On October 14, 2025, Traws Pharma announced the dosing of the first patient in its Phase 2 study of ratutrelvir, a ritonavir‑free oral protease inhibitor for COVID‑19. The study, conducted in the United States, will evaluate safety, infection rates, COVID symptoms, disease rebound, and the incidence of Long COVID in newly diagnosed patients. The trial will use a 600 mg/day dose for 10 days, administered once daily as a single tablet.
Chief Executive Officer Iain D. Dukes said the study will compare ratutrelvir to the current gold standard, PAXLOVID®, in a non‑inferiority design, while a second single‑arm trial will assess safety and efficacy in PAXLOVID‑ineligible patients—a population with limited treatment options. Dukes added that the company expects to report results from both trials by the end of 2025, potentially providing proof‑of‑concept data that could position ratutrelvir as a new standard of care.
The Phase 2 program is a key milestone in Traws Pharma’s strategic pivot from oncology to respiratory viral diseases. Successful outcomes could expand the company’s market reach, reduce rebound and Long COVID risks, and strengthen its competitive position against established antivirals. The announcement marks a tangible step forward in the development of a differentiated COVID‑19 therapy and is therefore material to investors and stakeholders.
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