CJC-1295: FDA status, DAC and human evidence
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The short answer
CJC-1295 is an experimental GHRH analog without FDA approval. FDA’s advisory committee voted against listing five forms, but an advisory vote is not itself a final rule. Current records do not establish a routine commercial compounding pathway. Human reports measured hormones or serum proteins; they do not establish muscle, fat-loss, sleep or anti-aging benefits from commercial preparations.
Definition
CJC-1295 is an experimental GHRH analog without FDA approval.
Key facts
| Fact | Detail |
|---|---|
| What it is | An experimental, long-acting growth-hormone-releasing peptide[6] |
| FDA-approved | Never, for any use |
| Compounding route | No legal US pharmacy route right now[1] |
| FDA advisers | Voted against all five forms FDA reviewed, December 4, 2024[5] |
| Human studies | Two 2006 hormone studies; no trial tested muscle, fat, sleep or aging[7] |
Read the molecule-specific regulatory limits before considering a commercial offer. Hormone changes in small studies do not establish a personal results timeline. The timeline guide explains that distinction, and the source finder links the actual documents.
CJC-1295 is a long-acting copy of GHRH
Your brain makes a hormone called GHRH that tells the pituitary to release growth hormone. Natural GHRH lasts minutes in the blood. CJC-1295 was built in the early 2000s to last much longer.
The trick is a chemical add-on called DAC. It lets the peptide latch onto albumin, a protein in your blood, after injection. In a 2006 study the DAC version had a half-life of 5.8 to 8.1 days [6]. That's days, not minutes.
Why bother? Researchers hoped a long-acting GHRH could help people whose pituitary still works but makes too little growth hormone. The 2006 authors said exactly that: long-acting versions "may have clinical utility in patients with intact pituitary GH secretory capability" [7]. That hope never became an approved drug.
One detail from those studies matters for anyone reading online claims. Growth hormone normally comes in pulses. A week after one injection, the pulses kept their usual timing and size; what rose was the baseline between pulses [7]. That's a hormone pattern, not proof of a body change.
"With DAC" and "no DAC" are two different molecules
Here's the catch. The published human studies used the DAC form. Much of what's sold online as "CJC-1295 no DAC" is a shorter-acting peptide also called mod GRF 1-29. It shares the GHRH backbone but behaves differently in the body.
FDA noticed the naming mess too. Its 2024 review covered five separate substances: two without DAC and three with it [5]. So when someone quotes a CJC-1295 study, ask which molecule it tested.
| CJC-1295 with DAC | "No DAC" (mod GRF 1-29) | |
|---|---|---|
| How long it lasts | Days (half-life 5.8 to 8.1 days in one study) [6] | No albumin link, so it lacks the long action DAC was added for [7] |
| Published human studies | Two 2006 hormone studies [6] [7] | None in the sources this page relies on |
| Forms FDA's advisers reviewed | Three (free base, acetate, trifluoroacetate) | Two (free base, acetate) |
| Routine commercial compounding pathway | Not established by current records | Not established by current records |
FDA's advisers voted no on every form
A 503A pharmacy needs a legal route for each ingredient: a USP monograph, a part of an approved drug, or a spot on FDA's bulks list. FDA's 2024 briefing says no CJC-1295 form has a monograph or is part of an approved drug [4]. Then the advisory committee voted on the list.
| Form | Vote | What this means |
|---|---|---|
| CJC-1295 (free base) | 0 / 13 / 0 | Unanimous no |
| CJC-1295 acetate | 1 / 12 / 0 | Near-unanimous no |
| CJC-1295 with DAC (free base) | 0 / 13 / 0 | Unanimous no |
| CJC-1295 with DAC acetate | 0 / 13 / 0 | Unanimous no |
| CJC-1295 with DAC trifluoroacetate | 0 / 13 / 0 | Unanimous no |
FDA final summary minutes record these recommendations [5]. An advisory vote is not a final FDA rule; current eligibility must be assessed separately.
| Date | What happened | What it means for you |
|---|---|---|
| October 25, 2024 | Federal Register notice schedules the advisory meeting [3] | Public review set |
| December 4, 2024 | Advisory committee votes against all five forms [5] | FDA's experts said no |
| Now | In no current 503A category; listed with withdrawn nominations on FDA's safety-risks page [2] | No routine commercial pathway established |
Hormone levels rose; no outcome was ever tested
The selected human reports include two 2006 hormone publications and a later serum-protein analysis. They do not establish benefit for commercial body-composition, sleep or anti-aging use. FDA identifies the later eleven-man serum analysis as a subset of the Ionescu study, not a new independent treatment cohort [6] [7] [9] [4].
| Study | Who | What it found |
|---|---|---|
| Teichman 2006 [6] | Healthy adults aged 21 to 61, two placebo-controlled trials of 28 and 49 days | One injection raised growth hormone 2- to 10-fold for 6 days or more and IGF-1 1.5- to 3-fold for 9 to 11 days |
| Ionescu 2006 [7] | Healthy men aged 20 to 40, one injection | A week later, baseline growth hormone was 7.5 times higher, mean growth hormone up 46% and IGF-1 up 45%; the natural pulse rhythm was kept |
| Sackmann-Sala 2009 [9] | Serum samples from 11 men in a subset of the Ionescu study | Serum protein-profile analysis; not a clinical muscle, fat-loss or aging outcome. FDA identifies this group as overlapping with Ionescu, not an independent cohort. |
FDA’s briefing summarizes 63 healthy adults, 87% men and 73% with one injection. It also explicitly identifies overlap between the Ionescu and Sackmann-Sala publications. The aggregate summary does not resolve a unique participant count across every publication, and the reports should not be treated as independent cohorts. These short data did not establish commercial wellness benefit. FDA also described a terminated HIV-associated-visceral-obesity trial without published outcome data. Publication counts should not be treated as proof of independent cohorts [4].
| Effect | How often |
|---|---|
| Headache | 63% active versus 14% placebo in the first Teichman study |
| Injection-site reactions | Approximately 70% of active subjects in the first study; urticarial rash in almost 30% |
| Flushing and vasodilatory reactions | 30% in the first study; dose-group frequencies40–100% in the second |
| Later brief study | All active subjects reported injection-site reactions; study designs and follow-up were limited |
Source: FDA advisory committee briefing, December 4, 2024 [4], summarizing the 2006 studies.
FDA’s briefing describes an unpublished terminated trial and a reported death after myocardial infarction. Its account relied on public reports and did not establish that CJC-1295 caused the death. The absence of published trial-level data limits assessment; it is not evidence of either causation or safety [4].
By goal: no trial measured what it's sold for
| Your goal | Human evidence | Go deeper |
|---|---|---|
| Fat loss | No applicable controlled fat-loss benefit established | Body composition shortlist |
| Muscle | No applicable controlled muscle benefit established | What sermorelin's muscle studies show |
| Results over weeks | No outcome trial | CJC-1295 and ipamorelin results timeline |
| Sleep or aging | No applicable controlled benefit established | Sleep and recovery shortlist |
Blends and stacks don't create a route
Combining CJC-1295 with ipamorelin does not solve the regulatory or evidence questions for either ingredient. The advisory votes were recommendations, not approvals or the legal act that removed eligibility. No applicable controlled evidence establishing the advertised combination benefits was identified. Adding sermorelin does not establish authorization or safety for the other ingredients.
No US pharmacy can legally make it
An ordinary prescription does not replace the ingredient and route requirements for compounding. Authorized research or applicable expanded access follows a separate regulatory framework; a research-use label or registry listing alone is not authorization. Read the detailed regulatory guide [8].
What a prescriber can offer instead
The sermorelin guide covers a different GHRH fragment, its former approved uses and the limits of adult evidence. Its status does not authorize CJC-1295 or establish that either is appropriate for healthy hormone enhancement.
Tesamorelin is another GHRH copy, approved as the brand Egrifta for belly fat in adults with HIV-associated lipodystrophy. FDA regulates it as a biologic, so it can't be compounded. Ask your prescriber:
- Is the peptide you're offering legal for your pharmacy to compound?
- Which lab values, such as IGF-1, will you check?
- What result would mean we stop?
Research on CJC-1295
Can you get ipamorelin or CJC-1295 legally? What FDA's record says
Neither peptide has a lawful pharmacy route today. Here's the dated record, and what a prescriber can offer instead.
How long CJC-1295 and ipamorelin take to work: what is actually known
Week-by-week timelines for this pair are everywhere. The cited studies do not establish such a response timetable. Here's what the hormone research does show.
Frequently asked
- Is CJC-1295 legal?
- It is not FDA-approved, and the cited current records do not establish a routine commercial compounding pathway. Authorized research or applicable expanded access is distinct from retail wellness prescribing. A research-use label alone is not authorization.
- What differs between CJC-1295 with and without DAC?
- DAC supports binding to albumin and prolonged action. A no-DAC product is a different preparation often called modified GRF1–29; studies of the DAC analog cannot simply establish its effects.
- Does CJC-1295 with ipamorelin burn fat?
- The cited hormone and serum-protein studies do not establish fat loss from the advertised combination. No applicable controlled combination evidence was identified.
- Can you combine CJC-1295, ipamorelin and sermorelin?
- Adding an ingredient with a different regulatory history does not authorize the others or establish combination safety. A clinician and pharmacy must satisfy the requirements for every ingredient and route.
- How much is CJC-1295?
- This guide does not quote a routine commercial prescription price because the cited sources do not establish an eligible compounding pathway. A research-vial price is not an approved treatment quote.
- Is CJC-1295 the same as sermorelin?
- No. They differ in molecular structure, regulatory history and evidence. A shared relationship to GHRH does not make them interchangeable clinical treatments.
Sources
- [1] FDA: Bulk drug substances nominated for use in compounding under section 503A (updated May 14, 2026) (2026). FDA
- [2] FDA: Certain bulk drug substances for use in compounding that may present significant safety risks (2026). FDA
- [3] Federal Register: Pharmacy Compounding Advisory Committee; notice of meeting (October 25, 2024) (2024). FDA
- [4] FDA briefing document, Pharmacy Compounding Advisory Committee, December 4, 2024. FDA
- [5] FDA final summary minutes, Pharmacy Compounding Advisory Committee, December 4, 2024 (2025). FDA
- [6] Teichman SL. Prolonged stimulation of growth hormone (GH) and insulin-like growth factor I secretion by CJC-1295, a long-acting analog of GH-releasing hormone, in healthy adults (2006). PMID 16352683
- [7] Ionescu M. Pulsatile secretion of growth hormone (GH) persists during continuous stimulation by CJC-1295, a long-acting GH-releasing hormone analog (2006). PMID 17018654
- [8] FDA Investigational New Drug application framework (2026). FDA
- [9] Sackmann-Sala L. Activation of the GH/IGF-1 axis by CJC-1295, a long-acting GHRH analog, results in serum protein profile changes in normal adult subjects (2009). PMID 19386527