Clinical Trial Design

This trial is a 24-week, Phase 3, randomized, double-blind, placebo-controlled (parallel-arm) study. It compares the group receiving BLU-5937 with a placebo group to evaluate efficacy and safety. Enrollment began on November 21, 2025, and is currently ongoing. The expansion includes additional recruitment of patients in China, reflecting a strategy to ensure data diversity.

Target Patient Population

The study targets patients with Refractory Chronic Cough (RCC), including adults who have not responded to existing treatments. The average age range is 40-65 years, and the duration of cough must be at least 8 weeks. This patient population has significant unmet medical needs due to limited treatment options.

Differentiation from Existing Treatments

BLU-5937 is a P2X3 receptor antagonist that targets the modulation of neuropathic cough. Unlike existing centrally acting antitussives or mucolytics, it is expected to have fewer side effects by suppressing the cough reflex itself. In particular, the reduction in cough frequency and intensity compared to placebo was statistically significant in the previous Phase 2 trial.

Market and Impact

The chronic cough market is worth billions of dollars annually worldwide, and China, in particular, has high growth potential due to its large population and smoking rate. This expansion in China increases the likelihood of local regulatory approval and can lower barriers to market entry for future global launches. Success will significantly contribute to strengthening GSK's respiratory portfolio and diversifying its revenue streams.