Last reviewed 2026-04-20 · How we verify

LEUPROLIDE ACETATE

At a glance

Approved indications

No approved indications tracked.

Common side effects

• Bone pain
• Hot flashes/sweating
• Decreased libido
• Erectile dysfunction
• Fatigue
• Headache
• Nausea
• Diarrhea
• Weakness
• Paresthesia

Serious adverse events

• Myocardial infarction
• Pulmonary emboli
• Stroke
• Transient ischemic attack
• Ruptured aortic aneurysm
• Gastrointestinal bleeding
• Pneumonia
• Pulmonary fibrosis
• Urinary obstruction
• Hepatitis

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

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