Leuprolide regulatory status

Current status of Leuprolide in the United States: FDA approved. In sport: WADA prohibited. Details, sources, and the dated timeline follow.

By the PeptideAgent Editorial Team. Draft, pending editorial review. Last verified Sep 23, 2026

What is the current status of Leuprolide?

FDA approvedWADA prohibitedVerified Sep 23, 2026

FDA and compounding

FDA approved as Lupron injection in April 1985 for advanced prostate cancer, with Lupron Depot (1989), Lupron Depot-Ped (1993), Eligard (2002), Fensolvi (2020), and Camcevi (2021) following for prostate cancer, endometriosis, fibroids, and central precocious puberty. Generic leuprolide injection is available. Compounding is limited to patient specific needs because approved products exist.

WADA

WADA prohibited

Access path

Prescription from a urologist, oncologist, gynecologist, or pediatric endocrinologist, usually administered in clinic.
Fertility clinics prescribe low dose leuprolide off label for IVF protocols.
Not available through compounding or telehealth peptide clinics.

Full Leuprolide page: evidence, dosing in the literature, and sources

How has the status of Leuprolide changed over time?

No dated regulatory event has been recorded for Leuprolide. That usually means no FDA, PCAC, Federal Register, or WADA action has named it specifically. Category-wide actions are listed on the tracker hub.

Sources

Numbered citations in the answers above point here, followed by the regulatory sources on record for Leuprolide and the source of each dated event.