{"id":"ondansetron-odt","safety":{"commonSideEffects":[{"rate":"9-27%","effect":"Headache"},{"rate":"5-11%","effect":"Constipation"},{"rate":"3-8%","effect":"Diarrhea"},{"rate":"2-8%","effect":"Fatigue"},{"rate":"2-5%","effect":"Dizziness"}]},"_chembl":{"chemblId":"CHEMBL1201111","moleculeType":"Small molecule","molecularWeight":"329.83"},"_dailymed":{"setId":"af836a30-5e51-5c97-e053-2995a90a15b9","title":"ONDANSETRON ODT (ONDANSETRON) TABLET, ORALLY DISINTEGRATING [ADVANCED RX OF TENNESSEE, LLC]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Ondansetron is a selective 5-HT3 receptor antagonist that inhibits serotonin signaling in the chemoreceptor trigger zone and gastrointestinal tract. By blocking these receptors, it prevents the emetic signals that trigger nausea and vomiting, particularly those induced by chemotherapy, radiation, or post-operative conditions. The ODT (orally disintegrating tablet) formulation allows rapid dissolution on the tongue for convenient administration.","oneSentence":"Ondansetron blocks serotonin (5-HT3) receptors on chemoreceptor trigger zone and vagal afferent nerves to prevent nausea and vomiting.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T04:18:26.113Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of nausea and vomiting induced by chemotherapy"},{"name":"Prevention of nausea and vomiting induced by radiotherapy"},{"name":"Prevention of post-operative nausea and vomiting"}]},"trialDetails":[{"nctId":"NCT07310563","phase":"PHASE1","title":"A Trial to Evaluate Interactions Between Antiemetic Medication and AMG 133 in Participants Living With Overweight or Obesity","status":"COMPLETED","sponsor":"Amgen","startDate":"2024-12-10","conditions":"Overweight, Obesity","enrollment":59},{"nctId":"NCT05035407","phase":"PHASE1","title":"T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers","status":"TERMINATED","sponsor":"National Cancer Institute (NCI)","startDate":"2022-03-08","conditions":"Kita-kyushu Lung Cancer Antigen 1, Human","enrollment":36},{"nctId":"NCT05418244","phase":"PHASE2, PHASE3","title":"Inhaled Isopropyl Alcohol for Treatment of Nausea","status":"RECRUITING","sponsor":"State University of New York at Buffalo","startDate":"2022-04-20","conditions":"Vomiting, Nausea, Children, Only","enrollment":84},{"nctId":"NCT00001337","phase":"PHASE2","title":"Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Previously Untreated Aggressive Non-Hodgkin's Lymphoma","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"1993-05-08","conditions":"Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal Large B-cell Lymphoma, Burkitt Lymphoma","enrollment":348},{"nctId":"NCT03030417","phase":"PHASE1","title":"Indenoisoquinoline LMP744 in Adults With Relapsed Solid Tumors and Lymphomas","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"2017-02-27","conditions":"Solid Tumors, Lymphoma","enrollment":36},{"nctId":"NCT03475693","phase":"EARLY_PHASE1","title":"A Cohort Study Evaluating the Efficacy of PO Magnesium in the Treatment of Acute Traumatic Brain Injury in Adolescents","status":"COMPLETED","sponsor":"Corewell Health South","startDate":"2017-09-01","conditions":"Concussion Post Syndrome","enrollment":17},{"nctId":"NCT00934180","phase":"PHASE1","title":"Ondansetron HCl Orally Disintegrating Tablets Under Fasting Conditions","status":"COMPLETED","sponsor":"Teva Pharmaceuticals USA","startDate":"2002-12","conditions":"Healthy","enrollment":24},{"nctId":"NCT00934921","phase":"PHASE1","title":"Ondansetron HCl Orally Disintegrating Tablets Under Non-Fasting Conditions","status":"COMPLETED","sponsor":"Teva Pharmaceuticals USA","startDate":"2003-02","conditions":"Healthy","enrollment":24},{"nctId":"NCT00649363","phase":"PHASE1","title":"Fasting Study of Ondansetron Orally Disintegrating Tablets 8 mg to Zofran ODT® Tablets 8 mg","status":"COMPLETED","sponsor":"Mylan Pharmaceuticals Inc","startDate":"2005-07","conditions":"Healthy","enrollment":28},{"nctId":"NCT00648804","phase":"PHASE1","title":"Food Study of Ondansetron Orally Disintegrating Tablets 8 mg to Zofran ODT® Tablets 8 mg","status":"COMPLETED","sponsor":"Mylan Pharmaceuticals Inc","startDate":"2005-07","conditions":"Healthy","enrollment":28},{"nctId":"NCT02601027","phase":"PHASE3","title":"Transversus Abdominis Plane Block in Microsurgical Breast Recon w/Abdominal Free Flap in Breast CA","status":"COMPLETED","sponsor":"Stanford University","startDate":"2015-11","conditions":"Breast - Female","enrollment":120},{"nctId":"NCT02732015","phase":"PHASE2","title":"Rolapitant Hydrochloride in Preventing Nausea/Vomiting in Patients With Sarcoma Receiving Chemotherapy","status":"TERMINATED","sponsor":"M.D. Anderson Cancer Center","startDate":"2016-10-12","conditions":"Locally Advanced Sarcoma","enrollment":37},{"nctId":"NCT00324467","phase":"PHASE2","title":"Tailoring Treatment for B Cell Non-hodgkin's Lymphoma Based on PET Scan Results Mid Treatment","status":"UNKNOWN","sponsor":"British Columbia Cancer Agency","startDate":"2006-08","conditions":"Lymphoma, Non-Hodgkin, Advanced Stage Diffuse Large B-Cell Non-Hodgkin's Lymphoma","enrollment":150},{"nctId":"NCT01220167","phase":"PHASE1","title":"Three-way Crossover Study Comparing Ondansetron ODFS Administered With and Without Water to Zofran ODT Without Water","status":"COMPLETED","sponsor":"Aquestive Therapeutics","startDate":"2008-08","conditions":"Healthy Participants","enrollment":18},{"nctId":"NCT01217190","phase":"PHASE1, PHASE2","title":"Crossover Study Comparing Ondansetron Orally Dissolving Film Strip (ODFS) With Zofran Orally Disintegrating Tablets","status":"COMPLETED","sponsor":"MonoSol Rx","startDate":"2008-09-16","conditions":"Nausea and Vomiting, Postoperative, Nausea With Vomiting Chemotherapy-Induced","enrollment":48},{"nctId":"NCT03254459","phase":"PHASE2","title":"Study of Buprenorphine Sublingual Spray Versus Standard of Care Narcotic Therapy for the Treatment of Post-Operative Pain","status":"COMPLETED","sponsor":"INSYS Therapeutics Inc","startDate":"2017-09-12","conditions":"Pain, Postoperative","enrollment":100},{"nctId":"NCT01217801","phase":"PHASE1","title":"Two Way Bioequivalence Study Under Fed Conditions","status":"COMPLETED","sponsor":"MonoSol Rx","startDate":"2008-10","conditions":"Healthy","enrollment":48},{"nctId":"NCT02174874","phase":"","title":"Ondansetron Oral Versus Orally Disintegrating Tablets (ODT)","status":"COMPLETED","sponsor":"Dr. Graham Thompson","startDate":"2011-06","conditions":"Acute Gastroenteritis","enrollment":462},{"nctId":"NCT01572012","phase":"PHASE1","title":"Phase 1 Safety, Tolerability and PK Study of Ondansetron and Hylenex Recombinant in Healthy Volunteers","status":"COMPLETED","sponsor":"Halozyme Therapeutics","startDate":"2012-02","conditions":"Healthy","enrollment":12},{"nctId":"NCT01393288","phase":"NA","title":"Developing Individualized Strategies to Prevent Nausea and Vomiting","status":"WITHDRAWN","sponsor":"University of California, San Francisco","startDate":"2013-11","conditions":"Postoperative Nausea and Vomiting, Genetic Polymorphisms","enrollment":""},{"nctId":"NCT01523119","phase":"NA","title":"Bioequivalence Study of Ondansetron Orally Disintegrating Tablets 8mg Under Fed Conditions","status":"COMPLETED","sponsor":"Ranbaxy Laboratories Limited","startDate":"2006-07","conditions":"Healthy","enrollment":35},{"nctId":"NCT01523093","phase":"NA","title":"Bioequivalence Study of Ondansetron Orally Disintegrating Tablets 8mg Under Fasting Conditions","status":"COMPLETED","sponsor":"Ranbaxy Laboratories Limited","startDate":"2006-07","conditions":"Healthy","enrollment":32},{"nctId":"NCT00659074","phase":"PHASE1","title":"Bioavailability Study of Ondansetron 24 mg Orally Disintegrating Tablets Under Fasting Conditions","status":"COMPLETED","sponsor":"Par Pharmaceutical, Inc.","startDate":"2003-10","conditions":"Healthy","enrollment":24},{"nctId":"NCT00659685","phase":"PHASE1","title":"Bioavailability Study of Ondansetron 16 mg Orally Disintegrating Tablets Under Fasting Conditions","status":"COMPLETED","sponsor":"Par Pharmaceutical, Inc.","startDate":"2003-11","conditions":"Healthy","enrollment":24},{"nctId":"NCT00654277","phase":"PHASE1","title":"Bioavailability Study of Ondansetron Orally Disintegrating Tablets Under Fasting Conditions","status":"COMPLETED","sponsor":"Par Pharmaceutical, Inc.","startDate":"2002-08","conditions":"Healthy","enrollment":32},{"nctId":"NCT00653458","phase":"PHASE1","title":"Bioavailability Study of Ondansetron Orally Disintegrating Tablets Under Fed Conditions","status":"COMPLETED","sponsor":"Par Pharmaceutical, Inc.","startDate":"2002-08","conditions":"Healthy","enrollment":18}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":6,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Zofran"],"phase":"marketed","status":"active","brandName":"Ondansetron (ODT)","genericName":"Ondansetron (ODT)","companyName":"MonoSol Rx","companyId":"monosol-rx","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Ondansetron (ODT) is a small molecule medication used to treat various conditions, including solid tumors, lymphoma, concussion post syndrome, and acute gastroenteritis, as indicated by ClinicalTrials.gov. It is available in the form of orally disintegrating tablets, as seen in studies such as NCT00934921, which investigated its bioavailability under non-fasting conditions.","enrichmentLevel":3,"visitCount":2,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}