Ensifentrine
As of the edition of 20 October 2026, Ensifentrine is a small molecule: marketed, first approved in 2024 (US); acts on PDE3A, PDE3B and PDE4A and 3 more; US protection ends in 2031.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Small molecule
- Brand name
- Ohtuvayre
- First approved
- 26 June 2024 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Merck & Co.
- Registered trials
- 20, 1 stopped early
- Disease areas
- Lungs and airways; Digestive system; Immune system; Inherited and neonatal
US protection
US protection ends in 2031.
The last listed US drug-substance patent ends in 2031. The application that gives this date is held by Merck & Co..
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product2 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
4 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product4 company-target rows are on route B because of Ensifentrine.
See the 4 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
| Gene | Protein | UniProt |
|---|---|---|
| PDE4A | 3',5'-cyclic-AMP phosphodiesterase 4A | P27815 |
| PDE4B | 3',5'-cyclic-AMP phosphodiesterase 4B | Q07343 |
| PDE4C | 3',5'-cyclic-AMP phosphodiesterase 4C | Q08493 |
| PDE4D | 3',5'-cyclic-AMP phosphodiesterase 4D | Q08499 |
| PDE3B | cGMP-inhibited 3',5'-cyclic phosphodiesterase 3B | Q13370 |
| PDE3A | cGMP-inhibited 3',5'-cyclic phosphodiesterase 3A | Q14432 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 3 | 3 | 0 | 0 |
| Phase 2 | 13 | 9 | 3 | 1 |
| Phase 3 | 4 | 4 | 0 | 0 |
| All trials | 20 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck & Co. | Originator, Applicant and Lead sponsor of trials | 2014 to now |