{"id":"hydroxyamfetamine","rwe":[{"pmid":"24573809","year":"2014","title":"Isotope-dilution mass spectrometric quantification of the prodrug lisdexamfetamine in human urine in doping control analysis.","finding":"","journal":"Rapid communications in mass spectrometry : RCM","studyType":"Clinical Study"}],"tags":[{"label":"Adrenergic Receptor Agonist","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Trace amine-associated receptor 1","category":"target"},{"label":"TAAR1","category":"gene"},{"label":"BACE1","category":"gene"},{"label":"Ophthalmic","category":"route"},{"label":"Solution","category":"form"},{"label":"Active","category":"status"},{"label":"Dilated pupil","category":"indication"},{"label":"Pharmics","category":"company"},{"label":"Approved 1960s","category":"decade"},{"label":"Mydriatics","category":"pharmacology"},{"label":"Peripheral Nervous System Agents","category":"pharmacology"},{"label":"Sympathomimetics","category":"pharmacology"}],"phase":"marketed","safety":{"commonSideEffects":[{"effect":"Transient stinging","drugRate":"","severity":"common","organSystem":""},{"effect":"Dryness of the mouth","drugRate":"","severity":"common","organSystem":""},{"effect":"Blurred vision","drugRate":"","severity":"common","organSystem":""},{"effect":"Photophobia","drugRate":"","severity":"common","organSystem":""},{"effect":"Corneal staining","drugRate":"","severity":"common","organSystem":""},{"effect":"Tachycardia","drugRate":"","severity":"common","organSystem":""},{"effect":"Headache","drugRate":"","severity":"common","organSystem":""},{"effect":"Allergic reactions","drugRate":"","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"","severity":"common","organSystem":""},{"effect":"Vomiting","drugRate":"","severity":"common","organSystem":""},{"effect":"Pallor","drugRate":"","severity":"common","organSystem":""},{"effect":"Muscle rigidity","drugRate":"","severity":"common","organSystem":""},{"effect":"Central nervous system disturbances","drugRate":"","severity":"common","organSystem":""}],"contraindications":["Angle-closure glaucoma","Conduction disorder of the heart","Diabetes mellitus","Hypertensive disorder","Hyperthyroidism","Myocardial ischemia","Ocular hypertension","Open-angle glaucoma"],"specialPopulations":{"Pregnancy":"Pregnancy Category C. Animal reproduction studies have not been conducted with PAREMYD(R). It is also not known whether PAREMYD(R) can cause fetal harm when administered to pregnant woman or can affect reproduction capability. PAREMYD(R) should be given to pregnant woman only if clearly needed.","Geriatric use":"No overall differences in safety or effectiveness have been observed between elderly and younger patients.","Paediatric use":"Safety and effectiveness in pediatric patients have not been established. PAREMYD(R) may rarely cause CNS disturbances which may be dangerous in infants and children. Psychotic reactions, behavioral disturbances and vasomotor or cardio-respiratory collapse in children have been reported with the use of anticholinergic drugs. (See WARNINGS). Keep this and all medications out of the reach of children."},"seriousAdverseEvents":[{"effect":"Increased intraocular pressure","drugRate":"","severity":"serious"},{"effect":"Psychotic reactions","drugRate":"","severity":"serious"},{"effect":"Behavioral disturbances","drugRate":"","severity":"serious"},{"effect":"Vasomotor collapse","drugRate":"","severity":"serious"},{"effect":"Cardiorespiratory collapse","drugRate":"","severity":"serious"},{"effect":"Myocardial infarction","drugRate":"","severity":"serious"},{"effect":"Ventricular fibrillation","drugRate":"","severity":"serious"},{"effect":"Significant hypotensive episodes","drugRate":"","severity":"serious"},{"effect":"Death","drugRate":"","severity":"serious"}]},"trials":[],"aliases":[],"company":"Pharmics","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=hydroxyamfetamine","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:13:27.569742+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:13:32.766779+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=hydroxyamfetamine","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:13:32.970991+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1546/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:13:33.836703+00:00"}},"allNames":"paremyd","offLabel":[],"synonyms":["hydroxyamphetamine hydrobromide","hydroxyamfetamine hydrobromide","hydroxyamfetamine","hydroxyamphetamine","oxamphetamine","hydroxyamphetamide","paredrine","hydroxyamphetamin","para-Hydroxyamphetamine","methyltyramine"],"timeline":[{"date":"1969-07-16","type":"positive","source":"DrugCentral","milestone":"FDA approval (Pharmics)"}],"aiSummary":"Paremyd (hydroxyamphetamine) is a small molecule adrenergic receptor agonist developed by PHARMICS, targeting the trace amine-associated receptor 1. It was approved by the FDA in 1969 for the treatment of dilated pupils. As an off-patent medication, its commercial status is likely generic. Key safety considerations include its potential effects on blood pressure and heart rate. Paremyd is a sympathomimetic agent that works by stimulating the adrenergic receptors in the eye.","approvals":[{"date":"1969-07-16","orphan":false,"company":"PHARMICS","regulator":"FDA"}],"brandName":"Paremyd","ecosystem":[{"indication":"Dilated pupil","otherDrugs":[{"name":"cyclopentolate","slug":"cyclopentolate","company":"Alcon Labs Inc"},{"name":"phenylephrine","slug":"phenylephrine","company":"Ani Pharms"},{"name":"scopolamine","slug":"scopolamine","company":"Novartis"},{"name":"tropicamide","slug":"tropicamide","company":""}],"globalPrevalence":null}],"mechanism":{"target":"Trace amine-associated receptor 1","novelty":"Follow-on","targets":[{"gene":"TAAR1","source":"DrugCentral","target":"Trace amine-associated receptor 1","protein":"Trace amine-associated receptor 1"},{"gene":"BACE1","source":"DrugCentral","target":"Beta-secretase 1","protein":"Beta-secretase 1"}],"moaClass":"Adrenergic Agonists","modality":"Small Molecule","drugClass":"Adrenergic Receptor Agonist","explanation":"","oneSentence":"","technicalDetail":"Paremyd acts as an agonist at the alpha-adrenergic receptors in the iris sphincter muscle, causing contraction and resulting in miosis."},"commercial":{"launchDate":"1969","revenueYear":2025,"_launchSource":"DrugCentral (FDA 1969-07-16, PHARMICS)","annualRevenue":172,"revenueSource":"Teva 2026-02-03 (verified from SEC filing)","revenueCurrency":"USD","revenueConfidence":"high"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1394","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=hydroxyamfetamine","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T11:57:50.058415","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:13:35.657766+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"chloroquine","drugSlug":"chloroquine","fdaApproval":"1949-10-31","patentStatus":"Unknown","relationship":"same-target"},{"drugName":"cianidanol","drugSlug":"cianidanol","fdaApproval":"","relationship":"same-target"},{"drugName":"donepezil","drugSlug":"donepezil","fdaApproval":"1996-11-25","patentExpiry":"Sep 23, 2037","patentStatus":"Patent protected","relationship":"same-target"},{"drugName":"gefitinib","drugSlug":"gefitinib","fdaApproval":"2003-05-05","genericCount":5,"patentStatus":"Off-patent — generic available","relationship":"same-target"}],"genericName":"hydroxyamfetamine","indications":{"approved":[{"name":"Dilated pupil","source":"DrugCentral","snomedId":37125009,"regulator":"FDA","eligibility":"Routine diagnostic procedures and conditions where short-term pupil dilation is desired"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"chloroquine","brandName":"chloroquine","genericName":"chloroquine","approvalYear":"1949","relationship":"same-target"},{"drugId":"cianidanol","brandName":"cianidanol","genericName":"cianidanol","approvalYear":"","relationship":"same-target"},{"drugId":"donepezil","brandName":"donepezil","genericName":"donepezil","approvalYear":"1996","relationship":"same-target"},{"drugId":"gefitinib","brandName":"gefitinib","genericName":"gefitinib","approvalYear":"2003","relationship":"same-target"}],"trialDetails":[],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Ophthalmic","formulation":"Solution","formulations":[{"form":"SOLUTION","route":"OPHTHALMIC","productName":"Paremyd"}]},"crossReferences":{"NUI":"N0000179438","MMSL":"4851","NDDF":"001823","UNII":"59IG47SZ0E","VUID":"4018012","CHEBI":"CHEBI:103855","VANDF":"4018012","INN_ID":"136","RXNORM":"7839","UMLSCUI":"C0030140","chemblId":"CHEMBL1546","ChEMBL_ID":"CHEMBL1546","KEGG_DRUG":"D04473","DRUGBANK_ID":"DB09352","PUBCHEM_CID":"3651","SNOMEDCT_US":"387062009","SECONDARY_CAS_RN":"306-21-8","MESH_DESCRIPTOR_UI":"D010136"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"1969-","companyName":"Pharmics","relationship":"Original Developer"}],"publicationCount":1,"therapeuticAreas":["Ophthalmology"],"_revenueScrapedAt":"2026-03-31 14:09:35.487336+00","biosimilarFilings":[],"originalDeveloper":"Pharmics","recentPublications":[{"date":"2014 Apr 15","pmid":"24573809","title":"Isotope-dilution mass spectrometric quantification of the prodrug lisdexamfetamine in human urine in doping control analysis.","journal":"Rapid communications in mass spectrometry : RCM"}],"combinationProducts":[{"brandName":"Paremyd","ingredients":"hydroxyamfetamine + tropicamide"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","companyName":"Pharmics","companyId":"pharmics","modality":"Small Molecule","firstApprovalDate":"1969","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1969-07-16T00:00:00.000Z","mah":"PHARMICS","brand_name_local":null,"application_number":""},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:13:35.657766+00:00","fieldsConflicting":2,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":false,"score":2}}