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NRX-101 Oral Capsule
NRX-101 is a fixed-dose combination of d-cycloserine and lurasidone that modulates NMDA receptor function and dopamine/serotonin signaling to treat acute suicidality and bipolar depression.
NRX-101 is a fixed-dose combination of d-cycloserine and lurasidone that modulates NMDA receptor function and dopamine/serotonin signaling to treat acute suicidality and bipolar depression. Used for Acute suicidality in bipolar I or II depression (Phase 3), Bipolar depression with suicidal ideation.
At a glance
| Generic name | NRX-101 Oral Capsule |
|---|---|
| Also known as | D-cycloserine + Lurasidone Fixed Dose Combination, Cyclurad |
| Sponsor | NeuroRx, Inc. |
| Drug class | Fixed-dose combination (NMDA receptor modulator + atypical antipsychotic) |
| Target | NMDA receptor (d-cycloserine component); dopamine D2 receptor and serotonin 5-HT7 receptor (lurasidone component) |
| Modality | Small molecule |
| Therapeutic area | Psychiatry / Neurology |
| Phase | Phase 3 |
Mechanism of action
NRX-101 combines d-cycloserine, a partial NMDA receptor agonist, with lurasidone, an atypical antipsychotic that antagonizes dopamine D2 and serotonin 5-HT7 receptors. This dual mechanism is designed to rapidly reduce suicidal ideation and depressive symptoms in patients with bipolar disorder by enhancing glutamatergic neurotransmission while modulating monoamine pathways. The combination targets both acute crisis intervention and longer-term mood stabilization.
Approved indications
- Acute suicidality in bipolar I or II depression (Phase 3)
- Bipolar depression with suicidal ideation
Common side effects
- Somnolence
- Akathisia
- Nausea
- Headache
- Parkinsonism
Key clinical trials
- NRX-101 for Maintenance of Remission From Severe Bipolar Depression in Patients With Suicidal Ideation (PHASE3)
- NRX101 Glx Biomarker Validation Study (PHASE2, PHASE3)
- Sequential Therapy for the Treatment of Severe Bipolar Depression. (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |