Repurposed Therapeutics, Inc.
Defender Pharmaceuticals is a privately held life sciences company based in St. Louis, MO, focused on developing innovative therapies to offer patients a sense of security and strength. The company aims to address challenging and potentially life-threatening conditions through novel science, leveraging the expertise of its team and partnerships with established institutions. Their work includes collaborations with the Department of Defense, NASA, and the Department of Veterans Affairs to improve health outcomes for both civilian and military populations.
Industries
Nr. of Employees
small (1-50)
Repurposed Therapeutics, Inc.
12935 N Outer Forty Rd, Suite #212, St. Louis, MO 63141
Products
Investigational intranasal scopolamine gel
An investigational intranasal gel formulation of scopolamine developed to prevent or mitigate motion-induced nausea and vomiting; completed a pivotal Phase III trial with positive efficacy outcomes, submitted for regulatory review via a New Drug Application (NDA), and subsequently received a regulatory Complete Response Letter (CRL) prompting planned regulatory meetings and remediation planning.
Investigational intranasal scopolamine gel
An investigational intranasal gel formulation of scopolamine developed to prevent or mitigate motion-induced nausea and vomiting; completed a pivotal Phase III trial with positive efficacy outcomes, submitted for regulatory review via a New Drug Application (NDA), and subsequently received a regulatory Complete Response Letter (CRL) prompting planned regulatory meetings and remediation planning.
Services
Co-development of clinical programs and operational evaluations with government agencies to test intranasal formulations and other investigational products in specialized populations.
Acquisition and development of investigational vaccine and therapeutic programs transferred from government laboratories, including access to INDs, data sets, and biological materials.
End-to-end clinical study conduct including randomized controlled trials, cross-over designs, open-label feasibility studies, data collection and endpoint analysis, with CRO coordination where applicable.
Co-development of clinical programs and operational evaluations with government agencies to test intranasal formulations and other investigational products in specialized populations.
Acquisition and development of investigational vaccine and therapeutic programs transferred from government laboratories, including access to INDs, data sets, and biological materials.
End-to-end clinical study conduct including randomized controlled trials, cross-over designs, open-label feasibility studies, data collection and endpoint analysis, with CRO coordination where applicable.
Expertise Areas
- Intranasal formulation and delivery
- Phase 2–3 clinical trial management
- Regulatory submissions and FDA engagement
- Pharmacokinetics and clinical pharmacology
Key Technologies
- Intranasal gel formulations
- Intranasal delivery vehicles and mucosal absorption
- Pharmacokinetic (PK) profiling
- Randomized double-blind and cross-over clinical trial designs
News & Updates
The FDA has accepted Defender Pharmaceuticals' New Drug Application for intranasally administered scopolamine gel (DPI-386 Nasal Gel), granting it priority review status at the request of the U.S. Navy. The PDUFA action date is set for January 26th, 2024.
Defender Pharmaceuticals has entered into an exclusive license agreement with the U.S. Army Medical Materiel Development Activity to develop and commercialize products for treating tropical diseases.
Defender Pharmaceuticals has initiated two Phase 2 clinical studies in collaboration with NASA to investigate DPI-386's ability to mitigate G-transition induced motion sickness and enhance sensorimotor performance.
Defender Pharmaceuticals received a Complete Response Letter from the FDA regarding its New Drug Application for intranasal scopolamine (DPI-386) for the prevention of nausea and vomiting induced by motion in adults. The company plans to address the issues raised in the letter and remains confident in the safety and efficacy of its product.
Defender Pharmaceuticals announced positive results from its pivotal Phase III clinical trial of DPI-386 Nasal Gel, demonstrating its effectiveness in preventing nausea and vomiting induced by motion. The trial showed significant results compared to placebo, marking an important milestone for the company.
An article discussing Defender Pharmaceuticals' funding and its efforts to gain approval for its lead drug candidate.
The FDA has accepted Defender Pharmaceuticals' New Drug Application for intranasally administered scopolamine gel (DPI-386 Nasal Gel), granting it priority review status at the request of the U.S. Navy. The PDUFA action date is set for January 26th, 2024.
Defender Pharmaceuticals has entered into an exclusive license agreement with the U.S. Army Medical Materiel Development Activity to develop and commercialize products for treating tropical diseases.
Defender Pharmaceuticals has initiated two Phase 2 clinical studies in collaboration with NASA to investigate DPI-386's ability to mitigate G-transition induced motion sickness and enhance sensorimotor performance.
Defender Pharmaceuticals received a Complete Response Letter from the FDA regarding its New Drug Application for intranasal scopolamine (DPI-386) for the prevention of nausea and vomiting induced by motion in adults. The company plans to address the issues raised in the letter and remains confident in the safety and efficacy of its product.
Defender Pharmaceuticals announced positive results from its pivotal Phase III clinical trial of DPI-386 Nasal Gel, demonstrating its effectiveness in preventing nausea and vomiting induced by motion. The trial showed significant results compared to placebo, marking an important milestone for the company.
An article discussing Defender Pharmaceuticals' funding and its efforts to gain approval for its lead drug candidate.