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Leuprolide Acetate 3 Month Depot
Leuprolide acetate is a gonadotropin-releasing hormone (GnRH) agonist that suppresses luteinizing hormone and follicle-stimulating hormone, leading to decreased testosterone and estrogen production.
Leuprolide acetate is a gonadotropin-releasing hormone (GnRH) agonist that suppresses luteinizing hormone and follicle-stimulating hormone, leading to decreased testosterone and estrogen production. Used for Advanced prostate cancer, Endometriosis, Uterine fibroids (leiomyomata).
At a glance
| Generic name | Leuprolide Acetate 3 Month Depot |
|---|---|
| Also known as | ABT-818, Lupron, Leuprorelin acetate |
| Sponsor | AbbVie (prior sponsor, Abbott) |
| Drug class | GnRH agonist |
| Target | GnRH receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology; Endocrinology |
| Phase | Phase 3 |
Mechanism of action
Leuprolide works by binding to GnRH receptors in the pituitary gland, initially causing a surge in LH and FSH (flare effect), followed by sustained suppression of these hormones through receptor desensitization. This results in castration-level testosterone suppression in males and estrogen suppression in females, making it effective for hormone-dependent conditions. The 3-month depot formulation provides sustained drug release over 12 weeks via intramuscular injection.
Approved indications
- Advanced prostate cancer
- Endometriosis
- Uterine fibroids (leiomyomata)
- Central precocious puberty
Common side effects
- Hot flashes
- Injection site reaction
- Decreased libido
- Erectile dysfunction
- Headache
- Fatigue
- Gynecomastia
- Bone density loss (with long-term use)
Key clinical trials
- 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 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)
- A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer (PHASE3)
- Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response (PHASE2)
- Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT (PHASE2)
- Phase IIIb Study of Ribociclib + ET in Early Breast Cancer (PHASE3)
- Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging (PHASE3)
- Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer (PHASE1)
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:
- Leuprolide Acetate 3 Month Depot CI brief — competitive landscape report
- Leuprolide Acetate 3 Month Depot updates RSS · CI watch RSS
- AbbVie (prior sponsor, Abbott) portfolio CI