NDAINHALATIONSUSPENSION
Approved
Jun 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
8
Data completeness
5/8 — Partial
OHTUVAYRE (ensifentrine) by Verona Pharma is phosphodiesterase 3 inhibitors [moa]. Approved for phosphodiesterase 3 inhibitor [epc]. First approved in 2024.
Drug data last refreshed 17h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OHTUVAYRE (ensifentrine) is a phosphodiesterase 3 inhibitor administered via inhalation suspension for the treatment of respiratory conditions. It represents a small-molecule therapeutic targeting PDE3 pathways to improve airway and pulmonary function. The drug was approved by the FDA on June 26, 2024, marking Verona Pharma's entry into the respiratory therapeutics market.
Growth17.8 years to LOE
Early-stage commercial growth phase with modest reimbursement signals; small initial team building opportunity in respiratory specialty segments.
Mechanism of Action
Phosphodiesterase 3 Inhibitors
Pharmacologic Class:
Phosphodiesterase 3 Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (8)
A Phase II Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Single Inhaled Doses of Ensifentrine-glycopyrrolate Fixed Dose Combination, Ensifentrine, and Glycopyrrolate in Subjects With Chronic Obstructive Pulmonary Disease
Started Oct 2025
33 enrolled
Chronic Obstructive Pulmonary Disease
Clinical Study of Ensifentrine-Glycopyrrolate (MK-5884A/RPL554) Fixed-dose Combination Dose Ranging in Participants With COPD (MK-5884A-029/RPL554-CO-212)
Started Jul 2025
497 enrolled
Chronic Obstructive Pulmonary Disease
A Phase II Study of Ensifentrine in Non-Cystic Fibrosis Bronchiectasis
Started Sep 2024
284 enrolled
Non-cystic Fibrosis Bronchiectasis
Effect of Ensifentrine Treatment on CAT Score
Started Jun 2024
20 enrolled
COPD
Effect of Ensifentrine on Sputum Markers of Inflammation in COPD
Started May 2022
56 enrolled
COPD
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.