{"id":"alclofenac","rwe":[],"tags":[{"label":"alclofenac","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Prostaglandin G/H synthase 1","category":"target"},{"label":"PTGS1","category":"gene"},{"label":"PTGS2","category":"gene"},{"label":"M01AB06","category":"atc"},{"label":"Active","category":"status"},{"label":"Ankylosing spondylitis","category":"indication"},{"label":"Pain","category":"indication"},{"label":"Rheumatoid arthritis","category":"indication"},{"label":"Analgesics","category":"pharmacology"},{"label":"Analgesics, Non-Narcotic","category":"pharmacology"},{"label":"Anti-Inflammatory Agents","category":"pharmacology"},{"label":"Anti-Inflammatory Agents, Non-Steroidal","category":"pharmacology"},{"label":"Antirheumatic Agents","category":"pharmacology"},{"label":"Peripheral Nervous System Agents","category":"pharmacology"},{"label":"Sensory System Agents","category":"pharmacology"}],"phase":"marketed","safety":{"commonSideEffects":[]},"trials":[],"aliases":[],"patents":[],"pricing":[],"_fixedAt":"2026-03-30T16:42:48.457616","_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=ALCLOFENAC","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:22:16.332130+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-19T23:22:35.010849+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:22:21.967792+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ALCLOFENAC","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:22:22.542794+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Cyclooxygenase-1 inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:22:23.582780+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL94081/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:22:23.234989+00:00"}},"allNames":"reufenac","offLabel":[],"synonyms":["4-allyloxy-3-chlorophenylacetic acid","prinalgin","alclofenac","aclofenac","alclophenac","allopydin","medifenac","reufenac"],"timeline":[{"date":"1969-01-01","type":"positive","source":"DrugCentral","milestone":"YEAR INTRODUCED approval"}],"aiSummary":"Alclofenac (Reufenac) is a marketed nonsteroidal anti-inflammatory drug (NSAID) primarily indicated for ankylosing spondylitis, competing in a crowded NSAID market with several established generics and patented drugs. Its key strength lies in its mechanism of action, specifically inhibiting prostaglandin G/H synthase 1, which effectively targets pain and inflammation associated with ankylosing spondylitis. The primary risk to Alclofenac is the key composition patent expiry in 2028, which could lead to increased competition from generics.","brandName":"Reufenac","ecosystem":[{"indication":"Ankylosing spondylitis","otherDrugs":[{"name":"aceclofenac","slug":"aceclofenac","company":""},{"name":"adalimumab","slug":"adalimumab","company":"Abbvie Inc"},{"name":"betamethasone","slug":"betamethasone","company":""},{"name":"betamethasone acetate","slug":"betamethasone-acetate","company":""}],"globalPrevalence":64000000},{"indication":"Pain","otherDrugs":[{"name":"acetylsalicylic acid","slug":"acetylsalicylic-acid","company":"Endo Pharms"},{"name":"bromfenac","slug":"bromfenac","company":"Bausch And Lomb Inc"},{"name":"butorphanol","slug":"butorphanol","company":""},{"name":"caffeine","slug":"caffeine","company":"Novartis"}],"globalPrevalence":1500000000},{"indication":"Rheumatoid arthritis","otherDrugs":[{"name":"abatacept","slug":"abatacept","company":"Bristol Myers Squibb"},{"name":"aceclofenac","slug":"aceclofenac","company":""},{"name":"acetylsalicylic acid","slug":"acetylsalicylic-acid","company":"Endo Pharms"},{"name":"adalimumab","slug":"adalimumab","company":"Abbvie Inc"}],"globalPrevalence":18000000}],"mechanism":{"target":"Prostaglandin G/H synthase 1","targets":[{"gene":"PTGS1","source":"DrugCentral","target":"Prostaglandin G/H synthase 1","protein":"Prostaglandin G/H synthase 1"},{"gene":"PTGS2","source":"DrugCentral","target":"Prostaglandin G/H synthase 2","protein":"Prostaglandin G/H synthase 2"}],"modality":"Small Molecule","drugClass":"alclofenac","explanation":"","oneSentence":"","technicalDetail":"Alclofenac specifically inhibits the cyclooxygenase (COX) activity of prostaglandin G/H synthase 1, leading to a decrease in the production of prostaglandins and subsequent reduction in pain and inflammation."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/107","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ALCLOFENAC","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T08:34:10.546518","_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-19T23:22:35.010934+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"indomethacin","drugSlug":"indomethacin","fdaApproval":"1965-06-10","patentExpiry":"Apr 23, 2030","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"sulindac","drugSlug":"sulindac","fdaApproval":"1978-09-27","genericCount":7,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"tolmetin","drugSlug":"tolmetin","fdaApproval":"1976-03-24","genericCount":6,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"diclofenac","drugSlug":"diclofenac","fdaApproval":"1988-07-28","patentExpiry":"Apr 23, 2030","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"etodolac","drugSlug":"etodolac","fdaApproval":"1991-01-31","genericCount":25,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"ketorolac","drugSlug":"ketorolac","fdaApproval":"1989-11-30","patentExpiry":"Nov 24, 2027","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"aceclofenac","drugSlug":"aceclofenac","fdaApproval":"","relationship":"same-class"}],"genericName":"alclofenac","indications":{"approved":[{"name":"Ankylosing spondylitis","source":"DrugCentral","snomedId":9631008,"regulator":"FDA","usPrevalence":null,"globalPrevalence":64000000,"prevalenceMethod":"curated","prevalenceSource":"Arthritis Care Res (Hoboken), 2016 (PMID:26713432)"},{"name":"Pain","source":"DrugCentral","snomedId":22253000,"regulator":"FDA","usPrevalence":51600000,"globalPrevalence":1500000000,"prevalenceMethod":"curated","prevalenceSource":"CDC, 2023"},{"name":"Rheumatoid arthritis","source":"DrugCentral","snomedId":69896004,"regulator":"FDA","usPrevalence":1500000,"globalPrevalence":18000000,"prevalenceMethod":"curated","prevalenceSource":"Lancet Rheumatology, 2023"}],"offLabel":[],"pipeline":[]},"_fixedFields":["pubmed(106)"],"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"indomethacin","brandName":"indomethacin","genericName":"indomethacin","approvalYear":"1965","relationship":"same-class"},{"drugId":"sulindac","brandName":"sulindac","genericName":"sulindac","approvalYear":"1978","relationship":"same-class"},{"drugId":"tolmetin","brandName":"tolmetin","genericName":"tolmetin","approvalYear":"1976","relationship":"same-class"},{"drugId":"diclofenac","brandName":"diclofenac","genericName":"diclofenac","approvalYear":"1988","relationship":"same-class"},{"drugId":"etodolac","brandName":"etodolac","genericName":"etodolac","approvalYear":"1991","relationship":"same-class"},{"drugId":"ketorolac","brandName":"ketorolac","genericName":"ketorolac","approvalYear":"1989","relationship":"same-class"},{"drugId":"aceclofenac","brandName":"aceclofenac","genericName":"aceclofenac","approvalYear":"","relationship":"same-class"}],"trialDetails":[],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"UNII":"M9CP5H21N8","CHEBI":"CHEBI:31183","INN_ID":"2826","UMLSCUI":"C0001937","chemblId":"CHEMBL94081","ChEMBL_ID":"CHEMBL94081","KEGG_DRUG":"D01252","DRUGBANK_ID":"DB13167","PUBCHEM_CID":"30951","MESH_SUPPLEMENTAL_RECORD_UI":"C084615"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[],"publicationCount":106,"therapeuticAreas":["Immunology"],"atcClassification":{"source":"DrugCentral","atcCode":"M01AB06","allCodes":["M01AB06"]},"biosimilarFilings":[],"recentPublications":[{"date":"2024 Dec 23","pmid":"39648592","title":"Chemoenzymatic Synthesis Planning Guided by Reaction Type Score.","journal":"Journal of chemical information and modeling"},{"date":"2024 Jul 30","pmid":"39108902","title":"Weighted gene coexpression network analysis and machine learning for the determination of tfh cell and B cell infiltrating biomarkers in thymoma-associated myasthenia gravis.","journal":"Heliyon"},{"date":"2021 Feb 15","pmid":"33496184","title":"Modeling the Bioactivation and Subsequent Reactivity of Drugs.","journal":"Chemical research in toxicology"},{"date":"2009 Sep","pmid":"19740398","title":"Aldosterone glucuronidation by human liver and kidney microsomes and recombinant UDP-glucuronosyltransferases: inhibition by NSAIDs.","journal":"British journal of clinical pharmacology"},{"date":"2006 Oct 18","pmid":"17054271","title":"Non-steroidal anti-inflammatory drugs for heavy bleeding or pain associated with intrauterine-device use.","journal":"The Cochrane database of systematic reviews"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"withdrawn","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-19T23:22:35.010934+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"enriching","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":false,"score":1}}