Cutia Therapeutics (HKG: 2487), a company specializing in dermatological therapies, has announced that its Phase I clinical study for CU-40101, a small-molecule thyroid hormone receptor agonist liniment for external use in androgenic alopecia in China, has successfully reached its primary endpoint.
Study Design and Results
The Phase I study was a randomized, double-blind, placebo-controlled, dosage escalation trial designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of CU-40101 in Chinese adult male patients with androgenic alopecia. The study was divided into two sections: single dose administration and multi-dose administration, each including 40 Chinese adult male subjects with androgenic alopecia. The results indicated that CU-40101 exhibited good safety, with no local tolerance issues observed after either single or multiple dose administrations. No abnormalities in thyroid function or thyroid ultrasound were reported. PK research revealed that the systemic exposure level after skin administration of CU-40101 was extremely low.
Mechanism of Action and Potential Use
CU-40101 targets thyroid receptors in hair follicle cells to stimulate hair regeneration. Applied directly to the scalp, it is designed to reduce systemic exposure and related side effects, offering a distinct mechanism of action compared to current treatments for androgenic hair loss. This therapy has the potential to be used for both male and female patients, providing a new option for those affected by hair loss conditions.-Fineline Info & Tech
