{"id":"nalidixic-acid","rwe":[],"tags":[{"label":"nalidixic acid","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"5-hydroxytryptamine receptor 2B","category":"target"},{"label":"HTR2B","category":"gene"},{"label":"PKM","category":"gene"},{"label":"J01MB02","category":"atc"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Mature","category":"status"},{"label":"Bacterial urinary infection","category":"indication"},{"label":"Approved 1960s","category":"decade"},{"label":"Anti-Bacterial Agents","category":"pharmacology"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Antineoplastic Agents","category":"pharmacology"},{"label":"Enzyme Inhibitors","category":"pharmacology"},{"label":"Topoisomerase II Inhibitors","category":"pharmacology"},{"label":"Topoisomerase Inhibitors","category":"pharmacology"}],"phase":"marketed","safety":{"contraindications":["Acute nephropathy","Anemia due to enzyme deficiency","Deficiency of glucose-6-phosphate dehydrogenase","Disease of liver","Disorder of the central nervous system","Peripheral nerve disease","Porphyria","Pseudomembranous enterocolitis","Seizure disorder","Severe Cerebral Arteriosclerosis","Tendinitis","Traumatic rupture of tendon"]},"trials":[],"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=NALIDIXIC ACID","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:13:47.260668+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:13:52.645240+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=NALIDIXIC ACID","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:13:52.958405+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Bacterial DNA gyrase inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:13:54.526073+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL5/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:13:54.184424+00:00"}},"allNames":"nalidixate","offLabel":[],"synonyms":["nalidixic acid","nalidic acid","nalidixinic acid","nalidixate","nalidixic acid sodium","nalidixic acid sodium salt"],"timeline":[{"date":"1964-03-06","type":"positive","source":"DrugCentral","milestone":"FDA approval"},{"date":"1988-06-29","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 2 manufacturers approved"}],"aiSummary":"Nalidixate, also known as Nalidixic Acid, is a small molecule drug that targets the 5-hydroxytryptamine receptor 2B. Originally developed in the 1960s, it is an off-patent, generic medication used to treat bacterial urinary infections. It was first approved by the FDA in 1964 and has a high bioavailability of 96%. Nalidixate is classified as a nalidixic acid drug and is manufactured by multiple generic manufacturers. As an off-patent medication, it is no longer protected by active patents.","approvals":[{"date":"1964-03-06","orphan":false,"company":"","regulator":"FDA"}],"brandName":"Nalidixate","ecosystem":[{"indication":"Bacterial urinary infection","otherDrugs":[{"name":"amikacin","slug":"amikacin","company":"Apothecon"},{"name":"amoxicillin","slug":"amoxicillin","company":"Apothecon"},{"name":"ampicillin","slug":"ampicillin","company":"Wyeth Ayerst"},{"name":"avibactam","slug":"avibactam","company":"Cerexa Inc"}],"globalPrevalence":null}],"mechanism":{"target":"5-hydroxytryptamine receptor 2B","novelty":"Follow-on","targets":[{"gene":"HTR2B","source":"DrugCentral","target":"5-hydroxytryptamine receptor 2B","protein":"5-hydroxytryptamine receptor 2B"},{"gene":"PKM","source":"DrugCentral","target":"Pyruvate kinase PKM","protein":"Pyruvate kinase PKM"}],"modality":"Small Molecule","drugClass":"nalidixic acid","explanation":"","oneSentence":"","technicalDetail":"Nalidixate exerts its antibacterial effect by inhibiting bacterial DNA gyrase, a type II topoisomerase enzyme essential for bacterial DNA replication, transcription, repair, and recombination."},"commercial":{"launchDate":"1964","_launchSource":"DrugCentral (FDA 1964-03-06, )"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1875","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=NALIDIXIC%20ACID","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=NALIDIXIC 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 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