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A Phase 3, 52-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Efficacy and Safety Study With Open-Label Extension of BLU-5937 in Adult Participants With Refractory Chronic Cough, Including Unexplained Chronic Cough (CALM-1)

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Trial Profile

A Phase 3, 52-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Efficacy and Safety Study With Open-Label Extension of BLU-5937 in Adult Participants With Refractory Chronic Cough, Including Unexplained Chronic Cough (CALM-1)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Jul 2026

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At a glance

  • Drugs Camlipixant (Primary)
  • Indications Cough
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms CALM-1
  • Sponsors BELLUS Health

Most Recent Events

  • 17 Jul 2026 According to a GSK media release, based on the aggregate data, the limited efficacy demonstrated is unlikely to transform patient care. GSK has decided not to progress further development of camlipixant in RCC. Results from the CALM phase III programme will be submitted for future presentation/publication to contribute to the scientific understanding of RCC.
  • 17 Jul 2026 Primary endpoint has been met. (24-Hour Cough Frequency), according to a GSK media release.
  • 14 Jul 2026 Status changed from active, no longer recruiting to completed.

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