{"id":"nrx-101-oral-capsule","safety":{"commonSideEffects":[{"rate":null,"effect":"Somnolence"},{"rate":null,"effect":"Akathisia"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Parkinsonism"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"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.","oneSentence":"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.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:23:35.297Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Acute suicidality in bipolar I or II depression (Phase 3)"},{"name":"Bipolar depression with suicidal ideation"}]},"trialDetails":[{"nctId":"NCT03396068","phase":"PHASE3","title":"NRX-101 for Maintenance of Remission From Severe Bipolar Depression in Patients With Suicidal Ideation","status":"UNKNOWN","sponsor":"NeuroRx, Inc.","startDate":"2019-12-01","conditions":"Bipolar Depression, Suicidal Ideation","enrollment":72},{"nctId":"NCT03402152","phase":"PHASE2, PHASE3","title":"NRX101 Glx Biomarker Validation Study","status":"COMPLETED","sponsor":"NeuroRx, Inc.","startDate":"2018-11-01","conditions":"Bipolar Depression, Suicidal Ideation","enrollment":8},{"nctId":"NCT02974010","phase":"PHASE2","title":"Sequential Therapy for the Treatment of Severe Bipolar Depression.","status":"COMPLETED","sponsor":"NeuroRx, Inc.","startDate":"2018-01-15","conditions":"Bipolar Depression, Suicidal Ideas, Suicidal Ideation","enrollment":22}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["D-cycloserine + Lurasidone Fixed Dose Combination","Cyclurad"],"phase":"phase_3","status":"active","brandName":"NRX-101 Oral Capsule","genericName":"NRX-101 Oral Capsule","companyName":"NeuroRx, Inc.","companyId":"neurorx-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"NRX-101 Oral Capsule is being studied as a treatment for severe bipolar depression, particularly for acute suicidal ideation and behavior. It is a biological vaccine that induces an immune response, similar to a live oral poliovirus vaccine.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}