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A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study of Nebulized Revefenacin Inhalation Solution in Chinese Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD).

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Trial Profile

A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study of Nebulized Revefenacin Inhalation Solution in Chinese Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD).

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Jul 2025

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At a glance

  • Drugs Revefenacin (Primary)
  • Indications Chronic obstructive pulmonary disease
  • Focus Registrational; Therapeutic Use
  • Sponsors Mylan Pharmaceuticals

Most Recent Events

  • 26 Jun 2025 According to Theravance Biopharma media release, the regulatory approval from NMPA triggers a one-time $7.5 million milestone from Viatris to Theravance Biopharma, which is expected to be received in Q3 2025
  • 26 Jun 2025 According to Theravance Biopharma media release, the company announced that it has secured regulatory approval from China's National Medical Products Administration (NMPA) for YUPELRI inhalation solution, the first once-daily nebulized long-acting muscarinic antagonist (LAMA) approved for maintenance treatment of chronic obstructive pulmonary disease (COPD) in China.
  • 13 Nov 2023 Primary endpoint has been met. (Trough FEV1 on Day 85), according to a Viatris Inc Media Release.

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