Zofran

(Ondansetron)

ApprovedSmall molecule

Ondansetron is used to prevent and treat nausea and vomiting, especially after surgery or from chemotherapy and radiation therapy for cancer.[2] Zofran is currently approved and in use across 46 indications[4].[1]

Zofran is one of 634 small molecule programs targeting Vomiting. It is currently in Approved.

Indications

286

Total Trials

Active Trials

633

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

HypotensionUnknown status

Substance Withdrawal SyndromeActive, not recruiting

Substance-Related DisorderActive, not recruiting

Cervical CancerApproved

Fish-Eye DiseaseApproved

Genital Neoplasm, FemaleApproved

Pancreas DiseaseApproved

HIV InfectionApproved

Rectum CancerActive, not recruiting

TonsillitisApproved

HypotensionApproved

Unknown status

Substance Withdrawal SyndromePreclinical

Active, not recruiting

Substance-Related DisorderPreclinical

Active, not recruiting

Cervical CancerApproved

Approved

Fish-Eye DiseaseApproved

Approved

Genital Neoplasm, FemaleApproved

Approved

Pancreas DiseaseApproved

Approved

HIV InfectionApproved

Approved

Rectum CancerPreclinical

Active, not recruiting

TonsillitisApproved

Approved

Showing 10 of 40 indications

Competition

Competitive Landscape

401 competitors in Lymphoma

#DrugCompanyPhaseTrials

Zofran

Novartis

Approved

2 2

Cabenuva

GSK

Preclinical

1 3

Norvir

AbbVie

Preclinical

1 4

Emend

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 5

Kenalog

BBausch Health Americas, Inc.

Preclinical

1 6

Nuvigil

NNuvo Research GmbH

Preclinical

1 7

Elitek

AAzienda U.S.L. 1 di Massa e Carrara

Preclinical

—8

Decadron

QQuince Therapeutics S.p.A.

Preclinical

—9

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Systemic Therapy

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Recruiting

Pancreatitis

NCT06861010

Phase 2Recruiting

Vasovagal Syncope

NCT05755737

Q1 2027

Phase 2/3Not yet recruiting

Hypotension

NCT06727201

Q4 2027

Post-ApprovalRecruiting

Atrial Fibrillation

NCT05844501

Q1 2028

Phase 2Recruiting

Diabetes Mellitus

NCT03865290

Clinical

Trials by Indication[1]

Nausea and vomiting46 trials

Acupressure and Acustimulation Wrist Bands for the Prevention of Nausea and Vomiting Caused by Chemotherapy

Completed·GGary Morrow·Phase 2·NCT00003817·700 enrolled

A Randomized Controlled Study of Rolapitant for the Prevention of Nausea and Vomiting Following Surgery (Study P04937AM1)(COMPLETED)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT00539721·619 enrolled

Dexamethasone for Postoperative Nausea and Vomiting

Completed·UUniversity of Jordan·Phase 4·NCT00825071·180 enrolled

Show 43 more trials

Effects of Ondansetron, Metoclopramide and Granisetron on Perioperative Nausea and Vomiting in Patients Undergone Bariatric Surgery

Completed·SShahid Beheshti University of Medical Sciences·Phase 3·NCT05087615·130 enrolled

Haloperidol for the Treatment of Nausea and Vomiting in the ED

Completed·—·Phase 4·NCT04764344·60 enrolled

Low Dose Olanzapine to the Prophylaxis of Nausea and Vomiting Induced by Chemotherapy in Children and Adolescents

Unknown status·FFederal Research Institute of Pediatric Hematology, Oncology and Immunology·Phase 3·NCT05346731·210 enrolled

Effect of Dexamethasone Combined With Ondansetron on Postoperative Nausea and Vomiting in Patients With Patient-controlled Analgesia After Video-assisted Thoracoscopic Surgery

Completed·YYonsei University·Phase 4·NCT01007500·123 enrolled

A Study of TAK-951 to Stop Adults Getting Nausea and Vomiting After Planned Surgery

Completed· Takeda logo

Takeda·Phase 2·NCT04557189·89 enrolled

A Study of IV Casopitant for the Prevention of Nausea and Vomiting Caused By Cisplatin-Based Highly Emetogenic Chemotherapy

Withdrawn· GSK logo

GSK·Phase 3·NCT00891761

Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting in Gynecologic Oncology Patients

Terminated·UUniversity of Michigan Rogel Cancer Center·Phase 3·NCT04503668·62 enrolled

Efficacy and Safety of Palonosetron Intravenous in Prevention of Chemotherapy Induced Nausea and Vomiting in Pediatric Patients

Completed·HHelsinn Healthcare SA·Phase 3·NCT01442376·502 enrolled

Dose-finding Study of APD403 to Prevent Nausea and Vomiting After Chemotherapy

Completed·AAcacia Pharma Ltd·Phase 2·NCT01857232·342 enrolled

Prophylactic Ondansetron in Post-op Cardiac Surgery Patients to Prevent Post-operative Nausea and Vomiting

Completed·UUniversity of British Columbia·N/A·NCT02966041·186 enrolled

Prophylactic Antiemetic Efficacy of Palonosetron Versus Ondansetron for the Prophylaxis of Postoperative Nausea and Vomiting (PONV) in Women Over 60 Years Undergoing Laparoscopic Cholecystectomy

Completed·HHospital Federal de Bonsucesso·Phase 4·NCT02541019·80 enrolled

Hyoscine Butyl-bromide Versus Ondansetron for Nausea and Vomiting During Cesarean Section Under Spinal Anesthesia

Completed·—·Phase 4·NCT04785118·165 enrolled

Comparison of the Effect of Ondansetron and Combined Ondansetron and Betahistine on Postoperative Nausea and Vomiting After Gynecological Laparoscopy

Completed·YYonsei University·N/A·NCT02026778·168 enrolled

Developing Individualized Strategies to Prevent Nausea and Vomiting

Withdrawn·UUniversity of California, San Francisco·N/A·NCT01393288

Acupuncture Point P6 Stimulation for Reduction of Nausea and Vomiting During Cesarean

Completed·RRutgers, The State University of New Jersey·Phase 4·NCT02959840·180 enrolled

Uncomplicated Nausea and Vomiting in the Emergency Department

Completed·WWellSpan Health·Phase 4·NCT00778011·137 enrolled

Comparison of Ondansetron, Metoclopramide and Promethazine for the Treatment of Nausea and Vomiting in the Adult ED

Terminated·VVanderbilt University·N/A·NCT00655642·171 enrolled

A Study Of IV Casopitant For The Prevention Of Chemotherapy Induced Nausea And Vomiting.

Completed· GSK logo

GSK·Phase 3·NCT00601172·710 enrolled

Prophylactic Effects of Ondansetron, Ramosetron, and Palonosetron on Patient-Controlled Analgesia Related Nausea and Vomiting After Urologic Laparoscopic Surgery

Completed·YYonsei University·N/A·NCT01169805·105 enrolled

Capsaicin Cream as an Adjunctive Therapy for Nausea and Vomiting of Pregnancy

Completed·WWomen and Infants Hospital of Rhode Island·Phase 2·NCT05098067·30 enrolled

A RCT of Ondansetron and Promethazine in the Treatment of Nausea and Vomiting in the Emergency Department

Completed·UUniversity of New Mexico·Phase 4·NCT00429832·120 enrolled

Pilot Study to Assess Palonosetron Versus Ondansetron as Rescue Medication in Subjects That Develop Postoperative Nausea and Vomiting (PONV) in the Postanesthesia Care Unit (PACU)

Completed· Eisai logo

Eisai·Phase 2·NCT00967499·239 enrolled

Ondansetron in Preventing Nausea and Vomiting in Patients Undergoing Stem Cell Transplant

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT00795769·49 enrolled

Effects of Intraoperative Dexamethasone and Ondansetron on Postoperative Nausea and Vomiting in Microvascular Decompression Surgery

Completed·KKhon Kaen University·N/A·NCT03685032·54 enrolled

Pharmacogenomics and Post-Operative Nausea and Vomiting

Completed·MMayo Clinic·Phase 4·NCT03503292·92 enrolled

Comparison of Postoperative Anti-nausea and Vomiting Effect Between Glycopyrronium and Ondansetron

Unknown status·TThe Second Affiliated Hospital of Chongqing Medical University·Phase 4·NCT05265507·480 enrolled

Ondansetron in Treating Patients With Advanced Cancer and Chronic Nausea and Vomiting Not Caused by Cancer Treatment

Completed·AAlliance for Clinical Trials in Oncology·Phase 3·NCT00006348·100 enrolled

Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis

Completed·VVanderbilt University·N/A·NCT02625181·27,034 enrolled

Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients

Completed·HHelsinn Healthcare SA·Phase 3·NCT01395901·670 enrolled

Effectiveness of Aprepitant in Addition to Ondansetron in the Prevention of Nausea and Vomiting Caused by Upper Abdominal Radiotherapy

Completed·UUniversity of Vermont·Phase 2·NCT00970905·52 enrolled

Ondansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department

Completed·EEmory University·Phase 2·NCT00590317·64 enrolled

Antiemetic Prophylaxis for Postdischarge Nausea and Vomiting After Hip Arthroscopy

Completed·HHospital for Special Surgery, New York·Phase 4·NCT00878228·98 enrolled

A Trial of HRS5580 in Prevention of Postoperative Nausea and Vomiting of Adults

Completed·FFujian Shengdi Pharmaceutical Co., Ltd.·Phase 2·NCT06475846·235 enrolled

Palonosetron, Ondansetron, and Dexamethasone for Delayed Nausea and Vomiting in Autologous Transplant Patients

Completed·NNorthside Hospital, Inc.·Phase 2·NCT01370408·85 enrolled

A Study to Evaluate Aprepitant for the Prevention of Post-Operative Nausea and Vomiting in Children (MK-0869-219)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT01732458·229 enrolled

Aprepitant in Preventing Nausea and Vomiting in Patients Who Are Undergoing a Stem Cell Transplant

Completed·OOHSU Knight Cancer Institute·N/A·NCT00248547·40 enrolled

Palonosetron Versus Ondansetron for the Prevention of Nausea and Vomiting

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT01031498·150 enrolled

Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting

Completed·SSeoul National University Hospital·Phase 3·NCT00971399·172 enrolled

A Study of Vestipitant (GW597599) in the Treatment of Breakthrough Postoperative Nausea and Vomiting (PONV)

Completed·AAccenture·Phase 2·NCT01507194·131 enrolled

Ondissolve in the Prophylaxis/Rescue of Radiation Induced Nausea and Vomiting

Completed·SSunnybrook Health Sciences Centre·Phase 2·NCT02006056·30 enrolled

Prevention of Postoperative Nausea and Vomiting (PONV) in Surgical Patients

Completed·VVA Office of Research and Development·N/A·NCT00757822·216 enrolled

Intravenous And Oral Casopitant (GW679769) For The Prevention Of Chemotherapy Induced Nausea And Vomiting

Completed· GSK logo

GSK·Phase 3·NCT00366834·1,840 enrolled

Clinical Trial to Investigate the Efficacy and Safety of Ondansetron (Danset - Adwia) Versus Placebo Plus the Standard of Care in the Treatment of Nausea and Vomiting in Adult Patients With Acute Gastroenteritis

Not yet recruiting·GGenuine Research Center, Egypt·Phase 3·NCT05876585·126 enrolled

Ondansetron25 trials

The Effect of Ondansetron During Intramuscular Ketamine Use in Children: A Trial in Emergency Department

Unknown status·SSeoul National University Hospital·N/A·NCT01477242·266 enrolled

Ondansetron for the Treatment of IBS With Diarrhoea (IBS-D)

Completed·UUniversity of Nottingham·Phase 4·NCT00745004·150 enrolled

Comparison of IV Fluid Loading and Ondansetron in Reduction of PONV After LC

Completed·SSiriraj Hospital·N/A·NCT03141645·171 enrolled

Show 22 more trials

The Effect of Ondansetron on Cardiac Output in Elective Cesarean Deliveries

Completed·UUniversity of British Columbia·Phase 2·NCT01841606·57 enrolled

Antiemetic Efficacy of Ondansetron Versus Metoclopramide

Unknown status·HHospital General Naval de Alta Especialidad - Escuela Medico Naval·Phase 3·NCT02619201·250 enrolled

Ondansetron, Alcohol Use, and Alcohol-Related Symptoms In HIV+ Persons

Completed·JJohns Hopkins University·Phase 2·NCT01254877·357 enrolled

Ondansetron Versus Aprepitant Plus Ondansetron for Emesis

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00954941·100 enrolled

Bioequivalence Study of Ondansetron Orally Disintegrating Tablets 8mg Under Fed Conditions

Completed·RRanbaxy Laboratories Limited·N/A·NCT01523119·35 enrolled

Examining the Effect of Ondansetron on Bowel Prep Success

Completed·SState University of New York - Downstate Medical Center·Phase 4·NCT05439772·41 enrolled

Study of APD421 With and Without Ondansetron

Completed·AAcacia Pharma Ltd·Phase 1·NCT03583489·30 enrolled

Granisetron Versus Ondansetron: Comparative Effects on ECG, QTc

Completed·TTata Memorial Hospital·Phase 4·NCT01352130·70 enrolled

Norepinephrine Consumption After Prophylactic Ondansetron

Completed·—·Phase 4·NCT02928601·108 enrolled

Bioavailability Study of Ondansetron Orally Disintegrating Tablets Under Fed Conditions

Completed·PPar Pharmaceutical, Inc.·Phase 1·NCT00653458·18 enrolled

Ondansetron Augmentation in Treatment-resistant OCD

Completed·—·Phase 4·NCT01303536·21 enrolled

Phase 1 Safety, Tolerability and PK Study of Ondansetron and Hylenex Recombinant in Healthy Volunteers

Completed·HHalozyme Therapeutics·Phase 1·NCT01572012·12 enrolled

Efficacy Study of IV Fluids Only vs Ondansetron to Treat Dehydration

Withdrawn·—·N/A·NCT00691275

EMS Use of Isopropyl Alcohol Aromatherapy Versus Ondansetron

Completed·TThe University of Texas Health Science Center at San Antonio·N/A·NCT02618343·51 enrolled

CSF Pharmacokinetics of Ondansetron

Completed·WWashington University School of Medicine·N/A·NCT02901054·19 enrolled

The Effects of Ondansetron on Brain Function

Completed·IIcahn School of Medicine at Mount Sinai·Phase 1·NCT02460341·54 enrolled

Efficacy of Co-Spinal Ondansetron In Inguinal Herniorrhaphy

Enrolling by invitation·SSuez Canal University·N/A·NCT06850740·46 enrolled

Fasting Study of Ondansetron Tablets 24 mg and Zofran® Tablets 24 mg

Completed· Mylan Pharmaceuticals Inc logo

Mylan Pharmaceuticals Inc·Phase 1·NCT00649532·28 enrolled

Mode of Action of Ondansetron, a 5-HT Receptor 3 Antagonist, in Lactulose Induced Diarrhoea

Completed·UUniversity of Nottingham·Phase 4·NCT03833999·16 enrolled

Haloperidol Versus Ondansetron for Cannabis Hyperemesis Syndrome (HaVOC)

Completed·—·Phase 4·NCT03056482·33 enrolled

Food Study of Ondansetron Tablets 24 mg and Zofran® Tablets 24 mg

Completed· Mylan Pharmaceuticals Inc logo

Mylan Pharmaceuticals Inc·Phase 1·NCT00648583·28 enrolled

Food Study of Ondansetron Orally Disintegrating Tablets 8 mg to Zofran ODT® Tablets 8 mg

Completed· Mylan Pharmaceuticals Inc logo

Mylan Pharmaceuticals Inc·Phase 1·NCT00648804·28 enrolled

Nausea8 trials

Comparison of Antiemetic Drugs in Preventing Delayed Nausea After Chemotherapy in Patients With Cancer

Completed·GGary Morrow·Phase 3·NCT00020657

Ondansetron Versus Dexamethasone/Ondansetron to Treat Acute Nausea in the Emergency Department

Terminated·OOhioHealth·Phase 4·NCT02985840·127 enrolled

Study for The Prevention Of Nausea in Cancer Patients Receiving Highly Emetogenic Cisplatin Based Chemotherapy

Completed· GSK logo

GSK·Phase 2·NCT00169572·492 enrolled

Show 5 more trials

Designing Optimal Prevention and Management of Postoperative Nausea and Emesis for Patients Undergoing Laparoscopic Sleeve Gastrectomy

Completed·SStony Brook University·Phase 4·NCT03435003·83 enrolled

Bioavailability Study of Anti Nausea Medication With and Without Food (EUR-1025)

Completed·FForest Laboratories·Phase 1·NCT00981487·22 enrolled

Noninvasive Markers of Functional Nausea in Children

Active, not recruiting·VVanderbilt University Medical Center·Phase 1·NCT03593811·42 enrolled

Isopropyl Alcohol vs Ondansetron for Nausea in the Emergency Department

Completed·—·Phase 4·NCT02760069·122 enrolled

Ondansetron vs. Dexamethasone for Postoperative Nausea

Completed·HHafiz Muhammad Hamza·Phase 4·NCT06886230·105 enrolled

Vomiting7 trials

Ondansetron With/Out Dexamethasone to Prevent Vomiting in Patients Receiving Radiation to the Upper Abdomen

Completed·NNCIC Clinical Trials Group·Phase 3·NCT00016380·211 enrolled

Trial to Evaluate Efficacy of Olanzapine With Short-acting 5HT3 Inhibitors in Chemotherapy-induced Nausea & Vomiting (CINV) Prophylaxis

Unknown status·—·Phase 2·NCT03478605·130 enrolled

Prevention Post Operative Nausea Vomiting in Ambulatory Gynecologic Laparoscopy

Completed·PPrince of Songkla University·Phase 2·NCT01543945·340 enrolled

Show 4 more trials

Post-Operative Therapy for Nausea or Vomiting

Terminated·UUniversity of California, Davis·Phase 4·NCT03075163·300 enrolled

Rolapitant Hydrochloride in Preventing Nausea/Vomiting in Patients With Sarcoma Receiving Chemotherapy

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT02732015·37 enrolled

Usage of Multiple Drugs in Treatment of Postoperative Vomiting After Laparoscopic Appendectomy

Completed·KKing Abdul Aziz Specialist Hospital··NCT04403191·240 enrolled

Ondansetron Reduce Vomiting Associated With Ketamine PSA

Completed·UUniversity of Colorado, Denver·N/A·NCT00387556·268 enrolled

Fasting Conditions6 trials

Ondansetron HCl Orally Disintegrating Tablets Under Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00934180·24 enrolled

Bioavailability Study of Ondansetron 16 mg Orally Disintegrating Tablets Under Fasting Conditions

Completed·PPar Pharmaceutical, Inc.·Phase 1·NCT00659685·24 enrolled

Ondansetron HCl Orally Disintegrating Tablets Under Non-Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00934921·24 enrolled

Show 3 more trials

Bioequivalence Study of Ondansetron Orally Disintegrating Tablets 8mg Under Fasting Conditions

Completed·RRanbaxy Laboratories Limited·N/A·NCT01523093·32 enrolled

Bioavailability Study of Ondansetron 24 mg Orally Disintegrating Tablets Under Fasting Conditions

Completed·PPar Pharmaceutical, Inc.·Phase 1·NCT00659074·24 enrolled

Bioavailability Study of Ondansetron Orally Disintegrating Tablets Under Fasting Conditions

Completed·PPar Pharmaceutical, Inc.·Phase 1·NCT00654277·32 enrolled

77 more indications

Gastroenteritis6 trials

Symptomatic Treatment of Acute Gastroenteritis

Completed·IIRCCS Burlo Garofolo·Phase 3·NCT01257672·356 enrolled

Ondansetron Versus Domperidone for Treating Vomiting in Acute Gastroenteritis in Children

Completed·—·N/A·NCT05076461·300 enrolled

Triage Administration of Ondansetron for Gastroenteritis in Children

Terminated·SSt. Justine's Hospital·Phase 2/3·NCT03052361·81 enrolled

Show 3 more trials

Ondansetron Administration to Children With Gastroenteritis, Vomiting and SOME Dehydration in EDs in Pakistan

Completed·—·Phase 4·NCT01870648·918 enrolled

Ondansetron Administration to WELL Children With Gastroenteritis Associated Vomiting in EDs in Pakistan

Completed·—·Phase 4·NCT01870635·625 enrolled

Multi-DOSE Oral Ondansetron for Pediatric Acute GastroEnteritis

Completed·UUniversity of Calgary·Phase 3·NCT03851835·1,030 enrolled

Hypotension5 trials

Interest of Intravenous Ondansetron in the Prevention of Spinal Anaesthesia-induced Hypotension in Caesarean Section

Terminated·—·N/A·NCT02862873·7 enrolled

Effects of Different Kinds, Different Doses of 5-HT3 Receptor Antagonists on Prevention of Hypotension

Unknown status·SSeoul National University Hospital·N/A·NCT01669213·100 enrolled

Reduction in Spinal-induced Hypotension With Ondansetron in Parturients Undergoing Caesarean Section

Completed·—·Phase 4·NCT02913768·160 enrolled

Show 2 more trials

Comparison Between Intravenous Hydrocortisone and Ondansetron in Prevention of Post Spinal Anesthesia Hypotension

Enrolling by invitation·NNada kamel Elgamal·N/A·NCT06930456·120 enrolled

Role of Ondansetron in Spinal Anaesthesia Induced Hypotension

Not yet recruiting·—·Phase 2/3·NCT06727201·160 enrolled

Chemotherapy-induced nausea and vomiting5 trials

A Korean Study of Efficacy and Safety of Aprepitant-based Triple Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in the First Cycle of Moderately Emetogenic Chemotherapy (Non-doxorubicin Hydrochloride [Adriamycin] and Cyclophosphamide Regimens) (MK-0869-225) (KMEC)

Completed· Merck & Co. logo

Merck & Co.·Phase 4·NCT01636947·494 enrolled

Efficacy and Safety of Fosaprepitant Dimeglumine in Preventing Chemotherapy-Induced Nausea and Vomiting (MK-0517-031)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01594749·1,015 enrolled

Dronabinol Versus Standard Ondansetron Antiemetic Therapy in Preventing Delayed-Onset Chemotherapy-Induced Nausea and Vomiting

Completed·SSolvay Pharmaceuticals·Phase 3·NCT00642512·64 enrolled

Show 2 more trials

A Study of the Safety and Efficacy of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Participants (MK-0869-208)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01362530·307 enrolled

Study of Aprepitant (MK-0869) for Chemotherapy-Induced Nausea and Vomiting (CINV) in Adolescent Participants (MK-0869-097)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00080444·50 enrolled

Cesarean Section4 trials

Prophylactic Antiemetic Efficacy of Palonosetron Versus Ondansetron for Cesarean Sections Under Regional Anesthesia

Completed·HHospital de Base·Phase 4·NCT02468323·150 enrolled

The Effect of Preventive Use of Ondansetron in the Cesarean Section Under Spinal Anesthesia

Unknown status·—·N/A·NCT02883192·100 enrolled

The Effect of Intravenous Granisetron and Ondansetron in Patients Undergoing Cesarean Section

Completed·—·Phase 3·NCT04613726·120 enrolled

Show 1 more trial

Prophylaxis Ephedrine or Ondansetron Prevents Hypotension After Spinal Anesthesia for Cesarean Section

Completed·MMahidol University·N/A·NCT02194192·168 enrolled

Schizophrenia4 trials

Evaluation of TAK-058 and Ondansetron on P50 Auditory Gating in Participants With Stable Schizophrenia

Terminated· Takeda logo

Takeda·Phase 1·NCT02614586·11 enrolled

Double Blind, Placebo-Controlled, Randomised Investigation of Ondansetron in Schizophrenia

Completed·BBayside Health·Phase 3·NCT01121042·85 enrolled

Role of Anti-Inflammatory Agents in Patients With Schizophrenia

Completed·PPakistan Institute of Living and Learning·Phase 1·NCT00929955·36 enrolled

Show 1 more trial

Randomized Double Blind Placebo Control Study in Patients with Schizophrenia

Completed·PPakistan Institute of Living and Learning·Phase 2·NCT01602029·303 enrolled

Dexamethasone4 trials

Continuous Infusion of First-Generation 5-HT3 Receptor Antagonists in Combination With Dexamethasone

Unknown status·IImmune Oncology Research Institute·Phase 3·NCT05872893·40 enrolled

A Study to Assess the Safety & Interaction Between GW679769, Dexamethasone, & Ondansetron When Taken by Healthy Adults

Completed· GSK logo

GSK·Phase 1·NCT00437229·37 enrolled

Ramosetron, Aprepitant and Dexamethasone Versus Ondansetron, Aprepitant and Dexamethasone

Unknown status·HHallym University Medical Center·Phase 3·NCT01536691·338 enrolled

Show 1 more trial

Comparative Efficacy of Dexamethasone - Ondansetron Versus Dexamethasone - Haloperidol in Reducing PONV

Completed·UUniversitas Padjadjaran·Phase 2·NCT06428084·38 enrolled

Postoperative Analgesia3 trials

Postoperative Analgesia in Patients With Microvascular Decompression

Unknown status·XXiangya Hospital of Central South University·Phase 4·NCT03152955·90 enrolled

Ondansetron's Opposite Effect on Postoperative Analgesia of Acetaminophen

Completed·MMustafa Kemal University·Phase 4·NCT02296333·80 enrolled

Effectiveness of Nalbuphine as an Adjuvant to Subarachnoid Block on Postoperative Analgesia in TURP Surgery

Completed·—·N/A·NCT06153602·80 enrolled

Emergency Department Patient2 trials

Ondansetron and the QT Interval In Adult Emergency Department Patients

Completed·—··NCT01759420·28 enrolled

Emergency Department (ED) Drug Interaction in Emergency Department Patients

Completed·UUniversity of Colorado, Denver·N/A·NCT01859715·502 enrolled

Lymphoma2 trials

Tailoring Treatment for B Cell Non-hodgkin's Lymphoma Based on PET Scan Results Mid Treatment

Unknown status·BBritish Columbia Cancer Agency·Phase 2·NCT00324467·150 enrolled

Aprepitant's Effect on Drug Metabolism in Multi-Day Combination (CHOP/R-CHOP) Chemotherapy Regimen in Lymphoma Patients

Completed·MM.D. Anderson Cancer Center·N/A·NCT00651755·23 enrolled

Chemotherapy2 trials

Ondansetron Versus Palonosetron Antiemetic Regimen Prior to Highly Emetogenic Chemotherapy(HEC)

Completed·OOhio State University Comprehensive Cancer Center·N/A·NCT01640340·40 enrolled

A Study of MK-0869 (Aprepitant) and MK-0517 (Fosaprepitant) in Pediatric Participants Receiving Chemotherapy (MK-0869-134)

Terminated· Merck & Co. logo

Merck & Co.·Phase 1·NCT00818259·92 enrolled

Pruritus2 trials

Prevention of Intrathecal Morphine Induced Pruritus: Comparison of Ondansetron and Palonosetron

Completed·KKyungpook National University Hospital·N/A·NCT01952626·80 enrolled

Does IV Ondansetron Prevent Pruritus After Intrathecal Morphine in Pediatric Patients?

Terminated·UUniversity of Michigan·Phase 4·NCT03262038·46 enrolled

Laparoscopic Cholecystectomy2 trials

Intraoperative Lidocaine Infusion vs. Esmolol Infusion for Postoperative Analgesia in Laparoscopic Cholecystectomy

Completed·—·Phase 4·NCT02327923·90 enrolled

Ondansetron Effect on Pain Relief After Laparoscopic Cholecystectomy

Completed·NNational Hepatology & Tropical Medicine Research Institute·Phase 2·NCT04468685·50 enrolled

Headache2 trials

The CHECK Trial: A Comparison of Headache Treatment in the ED: Compazine Versus Ketamine

Completed·UUniversity Medical Center of Southern Nevada·Phase 4·NCT02657031·54 enrolled

Contribution of Ondansetron to Preventing Post-Dural Puncture Headaches Following Spinal Anesthesia

Recruiting·MMongi Slim Hospital·N/A·NCT06444737·300 enrolled

Malignant Glioma2 trials

Patient Satisfaction, Efficacy and Compliance of Antiemetic Patch vs Pill in Malignant Glioma Patients

Withdrawn·—·Phase 2·NCT01952886

Rolapitant as an Antiemetic in Malignant Glioma Patients Receiving Radiotherapy and Temozolomide

Completed·—·Phase 2·NCT02991456·48 enrolled

Effectiveness1 trial

BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron

Recruiting·UUniversity of Illinois at Chicago·Phase 4·NCT04150614·90 enrolled

Anesthesia1 trial

Post Operative Shivering Following Anesthesia

Not yet recruiting·SSohag University·N/A·NCT07377903·60 enrolled

Surgical1 trial

Transversus Abdominis Plane Block in Microsurgical Breast Recon w/Abdominal Free Flap in Breast CA

Completed·SStanford University·Phase 3·NCT02601027·120 enrolled

Poisoning1 trial

Scottish and Newcastle Anti-emetic Pre-treatment for Paracetamol Poisoning Study (SNAP)

Completed·UUniversity of Edinburgh·Phase 4·NCT01050270·222 enrolled

Peripheral Blood Stem Cell Transplantation1 trial

Efficacy & Safety of the Oral Neurokinin-1 Antagonist, Aprepitant, in Combo With Ondansetron & Dexamethasone in Patients Undergoing Auto Peripheral Blood Stem Cell Transplantation

Completed·WWashington University School of Medicine·Phase 1·NCT00314743·48 enrolled

Methamphetamine Dependence1 trial

Ondansetron for the Treatment of Methamphetamine Dependence - 1

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00040053·154 enrolled

Sedation1 trial

Conscious Sedation Efficacy of the MKO Melt (Midazolam, Ketamine, Ondansetron)

Completed·AAvanti Anesthesia·N/A·NCT03653520·651 enrolled

Trial1 trial

Scheduled Prophylactic Antiemetics for Reduction of Emesis With Doxycycline (SPARED) Trial

Completed·UUniversity of Rochester·N/A·NCT02456662·319 enrolled

Adult Subject1 trial

To Investigate the Effect of Intravenous Ondansetron on Cardiac Conduction as Compared to Placebo and Moxifloxacin in Healthy Adult Subjects

Completed· GSK logo

GSK·Phase 1·NCT01449188·60 enrolled

Cardiac1 trial

5-HT3 Antagonists (Antiemetics) and Cardiac Safety

Completed·UUniversity of British Columbia··NCT02436798·266 enrolled

Breast Cancer1 trial

Effectiveness and Quality of Life Analysis of Palonosetron Against Ondansetron Combined With Dexamethasone and Fosaprepitant in Prevention of Acute and Delayed Emesis Associated to Chemotherapy Moderate and Highly Emetogenic in Breast Cancer.

Unknown status·IInstituto Nacional de Cancerologia de Mexico·Phase 2/3·NCT03606369·560 enrolled

Tic Disorder1 trial

Effects of Ondansetron in Obsessive-compulsive and Tic Disorders

Completed·NNYU Langone Health·Phase 4·NCT03239210·110 enrolled

Cognitive Change1 trial

Neurobiological and Cognitive Changes Following Exposure to Either Sevoflurane- or Propofol-based Anesthesia in Children

Completed·UUniversity of Calgary·Phase 3·NCT03022240·50 enrolled

Hand Surgery1 trial

Effects of Systemic or Adjunct Tramadol Addition to Lidocaine Used for IVRA in Patients Undergoing Hand Surgery

Completed·—·Phase 3·NCT02658721·60 enrolled

Juvenile Idiopathic Arthritis1 trial

The Ondansetron Premedication Trial in Juvenile Idiopathic Arthritis

Completed·UUniversity of British Columbia·N/A·NCT04169828·52 enrolled

Obsessive Compulsive Disorder (OCD)1 trial

Ondansetron in Treatment Resistant Obsessive Compulsive Disorder (OCD)

Completed·—·Phase 4·NCT00796497·14 enrolled

Vasovagal syncope1 trial

A Proof of Principle Study of Ondansetron for the Prevention of Vasovagal Syncope: The Eleventh Prevention of Syncope Trial (POST11)

Recruiting·UUniversity of Calgary·Phase 2·NCT05755737·70 enrolled

Laparoscopic Surgery1 trial

Therapeutic Efficacy of Ramosetron for Treatment of Established PONV After Laparoscopic Surgery

Completed·YYonsei University·N/A·NCT03017222·80 enrolled

ALS1 trial

Pharmacotherapy for HIV+ Stimulant Dependent Individuals

Unknown status·UUniversity of Virginia·N/A·NCT00599573·12 enrolled

Cocaine Dependence1 trial

Ondansetron for the Treatment of Cocaine Dependence - 1

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00033085·60 enrolled

Alcohol Dependence1 trial

Ondansetron With Olanzapine for the Treatment of Alcohol Dependence: A Preliminary Clinical Trial

Completed·UUniversity of Virginia·Phase 2·NCT00678457·40 enrolled

Children1 trial

Rescue Emetic Therapy for Children Having Elective Surgery

Withdrawn·FFranklyn Cladis·N/A·NCT01067677

Prospective1 trial

A Prospective, Multicenter, Study of APF530 (Granisetron) SC for Prevention of CINV in Patients Receiving HEC

Completed·HHeron Therapeutics·Phase 3·NCT02106494·942 enrolled

Overweight1 trial

A Trial to Evaluate Interactions Between Antiemetic Medication and AMG 133 in Participants Living With Overweight or Obesity

Completed· Amgen logo

Amgen·Phase 1·NCT07310563·59 enrolled

Locally Advanced1 trial

Avastin, Fluorouracil, Doxorubicin and Streptozocin in Locally Advanced and Metastatic Pancreatic Endocrine Tumors

Terminated·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT00609765·1 enrolled

Nerve Block1 trial

Evaluating Pain Outcomes of Caudal vs Ilioinguinal Nerve Block in Children Undergoing Orchiopexy Repair

Completed·—·N/A·NCT03041935·90 enrolled

Enhanced Recovery1 trial

Enhanced Recovery Pathway for Endoscopy

Withdrawn·NNorthwestern University·Phase 4·NCT04983498

Advanced Cancer1 trial

Phase 1 Every-3-Week Dosing of SCH 727965 in Patients With Advanced Cancer (Study P04630)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT00871910·81 enrolled

Vaginal Cancer1 trial

Oral Ondansetron Versus Transdermal Granisetron (Sancuso) for Women With Cervical, Endometrial or Vaginal Cancer Receiving Pelvic Chemoradiation

Completed·MM.D. Anderson Cancer Center·Phase 3·NCT01536392·76 enrolled

Nicotine Dependence1 trial

Role of Metabolites in Nicotine Dependence (3) - 6

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00000289

Gene Therapy1 trial

T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT05035407·36 enrolled

Carboplatin1 trial

Low Dose Aprepitant for Patients Receiving Carboplatin

Terminated·—·Phase 2·NCT03237611·15 enrolled

Obsessive-Compulsive Disorder1 trial

Efficacy and Safety Study of Low-Dose Ondansetron For Adjunctive Therapy In Adult Patients With Obsessive-Compulsive Disorder

Terminated·TTranscept Pharmaceuticals·Phase 2·NCT01275248·130 enrolled

Papilloma1 trial

E7 TCR T Cells for Human Papillomavirus-Associated Cancers

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT02858310·224 enrolled

Brain Injury1 trial

Ondansetron for Pediatric Mild Traumatic Brain Injury

Completed·SSt. Justine's Hospital·Phase 1·NCT01815125·16 enrolled

Dyspnea1 trial

Inhaled Ondansetron & Dyspnea

Completed·MMcGill University·Phase 1·NCT01851993·30 enrolled

Randomized Controlled Trial1 trial

Ondansetron As a Strategy for Reducing Propofol Injection Pain in Pediatrics: a Randomized Controlled Trial

Recruiting·EEmory University·Phase 2·NCT05378113·120 enrolled

Opioid Withdrawal1 trial

5HT3 Antagonists to Treat Opioid Withdrawal and to Prevent the Progression of Physical Dependence

Completed·SStanford University·N/A·NCT01549652·133 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Ondansetron Versus Metaclopromide Treatment in Infants With Gastro Oesophageal Reflux

Completed·MMuhammad Aamir Latif·N/A·NCT06898268·290 enrolled

Pregnancy1 trial

Ondansetron VS Doxylamine and Pyridoxine in Treating Nausea of Pregnancy

Completed·UUnited States Naval Medical Center, San Diego·N/A·NCT01668069·36 enrolled

Ondansetron Lozenge1 trial

Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Tonsillectomy

Not yet recruiting·TTanta University·N/A·NCT07489742·210 enrolled

Dysphagia1 trial

Trial- Dysphagia From ETT or GI Endoscopy

Withdrawn·—·N/A·NCT02460055

Knee Arthroscopy1 trial

Ultrasound-guided Blocks for Ambulatory Knee Arthroscopy

Completed·JJens Borglum Neimann·Phase 4·NCT01837394·60 enrolled

Alcohol Use Disorder1 trial

Pharmacogenetic Study of Ondansetron in Alcohol Use Disorder

Completed·UUniversity of Maryland, Baltimore·Phase 2·NCT02354703·293 enrolled

Idiopathic Scoliosis1 trial

Palonosetron vs Ondansetron In PONV Prophylaxis Among Idiopathic Scoliosis Patients

Completed·UUniversity of Malaya·Phase 4·NCT05956899·92 enrolled

Acetaminophen1 trial

Analgesic Effect of IV Acetaminophen in Tonsillectomies

Completed·NNationwide Children's Hospital·Phase 2·NCT01691690·250 enrolled

Pancreatitis1 trial

Evaluating the Safety and Efficacy of Ondansetron in the Prevention of Post Endoscopic Retrograde Cholangiopancreatography Pancreatitis

Recruiting·TTanta University·Phase 3·NCT06861010·44 enrolled

Septic Shock1 trial

The Efficacy of Adjunctive Use of Ondansetron in Patients With Sepsis and Septic Shock

Unknown status·NNoha Mansour·Phase 1/2·NCT05402553·40 enrolled

Spinal Anesthesia1 trial

Intravenous Ondansetron to Attenuate the Hypotensive, Bradycardic Response to Spinal Anesthesia in Healthy Parturients

Completed·UUniversity of Virginia·Phase 2/3·NCT01414777·68 enrolled

Single Dose1 trial

Evaluation of Fosaprepitant (MK0517) in Single Dose Schedule (0517-017)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00619359·2,322 enrolled

Induction Chemotherapy1 trial

Study to Evaluate the Effect of Aprepitant in Children and Adolescents Receiving AML Remission Induction Chemotherapy

Unknown status·DDr Atul Sharma·Phase 3·NCT02979548·116 enrolled

ARDS1 trial

5-HT3 Receptor Antagonist and Respiratory Drive in Patients With ARDS

Unknown status·CCentre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal·Phase 4·NCT05514483·10 enrolled

Cesarean Delivery1 trial

Dexamethasone vs Ondansetron After Cesarean Delivery

Completed·—·Phase 4·NCT05692245·100 enrolled

Caesarean Section1 trial

Hemodynamic Protection of Preoperative Ondansetron 15 Minutes Before Spinal Anaesthesia in Caesarean Section

Completed·UUniversity of Jordan·Phase 3·NCT04140058·151 enrolled

Alpha-1 Antitrypsin Deficiency1 trial

Liver Fibrosis in Alpha-1 Antitrypsin Deficiency (Liver AATD)

Completed·UUniversity of Florida··NCT01810458·109 enrolled

Irritable Bowel Syndrome1 trial

TReatment of Irritable Bowel Syndrome With Diarrhoea Using Titrated ONdansetron Trial

Completed·UUniversity of Leeds·Phase 3·NCT03555188·80 enrolled

Medication1 trial

New Medication Treatment for Stimulant Dependence

Completed·UUniversity of Virginia·Phase 2·NCT00689572·108 enrolled

Hyperemesis Gravidarum1 trial

Validating the Effect og Ondansetron and Mirtazapine in Treating Hyperemesis Gravidarum

Terminated·NNordsjaellands Hospital·Phase 2·NCT03785691·58 enrolled

Bipolar Disorder1 trial

Ondansetron for Bipolar Disorder and Alcohol Use Disorders

Completed·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT02082678·70 enrolled

Efficacy1 trial

The Efficacy of B6 and Metoclopramide Combination in Comparison With the Other Antiemetics

Completed·UUniversity of Baghdad·Phase 2/3·NCT06390787·250 enrolled

Diabetes Mellitus1 trial

Effects of Ondansetron on Gastrointestinal Sensorimotor Dysfunctions in Diabetes Mellitus and Dyspepsia

Recruiting·MMayo Clinic·Phase 2·NCT03865290·150 enrolled

Fed1 trial

Two Way Bioequivalence Study Under Fed Conditions

Completed·MMonoSol Rx·Phase 1·NCT01217801·48 enrolled

Atrial Fibrillation1 trial

Ondansetron for the Management of Atrial Fibrillation

Recruiting·IIndiana University·Phase 4·NCT05844501·80 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 4, 1991

ZOFRAN

NDA NDA020007

Dec 31, 1992

ZOFRAN

NDA NDA020103

Jan 31, 1995

ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

NDA NDA020403

Jan 24, 1997

ZOFRAN

NDA NDA020605

Jan 27, 1999

ZOFRAN ODT

NDA NDA020781

Jul 2, 2010

ZUPLENZ

NDA NDA022524

Sources

References

[1]
ClinicalTrials.gov — 286 trial records for Ondansetron. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Zofran drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Ondansetron compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Ondansetron. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA022524). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Zofran. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Serotonin 3a (5-Ht3a) Receptor Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Novartis

Patent Landscape[6]

Patent Cliff

Nov 23, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8580830Nov 23, 2029

9095577Jul 13, 2030