SOFDRA (Sofpironium)
Topical anticholinergic for axillary hyperhidrosis used in Japan and the US
이 치료에 대해
SOFDRA (sofpironium bromide gel) is a topical anticholinergic for primary axillary hyperhidrosis. Japan introduced the molecule earlier as ECCLOCK 5%, and the US approved SOFDRA 12.45% on June 18, 2024.
It is applied to the axillae nightly, offering a lower-intervention option than toxin injections or device procedures for patients troubled by sweat marks, odor worsening, and social distress. It is not a permanent one-time treatment; it is designed for ongoing sweat control with repeated use.
작용 기전
It blocks muscarinic M3 receptors on eccrine sweat glands, reducing acetylcholine-driven sweat signaling. Sofpironium was designed as a retrometabolic topical anticholinergic to provide local efficacy while limiting systemic anticholinergic burden.
적응증
기대 효과
In pooled phase 3 trials, SOFDRA showed statistically significant improvement versus vehicle in both symptom severity (HDSM-Ax-7) and gravimetric sweat reduction over 6 weeks. Some patients notice easier dryness within days, but formal assessment is usually made over 2-6 weeks. Ongoing application is required to maintain effect.
임상 근거
위험 및 부작용
Application-site irritation, dryness, and dermatitis can occur, along with anticholinergic effects such as dry mouth, dilated pupils, blurred vision, and urinary difficulty. Reduced sweating in hot environments may also increase heat-retention risk.