Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Zaleplon AP formulation · 1 trial · 1 indication
The change from baseline on the mean of drug nights 1 and 2 relative to placebo.
| Arm | Type | Description |
|---|---|---|
| Zaleplon AP formulation | EXPERIMENTAL | Gastric Retentive Dual Release Zaleplon (Zaleplon AP) |
| Placebo | PLACEBO_COMPARATOR | Identical placebo capsule |
| Name | Type | Description |
|---|---|---|
| Zaleplon AP formulation | DRUG | Gastric retentive dual release Zaleplon |
| Placebo capsule | DRUG | Identical placebo capsule |
Inclusion Criteria: * Subjects between the ages of 18 and 65 years of age * Subjects that meet DSM IV diagnostic criteria for Primary Insomnia * Subjects that report a time in bed ≥6.5 and ≤9 hours * Subjects that report on a one week sleep diary (on at least 3 of 7 nights) TST ≤6.5 hours * Subject...
Top 2 of 6 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Suvorexant |
| Vanda Pharmaceuticals Inc. | VNDA | 2 | PHASE3 | tasimelteon |
Zaleplon AP formulation is an investigational small molecule developed by Indaptus Therapeutics, Inc. (ticker INDP) for the treatment of insomnia. It is a gastric retentive accordion pill version of zaleplon designed to deliver the drug in a controlled manner. It is in Phase 2 clinical development.
Zaleplon AP formulation is being developed for insomnia, a sleep disorder characterized by difficulty falling or staying asleep. The Phase 2 program evaluated it in adult subjects with insomnia. It has not been approved for any indication and remains investigational.
Zaleplon AP formulation targets GABRA1, GABRG2, and GABRB1, which are subunits of the GABA-A receptor. It acts as a positive allosteric modulator at these receptor subunits, enhancing inhibitory GABA signaling in the central nervous system, a mechanism consistent with its development for insomnia.
Indaptus Therapeutics, Inc., which trades under the ticker INDP, is the developer of Zaleplon AP formulation. The company is advancing the asset for insomnia as part of its clinical pipeline.
Zaleplon AP formulation is in Phase 2 clinical development. It is investigational and has not been approved by the FDA or any other regulatory agency. The Phase 2 trial has been completed, and no active trials are currently listed for this asset.
Zaleplon AP formulation was studied in one completed Phase 2 trial, NCT01277107, titled a polysomnographic study comparing the efficacy of gastric retentive zaleplon accordion pill to placebo in subjects with insomnia. The randomized, double-blind, placebo-controlled trial enrolled 83 participants across the United States and Israel.