FDA Approves VABRINTY (leuprolide acetate) for Advanced Prostate Cancer

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FDA Published May 12, 2026 Medically reviewed May 12, 2026 DOI ↗ By Dr. Julia Lee, PhD · Oncology, Genomics & Drug Development

Key Takeaway

Consider VABRINTY as a GnRH agonist option for advanced prostate cancer with flexible subcutaneous dosing intervals.

The FDA has approved VABRINTY (leuprolide acetate) for the treatment of advanced prostate cancer. VABRINTY is a gonadotropin-releasing hormone (GnRH) agonist that provides continuous release of leuprolide acetate over one, three, four, or six months depending on the dose. The approval offers clinicians a flexible dosing option for patients with advanced prostate cancer, allowing for less frequent injections. VABRINTY must be administered by a healthcare provider via subcutaneous injection. The recommended doses are 7.5 mg every month, 22.5 mg every 3 months, 30 mg every 4 months, and 45 mg every 6 months. In clinical trials, injections were given in the upper or mid-abdominal area. Treatment is usually continued upon development of metastatic castration-resistant prostate cancer.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

VABRINTY is a gonadotropin releasing hormone (GnRH) agonist. It acts by suppressing pituitary gonadotropin secretion, leading to reduced testosterone levels.

Indication & Patient Population

VABRINTY is indicated for the treatment of advanced prostate cancer.

Dosing & Administration

VABRINTY is administered subcutaneously by a healthcare provider. The recommended doses are: 7.5 mg every month, 22.5 mg every 3 months, 30 mg every 4 months, and 45 mg every 6 months. The injection site should vary periodically and be in an area with sufficient soft or loose subcutaneous tissue. In clinical trials, injections were given in the upper or mid-abdominal area. Avoid areas with brawny or fibrous tissue or locations that could be rubbed or compressed. The product must be mixed as described and administered within 30 minutes of mixing.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

VABRINTY provides a GnRH agonist option for advanced prostate cancer with flexible dosing intervals. In patients treated with GnRH analogues for prostate cancer, treatment is usually continued upon development of metastatic castration-resistant prostate cancer.

Study Details

Study typeFda approval

PublishedDec 2004

View Original Abstract ↓

1 INDICATIONS AND USAGE VABRINTY is indicated for the treatment of advanced prostate cancer. VABRINTY is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of advanced prostate cancer. ( 1 )