scopolamine intranasal (DPI-386) / Defender Pharma - LARVOL DELTA

Combination of Intranasal Scopolamine and Sensory Augmentation to Mitigate G-transition Induced Motion Sickness and Enhance Sensorimotor Performance (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Repurposed Therapeutics, Inc.

New P2 trial

Defender Pharmaceuticals Reports Positive Results from Pivotal Phase III Clinical Trial of Intranasal Scopolamine for the Prevention of Nausea and Vomiting Induced by Motion (GlobeNewswire) - P3 | N=503 | NCT05548270 | Sponsor: Repurposed Therapeutics, Inc | "Defender Pharmaceuticals, Inc...announced positive results from the Company’s pivotal phase III clinical trial of intranasally administered DPI-386 Nasal Gel...achieved the primary endpoint in this recently completed, confirmatory Phase III clinical trial...The primary endpoint in this study was assessment of the effectiveness of DPI-386 (defined as 'Completer Response') in reducing the proportion of participants who reported no vomiting and who did not request rescue treatment (e.g., antihistamine) in comparison with placebo. Positive results demonstrated that the proportion of participants in the DPI-386 treatment arm who did not report vomiting and did not request rescue treatment was significantly greater (p<0.0001) than participants receiving placebo."

P3 data • CNS Disorders • Otorhinolaryngology

Combination of Intranasal Scopolamine and Sensory Augmentation to Mitigate G-transition Induced Motion Sickness and Enhance Sensorimotor Performance (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Repurposed Therapeutics, Inc.

New P2 trial

Prevention and Treatment of Nausea Associated With Motion Sickness in Senior Subjects (clinicaltrials.gov) - P3 | N=98 | Completed | Sponsor: Repurposed Therapeutics, Inc. | Unknown status ➔ Completed

Trial completion

Efficacy and Safety of DPI-386 Nasal Gel for the Prevention of Nausea and Vomiting Associated With Motion (clinicaltrials.gov) - P3 | N=503 | Completed | Sponsor: Repurposed Therapeutics, Inc. | Recruiting ➔ Completed

Trial completion

Efficacy and Safety of DPI-386 Nasal Gel for the Prevention of Nausea and Vomiting Associated With Motion (clinicaltrials.gov) - P3 | N=500 | Recruiting | Sponsor: Repurposed Therapeutics, Inc.

New P3 trial

Nasal Gel for the Prevention of Nausea and Vomiting Associated With Motion (clinicaltrials.gov) - P3; N=140; Completed; Sponsor: Repurposed Therapeutics, Inc.; Recruiting ➔ Completed; Trial completion date: Dec 2021 ➔ Aug 2021

Clinical • Trial completion • Trial completion date

Nasal Gel for the Prevention of Nausea and Vomiting Associated With Motion (clinicaltrials.gov) - P3; N=150; Recruiting; Sponsor: Repurposed Therapeutics, Inc.

Clinical • New P3 trial

Intranasal Scopolamine for Motion Sickness. (PubMed, Aerosp Med Hum Perform) - "Aerosp Med Hum Perform. 2019; 90(11):917-924."

Journal

Prevention and Treatment of Nausea Associated With Motion Sickness in Senior Subjects (clinicaltrials.gov) - P3; N=100; Recruiting; Sponsor: Repurposed Therapeutics, Inc.; Trial primary completion date: Aug 2019 ➔ Feb 2020

Clinical • Trial primary completion date

The Prevention and Treatment of Nausea Associated With Motion Sickness (clinicaltrials.gov) - P3; N=300; Completed; Sponsor: Repurposed Therapeutics, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion

Nasal Gel for the Prevention and Treatment of Nausea Associated With Motion Sickness (clinicaltrials.gov) - P3; N=102; Completed; Sponsor: Repurposed Therapeutics, Inc.

Clinical • New P3 trial

Generalization of Extinction Learning (clinicaltrials.gov) - P1; N=60; Completed; Sponsor: University of California, Los Angeles; Recruiting ➔ Completed; N=100 ➔ 60

Enrollment change • Trial completion