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Ohtuvayre (ENSIFENTRINE)
Ohtuvayre works by blocking an enzyme called phosphodiesterase 3, which helps to increase the levels of a molecule called cyclic AMP in the lungs.
Ohtuvayre (ensifentrine) is a small molecule phosphodiesterase 3 inhibitor developed by Verona Pharma. It is approved for the treatment of chronic obstructive pulmonary disease (COPD) and received FDA approval in 2024. As a phosphodiesterase 3 inhibitor, ohtuvayre works by increasing the levels of cyclic AMP in the lungs, which helps to improve lung function and reduce symptoms of COPD. Ohtuvayre is a patented medication with no generic manufacturers available. Key safety considerations include its potential effects on the cardiovascular system.
At a glance
| Generic name | ENSIFENTRINE |
|---|---|
| Sponsor | Verona Pharma |
| Drug class | Phosphodiesterase 3 Inhibitor [EPC] |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | FDA-approved |
| First approval | 2024 |
Mechanism of action
Ensifentrine is a small molecule that is an inhibitor of the PDE3 and PDE4 enzymes. PDE3 primarily hydrolyzes the second-messenger molecule cyclic adenosine monophosphate (cAMP) but is also capable of hydrolyzing cyclic guanosine monophosphate (cGMP). PDE4 hydrolyzes cAMP only. Inhibition of PDE3 and PDE4 results in accumulation of intracellular levels of cAMP and/or cGMP, resulting in various downstream signalling effects.
Approved indications
- chronic obstructive pulmonary disease (COPD)
Common side effects
- Back pain
- Hypertension
- Urinary tract infection
- Diarrhea
- Discontinued treatment due to adverse reactions
Key clinical trials
- A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD (PHASE2)
- Effect of Ensifentrine on Sputum Markers of Inflammation in COPD (PHASE2)
- 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 (PHASE2)
- A Phase II Study of Ensifentrine in Non-Cystic Fibrosis Bronchiectasis (PHASE2)
- A Study to Evaluate the Efficacy and Safety of Ensifentrine for 24 Weeks in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (PHASE3)
- Effect of Ensifentrine Treatment on CAT Score (PHASE3)
- A Study of RPL554 in Patients With Cystic Fibrosis (PHASE2)
- A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ohtuvayre CI brief — competitive landscape report
- Ohtuvayre updates RSS · CI watch RSS
- Verona Pharma portfolio CI