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 62 indications[4].[1]

Zofran is one of 1006 small molecule programs targeting Glioma. It is currently in Approved.

Indications

282

Total Trials

Active Trials

1,005

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

GliomaActive, not recruiting

HIV InfectionApproved

Methamphetamine DependenceActive, not recruiting

Nicotine DependenceActive, not recruiting

Neuropathic PainApproved

PoisoningActive, not recruiting

DysphagiaActive, not recruiting

Post Operative Nausea and VomitingActive, not recruiting

Wound HealingActive, not recruiting

Tic DisorderActive, not recruiting

GliomaPhase 2

Active, not recruiting

HIV InfectionApproved

Approved

Methamphetamine DependencePhase 2

Active, not recruiting

Nicotine DependencePhase 2

Active, not recruiting

Neuropathic PainApproved

Approved

PoisoningApproved

Active, not recruiting

DysphagiaPreclinical

Active, not recruiting

Post Operative Nausea and VomitingPhase 2

Active, not recruiting

Wound HealingPreclinical

Active, not recruiting

Tic DisorderApproved

Active, not recruiting

Showing 10 of 54 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Zofran

Novartis

Approved

1 2

Avastin

BBio-Thera Solutions

Preclinical

153 3

Gemzar

GGynecologic Oncology Group

Preclinical

22 4

Megace

Bristol-Myers Squibb

Preclinical

4 5

Voltaren

Novartis

Preclinical

1 6

Effexor

WWyeth-Lederle Vaccines

Preclinical

2 7

Acupan

YYonsei University

Preclinical

1 8

Avastin

Roche

Preclinical

4 9

Systemic Therapy

Bristol-Myers Squibb

Preclinical

1 10

Fentanyl Citrate

IINSYS Therapeutics Inc

Preclinical

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

Timeline

Expected Milestones

Q3 2026

Phase 1Active, not recruiting

Nausea

NCT03593811

Q4 2026

N/ARecruiting

Laparoscopic Sleeve Gastrectomy

NCT06810882

Phase 2Recruiting

Vasovagal Syncope

NCT05755737

Q2 2027

Phase 2Not yet recruiting

Immune Checkpoint Inhibitor

NCT07381634

Q3 2027

Recruiting

Infants

NCT03511118

Clinical

Trials by Indication[1]

Nausea and vomiting49 trials

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

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

Show 46 more trials

Effect of Ramosetron in Prevention of Intrathecal Morphine Induced Nausea and Vomiting

Completed·TThammasat University·Phase 3·NCT02830906·99 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

Effect of Dexmedetomidine on Prevention of Postoperative Nausea and Vomiting in Children

Completed·TTanta University·Phase 1·NCT05124067·4 enrolled

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

Depth of Hypnosis and Postoperative Nausea and Vomiting During Xenon Anaesthesia

Completed·RRWTH Aachen University·Phase 4·NCT00793663·220 enrolled

Uncomplicated Nausea and Vomiting in the Emergency Department

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

"Olanzapine for Prevention of Chemotherapy Induced Nausea and Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy (HEC)"

Completed·—·Phase 3·NCT03219710·240 enrolled

Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Vitrectomy Under Local Anesthesia

Unknown status·UUniversity of Catania·Phase 4·NCT02386059·1,200 enrolled

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

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

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

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

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

Completed·—·Phase 4·NCT04785118·165 enrolled

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

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 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

Patient Education in Preventing Nausea and Vomiting in Cancer Patients Receiving Chemotherapy

Completed·UUniversity of Rochester·N/A·NCT00005994

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

Completed·AAccenture·Phase 2·NCT01507194·131 enrolled

Pharmacogenomics and Post-Operative Nausea and Vomiting

Completed·MMayo Clinic·Phase 4·NCT03503292·92 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

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

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

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

Evaluating the Effectiveness of Ondansetron Versus Dexamethasone Versus Placebo for the Control of Intraoperative Nausea and Vomiting in Patients Undergoing Lower-segment Caesarean Section Under Spinal Anesthesia

Unknown status·MMuhammad Mubariz·Phase 4·NCT05583214·90 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

Effect of Acupuncture on Postoperative Nausea and Vomiting

Completed·—·Phase 4·NCT00674713·140 enrolled

Dexamethasone for Postoperative Nausea and Vomiting

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

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

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

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

Aprepitant Versus Ondansetron in Preoperative Triple-therapy Treatment of Nausea and Vomiting

Completed·SSergio Bergese·Phase 4·NCT01474915·122 enrolled

Haloperidol for the Treatment of Nausea and Vomiting in the ED

Completed·—·Phase 4·NCT04764344·60 enrolled

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

Completed· GSK logo

GSK·Phase 3·NCT00601172·710 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 IV Casopitant for the Prevention of Nausea and Vomiting Caused By Cisplatin-Based Highly Emetogenic Chemotherapy

Withdrawn· GSK logo

GSK·Phase 3·NCT00891761

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

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

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

Ondansetron26 trials

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

Ondansetron Augmentation in Treatment-resistant OCD

Completed·—·Phase 4·NCT01303536·21 enrolled

Show 23 more trials

Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults

Terminated·UUniversity of Maryland, Baltimore·Phase 2·NCT00890149·74 enrolled

CSF Pharmacokinetics of Ondansetron

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

The Effects of Ondansetron on Brain Function

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

Comparison of Intravenous Ondansetron and Low Dose Ketamine in Preventing Post Spinal Shivering

Completed·—·N/A·NCT07334223·180 enrolled

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

The Effect of Ondansetron on Cardiac Output in Elective Cesarean Deliveries

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

Norepinephrine Consumption After Prophylactic Ondansetron

Completed·—·Phase 4·NCT02928601·108 enrolled

Antiemetic Efficacy of Ondansetron Versus Metoclopramide

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

Chewing Gum vs. Ondansetron as Rescue Treatment for PONV in Female Patients

Active, not recruiting·MMakassed General Hospital·Phase 1·NCT07201883·90 enrolled

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

Completed· Mylan Pharmaceuticals Inc logo

Mylan Pharmaceuticals Inc·Phase 1·NCT00649363·28 enrolled

Crossover Study Comparing Ondansetron Orally Dissolving Film Strip (ODFS) With Zofran Orally Disintegrating Tablets

Completed·MMonoSol Rx·Phase 1/2·NCT01217190·48 enrolled

Evaluating Neostigmine Effect on Reducing Gastric Residual Volume as Compared With Metoclopramide and Ondansetron

Completed·TTanta University·Phase 2·NCT05342818·90 enrolled

Combined Pharmacotherapies for Alcoholism (Naltrexone/Ondansetron)

Completed·NNational Institute on Alcohol Abuse and Alcoholism (NIAAA)·Phase 2·NCT00027079·360 enrolled

Efficacy of Ondansetron in LARS Treatment

Completed·EEnte Ospedaliero Cantonale, Bellinzona·N/A·NCT03182179·48 enrolled

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

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

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

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

Bioavailability Study of Ondansetron Orally Disintegrating Tablets Under Fed Conditions

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

Chemotherapy-induced nausea and vomiting7 trials

Study of the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Fosaprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Children (MK-0517-029)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT01697579·240 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

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

Show 4 more 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 Study of Fosaprepitant (MK-0517) Plus Ondansetron Versus Ondansetron Alone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Participants (MK-0517-044)

Terminated· Merck & Co. logo

Merck & Co.·Phase 3·NCT02519842·75 enrolled

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

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

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

Nausea7 trials

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

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

Bioavailability Study of Anti Nausea Medication With and Without Food

Completed·FForest Laboratories·Phase 1·NCT00905190·22 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 4 more trials

Noninvasive Markers of Functional Nausea in Children

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

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

Terminated·OOhioHealth·Phase 4·NCT02985840·127 enrolled

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

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

Completed·GGary Morrow·Phase 3·NCT00020657

Vomiting6 trials

Postoperative Vomiting in Children - Is Dextrose an Effective Prophylactic Anti-emetic?

Completed·UUniversity of Saskatchewan·N/A·NCT01912807·300 enrolled

Post-Operative Therapy for Nausea or Vomiting

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

Prevention Post Operative Nausea Vomiting in Ambulatory Gynecologic Laparoscopy

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

Show 3 more trials

Ondansetron Reduce Vomiting Associated With Ketamine PSA

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

81 more indications

Hypotension5 trials

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

The Effect of iv Ondansetron on Reducing Hypotension Due to BCIS in Total Knee Prosthesis Surgery

Unknown status·—··NCT05405608·1 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

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

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

Dexamethasone5 trials

Ramosetron, Aprepitant and Dexamethasone Versus Ondansetron, Aprepitant and Dexamethasone

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

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

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

Ondansetron vs Ondansetron Plus Dexamethasone for Relieving Intrathecal Morphine Side Effects After C-section

Completed·MMakassed General Hospital·N/A·NCT02793843·194 enrolled

Show 2 more trials

Preoperative Oral Dexamethasone to Improve Recovery After Surgery

Unknown status·UUniversity of Manitoba·Phase 2·NCT02234466·80 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

Schizophrenia4 trials

Role of Anti-Inflammatory Agents in Patients With Schizophrenia

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

Randomized Double Blind Placebo Control Study in Patients with Schizophrenia

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

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

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

Show 1 more trial

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

Terminated· Takeda logo

Takeda·Phase 1·NCT02614586·11 enrolled

Cesarean Section3 trials

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

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

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

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

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

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

Fasting Conditions3 trials

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

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

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

Chemotherapy3 trials

Heart Safety Study of Ondansetron in Children Receiving Chemotherapy

Withdrawn·UUniversity of Oklahoma·Phase 4·NCT01896440

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

Gastroenteritis3 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

Symptomatic Treatment of Acute Gastroenteritis

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

Laparoscopic Cholecystectomy2 trials

Ondansetron Effect on Pain Relief After Laparoscopic Cholecystectomy

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

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

Completed·—·Phase 4·NCT02327923·90 enrolled

Acetaminophen2 trials

Analgesic Effect of IV Acetaminophen in Tonsillectomies

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

Antagonism Research Between Antiemetics Agents and Acetaminophen in Thyroidectomy's Post-operative Analgesia.

Completed·UUniversity Hospital, Lille·Phase 3·NCT01679093·66 enrolled

Lymphoma2 trials

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

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

Emergency Department Patient2 trials

Emergency Department (ED) Drug Interaction in Emergency Department Patients

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

Ondansetron and the QT Interval In Adult Emergency Department Patients

Completed·—··NCT01759420·28 enrolled

Pruritus2 trials

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

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

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

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

Syncope1 trial

Study of Ondansetron in the Prevention of Sleep Syncope: The Nineth Prevention of Syncope Trial (POST9)

Not yet recruiting·UUniversity of Calgary·Phase 3·NCT05657925·24 enrolled

Alcohol Use Disorder1 trial

Pharmacogenetic Study of Ondansetron in Alcohol Use Disorder

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

Postoperative Pain Control1 trial

Post Operative Pain Control After Pediatric Hip Surgery

Terminated·SSeattle Children's Hospital·N/A·NCT03435692·42 enrolled

Alpha-1 Antitrypsin Deficiency1 trial

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

Completed·UUniversity of Florida··NCT01810458·109 enrolled

PrEP1 trial

Aprepitant and Fosaprepitant Time-on-Target PET (Positron Emission Tomography) Study (0869-183)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01111851·16 enrolled

Glioma1 trial

Emend and Ondansetron Compared to Ondansetron Alone to Prevent CINV in Glioma Patients Receiving Temozolomide

Completed·KKaty Peters·Phase 2·NCT01450826·136 enrolled

Idiopathic Scoliosis1 trial

Palonosetron vs Ondansetron In PONV Prophylaxis Among Idiopathic Scoliosis Patients

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

Dyspnea1 trial

Inhaled Ondansetron & Dyspnea

Completed·MMcGill University·Phase 1·NCT01851993·30 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

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

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

Hernia1 trial

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

Unknown status·—·N/A·NCT03041948·88 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

Malignant Glioma1 trial

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

Completed·—·Phase 2·NCT02991456·48 enrolled

Papilloma1 trial

E7 TCR T Cells for Human Papillomavirus-Associated Cancers

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

Immune Checkpoint Inhibitor1 trial

The Safety and Efficacy of Ondansetron in Reducing Immune Checkpoint Inhibitor-Related Toxicities

Not yet recruiting·FFirst Affiliated Hospital of Wenzhou Medical University·Phase 2·NCT07381634·134 enrolled

Knee Arthroscopy1 trial

Ultrasound-guided Blocks for Ambulatory Knee Arthroscopy

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

Bipolar Disorder1 trial

Ondansetron for Bipolar Disorder and Alcohol Use Disorders

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

Juvenile Idiopathic Arthritis1 trial

The Ondansetron Premedication Trial in Juvenile Idiopathic Arthritis

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

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

Children1 trial

Rescue Emetic Therapy for Children Having Elective Surgery

Withdrawn·FFranklyn Cladis·N/A·NCT01067677

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

ALS1 trial

Pharmacotherapy for HIV+ Stimulant Dependent Individuals

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

Postoperative Analgesia1 trial

Postoperative Analgesia in Patients With Microvascular Decompression

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

Nerve Block1 trial

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

Completed·—·N/A·NCT03041935·90 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

Interaction1 trial

Interaction Between Tramadol and Ondansetron

Completed·—·Phase 4·NCT04745273·60 enrolled

Breast Surgery1 trial

PECS-2 for Breast Surgery

Completed·UUmeå University·N/A·NCT03117894·200 enrolled

Thoracic Surgery1 trial

Antiemetic Prophylaxis With Fosaprepitant and Ondansetron in Patients Undergoing Thoracic Surgery

Unknown status·QQilu Hospital of Shandong University·N/A·NCT05881486·234 enrolled

Laparoscopic Sleeve Gastrectomy1 trial

Intravenous Versus Perineural Ondansetron for Laparoscopic Sleeve Gastrectomy

Recruiting·TTanta University·N/A·NCT06810882·170 enrolled

Cesarean Delivery1 trial

Ephedrine Versus Ondansetron During Cesarean Delivery

Completed·—·Phase 4·NCT05127876·168 enrolled

Caesarean Section1 trial

The Effect of Ondansetron on Spinal Anesthesia in Caesarean Section

Unknown status·—·Phase 3·NCT03931863·180 enrolled

Post Operative Nausea and Vomiting1 trial

A Study To Evaluate An NK-1 Antiemetic For The Prevention Of Post Operative Nausea And Vomiting

Completed· GSK logo

GSK·Phase 2·NCT00108095·701 enrolled

Carboplatin1 trial

Low Dose Aprepitant for Patients Receiving Carboplatin

Terminated·—·Phase 2·NCT03237611·15 enrolled

Quality of Recovery1 trial

Quality of Recovery After Dexamethasone, Ondansetron or Placebo Intrathecal Morphine Administration

Completed·PPontificia Universidade Catolica de Sao Paulo·Phase 4·NCT03035942·135 enrolled

Brain Injury1 trial

Ondansetron for Pediatric Mild Traumatic Brain Injury

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

Pediatric1 trial

A Study of Aprepitant (MK-0869) in Pediatric Participants Undergoing Surgery (MK-0869-148)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT00819039·98 enrolled

Vertigo1 trial

Treating Benign Paroxysmal Positional Vertigo (BPPV) in ED Patients

Completed·LLehigh Valley Hospital·N/A·NCT00641797·26 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

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

Kidney Injury1 trial

Cisplatin Disposition and Kidney Injury

Active, not recruiting·UUniversity of Colorado, Denver·Phase 3·NCT03817970·72 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

Methamphetamine Dependence1 trial

Ondansetron for the Treatment of Methamphetamine Dependence - 1

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

Small Cell Cancer1 trial

PLX038 (PEGylated SN38) and Rucaparib in Solid Tumors and Small Cell Cancers

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT04209595·10 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

Obsessive Compulsive Disorder (OCD)1 trial

Ondansetron in Treatment Resistant Obsessive Compulsive Disorder (OCD)

Completed·—·Phase 4·NCT00796497·14 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

Headache1 trial

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

Tic Disorder1 trial

Effects of Ondansetron in Obsessive-compulsive and Tic Disorders

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

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

Infants1 trial

Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

Recruiting·—··NCT03511118·1,600 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

Cocaine Dependence1 trial

Ondansetron for the Treatment of Cocaine Dependence - 1

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

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

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

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

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 — 282 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