Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ensifentrine twice daily · 1 trial · 1 indication
Responders are defined as an improvement (decrease) from baseline of ≥2 points. The COPD Assessment Test(tm) (CAT) is a one-page, 8-item questionnaire suitable for completion by patients diagnosed with COPD. When completing the questionnaire, individuals rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment) with a scoring range of 0-40. Higher scores indicate greater disease impact. The individual items are: Cough, Mucus, Chest Tight, Breathless, Limited Activities, Confident, Sleep and Energy). CAT was self-completed at baseline, week 6 and week 12.
| Arm | Type | Description |
|---|---|---|
| Ensifentrine | EXPERIMENTAL | Inhaled ensifentrine twice daily for 12 weeks via standard jet nebulizer in addition to standard dual (LAMA/LABA) or triple (LAMA/LABA/ICS) COPD therapy. |
| Name | Type | Description |
|---|---|---|
| Ensifentrine 3 mg twice daily | DRUG | All subjects will receive ensifentrine. |
Inclusion Criteria: * Capable of giving informed consent. * Current or former cigarette smokers with a history of cigarette smoking ≥ 10 pack years. * Established clinical history of moderate to severe COPD. * Pre- and post-albuterol FEV1/FVC ratio of \< 0.70. * Post-albuterol FEV1 ≥ 30 % and ≤ 75%...
Top 11 of 14 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 8 | PHASE3 | Depemokimab, GSK5784283, GSK3862995B |
| AstraZeneca PLC | AZN | 14 | PHASE3 | Tezepelumab, Breztri, Bevespi, Tozorakimab, AZD6793 |
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Lunsekimig, SAR447537, Dupilumab |
| Merck & Co., Inc. | MRK | 3 | PHASE3 | Ensifentrine, Frespaciguat |
| Pfizer Inc. | PFE | 2 | PHASE3 | Tilrekimig, PF-07275315 |
| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE3 | Alpha-1 MP |
| Hoffmann-La Roche | RHHBY | 4 | PHASE3 | Astegolimab, RO7830698, GDC-6988 |
| Upstream Bio, Inc. | UPB | 1 | PHASE2 | Verekitug |
| Generate Biomedicines, Inc. | GENB | 1 | PHASE1 | GB-0895 |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
| United Therapeutics Corporation | UTHR | 1 | PHASE2 | Tyvaso (treprostinil) |
Ensifentrine twice daily is an investigational small molecule being developed for chronic obstructive pulmonary disease, or COPD. It is given as a twice-daily dose, with the 3 mg twice-daily regimen also referred to as ensifentrine 3 mg twice daily. It is a Phase 3 candidate and has not been approved by the FDA.
Ensifentrine twice daily is being studied for the treatment of COPD, a chronic respiratory condition. The clinical program has evaluated its effect on COPD symptom burden, including a Phase 3 trial that measured changes in CAT score, a patient-reported assessment of COPD impact. It remains investigational for this indication.
Ensifentrine twice daily inhibits the phosphodiesterase enzymes PDE3A, PDE3B, PDE4A, PDE4B, PDE4C, and PDE4D. By inhibiting these PDE3 and PDE4 subtypes, the drug acts as a dual phosphodiesterase inhibitor. This target profile is the basis for its development in respiratory disease such as COPD.
Ensifentrine twice daily is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is the sponsor behind the clinical program for this small molecule in respiratory medicine.
Ensifentrine twice daily is in Phase 3 development. It is an investigational therapy and is not FDA approved. The Phase 3 study in its program has been completed, and no trials for this asset are currently listed as active.
Ensifentrine twice daily has been studied in the Phase 3 trial NCT06460493, titled Effect of Ensifentrine Treatment on CAT Score. That trial enrolled 20 participants with COPD in the United States, had a minimum age of 40 years, and is now completed. It was an uncontrolled study.