OHTUVAYRE

Growth

ensifentrine

NDAINHALATIONSUSPENSION
Approved
Jun 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
8

Mechanism of Action

Phosphodiesterase 3 Inhibitors

Pharmacologic Class:

Phosphodiesterase 3 Inhibitor

Clinical Trials (5)

NCT07132983Phase 2Completed

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
NCT07016412Phase 2Recruiting

A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD

Started Jul 2025
480 enrolled
Chronic Obstructive Pulmonary Disease
NCT06559150Phase 2Recruiting

A Phase II Study of Ensifentrine in Non-Cystic Fibrosis Bronchiectasis

Started Sep 2024
180 enrolled
Non-cystic Fibrosis Bronchiectasis
NCT06460493Phase 3Completed

Effect of Ensifentrine Treatment on CAT Score

Started Jun 2024
20 enrolled
COPD
NCT05270525Phase 2Recruiting

Effect of Ensifentrine on Sputum Markers of Inflammation in COPD

Started May 2022
56 enrolled
COPD

Loss of Exclusivity

LOE Date
Jun 25, 2044
222 months away
Patent Expiry
Jun 25, 2044
Exclusivity Expiry
Jun 26, 2029

Patent Records (5)

Patent #ExpiryTypeUse Code
9062047
Aug 21, 2031
Substance
U-3962
10945950
Sep 15, 2035
Product
9956171
Sep 15, 2035
Product
U-3962
12409180
Feb 20, 2043
Product
12251384
Jun 25, 2044
Product