At a glance
- Leuprolide (leuprorelin) is an FDA-approved drug, marketed as Lupron, Leuprolide, Eligard, Fensolvi, Camcevi (first approval: January 26, 1989).
- PubMed lists 3,091 publications mentioning it, including 452 randomized controlled trials and 329 animal-only studies.
- ClinicalTrials.gov lists 520 registered studies testing it (129 active).
- FDA's adverse event system (FAERS) holds 94,985 reports mentioning it; 46,764 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
| Application | Product | Status | First approval | Sponsor |
|---|---|---|---|---|
| NDA019010 | LUPRON | Approved, discontinued | April 9, 1985 | ABBVIE ENDOCRINE INC |
| NDA019732 | LUPRON DEPOT | Approved, marketed | January 26, 1989 | ABBVIE ENDOCRINE INC |
| NDA020011 | LUPRON DEPOT | Approved, marketed | October 22, 1990 | ABBVIE ENDOCRINE INC |
| NDA020263 | LUPRON DEPOT-PED KIT | Approved, marketed | April 16, 1993 | ABBVIE ENDOCRINE INC |
| NDA019943 | LUPRON DEPOT | Approved, marketed | March 30, 1995 | ABBVIE ENDOCRINE INC |
| NDA020517 | LUPRON DEPOT | Approved, marketed | December 22, 1995 | ABBVIE ENDOCRINE INC |
| NDA020708 | LUPRON DEPOT | Approved, marketed | March 7, 1997 | ABBVIE ENDOCRINE INC |
| ANDA074728 | LEUPROLIDE ACETATE | Approved, marketed | August 4, 1998 | SANDOZ |
| NDA021088 | VIADUR | Approved, discontinued | March 3, 2000 | ORTHO MCNEIL JANSSEN |
| ANDA075471 | LEUPROLIDE ACETATE | Approved, marketed | October 25, 2000 | MEITHEAL |
| ANDA075721 | LEUPROLIDE ACETATE | Approved, discontinued | November 29, 2001 | GENZYME |
| NDA021343 | ELIGARD KIT | Approved, marketed | January 23, 2002 | TOLMAR |
| NDA021379 | ELIGARD KIT | Approved, marketed | July 24, 2002 | TOLMAR |
| NDA021488 | ELIGARD KIT | Approved, marketed | February 13, 2003 | TOLMAR |
| NDA021731 | ELIGARD KIT | Approved, marketed | December 14, 2004 | TOLMAR |
| ANDA078885 | LEUPROLIDE ACETATE | Approved, marketed | March 9, 2009 | SUN PHARM |
| NDA203696 | LUPANETA PACK | Approved, discontinued | December 14, 2012 | ABBVIE ENDOCRINE |
| NDA205054 | LEUPROLIDE ACETATE FOR DEPOT SUSPENSION | Approved, marketed | August 28, 2018 | INVAGEN PHARMS |
| NDA213150 | FENSOLVI KIT | Approved, marketed | May 1, 2020 | TOLMAR |
| NDA211488 | CAMCEVI KIT | Approved, marketed | May 25, 2021 | ACCORD |
| ANDA213829 | LEUPROLIDE ACETATE | Approved, marketed | August 13, 2021 | SOMERSET THERAPS LLC |
| ANDA212963 | LEUPROLIDE ACETATE | Approved, marketed | June 6, 2022 | EUGIA PHARMA |
| ANDA215336 | LEUPROLIDE ACETATE | Approved, marketed | October 28, 2022 | AMNEAL |
| ANDA217957 | LEUPROLIDE ACETATE | Approved, marketed | October 17, 2024 | UBI |
| ANDA217437 | LEUPROLIDE ACETATE | Approved, discontinued | June 9, 2025 | PH HEALTH |
| NDA219745 | CAMCEVI ETM | Approved, marketed | August 25, 2025 | ACCORD |
| ANDA215826 | LEUPROLIDE ACETATE | Approved, marketed | November 13, 2025 | ZYDUS PHARMS |
| NDA213225 | VOBRIG | Approved, discontinued | August 26, 2026 | SUN PHARM |
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Gonadotropin-releasing hormone antagonists versus agonists for endometriosis: a systematic review and meta-analysis of randomized controlled trials.
- A Systematic Review of Elagolix for the Management of Endometriosis-associated Pain.
- Bacterial Meningitis Following Robot-Assisted Radical Prostatectomy After Neoadjuvant Precision Oncology-Directed Therapy: A Case Report.
- Durable biochemical and radiographic response during toripalimab treatment in MSI-high/TMB-high mCRPC: a case report.
- Effects of the GnRH agonist leuprorelin on liver volume in premenopausal women with severe polycystic liver disease.
- Gene Therapy for Metastatic Castration-Resistant Prostate Cancer Using the JC Polyomavirus (JCPyV) Virus-Like Particles as a Gene Delivery Vector.
- Comparison of cardiovascular events in patients with metastatic hormone sensitive prostate cancer treated with LHRH agonists to LHRH antagonists in the US: A retrospective cohort study.
- Acute Urinary Retention Leading to Post-renal Acute Kidney Injury Post-radiotherapy: A Case Report.
- Persistently elevated estradiol after bilateral salpingo-oophorectomy in recurrent low-grade endometrial stromal sarcoma: a case report.
- Prostatic Adenosquamous Carcinoma With a Minute Squamous Component in the Initial Biopsy and Early Liver Metastasis: A Case Report.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 520
- Active
- 129
- With posted results
- 173
Conditions studied
Show 40 more studies
All 520 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 94,985
- Serious
- 46,764
- With death outcome
- 14,270
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
FDA prescribing information
Official US prescribing information. Dosing sections are intentionally not shown.
- LEUPROLIDE ACETATE
- Leuprolide Acetate
- LEUPROLIDE ACETATE
- Vabrinty
- Eligard
- leuprolide acetate
- Leuprolide Acetate
- leuprolide acetate
- Lupron Depot
- CAMCEVI
- LEUPROLIDE ACETATE
- leuprolide acetate
- Leuprolide Acetate
- Lupron Depot-PED
- Fensolvi
- Lupron Depot
- Lupron Depot
- Leuprolide Acetate
- LUTRATE DEPOT
- LEUPROLIDE ACETATE DEPOT
- LEUPROLIDE ACETATE
- ELIGARD
Source: DailyMed / openFDA
Change history
No changes since monitoring began on October 30, 2026.