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Leuprolide (GnRH agonists)
Leuprolide (GnRH agonists) is a GnRH agonist Small molecule drug developed by University of Pisa. It is currently FDA-approved for Advanced prostate cancer, Endometriosis, Uterine fibroids (leiomyomata).
Leuprolide is a GnRH agonist that initially stimulates, then suppresses gonadotropin release, leading to decreased testosterone and estrogen production.
Leuprolide is a gonadotropin-releasing hormone receptor agonist that belongs to the drug class of AGONIST. It is used to treat conditions such as Central Precocious Puberty, Fibroids, Adenomyosis, and Prostate Cancer.
At a glance
| Generic name | Leuprolide (GnRH agonists) |
|---|---|
| Sponsor | University of Pisa |
| Drug class | GnRH agonist |
| Target | GnRH receptor (GNRHR) |
| Modality | Small molecule |
| Therapeutic area | Oncology; Endocrinology |
| Phase | FDA-approved |
Mechanism of action
Leuprolide binds to GnRH receptors on pituitary gonadotroph cells, causing an initial surge in luteinizing hormone (LH) and follicle-stimulating hormone (FSH). With continuous exposure, the pituitary becomes desensitized and downregulates GnRH receptors, resulting in sustained suppression of LH and FSH, which dramatically reduces sex hormone production. This mechanism is exploited therapeutically in hormone-dependent cancers and certain reproductive disorders.
Approved indications
- Advanced prostate cancer
- Endometriosis
- Uterine fibroids (leiomyomata)
- Precocious puberty
- Breast cancer (premenopausal women)
Common side effects
- Hot flashes
- Decreased libido
- Erectile dysfunction
- Injection site reactions
- Bone density loss (osteoporosis with long-term use)
- Headache
- Fatigue
Key clinical trials
- Radiotherapy After Prostatectomy for Node Positive Prostate Cancer (PHASE3)
- A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors (PHASE2)
- Hormone Therapy, Radiation Therapy, and Steroid 17alpha-monooxygenase TAK-700 in Treating Patients With High-Risk Prostate Cancer (PHASE3)
- Contributions to Hypertension With Androgen Deprivation Therapy (PHASE4)
- Phase II Trial of PSA Response-based Androgen Deprivation Therapy and Nodal Coverage for Prostate Cancer Early Salvage Radiotherapy (RANGER) (PHASE2)
- Pembrolizumab With Androgen Deprivation Therapy and Radiotherapy for the Treatment of Patients With High Risk Localized Prostate Cancer (PHASE2)
- ODM-201 vs Androgen Deprivation Therapy in Hormone naïve Prostate Cancer (PHASE2)
- Management of Castration-Resistant Prostate Cancer with Oligometastases (PHASE2, 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 (GnRH agonists) CI brief — competitive landscape report
- Leuprolide (GnRH agonists) updates RSS · CI watch RSS
- University of Pisa portfolio CI
Frequently asked questions about Leuprolide (GnRH agonists)
What is Leuprolide (GnRH agonists)?
How does Leuprolide (GnRH agonists) work?
What is Leuprolide (GnRH agonists) used for?
Who makes Leuprolide (GnRH agonists)?
What drug class is Leuprolide (GnRH agonists) in?
What development phase is Leuprolide (GnRH agonists) in?
What are the side effects of Leuprolide (GnRH agonists)?
What does Leuprolide (GnRH agonists) target?
Related
- Drug class: All GnRH agonist drugs
- Target: All drugs targeting GnRH receptor (GNRHR)
- Manufacturer: University of Pisa — full pipeline
- Therapeutic area: All drugs in Oncology; Endocrinology
- Indication: Drugs for Advanced prostate cancer
- Indication: Drugs for Endometriosis
- Indication: Drugs for Uterine fibroids (leiomyomata)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing