18+ · Research Use Only · Not for Human Consumption
Regulation answer
Are CJC-1295 and ipamorelin FDA approved?
No. As of 23 September 2026, neither CJC-1295 nor ipamorelin has an approved application with the US FDA or a record with the EMA. FDA lists both on its compounding safety-risk page, and says it has identified serious adverse events with CJC-1295, including increased heart rate. No FDA Philippines advisory names either.
Primara Labs sells some of the compounds covered here. Every figure on this page links to its source and the date it was checked.
Updated 23 September 2026
01
CJC-1295
FDA's compounding page (current as of 22 April 2026) says: "Compounded drugs containing CJC-1295 may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization. FDA has identified serious adverse events associated with CJC-1295 including increased heart rate and systemic vasodilatory reaction."
Drugs@FDA: "no record found". EMA: "no record found".
02
Ipamorelin
The same page says of ipamorelin acetate: "Compounded drugs containing Ipamorelin acetate may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation or peptide-related impurities. Ipamorelin acetate also contains unnatural amino acids, which add to the complexity of peptide characterization."
Drugs@FDA: "no record found". Ipamorelin reached a phase 2 trial after bowel surgery, which did not meet its main goal; the Research Desk rates its evidence phase 2 human.
03
Philippines
Searches of fda.gov.ph for "CJC-1295" and "ipamorelin" on 23 September 2026 returned no advisory, and neither registration record could be read from the verification portal.
04
What FDA's page is, and is not
FDA publishes the page to tell US compounding pharmacies which bulk substances it considers may present significant safety risks. It records hazards and evidence gaps; it is not an approval decision and does not rule on any product sold outside US compounding.
The Research Desk rates CJC-1295's evidence as small human studies and ipamorelin's as phase 2 human. No published study has given the two together.
05
The human data
Human data are two small pharmacology trials of the DAC form; the rest is animal work.
One phase 2 human trial, which found no significant effect; the rest is animal work.
This is general information, not legal advice.
Sources
Where every figure comes from
- US FDA record for CJC-1295 · checked 23 September 2026
- EMA record for CJC-1295 · checked 23 September 2026
- FDA, bulk drug substances that may present significant safety risks in compounding · checked 23 September 2026
- US FDA record for Ipamorelin · checked 23 September 2026
- FDA Philippines site search, ipamorelin · checked 23 September 2026
Last reviewed 23 September 2026