Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nafamostat Mesilate · 1 trial · 1 indication
Number of participants with adverse events including out-of-range clinical laboratory measures, vital signs, ECG, and spontaneous adverse event reports throughout the 14 day study period
| Arm | Type | Description |
|---|---|---|
| 10 mg | EXPERIMENTAL | 10 mg nafamostat three times a day (t.i.d., approximately q8h) for up to 5 days |
| 50 mg | EXPERIMENTAL | 50 mg nafamostat three times a day (t.i.d., approximately q8h) for up to 5 days |
| 100 mg | EXPERIMENTAL | 100 mg nafamostat three times a day (t.i.d., approximately q8h) for up to 5 days |
| 200 mg | EXPERIMENTAL | 200 mg nafamostat three times a day (t.i.d., approximately q8h) for up to 5 days |
| Placebo | PLACEBO_COMPARATOR | Placebo administered three times a day (t.i.d., approximately q8h) for up to 5 days |
| Name | Type | Description |
|---|---|---|
| Nafamostat Mesilate | DRUG | Oral nafamostat, 10, 50, 100, or 200 mg administered three times daily for up to 5 days |
| Placebo | DRUG | Oral placebo administered three times daily for up to 5 days |
Inclusion Criteria: 1. Males or females, age 18 to 70 years old, able and willing to provide written informed consent to participate in the study; 2. Subjects must be in generally good health as determined by pre-study medical history, physical examination, clinical laboratory tests, and 12-lead el...
Nafamostat Mesilate is a small molecule drug being developed by Ensysce Biosciences, Inc. (ticker ENSC). It is an enzyme inhibitor in the -stat target class and is currently in Phase 1 clinical development. The specific medical conditions it is intended to treat have not been disclosed.
Nafamostat Mesilate targets enzymes in the -stat inhibitor class. It is a small molecule designed to inhibit this class of enzyme targets. Ensysce Biosciences is developing the compound, and its clinical program has focused on pharmacokinetic evaluation in healthy volunteers rather than a disclosed disease indication.
Nafamostat Mesilate is being developed by Ensysce Biosciences, Inc., which trades under the ticker ENSC. The company is the sponsor of the clinical program for this small molecule enzyme inhibitor. The drug is in Phase 1 development, with one completed trial conducted in the United States.
Nafamostat Mesilate is in Phase 1 clinical development. It is an investigational drug and is not approved by the FDA. Ensysce Biosciences has completed one Phase 1 trial of the oral formulation, and no active trials are currently listed for this asset.
Nafamostat Mesilate has been studied in one completed Phase 1 trial, NCT04406415, titled Oral Nafamostat in Healthy Volunteers (NAF-101). The trial enrolled 17 healthy adult volunteers in the United States, was randomized and placebo controlled, and evaluated pharmacokinetics. It is listed as completed.
The Phase 1 trial NCT04406415 evaluated oral Nafamostat in 17 healthy volunteers aged 18 and older in the United States. It was a randomized, placebo-controlled study focused on pharmacokinetics. The trial is complete, and it was not double blinded and did not use biomarker-based patient selection.