Dong-A ST announced on February 4 that it has received marketing approval for Dutana Tab, a fixed-dose combination treatment for benign prostatic hyperplasia (BPH), containing dutasteride (0.5 mg) and tadalafil (5.0 mg).

Designed to treat moderate-to-severe BPH, Dutana Tab is administered orally once daily. Dutasteride, an androgen inhibitor, is commonly used for BPH and male pattern baldness, while tadalafil is widely known as a treatment for erectile dysfunction.

The approval was based on a 48-week Phase 3 clinical trial involving 654 BPH patients across 19 hospitals in South Korea. The study demonstrated that Dutana Tab significantly improved Total IPSS (International Prostate Symptom Score) compared to monotherapies of either dutasteride or tadalafil, confirming its superior efficacy in symptom relief.

A Dong-A ST representative stated, “Dutana Tab is the world’s first combination therapy of dutasteride and tadalafil for BPH. Clinical trials have validated its superior symptom improvement and safety compared to monotherapies. We are committed to bringing Dutana Tab to market as soon as possible to provide BPH patients with a new treatment option and improve their quality of life.”

BPH is a condition in which an enlarged prostate compresses the urethra, leading to difficulties in urination. It primarily affects men over 50 and is associated with symptoms such as weak urinary stream, residual urine sensation, frequent urination, and nocturia. With the approval of Dutana Tab, Dong-A ST aims to offer an effective and convenient treatment solution for BPH patients worldwide.