ECCLOCK® Gel Approved in South Korea, Botanix Eyes Asian Market Growth
Botanix Pharmaceuticals’ ECCLOCK® gel, a treatment for excessive sweating, has secured regulatory approval in South Korea, paving the way for a commercial launch in early 2026.
- ECCLOCK® gel approved by South Korean Ministry of Food and Drug Safety
- Launch planned for Q1 2026 by sublicensee Dongwha Pharm
- Manufacturing to be handled by Kaken Pharmaceutical in Japan
- Botanix to receive 50% royalties from Kaken’s South Korean sales
- Initial revenue from South Korea expected to be immaterial
Regulatory Milestone in South Korea
Botanix Pharmaceuticals Limited has achieved a significant regulatory milestone with the approval of its ECCLOCK® gel, 5% (Sofpironium Bromide), by South Korea’s Ministry of Food and Drug Safety on 29 August 2025. This approval authorizes the product’s entry into the South Korean market, expanding Botanix’s footprint in Asia beyond its established presence in Japan.
Strategic Partnerships Drive Market Entry
The South Korean launch will be executed by Dongwha Pharm. Co., Ltd., a venerable pharmaceutical company with a history dating back to 1897. Dongwha secured the sublicense from Kaken Pharmaceutical Co. Ltd., which originally launched ECCLOCK in Japan in 2020. This layered partnership model leverages Kaken’s manufacturing capabilities and Dongwha’s extensive distribution network, positioning ECCLOCK for a strong market introduction in Q1 2026.
Financial and Commercial Outlook
Under the sublicense agreement, Botanix will receive 50% of the royalties paid to Kaken from Dongwha’s net sales in South Korea, while Kaken retains upfront and milestone payments. Although the company does not anticipate material revenue from this deal in the near term, the approval and upcoming launch represent a strategic step toward building recurring royalty streams in Asia. Botanix also maintains rights to sublicense Sofpironium Bromide outside Asian territories, preserving avenues for future growth.
Broader Implications for Botanix
This approval complements Botanix’s existing FDA-approved product, Sofdra, for treating primary axillary hyperhidrosis in the US. ECCLOCK’s entry into South Korea signals Botanix’s commitment to expanding its dermatology portfolio internationally through partnerships and sublicensing, mitigating risks while accessing established regional players. The company’s approach exemplifies a pragmatic path to commercialisation in competitive pharmaceutical markets.
Bottom Line?
South Korean approval marks a promising expansion for Botanix, but market uptake and revenue growth remain to be proven.
Questions in the middle?
- How quickly will Dongwha ramp up ECCLOCK sales following the launch?
- What competitive pressures might ECCLOCK face in South Korea’s hyperhidrosis market?
- Could Botanix secure additional sublicenses or partnerships in other Asian countries soon?
