{"id":"gnbac1","safety":{"commonSideEffects":[{"rate":"null","effect":"Injection site reactions"},{"rate":"null","effect":"Headache"},{"rate":"null","effect":"Fatigue"}]},"_chembl":{"chemblId":"CHEMBL4594547","moleculeType":"Antibody"},"_fixedAt":"2026-03-30T12:54:35.635041","_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"GNbAC1 works by binding to the Fc region of IgG1 antibodies, thereby preventing their interaction with Fc receptors on immune cells. This mechanism of action is thought to modulate the immune response and potentially reduce inflammation and autoimmune disease activity.","oneSentence":"GNbAC1 is a recombinant immunoglobulin targeting the human immunoglobulin G1 (IgG1) Fc region.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T02:39:00.619Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Multiple sclerosis"}]},"_fixedFields":["pubmed(23)"],"trialDetails":[{"nctId":"NCT04480307","phase":"PHASE2","title":"Clinical Trial Assessing Temelimab Following Rituximab Treatment in Patients With Relapsing Forms of Multiple Sclerosis","status":"COMPLETED","sponsor":"GeNeuro Innovation SAS","startDate":"2020-06-17","conditions":"Multiple Sclerosis","enrollment":41},{"nctId":"NCT05497089","phase":"PHASE2","title":"Temelimab as a Disease Modifying Therapy in Patients With Neuropsychiatric Symptoms in Post-COVID 19 or PASC Syndrome","status":"COMPLETED","sponsor":"GeNeuro SA","startDate":"2022-08-29","conditions":"Post-COVID-19 Syndrome","enrollment":203},{"nctId":"NCT05049161","phase":"PHASE2","title":"A Long-term Extension of Study GNC-401","status":"TERMINATED","sponsor":"GeNeuro Innovation SAS","startDate":"2021-08-27","conditions":"Multiple Sclerosis","enrollment":33},{"nctId":"NCT01639300","phase":"PHASE2","title":"Safety Study of GNbAC1 in Multiple Sclerosis Patients","status":"COMPLETED","sponsor":"GeNeuro Innovation SAS","startDate":"2012-07","conditions":"Multiple Sclerosis","enrollment":10},{"nctId":"NCT02452996","phase":"PHASE1","title":"Safety Study of GNbAC1 Monoclonal Antibody in Healthy Male Volunteers","status":"COMPLETED","sponsor":"GeNeuro Innovation SAS","startDate":"2015-04","conditions":"Healthy Volunteers","enrollment":21},{"nctId":"NCT03574428","phase":"PHASE1","title":"Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers","status":"COMPLETED","sponsor":"GeNeuro Australia PTY Ltd","startDate":"2018-05-08","conditions":"Multiple Sclerosis","enrollment":24},{"nctId":"NCT01699555","phase":"PHASE1","title":"First-in-Human Study With GNbAC1 in Healthy Volunteers","status":"COMPLETED","sponsor":"GeNeuro Innovation SAS","startDate":"2011-07","conditions":"Multiple Sclerosis","enrollment":33},{"nctId":"NCT03179423","phase":"PHASE2","title":"Clinical Trial Assessing the GNbAC1 in Patients With Onset of Type 1 Diabetes Within 4 Years","status":"COMPLETED","sponsor":"GeNeuro Australia PTY Ltd","startDate":"2017-06-14","conditions":"Diabetes Mellitus Type 1","enrollment":64},{"nctId":"NCT03239860","phase":"PHASE2","title":"Assessing the HERV-W Env ANtagonist GNbAC1 for Evaluation in an Open Label Long-term Safety Study in Patients With Multiple Sclerosis","status":"TERMINATED","sponsor":"GeNeuro SA","startDate":"2017-06-06","conditions":"Multiple Sclerosis, Relapsing-Remitting","enrollment":220},{"nctId":"NCT02782858","phase":"PHASE2","title":"Clinical Trial Assessing the HERV-W Env Antagonist GNbAC1 for Efficacy in MS","status":"COMPLETED","sponsor":"GeNeuro SA","startDate":"2016-04","conditions":"Multiple Sclerosis, Relapsing-Remitting","enrollment":270}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":23,"recentPublications":[{"date":"2023 Jun 29","pmid":"37255431","title":"CancerHERVdb: Human Endogenous Retrovirus (HERV) Expression Database for Human Cancer Accelerates Studies of the Retrovirome and Predictions for HERV-Based Therapies.","journal":"Journal of virology"},{"date":"2023 Feb 3","pmid":"36769337","title":"HERV-W ENV Induces Innate Immune Activation and Neuronal Apoptosis via linc01930/cGAS Axis in Recent-Onset Schizophrenia.","journal":"International journal of molecular sciences"},{"date":"2022 Jan 14","pmid":"35062349","title":"HERV-W Envelope Triggers Abnormal Dopaminergic Neuron Process through DRD2/PP2A/AKT1/GSK3 for Schizophrenia Risk.","journal":"Viruses"},{"date":"2020 Dec","pmid":"32794123","title":"Temelimab, an IgG4 Anti-Human Endogenous Retrovirus Monoclonal Antibody: An Early Development Safety Review.","journal":"Drug safety"},{"date":"2020 Jan 28","pmid":"32012815","title":"Infections, Vaccines and Autoimmunity: A Multiple Sclerosis Perspective.","journal":"Vaccines"}],"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_2","status":"active","brandName":"GNbAC1","genericName":"GNbAC1","companyName":"GeNeuro Innovation SAS","companyId":"geneuro-innovation-sas","modality":"Biologic","firstApprovalDate":"","aiSummary":"GNbAC1 is a recombinant immunoglobulin targeting the human immunoglobulin G1 (IgG1) Fc region. Used for Multiple sclerosis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}