Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ensifentrine · 5 trials · 2 indications
Forced spirometry maneuvers including the FEV1 were used to assess pulmonary function. Average FEV1 AUC0-12h was defined as AUC over 12 hours of the FEV1, divided by 12 hours. Baseline FEV1 is the mean of the 2 measurements taken before study medication on the day of first dosing, that is, \<=40 minutes pre-dose on Day 1. Spirometry assessments were performed in accordance with American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines.
To measure the effect of nebulized ensifentrine on sputum absolute neutrophil count after twice daily dosing.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Ensifentrine Nebulized Suspension; 3 mg BID |
| Arm 2 | PLACEBO_COMPARATOR | Placebo Nebulized BID |
| Treatment A: Ensifentrine plus Glycopyrrolate | EXPERIMENTAL | (fixed-dose combination formulation) Subjects will receive a single dose of study medication in each treatment period followed by a 7 to 9-day washout period before receiving the next treatment in the sequence they were assigned to |
| Treatment B: Ensifentrine monotherapy | EXPERIMENTAL | (fixed-dose combination formulation) Subjects will receive a single dose of study medication in each treatment period followed by a 7 to 9-day washout period before receiving the next treatment in the sequence they were assigned to |
| Treatment C: Glycopyrrolate monotherapy | EXPERIMENTAL | (fixed-dose combination formulation) Subjects will receive a single dose of study medication in each treatment period followed by a 7 to 9-day washout period before receiving the next treatment in the sequence they were assigned to |
| Treatment D: Ensifentrine monotherapy | EXPERIMENTAL | (fixed-dose combination formulation) Subjects will receive a single dose of study medication in each treatment period followed by a 7 to 9-day washout period before receiving the next treatment in the sequence they were assigned to |
| Treatment E: Ensifentrine monotherapy (marketed formulation) | EXPERIMENTAL | Subjects will receive a single dose of study medication in each treatment period followed by a 7 to 9-day washout period before receiving the next treatment in the sequence they were assigned to |
| Treatment Arm A: Ensifentrine plus Glycopyrrolate | EXPERIMENTAL | Ensifentrine 3 mg / Glycopyrrolate 42.5 mcg |
| Treatment Arm B: Ensifentrine plus Glycopyrrolate | EXPERIMENTAL | Ensifentrine 3 mg / Glycopyrrolate 21.25 mcg |
| Treatment Arm C: Glycopyrrolate | ACTIVE_COMPARATOR | Glycopyrrolate monotherapy 42.5 mcg |
| Treatment Arm D: Glycopyrrolate | ACTIVE_COMPARATOR | Glycopyrrolate monotherapy 21.25 mcg |
| Treatment Arm E: Ensifentrine | ACTIVE_COMPARATOR | Ensifentrine monotherapy 3 mg |
| Treatment Arm F: Placebo | PLACEBO_COMPARATOR | Placebo |
| Treatment Sequence 1 | EXPERIMENTAL | Treatment Period 1 (blinded Ensifentrine) followed by Treatment Period 2 (blinded Placebo) |
| Treatment Sequence 2 | EXPERIMENTAL | Treatment Period 1 (blinded Placebo) followed by Treatment Period 2 (blinded Ensifentrine) |
| Name | Type | Description |
|---|---|---|
| Ensifentrine | DRUG | Dosage Formulation: Ensifentrine Nebulizer suspension Dosage 3mg Frequency: Twice Daily for 24 weeks or 48 weeks |
| Placebo | DRUG | Dosage Formulation: Ensifentrine Placebo Nebulizer solution Frequency: Twice Daily for 24 weeks or 48 weeks |
| Ensifentrine 3 mg | DRUG | Single dose, administered by oral inhalation using a standard jet nebulizer |
| Glycopyrrolate 42.5 mcg | DRUG | Single dose, administered by oral inhalation using a standard jet nebulizer |
| Ensifentrine 1.5 mg | DRUG | Single dose, administered by oral inhalation using a standard jet nebulizer |
| Ensifentrine 3 mg (marketed formulation) | DRUG | Single dose, administered by oral inhalation using a standard jet nebulizer |
| Glycopyrrolate 21.25 mcg | DRUG | Administered by a standard jet nebulizer, twice daily for 28 consecutive days |
Inclusion Criteria: Informed Consent 1. Capable of giving informed consent indicating that they understand the purpose of the study and study procedures and agree to comply with the requirements and restrictions listed in the informed consent form (ICF). Age and Sex 2. Age: Patient must be 40 ...
Ensifentrine is an investigational small molecule being developed for the treatment of chronic obstructive pulmonary disease (COPD). It is currently in Phase 2 clinical development and has been studied in multiple trials involving patients with COPD.
Ensifentrine is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with COPD.
Ensifentrine is currently in Phase 2 clinical development for COPD. While some completed trials have been Phase 3, the drug's overall development stage is Phase 2, and it remains investigational and not yet approved.
Ensifentrine has been studied in several clinical trials, including NCT04535986, a Phase 3 trial in COPD; NCT05270525, a Phase 2 trial examining sputum markers of inflammation; NCT07016412, a Phase 2b dose-ranging study of an ensifentrine-glycopyrrolate combination; and NCT07132983, a Phase 2 pharmacokinetic study.
Ensifentrine and ensifentrine-glycopyrrolate are related but distinct. Ensifentrine is a single agent, while ensifentrine-glycopyrrolate is a fixed-dose combination of ensifentrine with glycopyrrolate. Both have been evaluated in clinical trials for COPD.