Bipolar depression refers to depressive episodes occurring within bipolar disorder, characterized by persistent low mood, reduced energy, loss of interest, and functional impairment as part of cyclical mood illness that also includes mania or hypomania.
NRx said the FDA issued a positive review letter on its preservative-free ketamine ANDA, requesting only minor administrative changes. The company also received FDA guidance outlining a path to an NDA for NRX-100 using clinical trial data and real-world evidence.
Xenon Pharmaceuticals reported positive Phase III X-TOLE2 results for azetukalner in focal onset seizures. The company plans an FDA new drug application in Q3 2026.
NRx said the FDA outlined a path for a New Drug Application for NRX-100, a preservative-free ketamine formulation for depression with suicidality. The company plans to submit the NDA by June 2026 and said no additional nonclinical or bridging studies would be required.
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.
Xenon Pharmaceuticals will announce topline data from its Phase 3 X-TOLE2 study of azetukalner in patients with focal onset seizures on March 9, 2026, during a conference call at 8:00 a.m. ET.
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 |
|---|---|---|---|
| NCT07472920 |
Empagliflozin Adjunctive Therapy in Bipolar Depression |
NOT_YET_RECRUITING | NA |
| NCT07266545 |
RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE) |
RECRUITING | PHASE4 |
| NCT07246044 |
HD-tDCS for Adolescent Bipolar Depression Targeting S1 |
RECRUITING | NA |
| NCT07217860 |
An Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE) |
ENROLLING_BY_INVITATION | PHASE3 |
| NCT07172516 |
A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression) |
RECRUITING | PHASE3 |
| NCT07121894 |
Ketogenic Intervention for Bipolar Depression |
RECRUITING | NA |
| NCT07108257 |
Magnetic Resonance-Guided Focused Ultrasound Bilateral Capsulotomy for the Treatment of Refractory Bipolar Depression |
RECRUITING | NA |
| NCT07097025 |
2-Year Study of Vagus Nerve Stimulation for Higher-Grade Treatment-Resistant Depression: Clinical Outcomes and Policy Recommendation |
COMPLETED | |
| NCT07021508 |
Efficacy and Safety Assessment of Temporal Interference Stimulation to Improve Bipolar Depression |
RECRUITING | NA |
| NCT06620042 |
FMRI of Patients Receiving IV Ketamine for Treatment Resistant Bipolar Depression |
COMPLETED | PHASE2 |
