{"id":"etifoxine","rwe":[{"pmid":"41883424","year":"2026","title":"A rapid clinical response to etifoxine in treatment-resistant obsessive-compulsive disorder: a case report of a patient with comorbid bipolar disorder.","finding":"","journal":"Therapeutic advances in psychopharmacology","studyType":"Clinical Study"},{"pmid":"41763071","year":"2026","title":"Efficacy and safety of etifoxine versus alprazolam in generalized anxiety disorders with somatic symptoms: A randomized, double-blind, comparative study.","finding":"","journal":"Journal of anxiety disorders","studyType":"Clinical Study"},{"pmid":"41711108","year":"2026","title":"Etifoxine-A Novel Treatment Approach for Attenuating Premenstrual Exacerbation of Depressive Disorder: A Case Report.","finding":"","journal":"Journal of clinical psychopharmacology","studyType":"Clinical Study"},{"pmid":"41492938","year":"2026","title":"Metal-free oxidative all-halogen-compatible halogenation of methylenecyclopropane for accessing benzoxazines.","finding":"","journal":"Chemical communications (Cambridge, England)","studyType":"Clinical Study"},{"pmid":"40744157","year":"2025","title":"Exploring GABA-A dysfunction in chronic functional vomiting: An intrinsic case study of TMS-EMG guided precision treatment with etifoxine.","finding":"","journal":"Brain stimulation","studyType":"Clinical Study"}],"tags":[{"label":"etifoxine","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"N05BX03","category":"atc"},{"label":"Active","category":"status"},{"label":"Anti-Anxiety Agents","category":"pharmacology"},{"label":"Central Nervous System Agents","category":"pharmacology"},{"label":"Central Nervous System Depressants","category":"pharmacology"},{"label":"Psychotropic Drugs","category":"pharmacology"},{"label":"Tranquilizing Agents","category":"pharmacology"}],"phase":"phase_3","safety":{"safetySignals":[{"llr":55.597,"date":"","count":21,"signal":"Altered state of consciousness","source":"DrugCentral FAERS","actionTaken":"Reported 21 times (LLR=56)"},{"llr":52.777,"date":"","count":11,"signal":"Cutaneous T-cell lymphoma","source":"DrugCentral FAERS","actionTaken":"Reported 11 times (LLR=53)"}],"commonSideEffects":[{"effect":"Altered state of consciousness","drugRate":"LLR 56","severity":"common"},{"effect":"Cutaneous T-cell lymphoma","drugRate":"LLR 53","severity":"common"}]},"trials":[],"aliases":[],"patents":[],"pricing":[],"allNames":"etifoxin","offLabel":[],"synonyms":["etifoxine hydrochloride","etafenoxine hydrochloride","etafenoxine","etifoxine","etifoxin"],"timeline":[],"approvals":[],"brandName":"Etifoxin","ecosystem":[],"mechanism":{"modality":"Small Molecule","drugClass":"etifoxine","explanation":"Think of GABA like a brake pedal in a car. When GABA is active, it helps slow down the activity of brain cells, which can help reduce feelings of anxiety. Etifoxine helps GABA work more effectively, which can lead to a calming effect on the brain.","oneSentence":"Etifoxine works by modulating the activity of GABA, a neurotransmitter that helps calm the brain.","technicalDetail":"Etifoxine is believed to modulate the activity of GABA_A receptors, which are responsible for the inhibitory effects of GABA on neuronal activity."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Etifoxine","title":"Etifoxine","extract":"Etifoxine, sold under the trade name Stresam among others, is a nonbenzodiazepine anxiolytic agent, primarily indicated for short-term management of adjustment disorder, specifically instances of situational depression accompanied by anxiety, such as stress-induced anxiety. Administration is by mouth.\n\nSide effects associated with etifoxine use include slight drowsiness, headache, skin eruptions, and allergic reactions. In rare cases, etifoxine has been linked to severe skin and liver toxicity, as well as menstrual bleeding between periods. Unlike benzodiazepines, etifoxine does not cause sedation or lack of coordination. Etifoxine acts as a ligand for translocator proteins.","wiki_history":"==History==\nEtifoxine was developed by Hoechst in the 1960s. It was introduced for medical use in France in 1979.","wiki_society_and_culture":"==Society and culture==\n\n===Names===\nEtifoxine is the generic name of the drug and its , , and . It is also known by the older and much-lesser-used synonym etafenoxine and by its developmental code name Hoe 36801. Some of the countries in which etifoxine has been marketed include Argentina, Bulgaria, Chile, France, Luxembourg, Malta, Romania, South Africa, Thailand and Ukraine."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1099","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=ETIFOXINE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ETIFOXINE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Etifoxine","fields":["history","overview"],"source":"Wikipedia"}],"_enrichedAt":"2026-03-30T11:09:17.686718","biosimilars":[],"competitors":[],"genericName":"etifoxine","indications":{"approved":[],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT03850301","phase":"NA","title":"Validation of the 18 kiloDalton Translocator Protein (TSPO) as a Novel Neuroimmunodulatory Target","status":"RECRUITING","sponsor":"Imperial College London","startDate":"2018-01-01","conditions":["Multiple Sclerosis"],"enrollment":44,"completionDate":"2025-01-31"},{"nctId":"NCT02147548","phase":"PHASE3","title":"Evaluation of the Effects of Etifoxine 100 mg and Lorazepam 2 mg on Vigilance and Cognitive Functions in the Elderly","status":"COMPLETED","sponsor":"Biocodex","startDate":"2013-12","conditions":["Healthy Volunteers"],"enrollment":31,"completionDate":"2015-10"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"NDDF":"005416","UNII":"X24X82MX4X","CHEBI":"CHEBI:135272","INN_ID":"2846","RXNORM":"236215","UMLSCUI":"C0059678","ChEMBL_ID":"CHEMBL2106227","KEGG_DRUG":"D07320","DRUGBANK_ID":"DB08986","PUBCHEM_CID":"135413553","IUPHAR_LIGAND_ID":"5468","SECONDARY_CAS_RN":"56776-32-0","MESH_SUPPLEMENTAL_RECORD_UI":"C002125"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[],"publicationCount":109,"therapeuticAreas":["Neuroscience"],"atcClassification":{"source":"DrugCentral","atcCode":"N05BX03","allCodes":["N05BX03"]},"biosimilarFilings":[],"recentPublications":[{"date":"2026","pmid":"41883424","title":"A rapid clinical response to etifoxine in treatment-resistant obsessive-compulsive disorder: a case report of a patient with comorbid bipolar disorder.","journal":"Therapeutic advances in psychopharmacology"},{"date":"2026 Feb 25","pmid":"41763071","title":"Efficacy and safety of etifoxine versus alprazolam in generalized anxiety disorders with somatic symptoms: A randomized, double-blind, comparative study.","journal":"Journal of anxiety disorders"},{"date":"2026 Feb 19","pmid":"41711108","title":"Etifoxine-A Novel Treatment Approach for Attenuating Premenstrual Exacerbation of Depressive Disorder: A Case Report.","journal":"Journal of clinical psychopharmacology"},{"date":"2026 Jan 27","pmid":"41492938","title":"Metal-free oxidative all-halogen-compatible halogenation of methylenecyclopropane for accessing benzoxazines.","journal":"Chemical communications (Cambridge, England)"},{"date":"2025 Sep-Oct","pmid":"40744157","title":"Exploring GABA-A dysfunction in chronic functional vomiting: An intrinsic case study of TMS-EMG guided precision treatment with etifoxine.","journal":"Brain stimulation"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Etifoxine is a small molecule that acts as an antagonist of the GABA-A receptor and anion channel. It has been studied in clinical trials for conditions such as multiple sclerosis and as a potential neuroimmunodulator.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":false,"safety":true,"trials":true,"score":3}}