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Lupron (leuprolide acetate)
Leuprolide is a GnRH agonist that suppresses luteinizing hormone and follicle-stimulating hormone, leading to decreased testosterone and estrogen production.
Leuprolide is a 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 | Lupron (leuprolide acetate) |
|---|---|
| Also known as | Lupron |
| Sponsor | Abbott |
| Drug class | GnRH agonist |
| Target | GnRH receptor (GNRHR) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Leuprolide binds to and activates GnRH receptors in the pituitary gland. Initially, this causes a surge in LH and FSH release, but with continuous exposure, it leads to receptor desensitization and downregulation, resulting in sustained suppression of gonadal hormone production. This effect is used to treat hormone-dependent cancers and certain reproductive disorders.
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
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)
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:
- Lupron (leuprolide acetate) CI brief — competitive landscape report
- Lupron (leuprolide acetate) updates RSS · CI watch RSS
- Abbott portfolio CI