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Leuprolide Depot
Leuprolide Depot is a GnRH agonist Small molecule drug developed by Enteris BioPharma Inc.. It is currently FDA-approved for Advanced prostate cancer, Endometriosis, Uterine fibroids (leiomyomata). Also known as: Lupron Depot® 3.75 mg.
Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist that suppresses luteinizing hormone and follicle-stimulating hormone, leading to decreased testosterone and estrogen production.
Leuprolide Depot is a gonadotropin-releasing hormone receptor agonist used to treat various conditions, including Prostate Cancer, Endometriosis, Infertility, Hyperandrogenemia, and Obesity. It works by activating the gonadotropin-releasing hormone receptor, a protein involved in regulating hormone production.
At a glance
| Generic name | Leuprolide Depot |
|---|---|
| Also known as | Lupron Depot® 3.75 mg |
| Sponsor | Enteris BioPharma Inc. |
| Drug class | GnRH agonist |
| Target | GnRH receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology; Urology; Gynecology |
| Phase | FDA-approved |
Mechanism of action
Leuprolide binds 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 depot formulation provides sustained drug release over weeks to months.
Approved indications
- Advanced prostate cancer
- Endometriosis
- Uterine fibroids (leiomyomata)
- Precocious puberty
- Breast cancer (premenopausal women)
Common side effects
- Hot flashes
- Injection site reaction
- Decreased libido
- Erectile dysfunction
- Headache
- Fatigue
- Bone density loss (with prolonged use)
- Transient testosterone surge (flare)
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 to Test the Drug Darolutamide Along With the Drugs Leuprolide Acetate and Exemestane in Patients With Recurrent Ovarian Granulosa Cell Tumors (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)
- 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)
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 Depot CI brief — competitive landscape report
- Leuprolide Depot updates RSS · CI watch RSS
- Enteris BioPharma Inc. portfolio CI
Frequently asked questions about Leuprolide Depot
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Related
- Drug class: All GnRH agonist drugs
- Target: All drugs targeting GnRH receptor
- Manufacturer: Enteris BioPharma Inc. — full pipeline
- Therapeutic area: All drugs in Oncology; Urology; Gynecology
- Indication: Drugs for Advanced prostate cancer
- Indication: Drugs for Endometriosis
- Indication: Drugs for Uterine fibroids (leiomyomata)
- Also known as: Lupron Depot® 3.75 mg
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing