Company: PHAT
Filing Date: 2025-03-06
Form Type: 10-K
Source: 0000950170-25-034183
Chunk: 44

Company: Phathom Pharmaceuticals, Inc.
Filing Date: 2025-03-06
Form: 10-K
Item: Item 1
Chunk 44
---
uprazan is launched in five countries and under health authority review in nine countries or regions. In the U.S., Sebela initiated three tegoprazan Phase 3 studies in Erosive GERD, Non-Erosive GERD and long-term safety–with expected completion in 2025. Outside the U.S., tegoprazan is launched in 14 countries, registered but not launched in one country and under health authority review in four countries. In the U.S., Cinclus obtained FDA agreement on their linaprazan glurate pediatric plan and plans to initiate two linaprazan glurate Phase 3 studies in patients with severe Erosive GERD in 2025 and two H. pylori Phase 3 dual therapy (with amoxicillin) studies in 2026. Outside the U.S., Cinclus, via their local partner, received a 2024 approval in GERD for linaprazan glurate in China--facilitating a potential launch there in 2025. No other registration activities are noted for linaprazan glurate. In Europe, Cinclus agreed to a pediatric investigation plan with the European Medicines Agency and received regulatory advice on Phase 2 and Phase 3 study designs. Lastly, there are two additional PCABs with registrations outside the U.S.—Jiangsu Carephar’s keverprazan which launched in China and Jeil’s zastaprazan which launched in South Korea. To the best of our knowledge, none of the above compounds have demonstrated superiority to PPIs in a Phase 3 clinical trial. 

Additionally, we are aware of two PPIs in territories outside of the U.S. that if developed and approved in our licensed territories may compete with vonoprazan. These include Dexa Medica’s DLBS-2411, launched in the Philippines and in Phase 3 in Indonesia and Sihuan Pharmaceutical’s anaprazole, launched in China.

Intellectual Property  

Intellectual property, including patents, trade secrets, trademarks and copyrights, is important to our business. Our commercial success depends in part on our ability to obtain and maintain proprietary intellectual property protection for vonoprazan, as well as for future product candidates and novel discoveries, product development technologies, and know-how. Our commercial success also depends in part on our ability to operate without infringing on the proprietary rights of others and to prevent others from infringing our proprietary rights. Our policy is to develop and maintain protection of our