Ensifentrine is a selective, dual phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4) inhibitor developed as an inhaled maintenance treatment for chronic obstructive pulmonary disease (COPD). It combines bronchodilator and anti-inflammatory activity through inhibition of PDE3 and PDE4.
Ensifentrine is administered through inhalation and is designed to act locally in the lungs. Inhibition of PDE3 promotes airway smooth-muscle relaxation, while PDE4 inhibition contributes to anti-inflammatory effects.
Ensifentrine is a synthetic small-molecule respiratory pharmaceutical ingredient. It is also known by the development code RPL554.
The U.S. FDA approved ensifentrine under the brand name Ohtuvayre in 2024 for the maintenance treatment of COPD in adults.
Swapnroop Drugs and Pharmaceuticals provides Ensifentrine API for qualified pharmaceutical manufacturing, formulation development, research and pharmaceutical sourcing requirements.
Ensifentrine is a specialized respiratory API relevant to PDE3/PDE4 inhibitor drug development.
Ensifentrine inhibits both PDE3 and PDE4.
This dual mechanism provides both bronchodilator and non-steroidal anti-inflammatory effects.
Ensifentrine is associated with:
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |
| Melting Point | 150°C – 154°C |