{"id":"aminosalicylic-acid","rwe":[{"pmid":"41901145","year":"2026","title":"Tibetan Fritillaria cirrhosa D. Don Extract Ameliorates DSS-Induced Ulcerative Colitis by Repairing Damage to the Intestinal Mucosal Barrier and Regulating the Gut Microbiota.","finding":"","journal":"Nutrients","studyType":"Clinical Study"},{"pmid":"41900866","year":"2026","title":"Anti-Psoriatic Effects of J2H-1802, a Mycophenolate Mofetil and 5-Aminosalicylic Acid Hybrid, in an Imiquimod-Induced Psoriasis-like Mouse Model.","finding":"","journal":"Pharmaceutics","studyType":"Clinical Study"},{"pmid":"41900781","year":"2026","title":"Adjunctive Multicomponent Crystals of Two Anti-Tubercular Drugs with Pyridoxine.","finding":"","journal":"Pharmaceutics","studyType":"Clinical Study"},{"pmid":"41883184","year":"2026","title":"Impact of 5-ASA discontinuation in children with ulcerative colitis on biologic therapy: A propensity score-matched study.","finding":"","journal":"Journal of pediatric gastroenterology and nutrition","studyType":"Clinical Study"},{"pmid":"41874945","year":"2026","title":"Analysis of possible baseline and treatment-course factors associated with non-remission in patients with Crohn's disease treated with ustekinumab: a retrospective real-life analysis.","finding":"","journal":"Pharmacological reports : PR","studyType":"Clinical Study"}],"tags":[{"label":"aminosalicylic acid","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Tyrosine-protein phosphatase non-receptor type 1","category":"target"},{"label":"PTPN1","category":"gene"},{"label":"PTGS1","category":"gene"},{"label":"PTGS2","category":"gene"},{"label":"J04AA01","category":"atc"},{"label":"Oral","category":"route"},{"label":"Granule","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Mature","category":"status"},{"label":"Acute tuberculosis","category":"indication"},{"label":"Pulmonary tuberculosis","category":"indication"},{"label":"Consolidated Midland","category":"company"},{"label":"Approved 1950s","category":"decade"},{"label":"Anti-Bacterial Agents","category":"pharmacology"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Antitubercular Agents","category":"pharmacology"}],"phase":"marketed","safety":{"safetySignals":[{"llr":662.712,"date":"","count":217,"signal":"Colitis ulcerative","source":"DrugCentral FAERS","actionTaken":"Reported 217 times (LLR=663)"},{"llr":392.103,"date":"","count":188,"signal":"Electrocardiogram QT prolonged","source":"DrugCentral FAERS","actionTaken":"Reported 188 times (LLR=392)"},{"llr":316.903,"date":"","count":120,"signal":"Frequent bowel movements","source":"DrugCentral FAERS","actionTaken":"Reported 120 times (LLR=317)"},{"llr":245.803,"date":"","count":409,"signal":"Off label use","source":"DrugCentral FAERS","actionTaken":"Reported 409 times (LLR=246)"},{"llr":214.398,"date":"","count":103,"signal":"Drug resistance","source":"DrugCentral FAERS","actionTaken":"Reported 103 times (LLR=214)"},{"llr":152.906,"date":"","count":101,"signal":"Haematochezia","source":"DrugCentral FAERS","actionTaken":"Reported 101 times (LLR=153)"},{"llr":142.112,"date":"","count":82,"signal":"Hepatotoxicity","source":"DrugCentral FAERS","actionTaken":"Reported 82 times (LLR=142)"},{"llr":127.787,"date":"","count":86,"signal":"Rectal haemorrhage","source":"DrugCentral FAERS","actionTaken":"Reported 86 times (LLR=128)"},{"llr":121.041,"date":"","count":124,"signal":"Intentional product use issue","source":"DrugCentral FAERS","actionTaken":"Reported 124 times (LLR=121)"},{"llr":99.455,"date":"","count":105,"signal":"Neuropathy peripheral","source":"DrugCentral FAERS","actionTaken":"Reported 105 times (LLR=99)"},{"llr":95.983,"date":"","count":32,"signal":"Mucous stools","source":"DrugCentral FAERS","actionTaken":"Reported 32 times (LLR=96)"},{"llr":84.887,"date":"","count":37,"signal":"Diarrhoea haemorrhagic","source":"DrugCentral FAERS","actionTaken":"Reported 37 times (LLR=85)"},{"llr":76.383,"date":"","count":63,"signal":"Pancreatitis","source":"DrugCentral FAERS","actionTaken":"Reported 63 times (LLR=76)"},{"llr":76.148,"date":"","count":42,"signal":"Polyneuropathy","source":"DrugCentral FAERS","actionTaken":"Reported 42 times (LLR=76)"},{"llr":75.837,"date":"","count":154,"signal":"Anaemia","source":"DrugCentral FAERS","actionTaken":"Reported 154 times (LLR=76)"}],"commonSideEffects":[],"contraindications":["Acidosis","Anemia due to enzyme deficiency","Chronic heart failure","Cobalamin deficiency","Crystalluria","Deficiency of glucose-6-phosphate dehydrogenase","Disease of liver","Duodenal ulcer disease","Gastric ulcer","Goiter","Hypokalemia","Kidney disease","Peptic ulcer"],"specialPopulations":{"Pregnancy":"Pregnancy Category C: Aminosalicylic acid has been reported to produce occipital malformations in rats when given at doses within the human dose range. Although there probably is dose response, the frequency of abnormalities was comparable to controls at the highest level tested (two times the human dosage). When administered to rabbits at mg/kg, throughout all three trimesters, no teratologic or embryocidal effects were seen. Literature reports on aminosalicylic acid in pregnant women are lacking."}},"trials":[],"aliases":[],"company":"Consolidated Midland","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=AMINOSALICYLIC ACID","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:39:46.901275+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:39:53.971318+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=AMINOSALICYLIC ACID","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:39:54.776750+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Dihydrofolate reductase inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:39:55.896899+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1169/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:39:55.806232+00:00"}},"allNames":"apacil","offLabel":[],"synonyms":["aminosalicylic acid resin complex","potassium aminosalicylate","p-aminosalicylic acid","aminosalicylic acid","4-Aminosalicylic acid","4-Carboxy-3-hydroxyaniline","apacil","calcium aminosalicylate","sodium aminosalicylate","para-aminosalicylic acid","aminosalicylate potassium","aminosalicylate sodium","teebacin"],"timeline":[{"date":"1950-03-08","type":"positive","source":"DrugCentral","milestone":"FDA approval (Consolidated Midland)"},{"date":"1994-06-30","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 1 manufacturer approved"}],"aiSummary":"Apacil (aminosalicylic acid) is a small molecule drug originally developed by Consolidated Midland, which remains its current owner. It targets tyrosine-protein phosphatase non-receptor type 1 and is used to treat acute and pulmonary tuberculosis. Apacil is classified as an aminosalicylic acid and was FDA-approved in 1950. It is now off-patent and has a generic manufacturer. As an off-patent drug, it is no longer protected by active patents.","brandName":"Apacil","ecosystem":[{"indication":"Acute tuberculosis","otherDrugs":[{"name":"capreomycin","slug":"capreomycin","company":"Akorn"},{"name":"cycloserine","slug":"cycloserine","company":"Purdue Gmp"},{"name":"ethambutol","slug":"ethambutol","company":"Sti Pharma Llc"},{"name":"ethionamide","slug":"ethionamide","company":"Wyeth Pharms Inc"}],"globalPrevalence":1280000},{"indication":"Pulmonary tuberculosis","otherDrugs":[{"name":"bedaquiline","slug":"bedaquiline","company":"Janssen Therap"},{"name":"capreomycin","slug":"capreomycin","company":"Akorn"},{"name":"cycloserine","slug":"cycloserine","company":"Purdue Gmp"},{"name":"ethambutol","slug":"ethambutol","company":"Sti Pharma Llc"}],"globalPrevalence":1280000}],"mechanism":{"target":"Tyrosine-protein phosphatase non-receptor type 1","targets":[{"gene":"PTPN1","source":"DrugCentral","target":"Tyrosine-protein phosphatase non-receptor type 1","protein":"Tyrosine-protein phosphatase non-receptor type 1"},{"gene":"PTGS1","source":"DrugCentral","target":"Cyclooxygenase","protein":"Prostaglandin G/H synthase 1"},{"gene":"PTGS2","source":"DrugCentral","target":"Cyclooxygenase","protein":"Prostaglandin G/H synthase 2"}],"modality":"Small Molecule","drugClass":"aminosalicylic acid","explanation":"","oneSentence":"","technicalDetail":"Apacil inhibits the activity of tyrosine-protein phosphatase non-receptor type 1, which is a crucial enzyme in the synthesis of bacterial cell wall components, thereby exerting its antibacterial effects."},"commercial":{"launchDate":"1950","_launchSource":"DrugCentral (FDA 1950-03-08, CONSOLIDATED MIDLAND)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/2050","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=AMINOSALICYLIC%20ACID","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=AMINOSALICYLIC ACID","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T08:43:25.921381","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:39:57.659421+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[],"genericName":"aminosalicylic acid","indications":{"approved":[{"name":"Acute tuberculosis","source":"DrugCentral","snomedId":25629007,"regulator":"FDA","eligibility":"patients with Multi-drug Resistant TB (MDR-TB) or in situations when therapy with isoniazid and rifampin is not possible due to combination of resistance and/or intolerance","usPrevalence":null,"globalPrevalence":1280000,"prevalenceMethod":"curated","prevalenceSource":"Orphanet (European Medicines Agency 2018[INST])"},{"name":"Pulmonary tuberculosis","source":"DrugCentral","snomedId":154283005,"regulator":"FDA","eligibility":"patients proven or suspected drug resistance, accompanied by at least one and preferably two other new agents to which the patient's organism is known or expected to be susceptible","usPrevalence":null,"globalPrevalence":1280000,"prevalenceMethod":"curated","prevalenceSource":"Orphanet (European Medicines Agency 2018[INST])"}],"offLabel":[{"name":"Crohn's disease","source":"DrugCentral","drugName":"AMINOSALICYLIC ACID","evidenceCount":641,"evidenceLevel":"strong"},{"name":"Ulcerative colitis","source":"DrugCentral","drugName":"AMINOSALICYLIC ACID"}],"pipeline":[]},"drugCategory":"mature","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[],"trialDetails":[{"nctId":"NCT05213234","phase":"NA","title":"Chronotherapy of 5-Aminosalicylic Acid in Ulcerative Colitis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Rush University Medical Center","startDate":"2021-07-09","conditions":["Ulcerative Colitis"],"enrollment":32,"completionDate":"2026-06-30"},{"nctId":"NCT05986136","phase":"PHASE2,PHASE3","title":"Activation of Autophagy and Suppression of Apoptosis by Dapagliflozin Attenuates Inflammatory Bowel Disease","status":"RECRUITING","sponsor":"Mostafa Bahaa","startDate":"2023-08-20","conditions":["Inflammatory Bowel Diseases"],"enrollment":50,"completionDate":"2028-07-20"},{"nctId":"NCT07389824","phase":"NA","title":"Efficacy of Acupuncture-Mesalazine 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