Shanghai (China) and Indianapolis (US), Jul. 22nd, 2025 – Acerand Therapeutics is pleased to announce that Acerand gets Center for Drug Evaluation (CDE) greenlight today for the open-label, multi-center Phase I study of ACE-232 (a novel CYP11A1 inhibitor) in China.

ACE-232 is a highly potent and selective small-molecule inhibitor of CYP11A1, a key adrenal enzyme involved in the first and rate-limiting step of steroid hormone biosynthesis. By targeting CYP11A1, ACE-232 aims to suppress the production of androgens and other steroid hormones, offering a novel therapeutic mechanism for the treatment of androgen-dependent (including enzalutamide or abiraterone-resistant) prostate cancer.

Preclinical data highlighted for presentation at AACR shows ACE-232 exhibited substantially greater potency in vitro in inhibiting CYP11A1. Furthermore, preclinical pharmacokinetic studies in multiple animal species indicated ACE-232 possesses favorable drug properties potentially supporting convenient once-daily dosing with sustained target inhibition and improved efficacy while reducing side effects associated with plasma concentration fluctuations.

The Investigational New Drug (IND) application for ACE-232 tablets was cleared for phase 1 trial by the U.S. Food and Drug Administration (FDA) on January 10, 2025. The first patient was dosed in early June, and clinical trials in the U.S. are currently progressing actively. The recent nod by the CDE is expected to further accelerate the clinical development of ACE-232 in China.