Leuprolide: FDA status and clinical evidence
Leuprolide is approved by the FDA and is on the US market, first approved April 9, 1985, under 28 applications. 521 studies are registered on ClinicalTrials.gov, reaching Phase 4. 20 unexpired patents are listed in the Orange Book.
FDA approval status
FDA review documents
Clinical evidence
By phase
Patents and generic availability
Molecular identity
From the FDA Global Substance Registration System, the registry that assigns every substance the FDA tracks a unique identifier.
Frequently asked questions
Is Leuprolide FDA-approved?
Yes. Leuprolide holds FDA approval and is marketed in the US. Approval covers the specific uses, doses and forms on the FDA label, not every use it is sold or discussed for.
How much clinical research is there on Leuprolide?
521 studies are registered on ClinicalTrials.gov with Leuprolide as an intervention, 225 of them completed. The highest phase reached is Phase 4. Registration counts research activity, not proven benefit.
What brand names is Leuprolide sold under?
FDA records list CAMCEVI ETM, CAMCEVI KIT, ELIGARD KIT, FENSOLVI KIT, LEUPROLIDE ACETATE, LEUPROLIDE ACETATE FOR DEPOT SUSPENSION, LUPANETA PACK, LUPRON, LUPRON DEPOT, LUPRON DEPOT-PED KIT, VIADUR, VOBRIG. Brand availability changes over time, and some applications on file are marked discontinued.
Where does the information on this page come from?
Four FDA and NIH sources: Drugs@FDA for approval records, the FDA Orange Book for patents and exclusivity, the FDA Global Substance Registration System for molecular identity, and ClinicalTrials.gov for trial counts. Each is refreshed on a schedule and the date above shows the last refresh.
Sources: Drugs@FDA, FDA Orange Book, FDA Global Substance Registration System and ClinicalTrials.gov. Last refreshed 2026-10-16.