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Leuprorelin Acetate Microspheres for Injection
Leuprorelin acetate is a GnRH agonist that suppresses luteinizing hormone and follicle-stimulating hormone, leading to decreased sex hormone production.
Leuprorelin acetate is a GnRH agonist that suppresses luteinizing hormone and follicle-stimulating hormone, leading to decreased sex hormone production. Used for Advanced prostate cancer, Endometriosis, Uterine fibroids.
At a glance
| Generic name | Leuprorelin Acetate Microspheres for Injection |
|---|---|
| Also known as | Tamoxifen Citrate Tablets |
| Sponsor | Changchun GeneScience Pharmaceutical Co., Ltd. |
| Drug class | GnRH agonist |
| Target | GnRH receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology; Endocrinology |
| Phase | Phase 3 |
Mechanism of action
Leuprorelin binds to GnRH receptors in the pituitary gland, initially stimulating LH and FSH release, but with continuous exposure causes downregulation of GnRH receptors and sustained suppression of gonadotropins. This results in profound reduction of testosterone (in males) or estrogen (in females), making it effective for hormone-dependent conditions. The microsphere formulation provides sustained release over weeks to months.
Approved indications
- Advanced prostate cancer
- Endometriosis
- Uterine fibroids
- Precocious puberty
Common side effects
- Hot flashes
- Injection site reaction
- Decreased libido
- Erectile dysfunction
- Headache
- Bone pain (initial flare)
Key clinical trials
- RWE About QOL and Compliance of Patients With OFS in China
- Safety, Efficacy and Pharmacokinetic Behavior of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subjects. (PHASE3)
- Safety and Efficacy Study of Leuprolide Acetate for Injectable Suspension 22.5 MG in the Treatment of 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 |
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