GSK Halts Camlipixant Development for Refractory Chronic Cough After Dual Phase III Trial Failure
Key Insights
GSK will discontinue development of camlipixant for refractory chronic cough (search) after the drug failed to meet key goals across two late-stage trials, sending shares down approximately 4%.
The 50 mg dose reduced daily coughing over 12 weeks in one trial but failed to replicate the result in a second 24-week study; the 25 mg dose showed no clear benefit in either.
GSK stated the limited benefit means the drug was "unlikely to transform patient care," though it will continue testing camlipixant for irritable bowel syndrome (search).
GSK announced on July 17 that it will halt development of its experimental drug camlipixant for refractory chronic cough (search) (RCC) after the P2X3 (search) receptor antagonist failed to meet key goals across two late-stage trials. The news sent the British drugmaker's shares down approximately 4% on Friday, reflecting investor concern over the company's pipeline trajectory.
The higher 50 mg dose of camlipixant reduced daily coughing over 12 weeks in one trial but failed to replicate that result in a second study conducted over 24 weeks, according to data released by the company. The drug's lower 25 mg dose did not provide a clear benefit in either study. Furthermore, neither of the two doses met key secondary goals, including patient-reported outcomes captured through a Chronic Cough Diary.
GSK acknowledged the disappointing results directly, stating that the limited benefit demonstrated by camlipixant means the drug was "unlikely to transform patient care."
Impact on GSK's Long-Term Revenue Ambitions
The trial failure could raise questions for investors who remain unconvinced that the company can achieve its target of £40 billion ($53.76 billion) in annual revenue by 2031. GSK had forecast peak annual sales of approximately £2.5 billion for camlipixant, although analyst estimates were closer to £1 billion.
JPMorgan analysts noted that GSK had positioned camlipixant as one way to help close the gap between analysts' forecasts of roughly £35 billion in 2031 sales and the company's £40 billion target. GSK, for its part, continues to stand by its long-term revenue target.
"The camlipixant development program was seen as having an above average risk of failing, as chronic cough is a difficult-to-treat disease," said Markus Manns, portfolio manager at GSK shareholder Union Investment, adding that the setback could increase pressure for further acquisitions.
Some analysts viewed the clinical failure as manageable. "Getting this through would have been a nice to have but not a must-have for the top-line trajectory," said Jefferies analyst Michael Leuchten, who pointed to recent acquisitions as potential drivers of sales growth not yet reflected in market expectations. Last month, GSK spent a record $10.6 billion to acquire U.S. cancer-focused drug developer Nuvalent.
Leadership and Pipeline Pressure
CEO Luke Miels, who succeeded Emma Walmsley in January, now faces increased pressure to convince investors that GSK can meet its ambitious revenue target while simultaneously managing looming patent expiries for the blockbuster HIV drug dolutegravir.
Future Development and Unmet Need
GSK will continue testing camlipixant as a treatment for irritable bowel syndrome (search). The company also plans to share the trial data to contribute to the scientific understanding of refractory chronic cough (search), a condition for which limited treatment options currently exist.
Nearly 10 million patients suffer from refractory chronic cough (search) globally each year, with the condition causing individuals to cough more than 900 times a day. GSK had acquired camlipixant through its $2 billion acquisition of Bellus Health (search) in 2023.