OHTUVAYRE
PDE NEB
Ensifentrine · Merck Sharp & Dohme (formerly Verona Pharma)
Active Medication & Mechanism
- Ensifentrine PDE3 mg per 2.5 mL unit-dose ampule
First-in-class selective dual inhibitor of phosphodiesterase 3 (PDE3) and PDE4. Raising intracellular cAMP/cGMP produces combined bronchodilator and non-steroidal anti-inflammatory effects.
FDA-Approved Dosing by Indication
// approval varies by strength + age COPD
1/1 approved regimens| Strength | Population | Dose & Frequency | Total Daily | Status |
|---|---|---|---|---|
| 3 mg/2.5 mL | Adults (≥18 years) | 1 ampule (3 mg) nebulized twice daily (morning and evening) Maintenance treatment of COPD in adults. Administer via a standard jet nebulizer with a mouthpiece connected to an air compressor. First inhaled agent with a novel COPD mechanism in over 20 years (approved June 26, 2024). | 6 mg | FDA Approved |
- 3 mg/2.5 mL FDA ApprovedPop · Adults (≥18 years)1 ampule (3 mg) nebulized twice daily (morning and evening)Maintenance treatment of COPD in adults. Administer via a standard jet nebulizer with a mouthpiece connected to an air compressor. First inhaled agent with a novel COPD mechanism in over 20 years (approved June 26, 2024).Total · 6 mg
Asthma
0/1 approved regimens| Strength | Population | Dose & Frequency | Total Daily | Status |
|---|---|---|---|---|
| Any strength | All patients | — | — | Not Approved Ohtuvayre is not indicated for asthma. |
- Any strength Not ApprovedPop · All patients—Total · — Ohtuvayre is not indicated for asthma.
Acute Use
0/1 approved regimens| Strength | Population | Dose & Frequency | Total Daily | Status |
|---|---|---|---|---|
| Any strength | Acute bronchospasm / rescue | — | — | Not Approved Not for acute symptoms of bronchospasm. Use a SABA. |
- Any strength Not ApprovedPop · Acute bronchospasm / rescue—Total · — Not for acute symptoms of bronchospasm. Use a SABA.