Drug intelligence / Profile preview

ludaterone acetate

Development stage
Unknown
Lead developer
ASKA Pharmaceutical
Modality
Small Molecules
Administration
Oral
01

Overview

AKP-009 (ludaterone acetate) is a small molecule steroidal anti-androgen developed by ASKA Pharmaceutical in collaboration with Kyorin Pharmaceutical. It acts as a potent antagonist of the androgen receptor, blocking the binding of testosterone and dihydrotestosterone (DHT) to their receptors. The drug is primarily being developed for the treatment of benign prostatic hyperplasia (BPH), where it aims to reduce prostate volume and alleviate lower urinary tract symptoms. Additionally, it is being investigated for the treatment of polycystic ovary syndrome (PCOS) to manage symptoms associated with hyperandrogenism. As of early 2026, ludaterone acetate is in Phase 3 clinical trials for BPH and is in the preparation stage for clinical trials in PCOS.

Other names
Saldrosterone acetate
02

Targets

AR (Adrenergic receptors)

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