- What is the FDA status of CJC-1295 and Ipamorelin?
- No compounding pathway today. CJC-1295: CJC-1295, with or without DAC, is not FDA-approved, and there is no pathway for a US pharmacy to compound it today. FDA removed it from its 503A Category 2 under a notice dated September 27, 2024, after the nominations were withdrawn, and FDA's Pharmacy Compounding Advisory Committee voted against every form it reviewed on December 4, 2024. Nothing favorable is pending. Checked against primary sources on October 13, 2026. Ipamorelin acetate: Ipamorelin is not FDA-approved, and there is no pathway for a US pharmacy or a 503B outsourcing facility to compound it today. FDA removed it from its 503A Category 2 under a notice dated September 27, 2024, after the nominations were withdrawn, and FDA's Pharmacy Compounding Advisory Committee voted against it on October 29, 2024. Ipamorelin acetate is still in FDA's 503B Category 2, the category for substances that may present significant safety risks. Checked against primary sources on October 13, 2026.
- Is compounded CJC-1295 and Ipamorelin an approved drug?
- No. Compounded medications are not approved by the FDA and have not been reviewed for safety, effectiveness, or quality. The CJC-1295 and Ipamorelin combination is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established. PEPLUX is a telehealth platform, not a pharmacy or drug manufacturer. Medications are compounded and dispensed by independently licensed US compounding pharmacies.
- What does the evidence support for CJC-1295 and Ipamorelin, and what does it not?
- Published human research on each peptide is limited and short-term, and the combination has not been shown to be safe or effective in people. FDA's safety-risks page cites serious adverse events reported with each peptide. FDA placed ipamorelin acetate in its 503B Category 2, substances that may present significant safety risks, in 2023, and in 2024 FDA's Pharmacy Compounding Advisory Committee voted against adding either peptide to the 503A bulks list.
- What are the risks of CJC-1295 and Ipamorelin?
- CJC-1295 and ipamorelin are not FDA-approved, and their safety in people, alone or together, has not been established. The full list of side effects, and of who should not use CJC-1295 and Ipamorelin, is in the risks section of this page. Your prescriber reviews your history before deciding whether it is appropriate for you.
- Why does CJC-1295 and Ipamorelin require baseline labs?
- Yes. A prescriber reviews baseline labs before a first prescription of CJC-1295 and Ipamorelin. Baseline labs are included in the price.
- What does CJC-1295 and Ipamorelin cost?
- $229 per month. Medication: included. Clinician visit: included. Baseline labs: included. Lab retests: included when ordered by your provider. Shipping: included. Patient portal access: included. Care-team chat support: included. *If medically eligible.
- Is CJC-1295 and Ipamorelin prohibited in sport?
- CJC-1295: Prohibited at all times under WADA class S2.2.4 (growth hormone releasing factors). Ipamorelin acetate: Prohibited at all times under WADA class S2.2.4 (growth hormone releasing factors). If you are subject to anti-doping testing, tell your prescriber before you start. Sanctions can follow from possession or purchase records alone, without a positive test.
- How is CJC-1295 and Ipamorelin given?
- Subcutaneous injection. Your prescriber decides whether it is appropriate for you and sets the regimen. PEPLUX does not publish dosing.