{"id":"gocovri","rwe":[{"pmid":"30000367","year":"2006","title":"Amantadine.","finding":"","journal":"","studyType":"Clinical Study"},{"pmid":"35988699","year":"2022","title":"Synergistic effect of serotonin 1A and serotonin 1B/D receptor agonists in the treatment of L-DOPA-induced dyskinesia in 6-hydroxydopamine-lesioned rats.","finding":"","journal":"Experimental neurology","studyType":"Clinical Study"},{"pmid":"35304480","year":"2022","title":"Amantadine delayed release/extended release capsules significantly reduce OFF time in Parkinson's disease.","finding":"","journal":"NPJ Parkinson's disease","studyType":"Clinical Study"},{"pmid":"34918543","year":"2022","title":"GOCOVRI(®) (amantadine) extended-release capsules in Parkinson's disease.","finding":"","journal":"Neurodegenerative disease management","studyType":"Clinical Study"},{"pmid":"34024025","year":"2021","title":"Effects of Gocovri (Amantadine) Extended-Release Capsules on Motor Aspects of Experiences of Daily Living in People with Parkinson's Disease and Dyskinesia.","finding":"","journal":"Neurology and therapy","studyType":"Clinical Study"}],"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Active","category":"status"},{"label":"Oregon Health and Science University","category":"company"}],"phase":"marketed","safety":{"safetySignals":[{"llr":1041.201,"date":"","count":580,"signal":"Hallucination","source":"DrugCentral FAERS","actionTaken":"Reported 580 times (LLR=1041)"},{"llr":1035.64,"date":"","count":467,"signal":"Dyskinesia","source":"DrugCentral FAERS","actionTaken":"Reported 467 times (LLR=1036)"},{"llr":577.247,"date":"","count":159,"signal":"On and off phenomenon","source":"DrugCentral FAERS","actionTaken":"Reported 159 times (LLR=577)"},{"llr":540.173,"date":"","count":263,"signal":"Hallucination, visual","source":"DrugCentral FAERS","actionTaken":"Reported 263 times (LLR=540)"},{"llr":406.612,"date":"","count":742,"signal":"Fall","source":"DrugCentral FAERS","actionTaken":"Reported 742 times (LLR=407)"},{"llr":395.279,"date":"","count":109,"signal":"Freezing phenomenon","source":"DrugCentral FAERS","actionTaken":"Reported 109 times (LLR=395)"},{"llr":349.538,"date":"","count":232,"signal":"Multiple sclerosis relapse","source":"DrugCentral FAERS","actionTaken":"Reported 232 times (LLR=350)"},{"llr":291.662,"date":"","count":369,"signal":"Tremor","source":"DrugCentral FAERS","actionTaken":"Reported 369 times (LLR=292)"},{"llr":270.669,"date":"","count":80,"signal":"Stoma site discharge","source":"DrugCentral FAERS","actionTaken":"Reported 80 times (LLR=271)"},{"llr":262.462,"date":"","count":105,"signal":"Bradykinesia","source":"DrugCentral FAERS","actionTaken":"Reported 105 times (LLR=262)"},{"llr":260.181,"date":"","count":392,"signal":"Gait disturbance","source":"DrugCentral FAERS","actionTaken":"Reported 392 times (LLR=260)"},{"llr":236.431,"date":"","count":54,"signal":"Dopamine dysregulation syndrome","source":"DrugCentral FAERS","actionTaken":"Reported 54 times (LLR=236)"},{"llr":235.92,"date":"","count":128,"signal":"Muscle rigidity","source":"DrugCentral FAERS","actionTaken":"Reported 128 times (LLR=236)"},{"llr":225.972,"date":"","count":139,"signal":"Multiple sclerosis","source":"DrugCentral FAERS","actionTaken":"Reported 139 times (LLR=226)"},{"llr":213.344,"date":"","count":133,"signal":"Neuroleptic malignant syndrome","source":"DrugCentral FAERS","actionTaken":"Reported 133 times (LLR=213)"}],"drugInteractions":[{"url":"/drug/bupropion","drug":"bupropion","action":"Monitor closely","effect":"May interact with Bupropion","source":"DrugCentral","drugSlug":"bupropion"}],"commonSideEffects":[{"effect":"Hallucinations","drugRate":"","severity":"common","organSystem":""},{"effect":"Dizziness","drugRate":"","severity":"common","organSystem":""},{"effect":"Dry mouth","drugRate":"","severity":"common","organSystem":""},{"effect":"Peripheral edema","drugRate":"","severity":"common","organSystem":""},{"effect":"Constipation","drugRate":"","severity":"common","organSystem":""},{"effect":"Fall","drugRate":"","severity":"common","organSystem":""},{"effect":"Orthostatic hypotension","drugRate":"","severity":"common","organSystem":""},{"effect":"Blurred vision","drugRate":"3%","severity":"common","organSystem":""},{"effect":"Dry mouth (women)","drugRate":"22%","severity":"common","organSystem":""},{"effect":"Peripheral edema (men)","drugRate":"19%","severity":"common","organSystem":""},{"effect":"Dizziness (men)","drugRate":"20%","severity":"common","organSystem":""},{"effect":"Hallucinations (age 65+)","drugRate":"31%","severity":"common","organSystem":""},{"effect":"Falls (age 65+)","drugRate":"17%","severity":"common","organSystem":""},{"effect":"Abnormal dreams","drugRate":"2%","severity":"common","organSystem":""},{"effect":"Dysphagia","drugRate":"2%","severity":"common","organSystem":""},{"effect":"Gait disturbance","drugRate":"2%","severity":"common","organSystem":""},{"effect":"Postural dizziness and syncope","drugRate":"2%","severity":"common","organSystem":""},{"effect":"Nausea (women)","drugRate":"13%","severity":"common","organSystem":""},{"effect":"Anxiety (men)","drugRate":"11%","severity":"common","organSystem":""},{"effect":"Livedo reticularis (women)","drugRate":"13%","severity":"common","organSystem":""}],"contraindications":["Angle-closure glaucoma","Chronic heart failure","Eczema","Edema","Epilepsy","Kidney disease","Malignant melanoma","Orthostatic hypotension","Psychiatric Disturbance","Psychotic disorder","Substance abuse","Suicidal thoughts"],"specialPopulations":{"Pregnancy":"The effect of amantadine on embryofetal and peri-postnatal development has not been adequately tested. However, in two non-GLP studies in rats, amantadine hydrochloride produced increases in embryonic death at an oral dose of 100 mg/kg.","Geriatric use":"Because amantadine is primarily excreted in the urine, it accumulates in the plasma and in the body when renal function declines. Thus, the dose of amantadine hydrochloride should be reduced in patients with renal impairment and in individuals who are 65 years of age or older.","Paediatric use":"The safety and efficacy of amantadine hydrochloride in newborn infants and infants below the age of 1 year have not been established.","Renal impairment":"The dose of amantadine hydrochloride should be reduced in patients with renal impairment."},"seriousAdverseEvents":[{"effect":"Suicide ideation or attempt","drugRate":"","severity":"serious"},{"effect":"Somnolence","drugRate":"","severity":"serious"},{"effect":"Fatigue","drugRate":"","severity":"serious"},{"effect":"Apathy","drugRate":"","severity":"serious"},{"effect":"Delusions","drugRate":"","severity":"serious"},{"effect":"Illusions","drugRate":"","severity":"serious"},{"effect":"Paranoia","drugRate":"","severity":"serious"},{"effect":"Cataracts (women)","drugRate":"7%","severity":"serious"}]},"trials":[],"aliases":[],"company":"Oregon Health and Science University","patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.1925/EA","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$70","description":"AMANTADINE 100 MG CAPSULE","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=GOCOVRI","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T05:39:27.667872+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Gocovri","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T05:39:36.149861+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T05:39:34.909555+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=GOCOVRI","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T05:39:35.106052+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL660/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T05:39:35.793608+00:00"}},"allNames":["gocovri"],"offLabel":[],"synonyms":[],"timeline":[{"date":"1968-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from ENDO PHARMS to Endo Pharms"},{"date":"1968-02-14","type":"positive","source":"DrugCentral","milestone":"FDA approval (Endo Pharms)"},{"date":"2017-08-24","type":"positive","source":"FDA Orange Book","milestone":"Gocovri approved — EQ 68.5MG BASE"},{"date":"2020-04-22","type":"positive","source":"FDA Orange Book","milestone":"Osmolex Er approved — EQ 161MG BASE"},{"date":"2021-08-20","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 26 manufacturers approved"}],"approvals":[],"ecosystem":[],"mechanism":{"target":"Sigma non-opioid intracellular receptor 1","novelty":"Follow-on","targets":[{"gene":"SIGMAR1","source":"DrugCentral","target":"Sigma non-opioid intracellular receptor 1","protein":"Sigma non-opioid intracellular receptor 1"},{"gene":"GRIN1","source":"DrugCentral","target":"Glutamate [NMDA] receptor","protein":"Glutamate receptor ionotropic, NMDA 1"},{"gene":"GRIN2A","source":"DrugCentral","target":"Glutamate [NMDA] receptor","protein":"Glutamate receptor ionotropic, NMDA 2A"},{"gene":"GRIN2B","source":"DrugCentral","target":"Glutamate [NMDA] receptor","protein":"Glutamate receptor ionotropic, NMDA 2B"},{"gene":"GRIN2C","source":"DrugCentral","target":"Glutamate [NMDA] receptor","protein":"Glutamate receptor ionotropic, NMDA 2C"},{"gene":"GRIN2D","source":"DrugCentral","target":"Glutamate [NMDA] receptor","protein":"Glutamate receptor ionotropic, NMDA 2D"},{"gene":"GRIN3A","source":"DrugCentral","target":"Glutamate [NMDA] receptor","protein":"Glutamate receptor ionotropic, NMDA 3A"},{"gene":"GRIN3B","source":"DrugCentral","target":"Glutamate [NMDA] receptor","protein":"Glutamate receptor ionotropic, NMDA 3B"},{"gene":"SLC47A1","source":"DrugCentral","target":"Multidrug and toxin extrusion protein 1","protein":"Multidrug and toxin extrusion protein 1"}],"moaClass":"M2 Protein Inhibitors","modality":"Small Molecule","drugClass":"Influenza A M2 Protein Inhibitor","explanation":"","oneSentence":"","technicalDetail":"Gocovri's mechanism of action is currently unknown, and further research is required to elucidate its pharmacological properties and potential therapeutic applications."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Amantadine","title":"Amantadine","extract":"Amantadine, sold under the brand name Gocovri among others, is a medication used to treat dyskinesia associated with parkinsonism and influenza caused by type A influenzavirus, though its use for the latter is no longer recommended because of widespread drug resistance. It is also used for a variety of other conditions. The drug is taken by mouth.","wiki_history":"==History==\n===Influenza A===\nAntiviral properties were first reported in 1963 at the University of Illinois Hospital in Chicago. In this amantadine trial study, volunteer college students were exposed to a viral challenge. The group who received amantadine (100 milligrams 18 hours before viral challenge) had less Asia influenza infections than the placebo group. in adults in 1976.\n\nDuring the 1980 influenza A epidemic, the first amantadine-resistance influenza viruses were reported. The frequency of amantadine resistance among influenza A (H3N2) viruses from 1991 and 1995 was as low as 0.8%. In 2004, the resistance frequency increased to 12.3%. A year later, resistance increase significantly to 96%, 72%, and 14.5% in China, South Korea, and the United States, respectively. By 2006, 90.6% of H3N2 strains and 15.6% of H1N1 were amantadine resistant. A majority of the amantadine-resistant H3N2 isolates (98.2%) was found to contain an S31N mutation in the M2 transmembrane domain that confers resistance to amantadine. Currently, adamantane resistance is high among circulating influenza A viruses. Thus, they are no longer recommended for treatment of influenza A.\n\n===Parkinson's disease===\nAn incidental finding in 1969 prompted investigations about amantadine's effectiveness for treating symptoms of Parkinson's disease. Additional studies followed patients for greater lengths of time and in different combinations of neurological drugs. It was found to be a safe drug that could be used over long periods of time with few side effects as monotherapy or in combination with L-dopa or anticholinergic drugs.","wiki_society_and_culture":"==Society and culture==\n===Names===\nBrand names of amantadine include Gocovri, Symadine, and Symmetrel.\n\n===Recreational use===\nRecreational use of amantadine at supratherapeutic doses has been reported. Recreational use of the related drug memantine has similarly been reported. In Western countries and according to international livestock regulations, amantadine is approved only for use in humans. Chickens in China have received an estimated 2.6 billion doses of amantadine.\n\nIn September 2015, the U.S. FDA announced the recall of Dingo Chip Twists \"Chicken in the Middle\" dog treats because the product has the potential to be contaminated with amantadine."},"commercial":{"launchDate":"1968","_launchSource":"DrugCentral (FDA 1968-02-14, ENDO PHARMS)"},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=gocovri","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=gocovri","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://en.wikipedia.org/wiki/Amantadine","fields":["history","overview"],"source":"Wikipedia"}],"_enrichedAt":"2026-03-31T10:22:36.991255","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T05:39:37.355967+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"amiodarone","drugSlug":"amiodarone","fdaApproval":"1985-12-24","patentExpiry":"Mar 13, 2029","patentStatus":"Patent protected","relationship":"same-target"},{"drugName":"amitriptyline","drugSlug":"amitriptyline","fdaApproval":"1961-04-07","genericCount":33,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"astemizole","drugSlug":"astemizole","fdaApproval":"1988-12-31","relationship":"same-target"},{"drugName":"azaperone","drugSlug":"azaperone","fdaApproval":"","relationship":"same-target"},{"drugName":"benzatropine","drugSlug":"benzatropine","fdaApproval":"1954-03-05","relationship":"same-target"},{"drugName":"buspirone","drugSlug":"buspirone","fdaApproval":"1986-09-29","genericCount":19,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"butenafine","drugSlug":"butenafine","fdaApproval":"1996-10-18","genericCount":1,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"caramiphen","drugSlug":"caramiphen","fdaApproval":"","relationship":"same-target"},{"drugName":"cefapirin","drugSlug":"cefapirin","fdaApproval":"1974-03-12","relationship":"same-target"},{"drugName":"chloroquine","drugSlug":"chloroquine","fdaApproval":"1949-10-31","patentStatus":"Unknown","relationship":"same-target"}],"genericName":"gocovri","indications":{"approved":[{"name":"Arteriosclerotic Parkinsonism","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Extrapyramidal disease","source":"DrugCentral","snomedId":76349003,"regulator":"FDA"},{"name":"Influenza A Prevention","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Influenza due to Influenza A virus","source":"DrugCentral","snomedId":442438000,"regulator":"FDA"},{"name":"Parkinson's disease","source":"DrugCentral","snomedId":49049000,"regulator":"FDA","usPrevalence":1000000,"globalPrevalence":8500000,"prevalenceMethod":"curated","prevalenceSource":"WHO, 2023"},{"name":"Parkinsonism","source":"DrugCentral","snomedId":32798002,"regulator":"FDA"},{"name":"Postencephalitic parkinsonism","source":"DrugCentral","snomedId":19972008,"regulator":"FDA"}],"offLabel":[{"name":"Arousal post traumatic brain injury","source":"DrugCentral","drugName":"AMANTADINE","evidenceCount":7,"evidenceLevel":"emerging"},{"name":"Cognitive Impairment following Traumatic Brain Injury","source":"DrugCentral","drugName":"AMANTADINE","evidenceCount":6,"evidenceLevel":"emerging"},{"name":"Cognitive impairment following traumatic brain injury","source":"DrugCentral","drugName":"AMANTADINE","evidenceCount":6,"evidenceLevel":"emerging"},{"name":"Fatigue due to Multiple Sclerosis","source":"DrugCentral","drugName":"AMANTADINE","evidenceCount":0,"evidenceLevel":"emerging"},{"name":"Jakob-Creutzfeldt disease","source":"DrugCentral","drugName":"AMANTADINE","evidenceCount":16,"evidenceLevel":"moderate"}],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT05140148","phase":"PHASE2","title":"Promoting Recovery After STroke With Amantadine","status":"RECRUITING","sponsor":"University of Pennsylvania","startDate":"2022-02-01","conditions":["Stroke, Ischemic","Stroke Hemorrhagic"],"enrollment":60,"completionDate":"2028-06-30"},{"nctId":"NCT04367883","phase":"","title":"Influenza Vaccination, ACEI and ARB in the Evolution of SARS-CoV2 Infection","status":"RECRUITING","sponsor":"Consorci Sanitari de Terrassa","startDate":"2020-03-01","conditions":["COVID19","Influenza Vaccination","ACE Inhibitors","ARB","Antihistamine Allergy","Amantadine"],"enrollment":3000,"completionDate":"2028-02-24"},{"nctId":"NCT05504057","phase":"","title":"Antihistamines, Amantadine and Evolution of the SARS-CoV-2 Infection","status":"RECRUITING","sponsor":"Consorci Sanitari de Terrassa","startDate":"2020-03-01","conditions":["COVID-19"],"enrollment":140660,"completionDate":"2028-02-24"},{"nctId":"NCT07470606","phase":"PHASE2","title":"Memantine +/- Raloxifene for Cognitive Preservation After Radiation Therapy to the Brain","status":"NOT_YET_RECRUITING","sponsor":"The University of Texas Health Science Center at San Antonio","startDate":"2026-03","conditions":["Brain Tumor"],"enrollment":108,"completionDate":"2031-03"},{"nctId":"NCT07151378","phase":"PHASE3","title":"Intestinal Levodopa + Entacapone Therapy (Lecigon®) to Counteract Dopaminergic Desensitization and Neuropsychiatric Complications in Parkinson's Disease","status":"RECRUITING","sponsor":"University Hospital Tuebingen","startDate":"2025-10-27","conditions":["PARKINSON DISEASE (Disorder)"],"enrollment":150,"completionDate":"2030-09-22"},{"nctId":"NCT04302870","phase":"PHASE2,PHASE3","title":"Motor Neurone Disease - Systematic Multi-Arm Adaptive Randomised Trial","status":"RECRUITING","sponsor":"University of Edinburgh","startDate":"2020-02-27","conditions":["Motor Neuron Disease, Amyotrophic Lateral Sclerosis"],"enrollment":1150,"completionDate":"2030-12"},{"nctId":"NCT04966546","phase":"EARLY_PHASE1","title":"Targeting Spreading Depolarization After Chronic Subdural Hematoma Surgery (TASD)","status":"WITHDRAWN","sponsor":"University of New Mexico","startDate":"2022-06-01","conditions":["Chronic Subdural Hematoma"],"enrollment":0,"completionDate":"2025-12-01"},{"nctId":"NCT03553875","phase":"PHASE3","title":"Memantine for the Treatment of Social Deficits in Youth With Disorders of Impaired Social Interactions","status":"TERMINATED","sponsor":"Massachusetts General Hospital","startDate":"2018-11-13","conditions":["Autism","Autism Spectrum Disorder","Nonverbal Learning Disability"],"enrollment":25,"completionDate":"2025-11-25"},{"nctId":"NCT07421427","phase":"NA","title":"Adding Amantadine or Duloxetine to Pregabalin on Occurrence of Post Mastectomy Pain Syndrome","status":"RECRUITING","sponsor":"Cairo University","startDate":"2026-02-21","conditions":["Amantadine","Duloxetine","Pregabalin","Mastectomy","Pain Syndrome"],"enrollment":150,"completionDate":"2027-01-01"},{"nctId":"NCT07248228","phase":"PHASE2","title":"Memory Avoidance Whole Brain Radiotherapy vs Hippocampal Avoidance Whole Brain Radiotherapy (Athena 2 Trial)","status":"NOT_YET_RECRUITING","sponsor":"Case Comprehensive Cancer Center","startDate":"2026-03","conditions":["Brain Metastases"],"enrollment":90,"completionDate":"2028-11"},{"nctId":"NCT07417670","phase":"PHASE4","title":"Satisfaction With Orodispersible vs Conventional Memantine in Moderate to Severe Alzheimer's Disease","status":"COMPLETED","sponsor":"Carnot Laboratories","startDate":"2024-10-04","conditions":["Alzheimer Disease"],"enrollment":105,"completionDate":"2025-08-18"},{"nctId":"NCT03527472","phase":"PHASE2","title":"Memantine for the Treatment of Cognitive Impairment in Systemic Lupus Erythematosus","status":"ACTIVE_NOT_RECRUITING","sponsor":"Vanderbilt University Medical Center","startDate":"2018-08-23","conditions":["Lupus Erythematosus, Systemic"],"enrollment":111,"completionDate":"2026-02-28"},{"nctId":"NCT04857983","phase":"PHASE2,PHASE3","title":"Memantine Augmentation of Targeted Cognitive Training in Schizophrenia","status":"COMPLETED","sponsor":"University of California, San Diego","startDate":"2021-07-06","conditions":["Schizophrenia","Schizoaffective Disorder"],"enrollment":62,"completionDate":"2025-03-30"},{"nctId":"NCT06055244","phase":"PHASE2","title":"Amantadine Therapy for Cognitive Impairment in Long COVID","status":"COMPLETED","sponsor":"Ohio State University","startDate":"2023-12-07","conditions":["Long COVID","Post-COVID19 Condition","Post-Acute COVID19 Syndrome"],"enrollment":64,"completionDate":"2025-12-29"},{"nctId":"NCT07351773","phase":"NA","title":"Ultrasound-Guided Stellate Ganglion Block for 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