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Lupron (leuprorelin)
Leuprolide acetate, a long-acting GnRH analog, initially stimulates then suppresses pituitary gonadotropins, reducing gonadal steroid secretion.
At a glance
| Generic name | leuprorelin |
|---|---|
| Sponsor | Accord Healthcare S.L.U. |
| Drug class | Gonadotropin Releasing Hormone Receptor Agonist |
| Target | GnRH receptors |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1985 |
Mechanism of action
Leuprolide acetate acts as a long-acting GnRH analog. Initially, it stimulates the release of pituitary gonadotropins, but with repeated dosing, it leads to a prolonged suppression of these hormones, resulting in decreased gonadal steroid production. This effect is reversible upon discontinuation of the drug.
Approved indications
- Advanced Prostatic Carcinoma
- Anemia due to Bleeding Uterine Leiomyoma
- Endometriosis
- Precocious puberty
Common side effects
- Intercepted product preparation error
- Syringe issue
- Device leakage
- Wrong technique in product usage process
- Prostatic specific antigen increased
- Intercepted medication error
- Hot flush
- Product physical consistency issue
- Blood testosterone abnormal
- Prostate cancer metastatic
- Product leakage
- Blood testosterone increased
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 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)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Lupron CI brief — competitive landscape report
- Lupron updates RSS · CI watch RSS
- Accord Healthcare S.L.U. portfolio CI