Nexalin Plans Q2 2026 FDA Amendment After U.S. and China Alzheimer’s Strategy Meetings
Nexalin completed high-level FDA Q-Submission meetings in the U.S. and China to finalize its De Novo application design for Alzheimer’s treatment. The company plans to submit amended Q-Submission application in Q2 2026, integrating extensive real-world DIFS neurostimulation data for primary and secondary endpoints.
1. Leadership Meetings and FDA Guidance
Nexalin’s executive and research teams held a productive Q-Submission interaction with the FDA alongside strategic discussions in China to align its global regulatory pathway for Alzheimer’s treatment. The FDA offered clinical direction on symptom reduction endpoints and regulatory requirements necessary for a De Novo application.
2. Clinical Trial Design and Endpoints
Nexalin is finalizing a clinical protocol that establishes primary and secondary endpoints focused on cognitive improvement and symptom reduction in Alzheimer’s patients. FDA feedback is guiding trial size, inclusion criteria and outcome measures to ensure robust assessment of treatment response.
3. International Collaboration and Data Integration
The company’s China team partnered with Professor Yi Tang at Xuanwu Hospital to incorporate one of the largest single-center datasets of deep intracranial frequency stimulation in dementia patients. These real-world insights are shaping endpoint selection, patient demographics and safety parameters.
4. Planned FDA Amendment Submission
Nexalin aims to file an amended Q-Submission application in Q2 2026, embedding insights from U.S. and China meetings and extensive DIFS neurostimulation evidence. This milestone paves the way for initiating its De Novo clinical trial for Alzheimer’s disease.