LongevityNot approvedEvidence tier: Human RCT

CJC-1295

Last updated October 21, 2026. Approval line checked October 21, 2026. Compounding sources checked October 10, 2026.

FDA status

Not approved

Not approved. This record is not an FDA-approved drug product. Approval, where it exists, is specific to a drug product, indication, and route.

FDA primary source on file

Evidence tier

Human RCT. The tier is the highest indexed study type. It is not a safety rating and it is not an FDA approval. Confidence score 3/5. 27 PubMed citations indexed.

Products sold as "research use only" are not approved for human use. FDA warning.

CJC-1295 in the literature

DAC-technology GHRH analog with 6–8 day half-life via albumin binding, sustaining pituitary GH and IGF-1 secretion; synergistic with ghrelin receptor agonists.

What the literature studies

Long-Acting Growth Hormone Release

Evidence tier

Human RCT

Compounding record

Nomination withdrawn

Confidence
3/5

Regulatory record

Nomination withdrawn. FDA substance context: CJC-1295 (not all no-DAC analogs). Previously in Category 2; FDA still identifies potential significant safety risks. Withdrawal is not FDA approval or a determination of safety or compounding eligibility. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route.

Regulatory source checked October 10, 2026. This compounding label is separate from the approval line above.

FDA primary source 1

Regulatory context and verification limits are documented below.

Questions

Educational only. Not medical advice. This page does not give doses or sourcing. See the medical and editorial disclaimer.

Short answer

Both raise the body's own growth hormone - CJC-1295 as a long-acting GHRH analog, ipamorelin as a ghrelin-receptor agonist - neither is FDA-approved, and FDA has flagged serious adverse events for both.

What it is

  • CJC-1295: GHRH analog with a drug-affinity complex extending half-life [R1].
  • Ipamorelin: selective GH secretagogue (pentapeptide) [R2].

Legal / FDA status (as of Oct 27 2026)

  • CJC-1295: nominated-but-withdrawn list; FDA cites serious adverse events incl. increased heart rate and systemic vasodilatory reaction [FDA-RISK].
  • Ipamorelin acetate: also listed; FDA notes it is in Category 2 under the 503B interim policy [FDA-RISK].
  • Neither was on the July 2026 PCAC agenda. Not approved.

Human evidence

  • CJC-1295 in healthy adults: dose-dependent, sustained GH and IGF-1 rises over days [R1]. No published efficacy outcomes (muscle, fat).
  • Ipamorelin: a small proof-of-concept RCT in postoperative ileus found it well tolerated, with no significant differences vs placebo on key endpoints [R3].

Animal / lab evidence

Ipamorelin selectively released GH in animals without big cortisol/prolactin rises [R2].

Risks and unknowns

FDA-cited cardiovascular reactions (CJC-1295) [FDA-RISK]; gray-market quality unverified.

What's coming

No pending FDA action identified.

Sources

  1. [R1] Teichman SL et al. Prolonged stimulation of growth hormone and IGF-I secretion by CJC-1295. J Clin Endocrinol Metab 2006;91:799-805. doi:10.1210/jc.2005-1536
  2. [R2] Raun K et al. Ipamorelin, the first selective growth hormone secretagogue. Eur J Endocrinol 1998;139:552-561. doi:10.1530/eje.0.1390552
  3. [R3] Beck DE et al. Prospective, randomized, controlled, proof-of-concept study of ipamorelin for postoperative ileus. Int J Colorectal Dis 2014;29:1527-1534. PMID 25331030
  4. [FDA-RISK] FDA. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
  5. [FDA-PCAC] FDA. July 23-24, 2026 Meeting of the Pharmacy Compounding Advisory Committee. https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026
  6. [OIRA] OIRA. Pending EO 12866 Review, RIN 0910-ZD94. https://www.reginfo.gov/public/do/eoDetails?rrid=1568964 ; meetings: https://www.reginfo.gov/public/do/eom12866SearchResults?pubId=&rin=0910-ZD94

Last checked 2026-10-27

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