{"id":"depakine-chrono","safety":{"commonSideEffects":[{"rate":"25-50%","effect":"Tremor"},{"rate":"20-30%","effect":"Weight gain"},{"rate":"5-10%","effect":"Alopecia (hair loss)"},{"rate":"1-3%","effect":"Thrombocytopenia"},{"rate":"<1%","effect":"Hepatotoxicity"},{"rate":"<1%","effect":"Pancreatitis"},{"rate":"10-20%","effect":"Nausea"},{"rate":"10-20%","effect":"Sedation"}]},"_chembl":null,"_fixedAt":"2026-03-30T15:55:10.358784","_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Valproic acid is a branched-chain fatty acid that enhances GABAergic neurotransmission by inhibiting GABA catabolism and increasing GABA synthesis. It also acts as a histone deacetylase inhibitor, modulating gene expression. These combined effects reduce neuronal excitability and stabilize mood, making it effective for seizure control and mood stabilization.","oneSentence":"Depakine Chrono (valproic acid) increases brain GABA levels and inhibits histone deacetylase, enhancing inhibitory neurotransmission and gene expression.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:32:23.652Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Epilepsy and seizure disorders"},{"name":"Bipolar disorder (acute mania)"},{"name":"Migraine prophylaxis"}]},"_fixedFields":["pubmed(18)"],"trialDetails":[{"nctId":"NCT06214130","phase":"PHASE1","title":"Bioavailability of Orfiril Long 500 mg Prolonged-Release Minitablets and Ergenyl Chrono 500 mg Prolonged-Release Tablets","status":"COMPLETED","sponsor":"Desitin Arzneimittel GmbH","startDate":"2023-09-22","conditions":"Multiple Drug Use","enrollment":22},{"nctId":"NCT06211283","phase":"PHASE1","title":"Bioavailability and Food Effect of Sodium Valproate Minitablets in Healthy Subjects.","status":"COMPLETED","sponsor":"Desitin Arzneimittel GmbH","startDate":"2023-09-11","conditions":"Food-drug Interaction","enrollment":28},{"nctId":"NCT04940572","phase":"PHASE2","title":"Efficacy Study of Daily Administration of VPA in Patients Affected by Wolfram Syndrome","status":"UNKNOWN","sponsor":"Centre d'Etude des Cellules Souches","startDate":"2021-11-26","conditions":"Wolfram Syndrome","enrollment":23},{"nctId":"NCT05641649","phase":"PHASE4","title":"Bioequivalence Study of Sodium Valproate and Valproic Acid Tablets","status":"UNKNOWN","sponsor":"Kathmandu University","startDate":"2023-08-06","conditions":"Epilepsy","enrollment":16},{"nctId":"NCT01342692","phase":"PHASE2","title":"Best Promising Drug Association With Azacitidine in Higher Risk Myelodysplastic Syndromes","status":"UNKNOWN","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2011-06","conditions":"MDS","enrollment":320},{"nctId":"NCT02896270","phase":"PHASE2, PHASE3","title":"Valproic Acid for Idiopathic Nephrotic Syndrome","status":"UNKNOWN","sponsor":"Universitair Ziekenhuis Brussel","startDate":"2016-10","conditions":"Idiopathic Nephrotic Syndrome, Focal Segmental Glomerulosclerosis, Minimal Change Disease","enrollment":15},{"nctId":"NCT00477373","phase":"PHASE4","title":"Gulf Evaluation of VAlproate (Depakine Chrono) in maNia Study","status":"COMPLETED","sponsor":"Sanofi","startDate":"2006-12","conditions":"Bipolar Disorder","enrollment":70}],"_emaApprovals":[],"_faersSignals":[{"count":342,"reaction":"EPILEPSY"},{"count":270,"reaction":"FOETAL EXPOSURE DURING PREGNANCY"},{"count":163,"reaction":"SOMNOLENCE"},{"count":123,"reaction":"LOSS OF CONSCIOUSNESS"},{"count":113,"reaction":"DYSMORPHISM"},{"count":102,"reaction":"DISTURBANCE IN ATTENTION"},{"count":101,"reaction":"TREMOR"},{"count":97,"reaction":"FALL"},{"count":93,"reaction":"CONFUSIONAL STATE"},{"count":90,"reaction":"SUICIDE ATTEMPT"}],"_approvalHistory":[],"publicationCount":18,"recentPublications":[],"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"depakine chrono","genericName":"depakine chrono","companyName":"Sanofi","companyId":"sanofi","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Depakine Chrono (valproic acid) increases brain GABA levels and inhibits histone deacetylase, enhancing inhibitory neurotransmission and gene expression. Used for Epilepsy and seizure disorders, Bipolar disorder (acute mania), Migraine prophylaxis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}