Ondansetron clinical trials
Ondansetron is named as an intervention in 20 current clinical trials in our Egypt, Canada, China, Turkey, Mexico, USA, Brazil, Australia and Israel registers. 11 are recruiting patients now. The most common phase is Phase 4. The sponsor with the most trials is Tanta University (4). The most-studied condition is Ondansetron. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Ondansetron is approved
All regulators →Of the three regulators tracked here, the first to approve Ondansetron was the US, on 4 Jan 1991. It is approved in 2 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Ondansetron
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Ondansetron works
All drug targets →- Serotonin 3a (5-HT3a) receptor antagonist AntagonistTarget: HTR3A 5-hydroxytryptamine receptor 3A✓ In ChEMBL and the Guide to Pharmacology
- PainPhase 3
- VomitingPhase 3
- Acute kidney injuryPhase 3
- Alcohol dependencePhase 3
- Cesarean sectionPhase 3
- GastroenteritisPhase 3
- Schizoaffective disorderPhase 3
- SchizophreniaPhase 3
- BradycardiaPhase 2
- HallucinationsPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL46, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 2290, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Ondansetron
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 27 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Ondansetron
- ATC code
- A04AA01
- ChEMBL
- CHEMBL46
- DrugBank
- DB00904
- PubChem CID
- 4595
- CAS number
- 99614-02-5
- FDA UNII
- 4AF302ESOS
- Wikidata
- Q410011
- Wikipedia
- Ondansetron
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Ondansetron
20 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Ondansetron in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Ondansetron. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
Postoperative recovery with the addition of long-acting NK1- and 5-HT3 receptor antagonists as prophylaxis for post-operative nausea and vomiting. A prospective, double-blind, randomized trial in laparoscopic surgery.
2025-522529-36-00 · CTIS ↗ · Anesthesia and Analgesia
|
Phase 3 | Authorised | Region Vaesternorrland, Umea University | Sweden |
Ondansetron across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
27 single-substance products containing Ondansetron on the HPRA medicines list.
- Emizof 4 mg film-coated tabletsViatris Limited · PA23266/041/001 · Marketed
- Emizof 8 mg film-coated tabletsViatris Limited · PA23266/041/002 · Marketed
- Ondansetron 2 mg/ml Solution for InjectionNoridem Enterprises Limited · PA1122/004/001 · Marketed
- Ondansetron 2 mg/ml Solution for Injection or InfusionViatris Limited · PA23266/040/001 · Marketed
- Ondansetron 2 mg/ml Solution for Injection or InfusionAccord Healthcare Ireland Ltd. · PA2315/168/001 · Marketed
Supply shortages
No entry for Ondansetron in the EMA, FDA or German BfArM shortage lists we track.
Recent approvals
- Ondansetron HydrochlorideFDA · 13 Jul 2015 · Generic (ANDA) · Accord Hlthcare
Conditions studied with Ondansetron
36 conditionsAll 36 conditions
| Condition (as registered) | Trials |
|---|---|
| Ondansetron | 4 |
| Postoperative Nausea and Vomiting | 2 |
| Spinal Anaesthesia Induced Hypotension | 2 |
| Lozenge | 2 |
| Intravenous | 2 |
| Healthy Volunteers | 1 |
| Nausea With Vomiting Chemotherapy-Induced | 1 |
| Hepatocellular Carcinoma (HCC) | 1 |
| IrAE | 1 |
| Spinal Anesthesia-Induced Hypotension | 1 |
| Cerebral Oxygenation | 1 |
| Intraoperative Nausea-retching-vomiting Episodes | 1 |
| Spinal Aneshtesia | 1 |
| Ceserean Section | 1 |
| Antiemetic Therapy | 1 |
| Germ Cell Cancer | 1 |
| Lactating Women on Select DOI | 1 |
| Breastfed Infants of Mothers on Select DOI | 1 |
| Vasovagal Syncope (VVS) | 1 |
| Syncope | 1 |
| Sleep Syncope | 1 |
| Postoperative Sleep Quality | 1 |
| Postoperative Behaviour | 1 |
| Postoperative Recovery in Children | 1 |
| Postoperative Nausea and Vomiting (PONV) | 1 |
| Postoperative Pain Management | 1 |
| Laparoscopic Cholecystectomy | 1 |
| Chemotherapy-Induced Nausea and Vomiting (CINV) | 1 |
| Radiotherapy-induced Nausea and Vomiting (RINV) | 1 |
| Prevention | 1 |
| Hernia, Inguinal | 1 |
| Shivering | 1 |
| Post Spinal Anaesthesia Hypotension | 1 |
| Laparoscopic | 1 |
| Gastrectomy | 1 |
| Pancreatic Diseases | 1 |
Sponsors
lead sponsor per trialBy country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Ondansetron trials
How many clinical trials are testing Ondansetron?
20 current trials in our Egypt, Canada, China, Turkey, Mexico, USA, Brazil, Australia and Israel registers name Ondansetron as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Ondansetron trials recruiting patients?
Yes. 11 of the 20 trials are recruiting: 4 with sites in Egypt, 2 with sites in Canada, 2 with sites in China, 1 with sites in Turkey, 1 with sites in Mexico, 1 with sites in USA and 1 with sites in Israel. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Ondansetron clinical trials?
Tanta University (4), University of Calgary (2), Assiut University (2) and Karuna Therapeutics, Inc., a Bristol Myers Squibb company (1), among 15 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Ondansetron licensed in Ireland?
Yes. The HPRA medicines list includes 27 single-substance products containing Ondansetron, for example Emizof 4 mg film-coated tablets (Viatris Limited). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Ondansetron shortage?
Not in the lists we track: Ondansetron has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Ondansetron works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Ondansetron works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Ondansetron (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.