{"id":"salsalate","rwe":[{"pmid":"41843337","year":"2026","title":"Unrevealing possible mechanism of Riluzole, Salsalate and Nimodipine in Alzheimer's disease: multi-target network pharmacological perspective.","finding":"","journal":"Inflammopharmacology","studyType":"Clinical Study"},{"pmid":"40873177","year":"2026","title":"Jiangtang Decoction for Type 2 Diabetes and NAFLD: Integrative Analysis via Network Pharmacology, Mendelian Randomization, Molecular Docking, and In Vitro Validation.","finding":"","journal":"Endocrine, metabolic & immune disorders drug targets","studyType":"Clinical Study"},{"pmid":"40759853","year":"2025","title":"Phytotherapeutic insights into hyperuricemia: a mechanistic and clinical perspective.","finding":"","journal":"Inflammopharmacology","studyType":"Clinical Study"},{"pmid":"30000946","year":"2006","title":"Salsalate.","finding":"","journal":"","studyType":"Clinical Study"},{"pmid":"40409217","year":"2025","title":"In silico study of salicylic acid derivatives as inhibitors of Ebola proteins through molecular docking.","finding":"","journal":"Computational biology and chemistry","studyType":"Clinical Study"}],"tags":[{"label":"salsalate","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"N02BA06","category":"atc"},{"label":"Oral","category":"route"},{"label":"Tablet","category":"form"},{"label":"Active","category":"status"},{"label":"Osteoarthritis","category":"indication"},{"label":"Rheumatoid arthritis","category":"indication"},{"label":"Analgesics","category":"pharmacology"},{"label":"Analgesics, Non-Narcotic","category":"pharmacology"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Anti-Inflammatory Agents","category":"pharmacology"},{"label":"Anti-Inflammatory Agents, Non-Steroidal","category":"pharmacology"},{"label":"Antifungal Agents","category":"pharmacology"},{"label":"Antirheumatic Agents","category":"pharmacology"},{"label":"Dermatologic Agents","category":"pharmacology"},{"label":"Keratolytic Agents","category":"pharmacology"},{"label":"Peripheral Nervous System Agents","category":"pharmacology"},{"label":"Sensory System Agents","category":"pharmacology"}],"phase":"discontinued","safety":{"safetySignals":[{"llr":37.908,"date":"","count":19,"signal":"International normalised ratio increased","source":"DrugCentral FAERS","actionTaken":"Reported 19 times (LLR=38)"},{"llr":28.164,"date":"","count":28,"signal":"Drug hypersensitivity","source":"DrugCentral FAERS","actionTaken":"Reported 28 times (LLR=28)"}],"drugInteractions":[{"url":"/drug/warfarin","drug":"warfarin","action":"Monitor closely","effect":"May interact with Warfarin","source":"DrugCentral","drugSlug":"warfarin"}],"commonSideEffects":[{"effect":"tinnitus","drugRate":"reported","severity":"unknown"},{"effect":"nausea","drugRate":"reported","severity":"unknown"},{"effect":"hearing impairment","drugRate":"reported","severity":"unknown"},{"effect":"rash","drugRate":"reported","severity":"unknown"},{"effect":"vertigo","drugRate":"reported","severity":"unknown"},{"effect":"abdominal pain","drugRate":"reported","severity":"unknown"},{"effect":"diarrhea","drugRate":"reported","severity":"unknown"},{"effect":"G.I. bleeding","drugRate":"reported","severity":"unknown"},{"effect":"anaphylactic shock","drugRate":"reported","severity":"serious"},{"effect":"angioedema","drugRate":"reported","severity":"serious"},{"effect":"bronchospasm","drugRate":"reported","severity":"serious"},{"effect":"decreased creatinine clearance","drugRate":"reported","severity":"serious"},{"effect":"hepatitis","drugRate":"reported","severity":"serious"},{"effect":"hypotension","drugRate":"reported","severity":"serious"},{"effect":"nephritis","drugRate":"reported","severity":"serious"},{"effect":"urticaria","drugRate":"reported","severity":"serious"},{"effect":"abnormal hepatic function","drugRate":"reported","severity":"serious"}],"contraindications":["Anemia","Anemia due to enzyme deficiency","Blood coagulation disorder","Body fluid retention","Breastfeeding (mother)","Cardiovascular event risk","Diabetes mellitus","Disease of liver","Disorder of cardiovascular system","Factor II deficiency","Gastritis","Gastroesophageal reflux disease","Gastrointestinal hemorrhage","Gastrointestinal ulcer","Hemophilia","Hepatic failure","Kidney disease","Nasal polyp","Pregnancy, function","Thrombotic thrombocytopenic purpura","Thyrotoxicosis","Vitamin K deficiency"],"specialPopulations":{"Pregnancy":"Use of NSAIDs, including TRADENAME, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of TRADENAME use between about 20 and 30 weeks of gestation, and avoid TRADENAME use at about 30 weeks of gestation and later in pregnancy (see Clinical Considerations, Data).Premature Closure of Fetal Ductus ArteriosusUse of NSAIDs, including TRADENAME, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus.Oligohydramnios/Neonatal Renal ImpairmentUse of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment.Data from observational studies regarding other potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In the general U.S. population, all clinically recognized pregnancies, regardless of drug exposure, have background rate of 2-4% for major malformations, and 15-20% for pregnancy loss. In animal reproduction studies ... (Note to Applicant: Existing risk summary statement(s) based on animal data should be included here.) Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular p","Geriatric use":"As with any NSAIDs, caution should be exercised in treating the elderly (65 years and older).","Paediatric use":"Safety and effectiveness of salsalate use in children have not been established.(See WARNINGS section)."}},"trials":[],"aliases":[],"patents":[],"pricing":[],"allNames":"sasapyrine","offLabel":[],"synonyms":["salsalate","salicylic acid salicylate","disalicylic acid","salicyl salicylate","salicyloxysalicylic acid","salicyloylsalicylic acid","salicylsalicylic acid","sasapyrine"],"timeline":[],"approvals":[{"date":"","orphan":false,"company":"","regulator":"FDA"}],"brandName":"Sasapyrine","ecosystem":[{"indication":"Osteoarthritis","otherDrugs":[{"name":"aceclofenac","slug":"aceclofenac","company":""},{"name":"acetylsalicylic acid","slug":"acetylsalicylic-acid","company":"Endo Pharms"},{"name":"celecoxib","slug":"celecoxib","company":"Gd Searle"},{"name":"choline magnesium trisalicylate","slug":"choline-magnesium-trisalicylate","company":""}],"globalPrevalence":655000000},{"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":{"novelty":"First-in-class","modality":"Small Molecule","drugClass":"salsalate","explanation":"Think of prostaglandins like messengers that tell your body to feel pain and become inflamed. Salsalate blocks these messengers from being made, which helps to reduce pain and inflammation. This makes it easier to move and feel comfortable in your joints.","oneSentence":"Salsalate works by inhibiting the enzyme COX-1 and COX-2, which are responsible for producing prostaglandins.","technicalDetail":"Salsalate acts as a nonsteroidal anti-inflammatory drug (NSAID) by irreversibly inhibiting the cyclooxygenase (COX) enzymes, specifically COX-1 and COX-2, which are responsible for the conversion of arachidonic acid to prostaglandins."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/2420","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=SALSALATE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=SALSALATE","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T15:38:12.019836","biosimilars":[],"competitors":[{"drugName":"acetylsalicylic acid","drugSlug":"acetylsalicylic-acid","fdaApproval":"1950-04-12","relationship":"same-class"},{"drugName":"salicylamide","drugSlug":"salicylamide","fdaApproval":"","relationship":"same-class"},{"drugName":"diflunisal","drugSlug":"diflunisal","fdaApproval":"1982-04-19","genericCount":7,"patentStatus":"Off-patent — generic available","relationship":"same-class"}],"genericName":"salsalate","indications":{"approved":[{"name":"Osteoarthritis","source":"DrugCentral","snomedId":396275006,"regulator":"FDA","eligibility":"No specific eligibility criteria mentioned","usPrevalence":null,"globalPrevalence":655000000,"prevalenceMethod":"curated","prevalenceSource":"Arthritis Res Ther, 2023 (PMID:36991481)"},{"name":"Rheumatoid arthritis","source":"DrugCentral","snomedId":69896004,"regulator":"FDA","usPrevalence":1500000,"globalPrevalence":18000000,"prevalenceMethod":"curated","prevalenceSource":"Lancet Rheumatology, 2023"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"acetylsalicylic-acid","brandName":"acetylsalicylic acid","genericName":"acetylsalicylic acid","approvalYear":"1950","relationship":"same-class"},{"drugId":"salicylamide","brandName":"salicylamide","genericName":"salicylamide","approvalYear":"","relationship":"same-class"},{"drugId":"diflunisal","brandName":"diflunisal","genericName":"diflunisal","approvalYear":"1982","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT06489249","phase":"EARLY_PHASE1","title":"Role of Inflammation in Vascular Phenotype Associated With E-cigarette Use","status":"RECRUITING","sponsor":"University of Iowa","startDate":"2024-08-15","conditions":["Electronic Cigarette Use","Endothelial Dysfunction","Inflammation"],"enrollment":24,"completionDate":"2026-10"},{"nctId":"NCT05169060","phase":"PHASE1,PHASE2","title":"Omega-3 Fatty Acid Lipidomics in Diabetes Peripheral Neuropathy","status":"RECRUITING","sponsor":"University of Iowa","startDate":"2023-06-12","conditions":["Diabetic Neuropathies"],"enrollment":100,"completionDate":"2027-07-01"},{"nctId":"NCT03229408","phase":"PHASE2","title":"Treating Inflammation in Polycystic Ovary Syndrome to Ameliorate Ovarian Dysfunction","status":"COMPLETED","sponsor":"University of Illinois at Chicago","startDate":"2018-12-05","conditions":["Polycystic Ovary Syndrome"],"enrollment":60,"completionDate":"2024-02-28"},{"nctId":"NCT03482440","phase":"EARLY_PHASE1","title":"Angiotensin II and Chronic Inflammation in Persistent Microvascular Dysfunction Following Preeclampsia","status":"COMPLETED","sponsor":"University of Iowa","startDate":"2018-08-26","conditions":["Preeclampsia"],"enrollment":24,"completionDate":"2022-12-31"},{"nctId":"NCT02936843","phase":"PHASE2,PHASE3","title":"Targeting Inflammation With Salsalate in Type 1 Diabetes Neuropathy","status":"COMPLETED","sponsor":"University of Michigan","startDate":"2016-10","conditions":["Type 1 Diabetes","Peripheral Neuropathy"],"enrollment":61,"completionDate":"2023-05-01"},{"nctId":"NCT03277573","phase":"PHASE1","title":"Salsalate in Patients Mild to Moderate Alzheimer's Disease","status":"COMPLETED","sponsor":"Adam Boxer","startDate":"2017-07-21","conditions":["Alzheimer Disease"],"enrollment":40,"completionDate":"2023-04-10"},{"nctId":"NCT05069740","phase":"EARLY_PHASE1","title":"Endometriosis and Microvascular Dysfunction: Role of Inflammation","status":"RECRUITING","sponsor":"Penn State University","startDate":"2022-01-01","conditions":["Endometriosis"],"enrollment":24,"completionDate":"2026-12-31"},{"nctId":"NCT01977417","phase":"PHASE2","title":"Inflammation Inhibition in Prediabetic Humans","status":"TERMINATED","sponsor":"Gary L. Pierce","startDate":"2012-11","conditions":["Prediabetes","Obese"],"enrollment":21,"completionDate":"2021-04"},{"nctId":"NCT04146038","phase":"PHASE2","title":"Salsalate, Venetoclax, and Decitabine or Azacitidine for the Treatment of Acute Myeloid Leukemia or Advanced Myelodysplasia/Myeloproliferative Disease","status":"COMPLETED","sponsor":"Rutgers, The State University of New Jersey","startDate":"2020-10-26","conditions":["Acute Myeloid Leukemia","Chronic Myelomonocytic Leukemia","Myeloblasts 10 Percent or More of Bone Marrow Nucleated Cells","Myelodysplastic Syndrome","Myeloproliferative Neoplasm","Recurrent Acute Myeloid Leukemia","Refractory Acute Myeloid Leukemia","Secondary Acute Myeloid Leukemia"],"enrollment":5,"completionDate":"2022-10-25"},{"nctId":"NCT03816488","phase":"PHASE1","title":"Oral Peri-operative TIming of Metformin (or) Salsalate to Improve Non-cardiac Surgery Glucose Control","status":"WITHDRAWN","sponsor":"McMaster University","startDate":"2023-12-01","conditions":["Diabetes Mellitus, Type 2","Hyperglycemia","Perioperative/Postoperative Complications"],"enrollment":0,"completionDate":"2024-12-01"},{"nctId":"NCT01182727","phase":"NA","title":"Salsalate for Insulin Resistance in Schizophrenia","status":"COMPLETED","sponsor":"University of Maryland, Baltimore","startDate":"2010-08","conditions":["Schizophrenia","Insulin Resistance"],"enrollment":13,"completionDate":"2011-12"},{"nctId":"NCT01514682","phase":"NA","title":"Anti-Inflammatory Treatment of Schizophrenia","status":"COMPLETED","sponsor":"University of Maryland, Baltimore","startDate":"2012-06","conditions":["Schizophrenia"],"enrollment":50,"completionDate":"2017-04-17"},{"nctId":"NCT02422485","phase":"PHASE1","title":"A 6 Month, Open-Label, Pilot Futility Clinical Trial of Oral Salsalate for Progressive Supranuclear Palsy","status":"COMPLETED","sponsor":"Adam Boxer","startDate":"2015-04","conditions":["Progressive Supranuclear Palsy"],"enrollment":10,"completionDate":"2019-12"},{"nctId":"NCT00330733","phase":"PHASE2,PHASE3","title":"Salsalate Therapy to Reduce Insulin Resistance and Cardiovascular Risk","status":"COMPLETED","sponsor":"VA Office of Research and Development","startDate":"2007-01","conditions":["Atherosclerosis","Cardiovascular Disease","Inflammation","Insulin Resistance","Noninsulin-dependent Diabetes Mellitus"],"enrollment":71,"completionDate":"2010-09"},{"nctId":"NCT03222206","phase":"PHASE4","title":"The Comparison of Effect Between Salsalate and Placebo in Osteoarthritis With Nonalcoholic Fatty Liver Disease","status":"COMPLETED","sponsor":"Korea University Guro Hospital","startDate":"2017-11-08","conditions":["Non Alcoholic Fatty Liver","Osteo Arthritis"],"enrollment":34,"completionDate":"2019-02-22"},{"nctId":"NCT00837590","phase":"PHASE1","title":"Vascular Function, Endothelin, and Inflammation in Pre-diabetic Obesity Versus Lean Healthy Controls","status":"TERMINATED","sponsor":"Indiana University","startDate":"2009-03","conditions":["Pre-diabetes","Obesity"],"enrollment":16,"completionDate":"2010-08"},{"nctId":"NCT00624923","phase":"PHASE2,PHASE3","title":"Targeting Inflammation Using Salsalate in CardioVascular Disease","status":"COMPLETED","sponsor":"Joslin Diabetes Center","startDate":"2008-09","conditions":["Coronary Artery Disease","Overweight"],"enrollment":340,"completionDate":"2016-07"},{"nctId":"NCT00258128","phase":"PHASE1,PHASE2","title":"Effect of Salicylate on Glucose Metabolism in Insulin Resistance States","status":"COMPLETED","sponsor":"Joslin Diabetes Center","startDate":"2000-01","conditions":["Insulin Resistance"],"enrollment":17,"completionDate":"2008-05"},{"nctId":"NCT00392678","phase":"PHASE2,PHASE3","title":"Targeting INflammation Using SALsalate in Type 2 Diabetes (TINSAL-T2D)","status":"COMPLETED","sponsor":"Joslin Diabetes Center","startDate":"2006-10","conditions":["Type 2 Diabetes"],"enrollment":277,"completionDate":"2010-12"},{"nctId":"NCT02406586","phase":"NA","title":"Free Fatty Acids-Induced Hypertension in Obese Subjects (Aim #2)","status":"COMPLETED","sponsor":"Emory University","startDate":"2009-07","conditions":["Hypertension","Diabetes"],"enrollment":36,"completionDate":"2011-03"},{"nctId":"NCT01775865","phase":"PHASE2","title":"Targeting Inflammation to Treat Cardiovascular Aging","status":"COMPLETED","sponsor":"Gary L. 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It is used to treat osteoarthritis and rheumatoid arthritis. The current owner of salsalate is not specified, and its commercial status is unknown. Salsalate works by inhibiting the production of prostaglandins, which are hormone-like substances that cause pain and inflammation. As a result, it helps to reduce pain and inflammation in the affected joints.","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":"","brand_name_local":null,"application_number":""},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":"","brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":"","brand_name_local":null,"application_number":null},{"country_code":"SA","regulator":"SFDA","status":"likely_approved","approval_date":null,"mah":"","brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":"","brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":"","brand_name_local":null,"application_number":null},{"country_code":"CA","regulator":"Health Canada","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":2,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}