Lurasidone is an atypical antipsychotic agent marketed as Latuda. It is used for schizophrenia and bipolar depression. The FDA first approved lurasidone on October 28, 2010, with later label expansions.
The bipolar depression treatment pipeline includes over 10 therapies from 8+ companies, with recent Phase 3 trials initiated for azetukalner and multiple emerging drugs targeting novel pathways expected to launch by 2036.
NRx Pharmaceuticals completed an in-person FDA Type C meeting regarding NRX-100, a preservative-free ketamine formulation for suicidal depression. The company received guidance on a path to file a New Drug Application based on existing trial data and Real World Evidence from over 65,000 patients.
NRx Pharmaceuticals completed a Type C meeting with the FDA, receiving guidance to file a New Drug Application for NRX-100 based on existing trial data and real-world evidence from over 65,000 patients, with submission planned for Q2 2026.
NRx Pharmaceuticals completed a Type C meeting with FDA leadership and received oral guidance supporting a New Drug Application for NRX-100 (preservative-free ketamine) based on existing trial data and Real World Evidence from over 65,000 patients.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06527885 |
Lurasidone Non-Interventional Study in Schizophrenia Patients |
COMPLETED | |
| NCT06433635 |
Sequential Multiple Assignment Randomized Trial for Bipolar Depression |
ACTIVE_NOT_RECRUITING | PHASE4 |
| NCT06328140 |
Sleep Quality, Cognitive Performance, and Computerized Cognitive Training |
WITHDRAWN | |
| NCT05480150 |
Chinese Longitudinal and Systematic Study of Bioplar Disorder |
RECRUITING | NA |
| NCT05351736 |
Impact of Structural and Myelin Abnormalities on Cognitive Impairments in Recent-onset Schizophrenia - Before and After Lurasidone Treatment (MARYLU) |
UNKNOWN | PHASE4 |
| NCT05213143 |
The Safety and Efficacy of Lurasidone In Subjects With Schizophrenia Switched From Olanzapine |
TERMINATED | PHASE4 |
| NCT05011669 |
The Safety and Efficacy of Lurasidone With Different Initiation Dose in Chinese Acute Phase Patients With Schizophrenia |
COMPLETED | PHASE4 |
| NCT04312503 |
Observational Study on the Effect of Switch to Lurasidone in Subjects With Schizophrenia" |
COMPLETED | |
| NCT03902613 |
18F-DOPA PET to Elucidate the Antidepressant Mechanism of Lurasidone in Bipolar Disorder |
COMPLETED | PHASE4 |
| NCT03557931 |
A Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication |
COMPLETED | PHASE2 |
