ensifentrine
Trade name: Ohtuvayre
Small moleculeapproved
Approved
Jun 26, 2024
Clinical trial activity
10 trials · 6 clinical orgs · 2 marketing orgs
Phase 1
1
Phase 2
9
Phase 3
3
Phase 4
0
Earliest trial started Apr 29, 2019 (NCT04091360)
Timeline
2010s
- Jan 1, 2019
Verona Pharma plc — Earliest Phase 2 Sponsor(trial)
2020s
- Jan 1, 2020
Verona Pharma plc — Earliest Phase 3 Sponsor(trial)
- Jan 1, 2023
Earliest Phase 1 Sponsor(trial)
- Jun 26, 2024
Verona Pharma plc — Earliest FDA Approval
- Jun 26, 2024
Verona Pharma plc — NDA Organization
- Jun 26, 2024
Merck — Marketing Organization
Indications
Mechanism of action
- Phosphodiesterase 1INHIBITOR
Phosphodiesterase 1 inhibitor
- Phosphodiesterase 3INHIBITOR
Phosphodiesterase 3 inhibitor
- Phosphodiesterase 4INHIBITOR
Phosphodiesterase 4 inhibitor
Approval history
- approvedJun 26, 2024
Chemistry & pharmacology
Loading structure…
SMILES
COc1cc2c(cc1OC)-c1c/c(=N\c3c(C)cc(C)cc3C)n(CCNC(N)=O)c(=O)n1CC2- Mol. weight
- 477.57 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Topical
- Availability
- Prescription Only
Oral
No
Parenteral
No
Topical
Yes
Sources
- ChEMBLCHEMBL4594287 ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07132983 | Phase 2 | Oct 6, 2025 | Verona Pharma plc |
| NCT07016412 | Phase 2 | Jul 31, 2025 | Verona Pharma plc |
| NCT05743075 | Phase 3 | Mar 10, 2023 | LabCorp, Nuance Biotech |
| NCT05758428 | Phase 1 | Mar 6, 2023 | Nuance Biotech |
| NCT05270525 | Phase 2 | May 27, 2022 | University of Alabama, Birmingham, Verona Pharma plc |
| NCT04535986 | Phase 3 | Sep 29, 2020 | IQVIA, Verona Pharma plc |
| NCT04542057 | Phase 3 | Sep 22, 2020 | IQVIA, Verona Pharma plc |
| NCT04527471 | Phase 2 | Sep 4, 2020 | Verona Pharma plc |
| NCT03937479 | Phase 2 | May 1, 2019 | IQVIA, LGC Limited, Verona Pharma plc |
| NCT04091360 | Phase 2 | Apr 29, 2019 | IQVIA, Verona Pharma plc |
Showing 10 of 10 trials
Page 1 / 1
Organizations
Research & Development (6)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Verona Pharma plc | For profit | 8 | 8 | 2 | 2019 |
| IQVIA | For profit | 4 | 0 | 2 | 2019 |
| Nuance Biotech | For profit | 2 | 2 | 2 | 2023 |
| LabCorp | For profit | 1 | 0 | 1 | 2023 |
| LGC Limited | For profit | 1 | 0 | 1 | 2019 |
| University of Alabama, Birmingham | Academic/Hospital | 1 | 0 | 1 | 2022 |
6 organizations
Page 1 / 1
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Merck | For profit | MKTG | Jun 26, 2024 |
| Verona Pharma plc | For profit | NDA | Jun 26, 2024 |