{"id":"flurbiprofen","rwe":[{"pmid":"41900212","year":"2026","title":"A Dissolving Microneedle Design for Poorly Water-Soluble Drugs for Enhanced Skin Permeation and Transdermal Delivery Fabricated Using 3D Printing.","finding":"","journal":"Micromachines","studyType":"Clinical Study"},{"pmid":"41878175","year":"2026","title":"A Case of Toxic Epidermal Necrolysis-Like Dermatosis Associated With Contact Exposure to a Flurbiprofen Plaster.","finding":"","journal":"Cureus","studyType":"Clinical Study"},{"pmid":"41874953","year":"2026","title":"The Association Between Body Mass Index and Acute Postoperative Pain in Bariatric Surgery Patients: A Prospective Cohort Study.","finding":"","journal":"Pain and therapy","studyType":"Clinical Study"},{"pmid":"41869841","year":"2026","title":"Bifunctional Analgesic-Pro-Healing Hydrogel Dressing for Postoperative Analgesia and Wound Healing in Mice.","finding":"","journal":"ACS biomaterials science & engineering","studyType":"Clinical Study"},{"pmid":"41868128","year":"2026","title":"Low-dose dexmedetomidine improves postoperative sleep and pain in gynecological surgery: a randomized trial.","finding":"","journal":"Frontiers in pharmacology","studyType":"Clinical Study"}],"_fda":{"id":"1e00e938-a04a-4192-e063-6394a90a75a6","set_id":"11db354f-caf9-4567-811e-6c9beb1330c7","openfda":{"unii":["Z5B97MU9K4"],"route":["OPHTHALMIC"],"rxcui":["1243585"],"spl_id":["1e00e938-a04a-4192-e063-6394a90a75a6"],"brand_name":["Flurbiprofen Sodium"],"spl_set_id":["11db354f-caf9-4567-811e-6c9beb1330c7"],"package_ndc":["24208-314-25"],"product_ndc":["24208-314"],"generic_name":["FLURBIPROFEN SODIUM"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["FLURBIPROFEN SODIUM"],"manufacturer_name":["Bausch & Lomb Incorporated"],"application_number":["ANDA074447"],"is_original_packager":[true]},"version":"7","warnings":["WARNINGS With some nonsteroidal anti-inflammatory drugs, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that flurbiprofen sodium ophthalmic solution may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. There is the potential for cross-sensitivity to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs."],"pregnancy":["Pregnancy Flurbiprofen has been shown to be embryocidal, delay parturition, prolong gestation, reduce weight, and/or slightly retard growth of fetuses when given to rats in daily oral doses of 0.4 mg/kg (approximately 300 times the human daily topical dose) and above. There are no adequate and well-controlled studies in pregnant women. Flurbiprofen sodium ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus."],"overdosage":["OVERDOSAGE Overdosage will not ordinarily cause acute problems. If accidentally ingested, drink fluids to dilute."],"description":["DESCRIPTION Flurbiprofen sodium ophthalmic solution USP, 0.03% is a sterile topical nonsteroidal anti-inflammatory product for ophthalmic use. Chemical Name: Sodium (±)-2-(2-fluoro-4-biphenylyl)propionate dihydrate. Structural Formula: Each mL contains: Active: flurbiprofen sodium 0.03%. Inactives: citric acid, edetate disodium, polyvinyl alcohol 1.4%, potassium chloride, purified water, sodium chloride, sodium citrate. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH (6.0 – 7.0). Preservative: thimerosal 0.005%. Diagram Description automatically generated"],"precautions":["PRECAUTIONS General Topical nonsteroidal anti-inflammatory drugs (NSAIDs) may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. It is recommended that flurbiprofen sodium ophthalmic solution be used with caution in surgical patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time. Information for Patients Patients should be instructed to avoid allowing the tip of the bottle to contact the eye or surrounding structures because this could cause the tip to become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. To avoid the potential for cross-contamination, the patient should be advised to use one bottle for each eye with bilateral ocular surgery. The use of the same bottle of eye drops for both eyes is not recommended with ocular surgery. Drug Interactions Interaction of flurbiprofen sodium ophthalmic solution with other topical ophthalmic medications has not been fully investigated. Although clinical studies with acetylcholine chloride and animal studies with acetylcholine chloride or carbachol revealed no interference, and there is no known pharmacological basis for an interaction, there have been reports that acetylcholine chloride and carbachol have been ineffective when used in patients treated with flurbiprofen sodium ophthalmic solution. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in mice and/or rats have shown no evidence of carcinogenicity with flurbiprofen. Long-term mutagenicity studies in animals have not been performed. Pregnancy Flurbiprofen has been shown to be embryocidal, delay parturition, prolong gestation, reduce weight, and/or slightly retard growth of fetuses when given to rats in daily oral doses of 0.4 mg/kg (approximately 300 times the human daily topical dose) and above. There are no adequate and well-controlled studies in pregnant women. Flurbiprofen sodium ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from flurbiprofen sodium, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients."],"how_supplied":["HOW SUPPLIED Flurbiprofen sodium ophthalmic solution USP, 0.03% is supplied in a plastic bottle with a controlled drop tip in the following size: 2.5 mL - NDC 24208-314-25 DO NOT USE"],"geriatric_use":["Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients."],"pediatric_use":["Pediatric Use Safety and effectiveness in pediatric patients have not been established."],"effective_time":"20240724","nursing_mothers":["Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from flurbiprofen sodium, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother."],"adverse_reactions":["ADVERSE REACTIONS Transient burning and stinging upon instillation and other minor symptoms of ocular irritation have been reported with the use of flurbiprofen sodium ophthalmic solution. Other adverse reactions reported with the use of flurbiprofen sodium ophthalmic solution include: fibrosis, hyphema, miosis, mydriasis, and ocular hyperemia. Increased bleeding tendency of ocular tissues in conjunction with ocular surgery has also been reported [see Warnings ]. To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch."],"contraindications":["CONTRAINDICATIONS Flurbiprofen sodium ophthalmic solution is contraindicated in individuals who are hypersensitive to any components of the medication."],"drug_interactions":["Drug Interactions Interaction of flurbiprofen sodium ophthalmic solution with other topical ophthalmic medications has not been fully investigated. Although clinical studies with acetylcholine chloride and animal studies with acetylcholine chloride or carbachol revealed no interference, and there is no known pharmacological basis for an interaction, there have been reports that acetylcholine chloride and carbachol have been ineffective when used in patients treated with flurbiprofen sodium ophthalmic solution."],"general_precautions":["General Topical nonsteroidal anti-inflammatory drugs (NSAIDs) may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. It is recommended that flurbiprofen sodium ophthalmic solution be used with caution in surgical patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time."],"storage_and_handling":["Storage: Store at 15°C to 25°C (59°F to 77°F). Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2022 Bausch & Lomb Incorporated or its affiliates Revised: September 2022 9100605 (Folded) 9100705 (Flat)"],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Flurbiprofen sodium is one of a series of phenylalkanoic acids that have shown analgesic, antipyretic, and anti-inflammatory activity in animal inflammatory diseases. Its mechanism of action is believed to be through inhibition of the cyclo-oxygenase enzyme that is essential in the biosynthesis of prostaglandins. Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed on animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilatation, increased vascular permeability, leukocytosis, and increased intraocular pressure. Prostaglandins also appear to play a role in the miotic response produced during ocular surgery by constricting the iris sphincter independently of cholinergic mechanisms. In clinical studies, flurbiprofen sodium ophthalmic solution has been shown to inhibit the miosis induced during the course of cataract surgery. Results from clinical studies indicate that flurbiprofen sodium has no significant effect upon intraocular pressure."],"indications_and_usage":["INDICATIONS AND USAGE Flurbiprofen sodium ophthalmic solution is indicated for the inhibition of intraoperative miosis."],"spl_unclassified_section":["Rx only FOR OPHTHALMIC USE ONLY"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION A total of four (4) drops of flurbiprofen sodium ophthalmic solution should be administered by instilling one (1) drop approximately every 1/2 hour beginning 2 hours before surgery."],"spl_product_data_elements":["Flurbiprofen Sodium Flurbiprofen Sodium CITRIC ACID MONOHYDRATE EDETATE DISODIUM HYDROCHLORIC ACID POTASSIUM CHLORIDE WATER SODIUM CHLORIDE SODIUM CITRATE, UNSPECIFIED FORM SODIUM HYDROXIDE THIMEROSAL POLYVINYL ALCOHOL, UNSPECIFIED FLURBIPROFEN SODIUM FLURBIPROFEN"],"package_label_principal_display_panel":["Principal Display Panel NDC 24208-314-25 Flurbiprofen Sodium Ophthalmic Solution, USP 0.03% (Sterile) FOR OPHTHALMIC USE ONLY Rx only 2.5 mL BAUSCH + LOMB 9540402 AB31404 carton"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in mice and/or rats have shown no evidence of carcinogenicity with flurbiprofen. Long-term mutagenicity studies in animals have not been performed."]},"tags":[{"label":"Nonsteroidal Anti-inflammatory Drug","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Prostaglandin G/H synthase 1","category":"target"},{"label":"PTGS1","category":"gene"},{"label":"PTGS2","category":"gene"},{"label":"AKR1C3","category":"gene"},{"label":"M01AE09","category":"atc"},{"label":"Topical","category":"route"},{"label":"Ophthalmic","category":"route"},{"label":"Oral","category":"route"},{"label":"Patch","category":"form"},{"label":"Solution/ Drops","category":"form"},{"label":"Tablet","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Osteoarthritis","category":"indication"},{"label":"Prevention of Ocular Surgery-Induced Miosis","category":"indication"},{"label":"Rheumatoid arthritis","category":"indication"},{"label":"Pharmacia And Upjohn","category":"company"},{"label":"Approved 1980s","category":"decade"},{"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":"Central Nervous System Agents","category":"pharmacology"},{"label":"Cyclooxygenase Inhibitors","category":"pharmacology"},{"label":"Enzyme Inhibitors","category":"pharmacology"},{"label":"Peripheral Nervous System Agents","category":"pharmacology"},{"label":"Sensory System Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"102 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"97 reports"},{"date":"","signal":"ANGIOEDEMA","source":"FDA FAERS","actionTaken":"89 reports"},{"date":"","signal":"URTICARIA","source":"FDA FAERS","actionTaken":"70 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"68 reports"},{"date":"","signal":"ARTHRALGIA","source":"FDA FAERS","actionTaken":"64 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"62 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"60 reports"},{"date":"","signal":"PNEUMONIA","source":"FDA FAERS","actionTaken":"57 reports"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"55 reports"}],"drugInteractions":[{"url":"/drug/fluconazole","drug":"fluconazole","action":"Monitor closely","effect":"May interact with Fluconazole","source":"DrugCentral","drugSlug":"fluconazole"},{"url":"/drug/lithium","drug":"lithium","action":"Monitor closely","effect":"May interact with Lithium","source":"DrugCentral","drugSlug":"lithium"},{"url":"/drug/methotrexate","drug":"methotrexate","action":"Monitor closely","effect":"May interact with Methotrexate","source":"DrugCentral","drugSlug":"methotrexate"},{"url":"/drug/phenprocoumon","drug":"phenprocoumon","action":"Monitor closely","effect":"May interact with Phenprocoumon","source":"DrugCentral","drugSlug":"phenprocoumon"},{"url":"/drug/voriconazole","drug":"voriconazole","action":"Monitor closely","effect":"May interact with Voriconazole","source":"DrugCentral","drugSlug":"voriconazole"},{"url":"/drug/warfarin","drug":"warfarin","action":"Monitor closely","effect":"May interact with Warfarin","source":"DrugCentral","drugSlug":"warfarin"}],"commonSideEffects":[{"effect":"Increased bleeding tendency of ocular tissues","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Fibrosis","drugRate":"reported","severity":"unknown"},{"effect":"Miosis","drugRate":"reported","severity":"unknown"},{"effect":"Mydriasis","drugRate":"reported","severity":"unknown"},{"effect":"Transient burning and stinging upon instillation","drugRate":"reported","severity":"unknown"},{"effect":"Other minor symptoms of ocular irritation","drugRate":"reported","severity":"unknown"}],"contraindications":["Acute nephropathy","Alcoholism","Blood coagulation disorder","Body fluid retention","Cardiovascular event risk","Chronic heart failure","Coronary artery bypass graft","Disease of liver","Disorder of cardiovascular system","Gastrointestinal hemorrhage","Gastrointestinal perforation","Gastrointestinal ulcer","Hypertensive disorder","Impaired wound healing","Kidney disease","Myocardial infarction","Ocular Bleeding","Peptic ulcer","Pregnancy, function","Smokes tobacco daily"],"specialPopulations":{"Pregnancy":"Use of NSAIDs during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs in pregnant women starting at 30 weeks gestation. Flurbiprofen has been shown to be embryocidal, delay parturition, prolong gestation, reduce weight, and/or slightly retard growth of fetuses when given to rats in daily oral doses of 0.4 mg/kg (approximately 300 times the human daily topical dose) and above. There are no adequate and well-controlled studies in pregnant women. Flurbiprofen Sodium Ophthalmic Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.","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."}},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$10.7080/ML","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$3,855","description":"FLURBIPROFEN 0.03% EYE DROP","retrievedDate":"2026-04-07"}],"_fixedAt":"2026-03-30T15:21:17.457391","_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=flurbiprofen","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:47:18.538488+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:47:25.170672+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-19T23:47:16.984447+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=flurbiprofen","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:47:25.925460+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:47:15.575285+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:47:15.575335+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-19T23:47:27.441308+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Cyclooxygenase inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:47:26.538471+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL563/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:47:26.421337+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA074447","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:47:15.575343+00:00"}},"allNames":"ocufen","offLabel":[],"synonyms":["flurbiprofen","(+/-)-Flurbiprofen","fluribiprofen","fluroben","flurofen","dl-Flurbiprofen","flurbiprofen sodium"],"timeline":[{"date":"1986-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from ALLERGAN to Pharmacia And Upjohn"},{"date":"1986-12-31","type":"positive","source":"DrugCentral","milestone":"FDA approval (Allergan)"},{"date":"1997-04-01","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 6 manufacturers approved"}],"aiSummary":"Ocufen (flurbiprofen) is a nonsteroidal anti-inflammatory drug (NSAID) developed by Allergan and currently owned by Pharmacia And Upjohn. It targets prostaglandin G/H synthase 1 to reduce inflammation and pain. Ocufen is approved to treat osteoarthritis, rheumatoid arthritis, and prevent ocular surgery-induced miosis. The drug is off-patent, with multiple generic manufacturers available. It has a high bioavailability of 92%.","approvals":[{"date":"1986-12-31","orphan":false,"company":"ALLERGAN","regulator":"FDA"}],"brandName":"Ocufen","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":"Prevention of Ocular Surgery-Induced Miosis","otherDrugs":[],"globalPrevalence":null},{"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","novelty":"Follow-on","targets":[{"gene":"PTGS1","source":"DrugCentral","target":"Prostaglandin G/H synthase 1","protein":"Prostaglandin G/H synthase 1","isPrimary":true,"activityType":"IC50","activityValue":8.74},{"gene":"PTGS2","source":"DrugCentral","target":"Prostaglandin G/H synthase 2","protein":"Prostaglandin G/H synthase 2"},{"gene":"AKR1C3","source":"DrugCentral","target":"Aldo-keto reductase family 1 member C3","protein":"Aldo-keto reductase family 1 member C3"},{"gene":"FABP2","source":"DrugCentral","target":"Fatty acid-binding protein, intestinal","protein":"Fatty acid-binding protein, intestinal"},{"gene":"AKR1C2","source":"DrugCentral","target":"Aldo-keto reductase family 1 member C2","protein":"Aldo-keto reductase family 1 member C2"}],"moaClass":"Cyclooxygenase Inhibitors","modality":"Small Molecule","drugClass":"Nonsteroidal Anti-inflammatory Drug","explanation":"","oneSentence":"","technicalDetail":"Ocufen is a small molecule that competitively inhibits the cyclooxygenase (COX) enzyme, specifically COX-1, which is responsible for the conversion of arachidonic acid to prostaglandin H2, a precursor to various prostaglandins involved in pain and inflammation."},"commercial":{"launchDate":"1986","_launchSource":"DrugCentral (FDA 1986-12-31, ALLERGAN)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1219","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=flurbiprofen","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=flurbiprofen","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":"2026-03-30T11:36:29.373484","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-19T23:47:31.681799+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"ibuprofen","drugSlug":"ibuprofen","fdaApproval":"1974-09-19","patentExpiry":"Sep 30, 2029","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"naproxen","drugSlug":"naproxen","fdaApproval":"1976-03-11","genericCount":31,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"ketoprofen","drugSlug":"ketoprofen","fdaApproval":"1986-01-09","genericCount":7,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"fenoprofen","drugSlug":"fenoprofen","fdaApproval":"1976-03-16","genericCount":16,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"benoxaprofen","drugSlug":"benoxaprofen","fdaApproval":"1982-04-19","relationship":"same-class"},{"drugName":"suprofen","drugSlug":"suprofen","fdaApproval":"1988-12-23","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"oxaprozin","drugSlug":"oxaprozin","fdaApproval":"1992-10-29","genericCount":13,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"esomeprazole","drugSlug":"esomeprazole","fdaApproval":"2001-02-20","patentExpiry":"Dec 8, 2036","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"misoprostol","drugSlug":"misoprostol","fdaApproval":"1988-12-27","genericCount":4,"patentStatus":"Off-patent — generic available","relationship":"same-class"}],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"genericName":"flurbiprofen","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":"Prevention of Ocular Surgery-Induced Miosis","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"No specific eligibility criteria mentioned"},{"name":"Rheumatoid arthritis","source":"DrugCentral","snomedId":69896004,"regulator":"FDA","eligibility":"No specific eligibility criteria mentioned","usPrevalence":1500000,"globalPrevalence":18000000,"prevalenceMethod":"curated","prevalenceSource":"Lancet Rheumatology, 2023"}],"offLabel":[{"name":"Dysmenorrhea","source":"DrugCentral","drugName":"flurbiprofen"}],"pipeline":[]},"_fixedFields":["primaryTarget"],"currentOwner":"Pharmacia And Upjohn","drugCategory":"established","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"ibuprofen","brandName":"ibuprofen","genericName":"ibuprofen","approvalYear":"1974","relationship":"same-class"},{"drugId":"naproxen","brandName":"naproxen","genericName":"naproxen","approvalYear":"1976","relationship":"same-class"},{"drugId":"ketoprofen","brandName":"ketoprofen","genericName":"ketoprofen","approvalYear":"1986","relationship":"same-class"},{"drugId":"fenoprofen","brandName":"fenoprofen","genericName":"fenoprofen","approvalYear":"1976","relationship":"same-class"},{"drugId":"benoxaprofen","brandName":"benoxaprofen","genericName":"benoxaprofen","approvalYear":"1982","relationship":"same-class"},{"drugId":"suprofen","brandName":"suprofen","genericName":"suprofen","approvalYear":"1988","relationship":"same-class"},{"drugId":"oxaprozin","brandName":"oxaprozin","genericName":"oxaprozin","approvalYear":"1992","relationship":"same-class"},{"drugId":"esomeprazole","brandName":"esomeprazole","genericName":"esomeprazole","approvalYear":"2001","relationship":"same-class"},{"drugId":"misoprostol","brandName":"misoprostol","genericName":"misoprostol","approvalYear":"1988","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT07223671","phase":"PHASE1","title":"Study to Evaluate the Effect of Repotrectinib on the Drug Levels of Transporter and CYP P450 Probe Substrates in Healthy Adult Participants","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2025-12-31","conditions":["Healthy Volunteers"],"enrollment":30,"completionDate":"2026-03-19"},{"nctId":"NCT07416136","phase":"NA","title":"The Aim of This Study is to Compare the Effects of Two Different Topical Agents (KLOROBEN® and KLORHEX PLUS®) Used in the Surgical Extraction of Mandibular Bilateral Mesioangular Impacted Third Molars on Postoperative Pain, Edema, and Trismus.","status":"COMPLETED","sponsor":"Marmara University","startDate":"2025-04-20","conditions":["Impacted Mandibular Third Molar"],"enrollment":40,"completionDate":"2025-10-19"},{"nctId":"NCT07163429","phase":"NA","title":"Efficacy of Flurbiprofen Spray for Postoperative Sore Throat Following Double-Lumen Endobronchial Intubation","status":"ACTIVE_NOT_RECRUITING","sponsor":"Kittitorn Supphapipat, MD","startDate":"2025-09-10","conditions":["Post Operative Sore Throat","Hoarseness"],"enrollment":58,"completionDate":"2027-06-30"},{"nctId":"NCT06566794","phase":"NA","title":"KF2022#4-trial: Effects of a Beta Blocker and NSAID on CYP Mediated Drug Metabolism","status":"COMPLETED","sponsor":"Helsinki University Central Hospital","startDate":"2024-08-22","conditions":["Drug Interaction"],"enrollment":12,"completionDate":"2025-01-10"},{"nctId":"NCT07154433","phase":"NA","title":"A Study on Reducing Opioid Use After Minimally Invasive Ankle Surgery","status":"RECRUITING","sponsor":"Second Affiliated Hospital, School of Medicine, Zhejiang University","startDate":"2025-09-01","conditions":["Ankle (Ligaments); Instability (Old Injury)","Ankle Sprain","Talus Osteochondral Defect","Opioid Analgesia","Non-Opioid Pain Management"],"enrollment":110,"completionDate":"2026-07-01"},{"nctId":"NCT07409311","phase":"","title":"Osellidine is Used for Analgesia During Daytime Hysteroscopic Surgery","status":"NOT_YET_RECRUITING","sponsor":"Tongji Hospital","startDate":"2026-02-10","conditions":["Gynecological Day Surgery"],"enrollment":310,"completionDate":"2028-02-01"},{"nctId":"NCT07426042","phase":"PHASE1","title":"Effect of Dexamethasone on CYP Enzyme Activity in Healthy Male Subjects","status":"NOT_YET_RECRUITING","sponsor":"Min Kyu Park","startDate":"2026-04","conditions":["Drug-Drug Interactions"],"enrollment":12,"completionDate":"2026-06"},{"nctId":"NCT07235748","phase":"PHASE1","title":"Drug-drug Interaction Study of Vorasidenib With Bupropion, Repaglinide, Flurbiprofen, Omeprazole, Midazolam, and Rosuvastatin in Healthy Adult Participants","status":"COMPLETED","sponsor":"Institut de Recherches Internationales Servier (I.R.I.S.)","startDate":"2025-10-07","conditions":["Healthy Adult Participants"],"enrollment":28,"completionDate":"2025-12-23"},{"nctId":"NCT07149545","phase":"NA","title":"Electrophysiologist-led Deep Sedation Protocols for Pulsed Field Ablation for Atrial Fibrillation Using a Bipolar Tip-Catheter: The DEEP-PFA Randomized Controlled Trial","status":"COMPLETED","sponsor":"Beijing Anzhen Hospital","startDate":"2025-10-15","conditions":["Atrial Fibrillation (AF)","PFA","Deep Sedation"],"enrollment":240,"completionDate":"2026-01-27"},{"nctId":"NCT07370402","phase":"NA","title":"The Analgesic Efficacy and Safety of Flurbiprofen Patch in Patients With Herpes Zoster","status":"RECRUITING","sponsor":"Beijing Tiantan Hospital","startDate":"2025-12-15","conditions":["Herpes Zoster","Pain"],"enrollment":750,"completionDate":"2027-12-31"},{"nctId":"NCT03947385","phase":"PHASE1,PHASE2","title":"Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions","status":"RECRUITING","sponsor":"IDEAYA Biosciences","startDate":"2019-06-28","conditions":["Metastatic Uveal Melanoma","Cutaneous Melanoma","Colorectal Cancer","Other Solid Tumors"],"enrollment":336,"completionDate":"2027-06-15"},{"nctId":"NCT07358065","phase":"NA","title":"Clinical Application of Dynamic Multimodal Analgesia Regimen After Perianal Abscess Surgery","status":"NOT_YET_RECRUITING","sponsor":"The Affiliated Hospital of Putian University","startDate":"2026-01-01","conditions":["Clinical Application of Dynamic Multimodal Analgesia Regimen After Perianal Abscess Surgery"],"enrollment":135,"completionDate":"2026-12-31"},{"nctId":"NCT07340307","phase":"NA","title":"Application Effects of Wrist-Ankle Acupuncture in Patients With Different Types of Pain Following Perianal Surgery","status":"RECRUITING","sponsor":"The Affiliated Hospital of Putian University","startDate":"2025-10-25","conditions":["Wrist-Ankle Acupuncture"],"enrollment":58,"completionDate":"2026-10-24"},{"nctId":"NCT07315022","phase":"PHASE4","title":"Enhanced Recovery After Surgery-Based Multimodal Preemptive Analgesia for Perioperative Management in Transarterial Chemoembolization of Intermediate-to-Advanced Hepatocellular Carcinoma","status":"COMPLETED","sponsor":"First Affiliated Hospital, Sun Yat-Sen University","startDate":"2024-08-01","conditions":["Enhanced Recovery After Surgery","Multimodal Analgesia","Real-world Study","Transarterial Chemoembolization"],"enrollment":129,"completionDate":"2025-08-30"},{"nctId":"NCT07264556","phase":"NA","title":"Effect of OFA, OSA Versus Opioid-based Anesthesia on NETs and Cancer Cell Malignancy After Colorectal Cancer Surgery","status":"RECRUITING","sponsor":"Fudan University","startDate":"2025-11-01","conditions":["Colorectal Cancer","Opioid-free Anesthesia","NETs"],"enrollment":90,"completionDate":"2025-12-15"},{"nctId":"NCT07259330","phase":"PHASE1","title":"To Determine the Effect of CYP Induction Following Administration of Nirogacestat in Healthy Adult Male Participants","status":"RECRUITING","sponsor":"SpringWorks Therapeutics, Inc.","startDate":"2025-11-17","conditions":["Healthy"],"enrollment":16,"completionDate":"2026-10"},{"nctId":"NCT05270434","phase":"NA","title":"Optimal Timing of Endoscopic Intervention in the Treatment of Chronic Pancreatitis.","status":"COMPLETED","sponsor":"Changhai Hospital","startDate":"2025-03-12","conditions":["Pancreatitis, Chronic"],"enrollment":220,"completionDate":"2025-10-20"},{"nctId":"NCT07209345","phase":"NA","title":"Pre-emptive Scalp Infiltration With Low-dose Flurbiprofen and Ropivacaine for Postoperative Analgesia After Craniotomy","status":"RECRUITING","sponsor":"Beijing Tiantan Hospital","startDate":"2025-10-15","conditions":["Post-craniotomy","Pain"],"enrollment":216,"completionDate":"2026-10-15"},{"nctId":"NCT05624359","phase":"NA","title":"Flurbiprofen Axetil as an Adjuvant to Pre-emptive Scalp Infiltration","status":"SUSPENDED","sponsor":"Beijing Tiantan Hospital","startDate":"2023-11-01","conditions":["Postoperative Pain"],"enrollment":216,"completionDate":"2026-03-01"},{"nctId":"NCT07034963","phase":"PHASE1,PHASE2","title":"Study on the Effective Dose and Safety of Esketamine in Hysteroscopic Surgery Under Monitored Anesthesia Care","status":"ACTIVE_NOT_RECRUITING","sponsor":"The First Affiliated Hospital of Xiamen University","startDate":"2025-06-26","conditions":["Intrauterine Polyp","Intrauterine Synechiae"],"enrollment":95,"completionDate":"2028-06-30"},{"nctId":"NCT04611763","phase":"PHASE1","title":"Effect of Preemptive Analgesia With Flurbiprofen Axetil on Perioperative Sleep Quality and Postoperative Pain in Patients Undergoing Laparoscopic Gynecological Surgery.","status":"COMPLETED","sponsor":"Beijing Friendship Hospital","startDate":"2021-09-01","conditions":["Flurbiprofen Axetil","Preemptive Analgesia","Postoperative Pain","Perioperative Sleep Quality","Postoperative Inflammatory Markers"],"enrollment":112,"completionDate":"2024-02-01"},{"nctId":"NCT05504265","phase":"PHASE2,PHASE3","title":"Perioperative Analgesia Modes in Minimally Invasive Esophagectomy","status":"RECRUITING","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","startDate":"2022-10-10","conditions":["Esophageal Cancer","Perioperative Analgesia","NSAIDs","Opioid","Patient-controlled Analgesia"],"enrollment":102,"completionDate":"2025-12-20"},{"nctId":"NCT05411159","phase":"NA","title":"Effect of Opioid-free Anesthesia on PostOperative Nausea and Vomiting in Patients Undergoing Video-assisted Thoracoscopic Surgery","status":"COMPLETED","sponsor":"Beijing Chao Yang Hospital","startDate":"2022-06-07","conditions":["Postoperative Nausea and Vomiting","Opioid Use","Thoracic Diseases"],"enrollment":168,"completionDate":"2024-11-30"},{"nctId":"NCT06823284","phase":"PHASE1","title":"To Assess the Bioavailability of TK-254RX in Comparison with Oral Flurbiprofen Tablets and the Adhesion of TK-254RX in Healthy Subjects","status":"COMPLETED","sponsor":"Teikoku Seiyaku Co., Ltd.","startDate":"2025-01-21","conditions":["Healthy"],"enrollment":26,"completionDate":"2025-02-24"},{"nctId":"NCT06790914","phase":"NA","title":"Investigation on the Status Quo of Hyperalgesia in Patients After Thoracoscopic Operation and Study on the Effect of Intraoperative Intervention","status":"RECRUITING","sponsor":"Fujian Medical University Union Hospital","startDate":"2024-03-17","conditions":["Thoracoscopic Surgery","Hyperalgesia"],"enrollment":90,"completionDate":"2025-03-17"},{"nctId":"NCT05955885","phase":"EARLY_PHASE1","title":"Effect of Over-the-counter NSAIDS on Cough Reflex Sensitivity in Patients with Upper Respiratory Tract Infections","status":"COMPLETED","sponsor":"University of Melbourne","startDate":"2023-07-01","conditions":["Cough","Upper Respiratory Tract Infections"],"enrollment":101,"completionDate":"2024-07-01"},{"nctId":"NCT05981365","phase":"PHASE1","title":"Voxelotor CYP and Transporter Cocktail Interaction Study","status":"COMPLETED","sponsor":"Pfizer","startDate":"2023-04-17","conditions":["Sickle Cell Disease"],"enrollment":44,"completionDate":"2023-10-04"},{"nctId":"NCT06015165","phase":"NA","title":"Outcomes for Anesthesiologist-Led Care of Analgesic Protocol in Anorectal Surgery","status":"RECRUITING","sponsor":"China-Japan Friendship Hospital","startDate":"2024-09-10","conditions":["Postoperative Pain"],"enrollment":216,"completionDate":"2025-10-10"},{"nctId":"NCT06220175","phase":"NA","title":"Pharynx Analgesia Before Upper Gastrointestinal Endoscopy","status":"COMPLETED","sponsor":"Carol Davila University of Medicine and Pharmacy","startDate":"2024-03-01","conditions":["Upper Gastrointestinal Endoscopy"],"enrollment":37,"completionDate":"2024-08-31"},{"nctId":"NCT06574451","phase":"NA","title":"Effectiveness and Safety of Adjuvant Software Based on Virtual Reality for Post-thoracoscopic Surgery Pain","status":"RECRUITING","sponsor":"Guangdong Provincial People's Hospital","startDate":"2023-04-22","conditions":["Acute Postoperative Pain","Video-assisted Thoracic Surgery","Virtual Reality"],"enrollment":215,"completionDate":"2025-04-24"},{"nctId":"NCT06531837","phase":"NA","title":"Electroencephalographic Characteristics of Chronic Pain in Patients With Spinal Cord Injury","status":"NOT_YET_RECRUITING","sponsor":"Beijing Tiantan Hospital","startDate":"2024-08-25","conditions":["Chronic Pain"],"enrollment":60,"completionDate":"2026-02-28"},{"nctId":"NCT06430645","phase":"NA","title":"Effects of Esketamine on Recovery of Consciousness After Propofol Anesthesia","status":"RECRUITING","sponsor":"Beijing Tiantan Hospital","startDate":"2024-05-05","conditions":["Post-anesthesia Recovery"],"enrollment":150,"completionDate":"2024-12-31"},{"nctId":"NCT06238154","phase":"PHASE4","title":"Flurbiprofen Tablet vs Spray In Oral Soft Tissue Wounds","status":"COMPLETED","sponsor":"Yuzuncu Yil University","startDate":"2023-10-26","conditions":["Oral Soft Tissue Conditions","Drug Effect","Drug Use"],"enrollment":40,"completionDate":"2024-01-20"},{"nctId":"NCT03171987","phase":"PHASE4","title":"The Safety and Efficacy of 5% Lidocaine Patch and Flurbiprofen Patch for Relieving Acute Low Back Pain","status":"COMPLETED","sponsor":"Taipei Medical University Hospital","startDate":"2017-06-14","conditions":["Acute Back Pain"],"enrollment":85,"completionDate":"2021-06-30"},{"nctId":"NCT05368831","phase":"PHASE1","title":"Open-label Study to Evaluate the Effects of NST-1024 on the PK of Multiple Drugs in Healthy Subjects","status":"COMPLETED","sponsor":"NorthSea Therapeutics B.V.","startDate":"2022-07-19","conditions":["Healthy Volunteers"],"enrollment":24,"completionDate":"2022-09-07"},{"nctId":"NCT03720366","phase":"PHASE1","title":"A Study of Perpetrator Drug Interactions of Enasidenib in AML Patients","status":"COMPLETED","sponsor":"Celgene","startDate":"2018-10-04","conditions":["Leukemia, Myeloid, Acute"],"enrollment":40,"completionDate":"2023-12-22"},{"nctId":"NCT04425902","phase":"PHASE1","title":"Evaluation of Pharmacokinetic Interaction Between GSK3640254 and Caffeine, Metoprolol, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin in Healthy Adults","status":"COMPLETED","sponsor":"ViiV Healthcare","startDate":"2020-12-16","conditions":["HIV Infections"],"enrollment":20,"completionDate":"2021-03-10"},{"nctId":"NCT05512013","phase":"PHASE1","title":"The Effects of NSAIDs on Bone Metabolism Following Exercise","status":"COMPLETED","sponsor":"United States Army Research Institute of Environmental Medicine","startDate":"2022-02-15","conditions":["Bone Resorption","Stress Fracture","Bone Injury"],"enrollment":12,"completionDate":"2023-04-01"},{"nctId":"NCT05932277","phase":"PHASE1","title":"A Study to Assess the Effect of BMS-986419 on the Single Dose Drug Levels of Probe Substrates in Healthy Participants","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2023-06-29","conditions":["Healthy Volunteers"],"enrollment":22,"completionDate":"2023-09-13"},{"nctId":"NCT05852769","phase":"PHASE1","title":"A Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2023-05-31","conditions":["Healthy Volunteers"],"enrollment":18,"completionDate":"2023-08-24"},{"nctId":"NCT06041178","phase":"PHASE4","title":"Flurbiprofen Versus Aloe Vera Gel in the Treatment of Chronic Periodontitis in Smoking Patients.","status":"COMPLETED","sponsor":"Beirut Arab University","startDate":"2022-09-30","conditions":["Periodontitis Chronic Generalized Severe"],"enrollment":60,"completionDate":"2023-07-19"},{"nctId":"NCT06000137","phase":"NA","title":"The Comparison of the Analgesic Effects of Dezocine and Sufentanil in Patient-controlled Analgesia After Laryngectomy","status":"COMPLETED","sponsor":"Eye & ENT Hospital of Fudan University","startDate":"2022-02-10","conditions":["Patient-controlled Analgesia"],"enrollment":129,"completionDate":"2023-01-30"},{"nctId":"NCT05742256","phase":"PHASE1","title":"Oxycodone in Combination With Parathoracic Nerve Block is Used for Postoperative Analgesia in Lung Cancer","status":"UNKNOWN","sponsor":"Qianfoshan Hospital","startDate":"2023-03-01","conditions":["Oxycodone"],"enrollment":159,"completionDate":"2024-12-31"},{"nctId":"NCT05577962","phase":"NA","title":"Opioid Free Anesthesia on the Quality of Early Recovery","status":"UNKNOWN","sponsor":"Beijing Friendship Hospital","startDate":"2023-02-01","conditions":["Opioid-free Anesthesia"],"enrollment":160,"completionDate":"2023-12-31"},{"nctId":"NCT05326542","phase":"NA","title":"Comparison of Efficacy of ESWL and Laser Lithotripsy in Chronic Pancreatitis With ERCP","status":"UNKNOWN","sponsor":"Changhai Hospital","startDate":"2022-09","conditions":["Pancreatitis, Chronic","Pancreatic Duct Stone"],"enrollment":80,"completionDate":"2022-12"},{"nctId":"NCT05450055","phase":"NA","title":"Intraperitoneal Lidocaine in Ovarian Cancer Surgery","status":"NOT_YET_RECRUITING","sponsor":"Peking University Third Hospital","startDate":"2022-07-18","conditions":["Ovarian Cancer","Post Operative Pain"],"enrollment":60,"completionDate":"2029-07-30"},{"nctId":"NCT05386667","phase":"","title":"Evaluation of the Effects of Medicaments Used After Free Gingival Graft on Postoperative Complications.","status":"COMPLETED","sponsor":"Pamukkale University","startDate":"2019-03-05","conditions":["Pain, Postoperative","Healing Wound","Hemorrhage","Analgesia"],"enrollment":60,"completionDate":"2022-03-15"},{"nctId":"NCT05254548","phase":"PHASE1","title":"A Study to Investigate the Effect of Single and Repeated Oral Doses of ACT-539313 on What the Body Does to Flurbiprofen, Omeprazole, Midazolam in Healthy Subjects","status":"COMPLETED","sponsor":"Idorsia Pharmaceuticals Ltd.","startDate":"2022-02-18","conditions":["Healthy"],"enrollment":22,"completionDate":"2022-04-13"},{"nctId":"NCT04602845","phase":"PHASE4","title":"Remimazolam Tosilate Sedation and Midazolam Sedation in Dental Patients","status":"COMPLETED","sponsor":"Peking University","startDate":"2021-04-01","conditions":["Sedation Complication","Midazolam","Remimazolam"],"enrollment":81,"completionDate":"2021-12-31"},{"nctId":"NCT05261997","phase":"NA","title":"Endotherapy for Painless Chronic Pancreatitis","status":"UNKNOWN","sponsor":"Changhai Hospital","startDate":"2022-03","conditions":["Pancreatitis, Chronic","Exocrine Pancreatic Insufficiency","Abdominal Pain","Cholangiopancreatography, Endoscopic Retrograde"],"enrollment":60,"completionDate":"2023-11"},{"nctId":"NCT05229913","phase":"PHASE4","title":"Effects of Esketamine on Postpartum Depression","status":"UNKNOWN","sponsor":"Qinghai University","startDate":"2022-02-20","conditions":["Postpartum Depression"],"enrollment":500,"completionDate":"2023-06-30"},{"nctId":"NCT04976790","phase":"NA","title":"Chinese Tuina Therapy for Treatment of Chronic Nonspecific Low Back Pain","status":"UNKNOWN","sponsor":"Beijing University of Chinese Medicine","startDate":"2021-10-28","conditions":["Chronic Nonspecific Low Back Pain"],"enrollment":90,"completionDate":"2022-05-15"},{"nctId":"NCT04643249","phase":"PHASE1","title":"Drug-drug Interaction Study of KL1333 in Healthy Subjects","status":"COMPLETED","sponsor":"Abliva AB","startDate":"2020-11-10","conditions":["Mitochondrial Disease"],"enrollment":14,"completionDate":"2020-12-17"},{"nctId":"NCT04306159","phase":"NA","title":"Application of Rectus Sheath Block based-on Incision in Upper Abdominal Surgery","status":"COMPLETED","sponsor":"The First Affiliated Hospital of Anhui Medical University","startDate":"2020-03-15","conditions":["Opioid Consumption"],"enrollment":126,"completionDate":"2021-08-16"},{"nctId":"NCT03200600","phase":"PHASE4","title":"Dexamethasone, Flurbiprofen Axetil and Delirium After Lung Cancer Surgery","status":"TERMINATED","sponsor":"Peking University First Hospital","startDate":"2017-08-02","conditions":["Carcinoma, Non-Small-Cell Lung","Surgery--Complications","Dexamethasone","Flubiprofen Axetil","Delirium"],"enrollment":126,"completionDate":"2018-12-26"},{"nctId":"NCT03422887","phase":"NA","title":"Nalbuphine and Flurbiprofen for Oculoplastic Surgery","status":"COMPLETED","sponsor":"Sun Yat-sen University","startDate":"2018-01-18","conditions":["Surgery","Anesthesia","Pain"],"enrollment":330,"completionDate":"2018-09-30"},{"nctId":"NCT04708964","phase":"PHASE2","title":"Oro-tracheal Intubation: Flurbiprofen Subglottic Instillation to Prevent Laryngeal Inflammation","status":"UNKNOWN","sponsor":"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","startDate":"2021-01","conditions":["D010612"],"enrollment":70,"completionDate":"2022-01-31"},{"nctId":"NCT04670601","phase":"PHASE1","title":"Bioequivalence of Flurbiprofen Lozenge vs Strepfen","status":"COMPLETED","sponsor":"Aziende Chimiche Riunite Angelini Francesco S.p.A","startDate":"2018-06-19","conditions":["Healthy"],"enrollment":24,"completionDate":"2018-07-15"},{"nctId":"NCT04627779","phase":"NA","title":"Sex Difference in Preemptive Analgesic Effects With Flurbiprofen Axetil on Postoperative Pain and Sleep Quality","status":"UNKNOWN","sponsor":"Beijing Friendship Hospital","startDate":"2021-01-01","conditions":["Preemptive Analgesia","Sex Difference","Flurbiprofen Axetil","Postoperative Pain","Postoperative Sleep Quality"],"enrollment":100,"completionDate":"2021-11-30"},{"nctId":"NCT04505787","phase":"PHASE1","title":"S-flurbiprofen Bioavailability Trial to Compare a Newly Developed Patch vs. a Marketed Tablet","status":"COMPLETED","sponsor":"SocraTec R&D GmbH","startDate":"2020-07-24","conditions":["Comparative Bioavailability"],"enrollment":26,"completionDate":"2020-09-24"},{"nctId":"NCT04507165","phase":"NA","title":"Opioid-free Anesthesia in VATS Lung Resection","status":"UNKNOWN","sponsor":"Peking University People's Hospital","startDate":"2020-08","conditions":["Opioid Free Anesthesia"],"enrollment":100,"completionDate":"2022-07"},{"nctId":"NCT03823846","phase":"NA","title":"the Effect of Doctor-nurse-patient Cooperative Analgesic Linkage Program on Movement Evoked Pain","status":"UNKNOWN","sponsor":"Second Affiliated Hospital, School of Medicine, Zhejiang University","startDate":"2017-11-01","conditions":["Pain, Postoperative","Anaplasia"],"enrollment":80,"completionDate":"2020-10-01"},{"nctId":"NCT04128410","phase":"","title":"A Study on Central Transport Characteristics of Flurbiprofen Axetil in Elderly Patients","status":"UNKNOWN","sponsor":"Yi Feng, MD","startDate":"2019-10","conditions":["Flurbiprofen Axetil","Cerebrospinal Fluid","Anesthesia, Spinal","Aged"],"enrollment":77,"completionDate":"2019-10"},{"nctId":"NCT04048070","phase":"NA","title":"The Effect of Enhanced Recovery After Surgery in Endoscopic Sinus Surgery","status":"COMPLETED","sponsor":"Beijing Tongren Hospital","startDate":"2018-05-03","conditions":["Chronic Rhinosinusitis (Diagnosis)","Surgery"],"enrollment":55,"completionDate":"2018-10-30"},{"nctId":"NCT01061112","phase":"","title":"Effects of Genotype on CYP2C9 Drug Interactions","status":"COMPLETED","sponsor":"University of Minnesota","startDate":"2009-12","conditions":["Healthy"],"enrollment":23,"completionDate":"2014-06"},{"nctId":"NCT03951038","phase":"PHASE4","title":"Efficacy and Safety of Ultrasound-guided Lateral Thoracolumbar Interfascial Plane Block (TLIPB) for Postoperative Pain in Patients Undergoing Herniated Lumbar Disc Surgery","status":"UNKNOWN","sponsor":"First Affiliated Hospital of Chongqing Medical University","startDate":"2019-08-01","conditions":["Postoperative Pain","Lumbar Disc Surgery"],"enrollment":100,"completionDate":"2020-02-14"},{"nctId":"NCT03172988","phase":"PHASE4","title":"Dexamethasone, Flurbiprofen Axetil and Long-term Survival After Lung Cancer Surgery","status":"TERMINATED","sponsor":"Peking University First Hospital","startDate":"2017-08-02","conditions":["Carcinoma, Non-Small-Cell Lung","Surgery","Dexamethasone","Flubiprofen Axetil","Long-term Effects Secondary to Cancer Therapy in Adults"],"enrollment":126,"completionDate":"2018-12-26"},{"nctId":"NCT03562611","phase":"NA","title":"Postoperative Pain and Discomfort After Orbital Decompression","status":"COMPLETED","sponsor":"Sun Yat-sen University","startDate":"2018-06-08","conditions":["Surgery","Anesthesia","Pain"],"enrollment":63,"completionDate":"2018-09-30"},{"nctId":"NCT03745599","phase":"PHASE4","title":"Evaluation of the Effects of Different Analgesics on Pericoronitis Pain and Quality of Life","status":"COMPLETED","sponsor":"Near East University, Turkey","startDate":"2017-11-01","conditions":["Pain","Quality of Life"],"enrollment":60,"completionDate":"2018-11-02"},{"nctId":"NCT02578277","phase":"PHASE1","title":"Study on Effects of BMS-955176 on the Pharmacokinetics of Probe Substrates","status":"COMPLETED","sponsor":"ViiV Healthcare","startDate":"2015-11-09","conditions":["HIV Infections"],"enrollment":59,"completionDate":"2015-12-23"},{"nctId":"NCT02984865","phase":"NA","title":"The Application of Transversus Abdominis Plane Block Plus Rectus Sheath Block in Clinical Anesthesia","status":"UNKNOWN","sponsor":"The First Affiliated Hospital of Anhui Medical University","startDate":"2016-12-20","conditions":["Postoperative Nausea and Vomiting","Surgery","Anesthesia","Peritoneal Dialysis","Rectus Sheath Block"],"enrollment":190,"completionDate":"2018-05-01"},{"nctId":"NCT02403687","phase":"","title":"Prospective Analgesic Compound Efficacy (PACE) Study","status":"COMPLETED","sponsor":"Express Specialty Pharmacy","startDate":"2015-06","conditions":["Arthritis","Tendonitis","Gout","Radiculopathy","Muscle Spasms","Synovitis","Migraine","Headache"],"enrollment":300,"completionDate":"2017-02"},{"nctId":"NCT00964106","phase":"PHASE1","title":"Validation Study of Multiple Probe Compounds for Drug Interaction Evaluation","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2009-08-26","conditions":["Drug Interactions"],"enrollment":87,"completionDate":"2011-08-29"},{"nctId":"NCT03131973","phase":"PHASE1","title":"Effects of Concomitant Administration of BMS-986195 on Methotrexate, Caffeine, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2017-05-13","conditions":["Rheumatoid Arthritis"],"enrollment":26,"completionDate":"2017-11-10"},{"nctId":"NCT03147066","phase":"PHASE4","title":"Dezocine for Prevention of Catheter-related Bladder Discomfort","status":"COMPLETED","sponsor":"Jian-jun Yang","startDate":"2017-09-01","conditions":["Catheter Related Bladder Discomfort"],"enrollment":96,"completionDate":"2017-10-30"},{"nctId":"NCT01986361","phase":"PHASE3","title":"Placebo-Controlled Onset-of-Action Study of Flurbiprofen Utilizing the Double-Stopwatch Method","status":"COMPLETED","sponsor":"Reckitt Benckiser LLC","startDate":"2013-09","conditions":["Acute Pharyngitis","Sore Throat"],"enrollment":122,"completionDate":"2014-04"},{"nctId":"NCT01048866","phase":"PHASE3","title":"A Study of Flurbiprofen 8.75 mg Lozenge in Patients With Pharyngitis","status":"COMPLETED","sponsor":"Reckitt Benckiser LLC","startDate":"2009-11","conditions":["Pharyngitis"],"enrollment":198,"completionDate":"2011-03"},{"nctId":"NCT01049334","phase":"PHASE3","title":"A Study of Flurbiprofen 8.75 mg Lozenge in Patient With Pharyngitis","status":"COMPLETED","sponsor":"Reckitt Benckiser LLC","startDate":"2009-11","conditions":["Pharyngitis"],"enrollment":204,"completionDate":"2011-03"},{"nctId":"NCT00615212","phase":"PHASE1","title":"Effect of GSK376501 on CYP450 Activity in Healthy Adult Subjects","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2008-01-02","conditions":["Diabetes Mellitus, Type 2"],"enrollment":23,"completionDate":"2008-02-15"},{"nctId":"NCT03165929","phase":"EARLY_PHASE1","title":"Oral Flurbiprofen Spray for Mucosal Graft Harvesting at the Palatal Area","status":"COMPLETED","sponsor":"Gazi University","startDate":"2016-05","conditions":["Surgery, Oral"],"enrollment":48,"completionDate":"2017-03"},{"nctId":"NCT02789527","phase":"NA","title":"Human Genomic Population Structure and Phenotype-genotype Variation in ADME Genes in Four Populations","status":"COMPLETED","sponsor":"Estella S. Poloni","startDate":"2015-11","conditions":["Healthy"],"enrollment":367,"completionDate":"2017-04"},{"nctId":"NCT02784041","phase":"NA","title":"Single Adductor-canal-block Versus Peri-articular Infiltration on Outcome After Total Knee Arthroplasty","status":"UNKNOWN","sponsor":"Peking Union Medical College Hospital","startDate":"2016-09","conditions":["Osteoarthritis,Knee"],"enrollment":200,"completionDate":"2018-12"},{"nctId":"NCT03090009","phase":"EARLY_PHASE1","title":"Microbiome Shift in Peri-mucositis by Anti-inflammatory Drugs","status":"UNKNOWN","sponsor":"Polak David","startDate":"2017-04","conditions":["Peri-implant Mucositis"],"enrollment":100,"completionDate":"2020-04"},{"nctId":"NCT02191358","phase":"","title":"YouScript IMPACT Registry","status":"COMPLETED","sponsor":"Genelex Corporation","startDate":"2014-10","conditions":["Adverse Drug Events","Adverse Drug Reactions","Drug Interaction Potentiation","Drug Metabolism, Poor, CYP2D6-RELATED","Drug Metabolism, Poor, CYP2C19-RELATED","Cytochrome P450 Enzyme Deficiency","Cytochrome P450 CYP2D6 Enzyme Deficiency","Cytochrome P450 CYP2C9 Enzyme Deficiency","Cytochrome P450 CYP2C19 Enzyme Deficiency","Cytochrome P450 CYP3A Enzyme Deficiency","Poor Metabolizer Due to Cytochrome P450 CYP2C9 Variant","Poor Metabolizer Due to Cytochrome P450 CYP2C19 Variant","Poor Metabolizer Due to Cytochrome P450 CYP2D6 Variant"],"enrollment":800,"completionDate":"2015-08"},{"nctId":"NCT02391688","phase":"PHASE1","title":"Evaluation of the Potential Pharmacokinetic Interactions Between Probe Drugs in the Geneva Phenotyping Cocktail","status":"COMPLETED","sponsor":"Jules Desmeules","startDate":"2014-11","conditions":["Drug Interaction"],"enrollment":30,"completionDate":"2015-04"},{"nctId":"NCT03014713","phase":"PHASE4","title":"Effect of Dexmedetomidine for Postoperative Intravenous Patient Controlled Analgesia","status":"UNKNOWN","sponsor":"Weifeng Tu","startDate":"2016-09","conditions":["Patient-Controlled Analgesia"],"enrollment":50,"completionDate":"2017-12"},{"nctId":"NCT00759330","phase":"PHASE2","title":"Flurbiprofen Tape for Treatment of Chronic Low Back Pain","status":"COMPLETED","sponsor":"Teikoku Pharma USA, Inc.","startDate":"2007-10","conditions":["Chronic Low Back Pain"],"enrollment":127,"completionDate":"2008-07"},{"nctId":"NCT02762123","phase":"PHASE1","title":"A Study to Assess the Effect of BMS-986142 on Pharmacokinetics (PK) of Probe Substrates","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2016-05","conditions":["Rheumatoid Arthritis"],"enrollment":28,"completionDate":"2016-08"},{"nctId":"NCT02674737","phase":"NA","title":"Evaluation of the Effect of Appropriate Sedation for Patients After Gastrectomy: A Prospective Randomised Controlled Study","status":"UNKNOWN","sponsor":"Chinese Medical Association","startDate":"2016-01","conditions":["Postoperative Sedation,Gastrectomy, Enhanced Recovery After Surgery"],"enrollment":80,"completionDate":""},{"nctId":"NCT02670954","phase":"NA","title":"Evaluation of the Effect of Appropriate Sedation for Patients After Abdominal Surgeries : A Prospective Randomised Controlled Study","status":"COMPLETED","sponsor":"Chinese Medical Association","startDate":"2015-10","conditions":["Postoperative Sedation, Abdominal Surgery"],"enrollment":154,"completionDate":"2016-01"},{"nctId":"NCT02456844","phase":"PHASE1","title":"Study to Investigate the Effect of BMS-986142 on the Pharmacokinetics (PK) of Methotrexate and Probe Substrate Cocktail in Healthy Patients","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2015-05","conditions":["Rheumatoid Arthritis"],"enrollment":24,"completionDate":"2015-07"},{"nctId":"NCT02043366","phase":"NA","title":"Effect of Butorphanol Combined With Flurbiprofen Axetil on Preventing Hyperalgesia Induced by Remifentanil in Patients","status":"COMPLETED","sponsor":"Tianjin Medical University General Hospital","startDate":"2014-02","conditions":["Pain","Anesthesia"],"enrollment":180,"completionDate":"2015-08"},{"nctId":"NCT02604797","phase":"NA","title":"Analgesia Effects of Nalbuphine vs Sulfentanil","status":"UNKNOWN","sponsor":"Fudan University","startDate":"2016-01","conditions":["C.Delivery; Surgery (Previous), Gynecological"],"enrollment":80,"completionDate":"2018-01"},{"nctId":"NCT02595333","phase":"NA","title":"Incision Pain and Uterine Contraction Pain After Cesarean Section","status":"UNKNOWN","sponsor":"Fudan University","startDate":"2015-11","conditions":["C.Delivery; Surgery (Previous), Gynecological"],"enrollment":80,"completionDate":"2017-12"},{"nctId":"NCT02569905","phase":"PHASE4","title":"Effect of Parecoxib Sodium and Flurbiprofen Injection on Postoperative Shivering","status":"COMPLETED","sponsor":"Guangxi Medical University","startDate":"2014-04","conditions":["Postoperative Shivering"],"enrollment":166,"completionDate":"2015-04"},{"nctId":"NCT02206854","phase":"PHASE1","title":"Bioavailability, Pharmacokinetics and Tissue Distribution of R-flurbiprofen Capsules in Healthy Subjects","status":"COMPLETED","sponsor":"Gerd Geisslinger","startDate":"2014-06","conditions":["Healthy Volunteers"],"enrollment":16,"completionDate":"2014-09"},{"nctId":"NCT02438072","phase":"NA","title":"Drug Metabolism and Antidepressant","status":"UNKNOWN","sponsor":"University Hospital, Geneva","startDate":"2014-12","conditions":["Depression"],"enrollment":100,"completionDate":"2015-12"},{"nctId":"NCT02094339","phase":"PHASE4","title":"Comparison of Three Kinds of Postoperative Analgesia After Total Knee Arthroplasty","status":"UNKNOWN","sponsor":"Guangzhou General Hospital of Guangzhou Military Command","startDate":"2014-03","conditions":["Pain","Complications"],"enrollment":45,"completionDate":"2016-06"},{"nctId":"NCT02114463","phase":"PHASE4","title":"Comparison of Two Kinds of Postoperative Analgesia After Amputation","status":"UNKNOWN","sponsor":"Guangzhou General Hospital of Guangzhou Military Command","startDate":"2014-03","conditions":["Pain","Complications"],"enrollment":36,"completionDate":"2016-08"},{"nctId":"NCT02367937","phase":"PHASE1","title":"PRC-4016 (Icosabutate) Phase I Drug-drug Interaction Study","status":"COMPLETED","sponsor":"Pronova BioPharma","startDate":"2014-08","conditions":["Healthy"],"enrollment":16,"completionDate":"2014-10"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Ophthalmic","formulation":"Patch, Solution/ Drops, Tablet","formulations":[{"form":"PATCH","route":"TOPICAL","productName":"Antiphlamine Pain Relieving"},{"form":"SOLUTION/ DROPS","route":"OPHTHALMIC","productName":"Flurbiprofen Sodium"},{"form":"SOLUTION/ DROPS","route":"OPHTHALMIC","productName":"FLURBIPROFEN SODIUM"},{"form":"TABLET, FILM COATED","route":"ORAL","productName":"FLURBIPROFEN"},{"form":"TABLET, FILM COATED","route":"ORAL","productName":"Flurbiprofen"}]},"_patentsChecked":true,"crossReferences":{"NUI":"N0000147399","MMSL":"4753","NDDF":"002382","UNII":"5GRO578KLP","VUID":"4019154","CHEBI":"CHEBI:42446","VANDF":"4019153","INN_ID":"3220","RXNORM":"4502","UMLSCUI":"C0016377","chemblId":"CHEMBL563","ChEMBL_ID":"CHEMBL563","KEGG_DRUG":"D00330","DRUGBANK_ID":"DB00712","PDB_CHEM_ID":" FLP","PUBCHEM_CID":"3394","SNOMEDCT_US":"11633008","IUPHAR_LIGAND_ID":"4194","SECONDARY_CAS_RN":"56767-76-1","MESH_DESCRIPTOR_UI":"D005480"},"formularyStatus":[],"_enricherVersion":"v2","_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[{"period":"1986-","companyName":"Allergan","relationship":"Original Developer"},{"period":"present","companyName":"Pharmacia And Upjohn","relationship":"Current Owner"}],"pharmacokinetics":{"source":"DrugCentral","bioavailability":"92%"},"publicationCount":2894,"therapeuticAreas":["Immunology"],"atcClassification":{"source":"DrugCentral","atcCode":"M01AE09","allCodes":["M01AE09","M02AA19","R02AX01","S01BC04"]},"biosimilarFilings":[],"originalDeveloper":"Allergan","recentPublications":[{"date":"2026 Mar 5","pmid":"41900212","title":"A Dissolving Microneedle Design for Poorly Water-Soluble Drugs for Enhanced Skin Permeation and Transdermal Delivery Fabricated Using 3D Printing.","journal":"Micromachines"},{"date":"2026 Feb","pmid":"41878175","title":"A Case of Toxic Epidermal Necrolysis-Like Dermatosis Associated With Contact Exposure to a Flurbiprofen Plaster.","journal":"Cureus"},{"date":"2026 Mar 24","pmid":"41874953","title":"The Association Between Body Mass Index and Acute Postoperative Pain in Bariatric Surgery Patients: A Prospective Cohort Study.","journal":"Pain and therapy"},{"date":"2026 Mar 23","pmid":"41869841","title":"Bifunctional Analgesic-Pro-Healing Hydrogel Dressing for Postoperative Analgesia and Wound Healing in Mice.","journal":"ACS biomaterials science & engineering"},{"date":"2026","pmid":"41868128","title":"Low-dose dexmedetomidine improves postoperative sleep and pain in gynecological surgery: a randomized trial.","journal":"Frontiers in pharmacology"}],"companionDiagnostics":[],"genericManufacturers":8,"_genericFilersChecked":true,"genericManufacturerList":["Ivax Sub Teva Pharms","Natco Pharma","New Heightsrx","Pliva","Rising","Sun Pharm Inds Inc","Teva","Theragen"],"status":"active","companyName":"Pharmacia And Upjohn","companyId":"pfizer","modality":"Small Molecule","firstApprovalDate":"1986","enrichmentLevel":4,"visitCount":4,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1986-12-31T00:00:00.000Z","mah":"ALLERGAN","brand_name_local":null,"application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1997-04-07T00:00:00.000Z","mah":"NEW HEIGHTSRX","brand_name_local":null,"application_number":"ANDA074431"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2000-06-27T00:00:00.000Z","mah":"BAUSCH AND LOMB","brand_name_local":null,"application_number":"ANDA074447"},{"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":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"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":"SG","regulator":"HSA","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":"AE","regulator":"MOH","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":"KR","regulator":"MFDS","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":"AU","regulator":"TGA","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},{"country_code":"GB","regulator":"MHRA","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}],"pricingByCountry":[{"country_code":"Un","currency":"USD","price_amount":"3855.00","price_per":"year","price_type":"NADAC","annual_cost_usd":null,"reimbursement_status":null}],"trialStats":{"total":5,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-19T23:47:31.681799+00:00","fieldsConflicting":2,"overallConfidence":0.8},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}