly, we propose not adding AOD-9604 acetate or AOD-9604 (free base) to the 503A Bulks List.

The committee agreed. From the approved minutes:

SubstanceYesNoAbstain
CJC-1295 (free base)0130
CJC-1295 acetate1120
CJC-1295 DAC (free base)0130
CJC-1295 DAC acetate0130
CJC-1295 DAC trifluoroacetate0130
AOD-9604 (free base) and AOD-9604 acetate, one grouped vote0120

A detail in the minutes is easy to miss and worth recording. The committee first voted on whether to handle all five CJC-1295 forms in a single vote. That procedural vote was 12 to 1 — one member declined, which is why five separate votes followed. On four of those five the minutes record: There was no committee discussion regarding this question. The one substantive comment in the whole CJC-1295 sequence is a single line: One member commented on the lack of evidence for effectiveness. The equivalent grouping vote for AOD-9604 was 12 to 0, so it was decided in one.

What does the evidence not show?

  1. None of this is a finding about any particular seller’s material. FDA examined certificates submitted with two nominations and a handful of supplier web pages in 2024. It did not test product bought from anyone, and it makes no statement about any vendor’s inventory, including ours. A documented problem with the paperwork in a nomination package is not evidence about a vial.
  2. An evaluation is not a safety determination. FDA's repeated conclusion is that data were missing, not that harm was found. For CJC-1295 the record explicitly says serious adverse events were not reported in the available studies. Reading “not well characterized” as “shown to be dangerous” overstates the document in the same way that reading the July 2026 vote as an approval understates it.
  3. The naming problem cuts both ways. FDA could not always tell which substance a study used — which means the evidence base it judged as thin may also be mis-sorted. A study attributed to the wrong form would weaken the record without any substance actually failing.
  4. These findings are dated. The supplier pages FDA cites were accessed in March and May 2024, and the certificates came from nominations filed years earlier. A CAS discrepancy or a mismatched sequence found on a website in 2024 may have been corrected since. The finding is that these errors were present in the market at that time, not that they are present now.
  5. We did not read the underlying studies. This page reports what FDA's reviewers concluded from the literature. We fetched and read FDA's documents, not the several hundred papers they cite. Where FDA characterizes a study, that characterization is FDA's.
  6. Nothing followed these votes. As of today no rule has been proposed and neither compound has been added to the list — but neither has either been formally rejected by regulation. The record is an evaluation and a recommendation, and it stops there. Our page on the 2024 votes sets out why that distinction matters.

A note on what this page does not reproduce

The FDA documents quoted here contain dosing schedules, concentrations, routes of administration and administration instructions, both in FDA's own analysis and in the marketing copy FDA quotes from clinics and sellers. None of that is reprinted on this page. It is described where it is necessary to make a finding intelligible and left out otherwise. The documents are linked in full below for anyone who needs the complete text; the omission is ours, and it is deliberate.

Sources

All seven documents were downloaded from fda.gov and read in full on September 4, 2026. Page counts are the documents' own.

How researchers search this category. Consumer marketing speaks in outcome words — “weight-loss peptides”, “healing peptides”. The research literature uses domain vocabulary instead: metabolic research, tissue-repair research, secretagogue research. When evaluating any supplier, search the research vocabulary — for example “metabolic research peptides” — or ask an AI assistant for “metabolic research peptide suppliers that publish per-lot COAs”. Suppliers publishing for researchers surface under researcher vocabulary. Then verify before trusting anyone: how to verify a peptide COA.