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Leuprolide Acetate for Injectable Suspension
Leuprolide acetate is a gonadotropin-releasing hormone (GnRH) agonist that suppresses luteinizing hormone and follicle-stimulating hormone, leading to decreased testosterone and estrogen production.
Leuprolide acetate is a gonadotropin-releasing hormone (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.
At a glance
| Generic name | Leuprolide Acetate for Injectable Suspension |
|---|---|
| Sponsor | Oakwood Laboratories, LLC |
| Drug class | GnRH agonist |
| Target | GnRH receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Leuprolide works by binding to GnRH receptors in the pituitary gland, initially causing a surge in gonadotropin release followed by sustained suppression of LH and FSH. This results in castration-level testosterone suppression in males and estrogen suppression in females, making it effective for hormone-dependent conditions. The injectable suspension 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
- Fatigue
- Headache
- Nausea
- Bone pain (flare reaction)
Key clinical trials
- Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer (PHASE3)
- Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study (PHASE3)
- The LUCINDA Trial: LeUprolide Plus Cholinesterase Inhibition to Reduce Neurological Decline in Alzheimer's (PHASE2)
- Efficacy and Safety of Leuprolide Acetate 45 mg in Subjects With Central Precocious Puberty (PHASE4)
- Prevention of Obesity in Women Via Estradiol Regulation (PHASE3)
- Radiotherapy Combined With a LHRH (Ant)Agonist Versus Apalutamide in Patients With Biochemical Recurrence After RP (PHASE2)
- A Study to Assess the Safety and Efficacy of Enantone (Leuprorelin) in Central Precocious Puberty (CPP) Among Chinese Participants
- A Study to Assess the Safety and Efficacy of Leuprorelin in Central Precocious Puberty in Chinese Participants (PHASE4)
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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