Treats chronic obstructive pulmonary disease (COPD). Sold as Ohtuvayre. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Ensifentrine (sold as Ohtuvayre), first approved Jun 26, 2024, with 0 new uses approved and 0 published complete response letters.
| OHTUVAYRE | Part B | $258M | New | 19,594 |
| Ohtuvayre | Part D | $480K | +323% | 56 |
| Ensifentrine (MK-5884) Study for the Prevention of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in Adults With a History of Moderate or Severe Exacerbations While Receiving Standard of Care (SOC) (MK-5884-031/RPL554/ENHANCE-3)Pulmonary Disease, Chronic Obstructive · Merck Sharp & Dohme LLC | Phase 3 | Recruiting | Oct 15, 2026 |
| A Phase II Study of Ensifentrine in Non-Cystic Fibrosis BronchiectasisNon-cystic Fibrosis Bronchiectasis · Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA | Phase 2 | Recruiting | Aug 19, 2024 |
| Effect of Ensifentrine (MK-5884/RPL554) on Sputum Markers of Inflammation in Chronic Obstructive Pulmonary Disease (COPD) (MK-5884-023/RPL554-CO-207)Pulmonary Disease, Chronic Obstructive, COPD · Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA | Phase 2 | Active, not recruiting | Mar 8, 2022 |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
