Wednesday, July 8, 2026

Drug profile · INN

ensifentrine

ensifentrine (OHTUVAYRE) is a phosphodiesterase 4 inhibitor. Route of administration: inhalation. Current US regulatory status: approved.

FDA: approved EMA: application withdrawn Respiratory system (R03) R03BX
US status approved
Patents linked 0
Pipeline programs 1
News articles 0
Drug details — ensifentrine
US status
approved
Class
Respiratory system (R03)
Route
INHALATION
Patents
0
Programs
1
Data quality
0.84

Quick answer

ensifentrine (OHTUVAYRE) is a phosphodiesterase 4 inhibitor. Route of administration: inhalation. Current US regulatory status: approved.

Key facts

INN ensifentrine
Brand OHTUVAYRE
Mechanism Phosphodiesterase 4 inhibitor
Target Phosphodiesterase 3
Therapeutic class Respiratory system (R03)
Route INHALATION
Formulation SUSPENSION
ATC code R03BX

Mechanism of action

Phosphodiesterase 4 inhibitor

Primary target: Phosphodiesterase 3

Approval history

Authority Status Date
FDA approved
EMA application withdrawn

Pipeline programs

  1. RPL554-NCFB-220 Phase 2 · Anaxis Pharma · Non-Cystic Fibrosis Bronchiectasis

Related & competitor drugs

  1. anagrelide hydrochloride Phosphodiesterase 3 inhibitor
  2. cilostazol Phosphodiesterase 3A inhibitor
  3. desloratadine Respiratory system (R01)
  4. deutivacaftor / tezacaftor / vanzacaftor Respiratory system (R07)
  5. dyphylline Phosphodiesterase 4 inhibitor
  6. ivacaftor Respiratory system (R07)

Frequently asked questions

What is ensifentrine?

ensifentrine (OHTUVAYRE) is a phosphodiesterase 4 inhibitor. Route of administration: inhalation. Current US regulatory status: approved.

What is the brand name for ensifentrine?

OHTUVAYRE is a marketed brand name for ensifentrine. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of ensifentrine?

ensifentrine has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.