{"id":"zipsor","safety":{"commonSideEffects":[{"rate":null,"effect":"Dyspepsia"},{"rate":null,"effect":"Abdominal pain"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Gastrointestinal bleeding (rare but serious)"}]},"_chembl":{"chemblId":"CHEMBL1200804","moleculeType":"Small molecule","molecularWeight":"334.24"},"_dailymed":{"setId":"c982eca0-fc41-11e1-a9c8-0002a5d5c51b","title":"ZIPSOR (DICLOFENAC POTASSIUM) CAPSULE, LIQUID FILLED [ASSERTIO THERAPEUTICS, INC.]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Zipsor contains diclofenac potassium, which blocks COX-1 and COX-2 enzymes responsible for prostaglandin production. By reducing prostaglandins, the drug decreases inflammatory mediators and provides analgesic and anti-inflammatory effects. Zipsor is formulated as an immediate-release oral capsule for rapid onset of action.","oneSentence":"Zipsor is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis and decrease inflammation and pain.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:16:34.622Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Mild to moderate acute pain in adults"}]},"trialDetails":[{"nctId":"NCT07475663","phase":"PHASE3","title":"Counterpain PXM Versus Diclofenac Versus Piroxicam","status":"COMPLETED","sponsor":"Taisho Pharmaceutical Indonesia","startDate":"2025-11-04","conditions":"Ankle Sprain, Back Pain, Osteoarthritis (OA) of the Knee","enrollment":180},{"nctId":"NCT07244029","phase":"NA","title":"Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery","status":"RECRUITING","sponsor":"Oman Medical Speciality Board","startDate":"2026-01-01","conditions":"Postoperative Pain, Facial Swelling, Trismus","enrollment":100},{"nctId":"NCT06685445","phase":"NA","title":"Continue ESPB & Continue ESPB Combined With SAPB for Thoracotomy","status":"COMPLETED","sponsor":"Bursa City Hospital","startDate":"2024-10-18","conditions":"Post-thoracotomy Pain","enrollment":60},{"nctId":"NCT07088042","phase":"PHASE4","title":"Assessment of Different Medications in Modifying the Efficacy of Anesthesia in Mandibular Molars With Acute Irreversible Pulpitis","status":"COMPLETED","sponsor":"Ain Shams University","startDate":"2024-09-15","conditions":"Pulpitis - Irreversible","enrollment":60},{"nctId":"NCT07016451","phase":"EARLY_PHASE1","title":"Efficacy of Low-Intensity Shockwave Therapy in Treating Radiation Cystitis","status":"ENROLLING_BY_INVITATION","sponsor":"Thanakrit Visuthikosol","startDate":"2024-04-02","conditions":"Radiation Cystitis","enrollment":40},{"nctId":"NCT06954181","phase":"NA","title":"Quantification of Diclofenac 2.32% (Voltaren) in Rinse Water After Different Application Methods","status":"COMPLETED","sponsor":"HALEON","startDate":"2025-03-26","conditions":"Healthy Participants","enrollment":33},{"nctId":"NCT02406014","phase":"PHASE4","title":"Efficacy and Safety of Ingenol Mebutate Gel 0.015% Compared to Diclofenac Sodium Gel 3% in Subjects With Actinic Keratoses on the Face or Scalp","status":"COMPLETED","sponsor":"LEO Pharma","startDate":"2015-04","conditions":"Actinic Keratosis (AK)","enrollment":502},{"nctId":"NCT05387525","phase":"PHASE4","title":"A Study of Tirbanibulin Ointment and Diclofenac Sodium Gel for the Treatment of Adult Participants With Actinic Keratosis on the Face or Scalp","status":"ACTIVE_NOT_RECRUITING","sponsor":"Almirall, S.A.","startDate":"2022-10-24","conditions":"Keratosis, Actinic","enrollment":447},{"nctId":"NCT06710600","phase":"NA","title":"Phototoxicity of Frequently Prescribed Medicines","status":"COMPLETED","sponsor":"Medical University of Vienna","startDate":"2022-09-22","conditions":"Phototoxicity","enrollment":12},{"nctId":"NCT06192420","phase":"PHASE3","title":"TRAUMED - a Clinical Trial in Acute Ankle Sprain","status":"COMPLETED","sponsor":"Biologische Heilmittel Heel GmbH","startDate":"2018-02-26","conditions":"Ankle Sprain","enrollment":809},{"nctId":"NCT05641246","phase":"PHASE2","title":"Effect of Topical Diclofenac on Clinical Outcome in Breast Cancer Patients Treated With Capecitabine","status":"COMPLETED","sponsor":"German University in Cairo","startDate":"2022-12-08","conditions":"Hand and Foot Syndrome","enrollment":86},{"nctId":"NCT05082662","phase":"PHASE1, PHASE2","title":"Bioequivalence Study to Compare Diclofenac Potassium Coated Tablet Versus Cataflam® 50 Coated Tablet","status":"COMPLETED","sponsor":"Humanis Saglık Anonim Sirketi","startDate":"2020-08-25","conditions":"Non-steroidal Anti-inflammatory (NSAID), Analgesic, Antipyretic","enrollment":36},{"nctId":"NCT04585334","phase":"PHASE4","title":"Effectiveness of Tricortin 1000 in Patients Affected by Chronic Low Back Pain","status":"UNKNOWN","sponsor":"Fidia Farmaceutici s.p.a.","startDate":"2019-03-25","conditions":"Low Back Pain, Mechanical","enrollment":300},{"nctId":"NCT04976088","phase":"PHASE3","title":"Clinical Trial With Diclofenac Sodium Medicated Plaster in Patients With Impact Injuries of the Limbs","status":"COMPLETED","sponsor":"Fidia Farmaceutici s.p.a.","startDate":"2018-05-25","conditions":"Trauma Injury, Inflammation","enrollment":214},{"nctId":"NCT05829707","phase":"PHASE4","title":"Long-term Outcomes of Breast Cancer Patients After Wound Infiltration Analgesia","status":"COMPLETED","sponsor":"Osijek University Hospital","startDate":"2009-01-05","conditions":"Postoperative Analgesia, Hand Strength, Health Related Quality of Life","enrollment":120},{"nctId":"NCT03493490","phase":"PHASE4","title":"Neodolpasse® Infusion Solution Versus Diclofenac 75 mg Infusion in the Treatment of Postoperative Pain After Elective Knee Surgery","status":"COMPLETED","sponsor":"Medical University of Vienna","startDate":"2018-03-01","conditions":"Pain, Postoperative, Analgesic Adverse Reaction, Cruciate Ligament Rupture","enrollment":72},{"nctId":"NCT04067492","phase":"PHASE2","title":"Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Evaluation of RPH-104 Administered at Different Doses to Patients With Acute Gout Attack","status":"TERMINATED","sponsor":"R-Pharm","startDate":"2018-03-26","conditions":"Gout Attack","enrollment":47},{"nctId":"NCT03172780","phase":"PHASE3","title":"A Bioequivalence Study Using Clinical Endpoint for Diclofenac Sodium Gel 1% in Osteoarthritis Knee\"","status":"COMPLETED","sponsor":"Mylan Pharmaceuticals Private Limited","startDate":"2017-05-24","conditions":"Osteoarthritis, Knee","enrollment":1220},{"nctId":"NCT01453179","phase":"PHASE4","title":"Long-term Effects of Imiquimod and Diclofenac in Actinic Keratoses (LEIDA 2)","status":"COMPLETED","sponsor":"MEDA Pharma GmbH & Co. KG","startDate":"2011-10","conditions":"Actinic Keratosis","enrollment":221},{"nctId":"NCT00777127","phase":"PHASE4","title":"Long-term Effects of Imiquimod and Diclofenac in Actinic Keratoses","status":"COMPLETED","sponsor":"MEDA Pharma GmbH & Co. KG","startDate":"2008-12","conditions":"Actinic Keratosis","enrollment":258},{"nctId":"NCT02121002","phase":"PHASE3","title":"Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren in the Treatment of Subjects With Osteoarthritis of the Knee","status":"COMPLETED","sponsor":"Amneal Pharmaceuticals, LLC","startDate":"2014-04","conditions":"Osteoarthritis","enrollment":1176},{"nctId":"NCT02913521","phase":"PHASE3","title":"Bioequivalence Study With Clinical Endpoint for Diclofenac Sodium Topical Gel 1%","status":"COMPLETED","sponsor":"Akorn, Inc.","startDate":"2015-06","conditions":"Osteoarthritis, Knee","enrollment":934},{"nctId":"NCT04132583","phase":"PHASE1","title":"Deflox Tablets Bioequivalence (BE) Trial","status":"COMPLETED","sponsor":"Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany","startDate":"2019-09-21","conditions":"Healthy","enrollment":16},{"nctId":"NCT04585321","phase":"PHASE1","title":"Comparative Bioavailability and Local Tolerability of Two Topical Diclofenac Plasters Applied Once and Twice a Day","status":"COMPLETED","sponsor":"Fidia Farmaceutici s.p.a.","startDate":"2017-11-28","conditions":"Bioequivalence Study","enrollment":52},{"nctId":"NCT02985671","phase":"PHASE3","title":"To Evaluate the Superiority of Fixed Combination (Orfenadrine 35mg, Acetaminophen 325mg, Caffeine 65mg and Diclofenac Sodium 50mg) Compared to Voltaren® (Diclofenac Sodium 50mg) in the Treatment of Acute Postural Low Back Pain.","status":"UNKNOWN","sponsor":"Ache Laboratorios Farmaceuticos S.A.","startDate":"2021-01","conditions":"Postural Low Back Pain, Mechanical Low Back Pain","enrollment":110},{"nctId":"NCT01962987","phase":"PHASE3","title":"A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® (Diclofenac Sodium) Gel 3% in the Treatment of Actinic Keratosis","status":"COMPLETED","sponsor":"Actavis Inc.","startDate":"2013-03","conditions":"Actinic Keratosis","enrollment":476},{"nctId":"NCT02324270","phase":"PHASE3","title":"Safety and Efficacy of Generic Diclofenac Epolamine Acute Pain Due to Minor Ankle Sprain","status":"COMPLETED","sponsor":"Actavis Inc.","startDate":"2014-05","conditions":"Ankle Sprain","enrollment":658},{"nctId":"NCT01982539","phase":"PHASE4","title":"Safety and Tolerability of Zipsor® in Pediatric Subjects (Ages 12-17 Years) With Mild to Moderate Acute","status":"COMPLETED","sponsor":"Depomed","startDate":"2013-11","conditions":"Pain","enrollment":25},{"nctId":"NCT04110587","phase":"PHASE4","title":"Hyaluronic Acid Evaluation as Adjuvant to Temporomandibular Joint Arthroscopy","status":"COMPLETED","sponsor":"Universidad Complutense de Madrid","startDate":"2013-12-10","conditions":"Temporomandibular Joint Disc Displacement, Temporomandibular Joint Disorders","enrollment":54},{"nctId":"NCT03996564","phase":"NA","title":"Battlefield Acupuncture for Acute/Subacute Back Pain in the Emergency Department","status":"COMPLETED","sponsor":"San Antonio Military Medical Center","startDate":"2016-02-22","conditions":"Low Back Pain, Mechanical","enrollment":26},{"nctId":"NCT03939884","phase":"PHASE4","title":"MuscleCare™ Pain Relief Therapy vs. Voltaren® in the Relief of Trapezius Trigger Point Musculoskeletal Pain.","status":"COMPLETED","sponsor":"University of Toronto","startDate":"2017-03-28","conditions":"Pain","enrollment":120},{"nctId":"NCT03074162","phase":"PHASE1","title":"Comparison of the Bioavailability of Diclofenac in a Combination Product (Diclofenac 2% + Capsaicin 0.075% Topical Gel) With Two Diclofenac Only Products, Diclofenac Mono Gel 2% and Voltarol® 12 Hour Emulgel 2.32% Gel, in Healthy Volunteers","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"2017-04-20","conditions":"Healthy","enrollment":48},{"nctId":"NCT03826550","phase":"PHASE3","title":"Therapeutic Equivalence of Diclofenac Sodium Gel 3% vs Solaraze ® in the Treatment of Actinic Keratosis","status":"COMPLETED","sponsor":"Encube Ethicals Pvt. Ltd.","startDate":"2018-01-12","conditions":"Actinic Keratoses","enrollment":655},{"nctId":"NCT01886352","phase":"PHASE4","title":"Intraperitoneal Atomization of Levobupivacaine During Gynaecological Laparoscopic Procedures ; Impact on Pain, Opioid Use and Length of Recovery Room Stay (IPLA).","status":"COMPLETED","sponsor":"University Hospital, Ghent","startDate":"2013-06-26","conditions":"Pain, Postoperative","enrollment":16},{"nctId":"NCT03597867","phase":"PHASE3","title":"PGE2 Levels in Patient Treated With NSAIDs","status":"COMPLETED","sponsor":"University of Trieste","startDate":"2018-04-25","conditions":"Ocular Inflammation","enrollment":104},{"nctId":"NCT02287376","phase":"PHASE4","title":"Pharmacokinetics & Safety of Cambia® in Migraine With or Without Aura in 12-17 Year Olds","status":"COMPLETED","sponsor":"Depomed","startDate":"2015-01","conditions":"Migraine","enrollment":25},{"nctId":"NCT02596451","phase":"PHASE3","title":"To Study Generic Diclofenac Sodium Topical Gel 1% in the Treatment of Osteoarthritis of the Knee (Degenerative Joint Disease Presented as Joint Pain, Stiffness, Swelling and Restricted Motion).","status":"COMPLETED","sponsor":"Glenmark Pharmaceuticals Ltd. India","startDate":"2015-08","conditions":"Osteoarthritis","enrollment":1164},{"nctId":"NCT02611804","phase":"PHASE3","title":"A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study Comparing Diclofenac Sodium Gel, 3% to Solaraze® Gel, 3% in the Treatment of Actinic Keratosis on the Face or Bald Scalp","status":"COMPLETED","sponsor":"Teva Pharmaceuticals USA","startDate":"2015-10","conditions":"Actinic Keratosis","enrollment":492},{"nctId":"NCT02826031","phase":"PHASE4","title":"Clinical Study of Artz in the Treatment of Knee Osteoarthritis","status":"UNKNOWN","sponsor":"Kunming Baker Norton Pharmaceutical Sales Co., Ltd.","startDate":"2016-04","conditions":"Knee Osteoarthritis","enrollment":300},{"nctId":"NCT02433418","phase":"PHASE3","title":"Tubal Flushing Using Water Soluble Media for Unexplained Infertility","status":"UNKNOWN","sponsor":"Cairo University","startDate":"2015-05","conditions":"Infertility","enrollment":300},{"nctId":"NCT01350622","phase":"NA","title":"Efficacy of PENNSAID® for Pain Management in the Emergency Department","status":"WITHDRAWN","sponsor":"University of Utah","startDate":"2011-12","conditions":"Pain, Ankle Sprain","enrollment":""},{"nctId":"NCT02597582","phase":"PHASE4","title":"LigaSure Small Jaw® Versus Conventional Neck Dissection in Head and Neck Cancer Patients","status":"COMPLETED","sponsor":"Taichung Veterans General Hospital","startDate":"2014-01","conditions":"Head and Neck Neoplasms","enrollment":41},{"nctId":"NCT02714842","phase":"PHASE1","title":"Delayed Release Diclofenac Sodium Formulation vs Voltaren®","status":"COMPLETED","sponsor":"BDD Pharma Ltd","startDate":"2016-03","conditions":"Pain","enrollment":36},{"nctId":"NCT01935531","phase":"PHASE4","title":"Effects of Topical Diclofenac on Tumor Metabolism","status":"COMPLETED","sponsor":"University Hospital Regensburg","startDate":"2013-06","conditions":"Actinic Keratoses","enrollment":38},{"nctId":"NCT00766402","phase":"PHASE4","title":"An Efficacy and Safety Study of Tramadol/Acetaminophen Versus Diclofenac in the Treatment of Pain in Participants With Ankylosing Spondylitis Receiving Stable Treatment of Disease Modifying Anti-rheumatic Drugs (DMARDs)","status":"TERMINATED","sponsor":"Johnson & Johnson Taiwan Ltd","startDate":"2008-10","conditions":"Spondylitis, Ankylosing, Pain","enrollment":8},{"nctId":"NCT01202799","phase":"PHASE1","title":"Pharmacokinetics, Bioavailability and Safety of PENNSAID® Gel","status":"COMPLETED","sponsor":"Mallinckrodt","startDate":"2010-09","conditions":"Pain","enrollment":30},{"nctId":"NCT01742663","phase":"PHASE1","title":"A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® Gel 3% in the Treatment of Actinic Keratosis","status":"COMPLETED","sponsor":"Sun Pharmaceutical Industries, Inc.","startDate":"2012-10","conditions":"Actinic Keratosis","enrollment":435},{"nctId":"NCT01858090","phase":"PHASE3","title":"Intrathecal Levobupivacaine With Opioids for Caesarean Section","status":"COMPLETED","sponsor":"Baskent University","startDate":"2009-01","conditions":"Elective Caesarean Section Surgeries","enrollment":93},{"nctId":"NCT00943098","phase":"PHASE3","title":"Evaluation of the Efficacy and Safety of Diclofenac HPBCD 75mg/ml in Treatment of Pain Following Dental Surgery","status":"COMPLETED","sponsor":"IBSA Institut Biochimique SA","startDate":"2009-09","conditions":"Dental Pain","enrollment":142},{"nctId":"NCT01761071","phase":"PHASE3","title":"Time Serial Analysis on Preemptive Analgesia of Preoperative Topical Diclofenac and Ketorolac in Photorefractive Keratectomy(PRK)","status":"COMPLETED","sponsor":"Yonsei University","startDate":"2012-01","conditions":"Myopes Who Have Undergone PRK.","enrollment":94},{"nctId":"NCT01054820","phase":"PHASE4","title":"Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain","status":"COMPLETED","sponsor":"Pfizer","startDate":"2010-01","conditions":"Acute Back Strain","enrollment":123},{"nctId":"NCT01456611","phase":"PHASE3","title":"Evaluation of Clinical Endpoints of Two Diclofenac Sodium Gel 1%","status":"COMPLETED","sponsor":"Anchen Pharmaceuticals, Inc","startDate":"2011-09","conditions":"Osteo Arthritis of the Knee","enrollment":749},{"nctId":"NCT00204542","phase":"PHASE4","title":"Comparison of the Efficacy and Tolerability of Solaraze for 3 Versus 6 Months in Patients With Mild to Moderate Actinic Keratosis Located on the Face and Head","status":"COMPLETED","sponsor":"University Hospital Tuebingen","startDate":"2005-06","conditions":"Photosensitivity Disorders","enrollment":418},{"nctId":"NCT00594854","phase":"PHASE3","title":"Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers in High Risk Subjects Compared to Arthrotec","status":"TERMINATED","sponsor":"POZEN","startDate":"2007-09","conditions":"Gastric Ulcer","enrollment":20},{"nctId":"NCT00805090","phase":"PHASE1","title":"Open-Label, Single-Dose Study to Evaluate the Safety and PK of DIC075V in Subjects With Renal Insufficiency and Hepatic Impairment Compared to Healthy Subjects and Evaluate the Safety and Pharmacokinetics of HPβCD When Administered in DIC075V Compared to Sporanox® in Healthy Subjects","status":"COMPLETED","sponsor":"Javelin Pharmaceuticals","startDate":"2008-12","conditions":"Renal Insufficiency, Chronic, Hepatic Insufficiency, Healthy","enrollment":37}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":4,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Diclofenac"],"phase":"marketed","status":"active","brandName":"Zipsor®","genericName":"Zipsor®","companyName":"Depomed","companyId":"depomed","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Zipsor is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis and decrease inflammation and pain. Used for Mild to moderate acute pain in adults.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}