Approval Probability
TA Base Rate
Adjusted LOA
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MELT-100 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| MELT-100 | ACTIVE_COMPARATOR | 3mg midazolam and 25mg ketamine sublingual tablet |
| IV midazolam | ACTIVE_COMPARATOR | 2mg Intravenous midazolam |
| IV ketamine | ACTIVE_COMPARATOR | 6mg Intravenous ketamine |
| Name | Type | Description |
|---|---|---|
| Midazolam injection | DRUG | 2mg IV |
| Ketamine Injectable Product | DRUG | 6mg IV |
| MELT-100 | DRUG | midazolam 3mg and ketamine 25mg SL tablet |
Inclusion Criteria: * A subject must satisfy all of the following criteria to be eligible for study participation: 1. Able to understand and voluntarily consent to participation in this study, and provides written informed consent before the start of any study-specific procedures. 2. Healthy a...
MELT-100 is an investigational small molecule being developed by Harrow, Inc. It is a sublingual formulation containing midazolam and ketamine. The drug is currently in Phase 1 clinical development and has been studied in healthy volunteers.
MELT-100 is being studied for use in healthy volunteers. The Phase 1 trial assessed its bioavailability compared to intravenous midazolam or ketamine. The specific intended therapeutic indication has not been disclosed beyond the healthy volunteer study population.
MELT-100 contains midazolam and ketamine. Midazolam is a benzodiazepine that acts on GABA-A receptors, and ketamine is an NMDA receptor antagonist. The combination is administered sublingually for absorption through the oral mucosa.
MELT-100 is being developed by Harrow, Inc., a company traded on the NASDAQ under the ticker symbol HROW. Harrow is responsible for the clinical development of this investigational drug.
MELT-100 is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. A Phase 1 bioavailability study has been completed, and the drug remains in early-stage clinical testing.
MELT-100 has one completed Phase 1 trial, NCT04485702, titled 'Phase 1 Bioavailability Study of MELT-100 (Midazolam and Ketamine Sublingual) and IV Midazolam or Ketamine.' The study enrolled 17 healthy volunteers in the United States and was active-controlled.