{"id":"biperiden","rwe":[{"pmid":"41745708","year":"2026","title":"Consensus Molecules Associated with Parkinson's Disease.","finding":"","journal":"Neurology international","studyType":"Clinical Study"},{"pmid":"41482110","year":"2026","title":"Chronic effects of traumatic brain injury and the impact of biperiden treatment in a male rat model.","finding":"","journal":"Experimental neurology","studyType":"Clinical Study"},{"pmid":"41462062","year":"2025","title":"Effects of acute biperiden treatment following traumatic brain injury in male rats.","finding":"","journal":"Scientific reports","studyType":"Clinical Study"},{"pmid":"41313723","year":"2025","title":"Effects of Biperiden (Cholinergic Muscarinic m1/m4 Receptor Antagonist) on Craving Nicotine: A Proof-Of-Concept Clinical Study.","finding":"","journal":"European addiction research","studyType":"Clinical Study"},{"pmid":"41035551","year":"2025","title":"Parkinson disease treatments on national essential medicines lists, African Region.","finding":"","journal":"Bulletin of the World Health Organization","studyType":"Clinical Study"}],"tags":[{"label":"Anticholinergic","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Muscarinic acetylcholine receptor M1","category":"target"},{"label":"CHRM1","category":"gene"},{"label":"CHRM4","category":"gene"},{"label":"CHRM3","category":"gene"},{"label":"N04AA02","category":"atc"},{"label":"Off-Patent","category":"patent"},{"label":"Active","category":"status"},{"label":"Arteriosclerotic Parkinsonism","category":"indication"},{"label":"Extrapyramidal disease","category":"indication"},{"label":"Parkinson's disease","category":"indication"},{"label":"Parkinsonism","category":"indication"},{"label":"Postencephalitic parkinsonism","category":"indication"},{"label":"Abbvie","category":"company"},{"label":"Approved 1950s","category":"decade"},{"label":"Anti-Dyskinesia Agents","category":"pharmacology"},{"label":"Antiparkinson Agents","category":"pharmacology"},{"label":"Central Nervous System Agents","category":"pharmacology"},{"label":"Cholinergic Agents","category":"pharmacology"},{"label":"Cholinergic Antagonists","category":"pharmacology"},{"label":"Muscarinic Antagonists","category":"pharmacology"},{"label":"Neurotransmitter Agents","category":"pharmacology"},{"label":"Parasympatholytics","category":"pharmacology"},{"label":"Peripheral Nervous System Agents","category":"pharmacology"}],"phase":"marketed","safety":{"safetySignals":[{"llr":631.218,"date":"","count":213,"signal":"Neuroleptic malignant syndrome","source":"DrugCentral FAERS","actionTaken":"Reported 213 times (LLR=631)"},{"llr":266.899,"date":"","count":169,"signal":"Suicide attempt","source":"DrugCentral FAERS","actionTaken":"Reported 169 times (LLR=267)"},{"llr":266.467,"date":"","count":123,"signal":"Intentional self-injury","source":"DrugCentral FAERS","actionTaken":"Reported 123 times (LLR=266)"},{"llr":264.987,"date":"","count":99,"signal":"Schizophrenia","source":"DrugCentral FAERS","actionTaken":"Reported 99 times (LLR=265)"},{"llr":246.318,"date":"","count":91,"signal":"Salivary hypersecretion","source":"DrugCentral FAERS","actionTaken":"Reported 91 times (LLR=246)"},{"llr":226.284,"date":"","count":98,"signal":"Extrapyramidal disorder","source":"DrugCentral FAERS","actionTaken":"Reported 98 times (LLR=226)"},{"llr":222.043,"date":"","count":162,"signal":"Intentional overdose","source":"DrugCentral FAERS","actionTaken":"Reported 162 times (LLR=222)"},{"llr":207.892,"date":"","count":90,"signal":"Delusion","source":"DrugCentral FAERS","actionTaken":"Reported 90 times (LLR=208)"},{"llr":207.749,"date":"","count":99,"signal":"Sopor","source":"DrugCentral FAERS","actionTaken":"Reported 99 times (LLR=208)"},{"llr":198.612,"date":"","count":281,"signal":"Drug interaction","source":"DrugCentral FAERS","actionTaken":"Reported 281 times (LLR=199)"},{"llr":184.71,"date":"","count":75,"signal":"Colitis ischaemic","source":"DrugCentral FAERS","actionTaken":"Reported 75 times (LLR=185)"},{"llr":179.767,"date":"","count":105,"signal":"Restlessness","source":"DrugCentral FAERS","actionTaken":"Reported 105 times (LLR=180)"},{"llr":162.572,"date":"","count":99,"signal":"Dyskinesia","source":"DrugCentral FAERS","actionTaken":"Reported 99 times (LLR=163)"},{"llr":156.244,"date":"","count":108,"signal":"Blood creatine phosphokinase increased","source":"DrugCentral FAERS","actionTaken":"Reported 108 times (LLR=156)"},{"llr":146.143,"date":"","count":91,"signal":"Altered state of consciousness","source":"DrugCentral FAERS","actionTaken":"Reported 91 times (LLR=146)"}],"commonSideEffects":[],"contraindications":["Achalasia of esophagus","Angle-closure glaucoma","Atony of colon","Benign prostatic hyperplasia","Bleeding","Chronic heart failure","Chronic obstructive lung disease","Conduction disorder of the heart","Disease of liver","Disorder of autonomic nervous system","Disorder of coronary artery","Dysentery","Dysuria","Fever","Gastric ulcer","Gastroesophageal reflux disease","Gastrointestinal obstruction","Hiatal hernia","Hypertensive disorder","Kidney disease","Low blood pressure","Myasthenia gravis","Open-angle glaucoma","Paralytic ileus","Pseudomembranous enterocolitis"]},"trials":[],"aliases":[],"company":"AbbVie","patents":[],"pricing":[],"_fixedAt":"2026-03-30T16:38:11.549038","_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=BIPERIDEN","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:14:04.083351+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Biperiden","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T03:14:11.126476+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:14:09.577591+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BIPERIDEN","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:14:10.069480+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Muscarinic acetylcholine receptor M1 antagonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:14:11.126392+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1201035/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:14:10.778886+00:00"}},"allNames":"akineton","offLabel":[],"synonyms":["biperiden","akineton","biperiden hydrochloride","biperiden lactate","biperiden HCl"],"timeline":[{"date":"1959-09-08","type":"positive","source":"DrugCentral","milestone":"FDA approval (Abbvie)"}],"aiSummary":"Akineton (Biperiden) is a small molecule anticholinergic medication originally developed by AbbVie and currently owned by the same company. It targets the muscarinic acetylcholine receptor M1 and is used to treat various conditions related to Parkinson's disease, including arteriosclerotic parkinsonism, extrapyramidal disease, and postencephalitic parkinsonism. Akineton was first approved by the FDA in 1959 and remains off-patent, with no active Orange Book patents. It has a half-life of 24 hours and bioavailability of 30%. As an anticholinergic, Akineton can have significant side effects, particularly in older adults, and its use should be carefully monitored.","brandName":"Akineton","ecosystem":[{"indication":"Arteriosclerotic Parkinsonism","otherDrugs":[{"name":"amantadine","slug":"amantadine","company":"Endo Pharms"},{"name":"benzatropine","slug":"benzatropine","company":""},{"name":"procyclidine","slug":"procyclidine","company":""},{"name":"trihexyphenidyl","slug":"trihexyphenidyl","company":""}],"globalPrevalence":null},{"indication":"Extrapyramidal disease","otherDrugs":[{"name":"amantadine","slug":"amantadine","company":"Endo Pharms"},{"name":"benzatropine","slug":"benzatropine","company":""},{"name":"procyclidine","slug":"procyclidine","company":""},{"name":"trihexyphenidyl","slug":"trihexyphenidyl","company":""}],"globalPrevalence":null},{"indication":"Parkinson's disease","otherDrugs":[{"name":"amantadine","slug":"amantadine","company":"Endo Pharms"},{"name":"apomorphine","slug":"apomorphine","company":"Us Worldmeds"},{"name":"benzatropine","slug":"benzatropine","company":""},{"name":"bromocriptine","slug":"bromocriptine","company":"Us Pharms Holdings I"}],"globalPrevalence":8500000},{"indication":"Parkinsonism","otherDrugs":[{"name":"amantadine","slug":"amantadine","company":"Endo Pharms"},{"name":"benzatropine","slug":"benzatropine","company":""},{"name":"carbidopa","slug":"carbidopa","company":"Merck Sharp Dohme"},{"name":"levodopa","slug":"levodopa","company":""}],"globalPrevalence":null},{"indication":"Postencephalitic parkinsonism","otherDrugs":[{"name":"amantadine","slug":"amantadine","company":"Endo Pharms"},{"name":"benzatropine","slug":"benzatropine","company":""},{"name":"bromocriptine","slug":"bromocriptine","company":"Us Pharms Holdings I"},{"name":"carbidopa","slug":"carbidopa","company":"Merck Sharp Dohme"}],"globalPrevalence":null}],"mechanism":{"target":"Muscarinic acetylcholine receptor M1","novelty":"Follow-on","targets":[{"gene":"CHRM1","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M1","protein":"Muscarinic acetylcholine receptor M1"},{"gene":"CHRM4","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M4","protein":"Muscarinic acetylcholine receptor M4"},{"gene":"CHRM3","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M3","protein":"Muscarinic acetylcholine receptor M3"},{"gene":"CHRM5","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M5","protein":"Muscarinic acetylcholine receptor M5"},{"gene":"CHRM2","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M2","protein":"Muscarinic acetylcholine receptor M2"},{"gene":"CHRNA2","source":"DrugCentral","target":"Neuronal acetylcholine receptor subunit alpha-2","protein":"Neuronal acetylcholine receptor subunit alpha-2"}],"moaClass":"Cholinergic Antagonists","modality":"Small Molecule","drugClass":"Anticholinergic","explanation":"","oneSentence":"","technicalDetail":"Akineton (Biperiden) is a selective muscarinic acetylcholine receptor M1 antagonist, which means it binds to and blocks the M1 receptor, preventing the action of acetylcholine and reducing the symptoms of Parkinson's disease."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Biperiden","title":"Biperiden","extract":"Biperiden, sold under the brand name Akineton among others, is a medication used to treat Parkinson disease, certain drug-induced movement disorders and Tourette Syndrome. It is not recommended for tardive dyskinesias. It is taken by mouth, injection into a vein, or muscle.","wiki_history":"== History ==\nBiperiden was synthesized by the German chemist W. Klavehn from Knoll AG, Germany. In March 1953 a patent was applied for in Germany and subsequently in many other countries. A US patent application was filed in March 1954 and granted in April 1957.\n\nOne website reported that it was not commercially available in the United States as of 2017."},"commercial":{"launchDate":"1959","_launchSource":"DrugCentral (FDA 1959-09-08, ABBVIE)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/374","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=BIPERIDEN","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BIPERIDEN","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Biperiden","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T09:00:32.347744","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:14:12.425063+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"trihexyphenidyl","drugSlug":"trihexyphenidyl","fdaApproval":"1949-05-13","genericCount":10,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"metixene","drugSlug":"metixene","fdaApproval":"","relationship":"same-class"},{"drugName":"procyclidine","drugSlug":"procyclidine","fdaApproval":"1955-07-27","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"profenamine","drugSlug":"profenamine","fdaApproval":"","relationship":"same-class"}],"genericName":"biperiden","indications":{"approved":[{"name":"Arteriosclerotic Parkinsonism","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Extrapyramidal disease","source":"DrugCentral","snomedId":76349003,"regulator":"FDA"},{"name":"Parkinson's 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patents","relatedDrugs":[{"drugId":"trihexyphenidyl","brandName":"trihexyphenidyl","genericName":"trihexyphenidyl","approvalYear":"1949","relationship":"same-class"},{"drugId":"metixene","brandName":"metixene","genericName":"metixene","approvalYear":"","relationship":"same-class"},{"drugId":"procyclidine","brandName":"procyclidine","genericName":"procyclidine","approvalYear":"1955","relationship":"same-class"},{"drugId":"profenamine","brandName":"profenamine","genericName":"profenamine","approvalYear":"","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT02078336","phase":"PHASE4","title":"Optimization of Procedural Sedation Protocol Used for Dental Care Delivery in People With Mental Disability","status":"ACTIVE_NOT_RECRUITING","sponsor":"Universitaire Ziekenhuizen KU Leuven","startDate":"2013-12","conditions":["Dental Care for Disabled"],"enrollment":40,"completionDate":"2025-07"},{"nctId":"NCT04945213","phase":"PHASE3","title":"Biperiden Trial for Epilepsy Prevention","status":"RECRUITING","sponsor":"Hospital Sirio-Libanes","startDate":"2023-01-10","conditions":["Brain Injury Traumatic Moderate","Brain Injury Traumatic Severe","Post Traumatic Epilepsy"],"enrollment":312,"completionDate":"2026-12-20"},{"nctId":"NCT01048138","phase":"PHASE3","title":"Use of Biperiden for the Prevention of Post-traumatic Epilepsy","status":"TERMINATED","sponsor":"Federal University of São Paulo","startDate":"2018-01-31","conditions":["Traumatic Brain Injury"],"enrollment":123,"completionDate":"2022-12-02"},{"nctId":"NCT01251393","phase":"PHASE3","title":"Cocaine/Crack and Reduction of Compulsion With Biperiden","status":"COMPLETED","sponsor":"Federal University of São Paulo","startDate":"2011-05","conditions":["Cocaine Dependence"],"enrollment":111,"completionDate":"2012-11"},{"nctId":"NCT02374567","phase":"PHASE3","title":"Pharmacovigilance in Gerontopsychiatric Patients","status":"TERMINATED","sponsor":"Hannover Medical School","startDate":"2015-01","conditions":["Dementia","Depression","Schizophrenia","Psychosomatic Disorders","Anxiety Disorders"],"enrollment":407,"completionDate":"2017-06-28"},{"nctId":"NCT00495092","phase":"PHASE2,PHASE3","title":"Efficacy of Caffeine, With and Without Biperiden, in the Detoxification of Cocaine Dependent Patients","status":"COMPLETED","sponsor":"Hospital Universitari Vall d'Hebron Research Institute","startDate":"2005-01","conditions":["Cocaine Related Disorders"],"enrollment":85,"completionDate":"2010-10"},{"nctId":"NCT00495183","phase":"PHASE4","title":"Efficacy of Caffeine, With and Without Biperiden, as a Maintenance Treatment for Cocaine Dependence","status":"UNKNOWN","sponsor":"Hospital Universitari Vall d'Hebron Research Institute","startDate":"2009-01","conditions":["Cocaine 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L/kg"},"publicationCount":542,"therapeuticAreas":["Neuroscience"],"atcClassification":{"source":"DrugCentral","atcCode":"N04AA02","allCodes":["N04AA02"]},"biosimilarFilings":[],"originalDeveloper":"Abbvie","recentPublications":[{"date":"2026 Jan 27","pmid":"41745708","title":"Consensus Molecules Associated with Parkinson's Disease.","journal":"Neurology international"},{"date":"2026 Apr","pmid":"41482110","title":"Chronic effects of traumatic brain injury and the impact of biperiden treatment in a male rat model.","journal":"Experimental neurology"},{"date":"2025 Dec 29","pmid":"41462062","title":"Effects of acute biperiden treatment following traumatic brain injury in male rats.","journal":"Scientific reports"},{"date":"2025","pmid":"41313723","title":"Effects of Biperiden (Cholinergic Muscarinic m1/m4 Receptor Antagonist) on Craving Nicotine: A Proof-Of-Concept Clinical Study.","journal":"European addiction research"},{"date":"2025 Oct 1","pmid":"41035551","title":"Parkinson disease treatments on national essential medicines lists, African Region.","journal":"Bulletin of the World Health Organization"}],"companionDiagnostics":[],"genericManufacturers":0,"_genericFilersChecked":true,"genericManufacturerList":[],"status":"approved","companyName":"AbbVie","companyId":"abbvie","modality":"Small molecule","firstApprovalDate":"1959","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health 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