Neurawell Therapeutics
NeuraWell Therapeutics is a clinical-stage research and development company focused on developing safe and effective medicines for the potential treatment of various CNS disorders, including major depressive disorder, treatment-resistant depression, and treatment-resistant anxiety. The company's mission is to offer CNS treatments that reliably deliver meaningful therapeutic responses with enhanced safety, filling unmet needs where other treatments have failed.
Industries
Nr. of Employees
small (1-50)
Neurawell Therapeutics
Products
CNS therapeutic development program (small-molecule candidate with reformulated delivery and combination pharmacology)
Development of small-molecule CNS therapeutics using combination pharmacology (broad-action antidepressant with a novel molecule) and a reformulated delivery mechanism intended to reduce serious side effects and improve patient compliance; primary targets include major depressive disorder, treatment‑resistant depression, and treatment‑resistant anxiety.
Digital patient application for treatment education and side-effect management
A patient-facing technical application designed to educate patients, manage side effects, and help avoid serious medication interaction risks; includes authenticated access and user verification.
CNS therapeutic development program (small-molecule candidate with reformulated delivery and combination pharmacology)
Development of small-molecule CNS therapeutics using combination pharmacology (broad-action antidepressant with a novel molecule) and a reformulated delivery mechanism intended to reduce serious side effects and improve patient compliance; primary targets include major depressive disorder, treatment‑resistant depression, and treatment‑resistant anxiety.
Digital patient application for treatment education and side-effect management
A patient-facing technical application designed to educate patients, manage side effects, and help avoid serious medication interaction risks; includes authenticated access and user verification.
Services
End-to-end clinical development capability including study design, clinical operations, site monitoring, and program management for CNS therapeutic programs.
Regulatory planning and execution for INDs and 505(b)-pathway submissions, label and REMS development, and FDA advisory committee preparation for CNS programs.
End-to-end clinical development capability including study design, clinical operations, site monitoring, and program management for CNS therapeutic programs.
Regulatory planning and execution for INDs and 505(b)-pathway submissions, label and REMS development, and FDA advisory committee preparation for CNS programs.
Expertise Areas
- Clinical trial management (Phases I–IV)
- CNS drug discovery and development
- Regulatory strategy and submissions (IND, 505b1/505b2)
- Drug formulation and drug-device combination development
Key Technologies
- Small-molecule medicinal chemistry
- Reformulated drug delivery systems
- Drug-device combination platforms
- Digital patient application / mobile health