Ensifentrine is a phosphodiesterase 3 inhibitor indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. It is available as inhalation suspension. MedsAcross supplies Ensifentrine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
OHTUVAYRE is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. OHTUVAYRE is a phosphodiesterase 3 (PDE3) inhibitor and phosphodiesterase 4 (PDE4) inhibitor indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.
Source: US FDA prescribing information
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 signaling effects.
Source: US FDA prescribing information
The recommended dosage of OHTUVAYRE is 3 mg (one unit-dose ampule) twice daily, once in the morning and once in the evening, administered by oral inhalation using a standard jet nebulizer with a mouthpiece. Recommended Dosage: 3 mg (one ampule) twice daily administered by oral inhalation using a standard jet nebulizer with a mouthpiece. See full prescribing information for administration instructions. Administration Instructions Remove OHTUVAYRE unit-dose ampule from foil pouch only immediately before use. For pouches of 5 ampules, remove one ampule and place the remaining ampules back into the pouch in an upright orientation until next use. Once the foil pouch is opened, discard ampules if not used within 14 days. Shake OHTUVAYRE ampule vigorously. Squeeze and completely empty contents of the ampule into the nebulizer cup for administration of OHTUVAYRE by oral inhalation.
Source: US FDA prescribing information
OHTUVAYRE is contraindicated in patients with hypersensitivity to ensifentrine or any component of this product.
Source: US FDA prescribing information
Should not use OHTUVAYRE to treat acute symptoms of bronchospasm. If paradoxical bronchospasm occurs, discontinue OHTUVAYRE and institute alternative therapy. An increase in psychiatric adverse reactions, including suicidality, were reported with use of OHTUVAYRE. Carefully weigh the risks and benefits of treatment with OHTUVAYRE in patients with a history of depression and/or suicidal thoughts or behavior.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: Paradoxical Bronchospasm Psychiatric Events Including Suicidality Most common adverse reactions (incidence greater and equal to 1% and more common than placebo) include back pain, hypertension, urinary tract infection, and diarrhea.
Source: US FDA prescribing information
Store at controlled room temperature (68°F to 77°F [20°C to 25°C], excursions permitted from 59ºF to 86ºF [15ºC to 30ºC]). Do not freeze. Store OHTUVAYRE in the protective foil pouch. Protect from direct sunlight and excessive heat. Do not store upside down.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Ensifentrine, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Ohtuvayre 3 mg/2.5 mL inhalation suspensionInhalation | Merck Sharp & Dohme | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Ensifentrine and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Ensifentrine, including Ohtuvayre.
Yes. The US FDA first approved Ensifentrine on 26 June 2024, according to Drugs@FDA.
No listed presentation of Ensifentrine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Ensifentrine is classified under ATC code R03BX (Asthma and COPD medicines, subgroup R03B, subgroup R03BX).
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