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Leuprolide Acetate (leuprolide-acetate)
Leuprolide acetate is a manufactured version of a hormone that regulates growth and development, used to treat hormone-related conditions.
Leuprolide acetate, developed by Pfizer Inc., is a hormone treatment for various conditions. It works by mimicking a natural hormone to regulate growth and development. Key indications include advanced prostatic carcinoma, anemia due to bleeding uterine leiomyoma, endometriosis, and precocious puberty. Leuprolide acetate's clinical differentiation lies in its ability to effectively manage hormone-related conditions. Its commercial significance is evident in its widespread use and revenue generation. Pipeline developments for similar treatments are ongoing, with a focus on improving efficacy and reducing side effects.
At a glance
| Generic name | leuprolide-acetate |
|---|---|
| Sponsor | Pfizer |
| Drug class | leuprorelin |
| Target | Gonadotropin-releasing hormone receptor |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1985 |
Mechanism of action
Leuprolide acetate is a synthetic hormone that mimics the natural hormone gonadotropin-releasing hormone (GnRH). This hormone plays a crucial role in regulating growth and development, particularly in the reproductive system. By mimicking GnRH, leuprolide acetate can help manage conditions such as advanced prostatic carcinoma, anemia due to bleeding uterine leiomyoma, endometriosis, and precocious puberty.
Approved indications
- Advanced Prostatic Carcinoma
- Anemia due to Bleeding Uterine Leiomyoma
- Endometriosis
- Precocious puberty
Common side effects
- Malaise
- fatigue
- hot flashes/sweats
- testicular atrophy
Drug interactions
- Warfarin
- Cimetidine
- Ketoconazole
- Rifampin
- Phenytoin
- Phenobarbital
- Carbamazepine
- Omeprazole
- Erythromycin
- Cyclosporine
Key clinical trials
- A Single-Arm Phase II Study of Neoadjuvant Intensified Androgen Deprivation (Leuprolide and Abiraterone Acetate) in Combination With AKT Inhibition (Capivasertib) for High-Risk Localized Prostate Cancer With PTEN Loss (PHASE2)
- Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires
- Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study (PHASE3)
- Study to Test the Drug Darolutamide Along With the Drugs Leuprolide Acetate and Exemestane in Patients With Recurrent Ovarian Granulosa Cell Tumors (PHASE2)
- Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (PHASE2, PHASE3)
- Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate Cancer (PHASE2)
- Neoadjuvant Endocrine Therapy, Palbociclib, Avelumab in Estrogen Receptor Positive Breast Cancer (PHASE2)
- Radiotherapy After Prostatectomy for Node Positive Prostate Cancer (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Leuprolide Acetate CI brief — competitive landscape report
- Leuprolide Acetate updates RSS · CI watch RSS
- Pfizer portfolio CI