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Leuprorelin acetate
Leuprorelin acetate is a gonadotropin-releasing hormone (GnRH) agonist that suppresses luteinizing hormone and follicle-stimulating hormone, leading to decreased sex hormone production.
Leuprorelin acetate is a gonadotropin-releasing hormone (GnRH) agonist that suppresses luteinizing hormone and follicle-stimulating hormone, leading to decreased sex hormone production. Used for Advanced prostate cancer, Hormone receptor-positive breast cancer, Endometriosis.
At a glance
| Generic name | Leuprorelin acetate |
|---|---|
| Also known as | Leuplin, Leuplin PRO for Injection Kit 22.5 mg, Leuplin SR for Injection Kit 11.25 mg, Prostap® SR, Leuplin SR 11.25 mg Injection Kit |
| Sponsor | Takeda |
| Drug class | GnRH agonist |
| Target | GnRH receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Leuprorelin works by binding to GnRH receptors in the pituitary gland, initially causing a surge in LH and FSH release (flare effect), followed by sustained suppression of these hormones through receptor desensitization. This results in profound reduction of testosterone in males and estrogen in females, making it useful for hormone-dependent cancers and certain reproductive conditions.
Approved indications
- Advanced prostate cancer
- Hormone receptor-positive breast cancer
- Endometriosis
- Uterine fibroids
- Precocious puberty
Common side effects
- Hot flashes
- Injection site reaction
- Decreased libido
- Erectile dysfunction
- Headache
- Fatigue
- Bone pain (flare reaction)
- Gynecomastia
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)
- Exploration of Treatment Effect of Novel Hormone Therapy Combined With Local Treatment Based on PSMA PET/CT Evaluation in mHSCP Patients (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 Endocrine Therapy, Palbociclib, Avelumab in Estrogen Receptor Positive Breast Cancer (PHASE2)
- Study of Recurrence-directed Therapy (RDT) With or Without Androgen-Deprivation Therapy (ADT) In Patients With Radio-recurrent Oligo-metastatic Hormone/Castrate Sensitive Prostate Cancer (romCSPC) (PHASE2)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Leuprorelin acetate CI brief — competitive landscape report
- Leuprorelin acetate updates RSS · CI watch RSS
- Takeda portfolio CI