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 being studied for pharmacokinetics, meaning the trials are designed to measure how the drug is absorbed, distributed, metabolized, and excreted in the body. It is an investigational small molecule being developed by Ensysce Biosciences, Inc. and is currently in Phase 1 clinical development.
Nafamostat Mesilate is being developed by Ensysce Biosciences, Inc., a company traded under the ticker ENSC. The drug is currently in Phase 1 clinical development, with one completed clinical trial in healthy volunteers.
Nafamostat Mesilate is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA and is still undergoing clinical trials to evaluate its safety and pharmacokinetics in humans.
Nafamostat Mesilate has one completed Phase 1 clinical trial, identified as NCT04406415, titled "Oral Nafamostat in Healthy Volunteers (NAF-101)." This trial enrolled 17 healthy volunteers in the United States and was placebo-controlled, though it was not double-blinded.
Nafamostat Mesilate is a form of nafamostat, a synthetic serine protease inhibitor. The drug is being developed as an oral formulation by Ensysce Biosciences, Inc. and is currently in Phase 1 clinical trials for pharmacokinetic evaluation.