Trial Profile
A Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ensifentrine Over 24 Weeks (With a 48-week Safety Subset) in Subjects With Moderate to Severe COPD
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 17 Nov 2023
Price :
$35
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At a glance
- Drugs Ensifentrine (Primary)
- Indications Chronic obstructive pulmonary disease
- Focus Registrational; Therapeutic Use
- Acronyms ENHANCE-1
- Sponsors Verona Pharma
- 17 Nov 2023 Last checked against ClinicalTrials.gov record.
- 03 Oct 2023 According to a Verona Pharma media release, data from this study will be presented at CHEST Annual Meeting (CHEST) 2023.
- 11 Sep 2023 According to a Verona Pharma media release, based on the ENHANCE studies, the US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) seeking approval of ensifentrine for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 26, 2024, and is not currently planning to hold an advisory committee meeting to discuss the application.