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Drug

Ondansetron

Regulatory activity · FDA / MHRA
Emerging researchLate-stage development

Also known as Zofran, Zuplenz, Ondansetron Hydrochloride.

RxNorm26225ChEMBLCHEMBL46UNII4AF302ESOS
2
Research papers
18
Active clinical trials
3
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 4, Randomized, Open Label Study to Evaluate the Safety and Tolerability of Twice Daily Xanomeline/Trospium Chloride (KarXT) With Prophylactic and PRN Antiemetic Use in Healthy Volunteers

Clinical trial2026-07-02Results expected Q4 2026 · ClinicalTrials.gov

Inhaled Isopropyl Alcohol for the Treatment of Nausea in a Pediatric Emergency Department: A Open Label, Randomized Controlled Clinical Trial

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

A Pilot Feasibility Study of a Steroid-Sparing Anti-Nausea and Vomiting Regimen With Netupitant/Palonosetron for Patients With Germ Cell Tumours Receiving Multi-Day Cisplatin-Based Chemotherapy at The Ottawa Hospital

Clinical trial2026-06-23Results expected Q3 2027 · ClinicalTrials.gov

Time-to-first-rescue Antiemetic With Ondansetron Plus Metoclopramide Versus Dexamethasone Plus Metoclopramide for PONV Prophylaxis in Laparoscopic Cholecystectomy: a Randomized, Triple-Blind, Superiority Trial

Clinical trial2026-06-11Results expected Q1 2027 · ClinicalTrials.gov

Randomized, Embedded, Multifactorial Adaptive Platform for Perioperative Medicine at UPMC (UPMC REMAP): Core Protocol - Enhanced Recovery Protocols (ERP)

Clinical trial2026-05-28Results posted · ClinicalTrials.gov

Antiemetic Fosaprepitant To Remedy Nausea and Vomiting

Clinical trial2026-05-18Results expected Q1 2027 · ClinicalTrials.gov

Intravenous Versus Perineural Ondansetron as an Adjuvant in Autonomic Neural Blockade for Laparoscopic Sleeve Gastrectomy: A Two-Center, Randomized, Double-Blind, Non-inferiority Trial

Clinical trial2026-05-15Results expected Q1 2027 · ClinicalTrials.gov

Recall (Class II): ONDANSETRON

Regulatory2025-12-30FDA

Drug Safety Update: Ondansetron: small increased risk of oral clefts following use in the first 12 weeks of pregnancy

Regulatory2020-01-27MHRA

Acute opioid withdrawal is associated with increased neural activity in reward-processing centers in healthy men: A functional magnetic resonance imaging study.

Research2015-05-27Drug and alcohol dependence

Drug Safety Update: Ondansetron (Zofran): important new intravenous dose restriction

Regulatory2014-12-11MHRA

Ondansetron pharmacokinetics in pregnant women and neonates: towards a new treatment for neonatal abstinence syndrome.

Research2014-12-04Clinical pharmacology and therapeutics

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Ondansetron
Aliases & brands
ZofranZuplenzOndansetron Hydrochloride
RxNorm CUI
26225
ChEMBL ID
CHEMBL46
UNII
4AF302ESOS
Regulatory jurisdictions
fdamhra

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Authorities
FDA · MHRA
Total events
3
fdaU.S. Food and Drug Administration· 1 event
2025-12-30RecallSafety
Recall (Class II): ONDANSETRON
Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 2 events
2020-01-27Safety communicationSafety
Drug Safety Update: Ondansetron: small increased risk of oral clefts following use in the first 12 weeks of pregnancy
Evidence ↗
2014-12-11Safety communicationSafety
Drug Safety Update: Ondansetron (Zofran): important new intravenous dose restriction
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

189 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
189
registered trials across all phases
LATEST COMPLETION 2025
18
Active studies
16
Recruiting
127
Late-stage (III+)
128
Completed
43
Discontinued
PHASE DISTRIBUTIONn = 189
Early Phase 14Phase 118Phase 1 / 25Phase 235Phase 2 / 37Phase 335Phase 444Phase N / A41

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Inhibition of Small Conductance Calcium-Activated Potassium Current: A New Therapeutic Approach for Atrial Fibrillation

RecruitingPH IVIndiana Universityn=802027

Time-to-first-rescue Antiemetic With Ondansetron Plus Metoclopramide Versus Dexamethasone Plus Metoclopramide for PONV Prophylaxis in Laparoscopic Cholecystectomy: a Randomized, Triple-Blind, Superiority Trial

Not yet recruitingPH IVFaisalabad Medical Universityn=2642027

A Phase 4, Randomized, Open Label Study to Evaluate the Safety and Tolerability of Twice Daily Xanomeline/Trospium Chloride (KarXT) With Prophylactic and PRN Antiemetic Use in Healthy Volunteers

Not yet recruitingPH IVKaruna Therapeutics, Inc., a Bristol Myers Squibb companyn=2252026

Effect of Ondansetron on Patient Tolerance, Efficacy and Endoscopist Workload in Unsedated Endoscopy for Upper Gastrointestinal Bleeding

Not yet recruitingPH IVPeking Union Medical College Hospitaln=802026

Effect of a 5-HT3 Receptor Antagonist on Respiratory Drive in Spontaneously Breathing Mechanically Ventilated Patients With Acute Respiratory Distress Syndrome (ARDS): a Pilot Proof-of-concept Crossover Non-randomized Controlled Trial

Unknown statusPH IVCentre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montrealn=102024

Recent completions

Trials that read out recently, adding to the completed evidence base.

Randomized, Double-Blind, Placebo-Controlled, Single-Dose, 3-Escalating Cohort, 2 Period Crossover Study Investigating the Tolerability, Safety, and Pharmacokinetics of Ondansetron Inhalation Powder

CompletedPH ILuxena Pharmaceuticals, Inc.n=242025

A Phase I/II Trial of T Cell Receptor Gene Therapy Targeting HPV-16 E7 for HPV-Associated Cancers

CompletedPH I/IINational Cancer Institute (NCI)n=2242025

A Phase 1, Randomized, Open-label, Parallel-group, Drug-drug Interaction Study to Evaluate the Effect of Antiemetic Medication on the Pharmacokinetics of AMG 133 in Participants Living With Overweight or Obesity

CompletedPH IAmgenn=592025

Comparative Clinical Study Among Ondansetron and Gabapentin in Preventing Postoperative Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy

CompletedPH IIITanta Universityn=1002025

Randomized, Embedded, Multifactorial Adaptive Platform for Perioperative Medicine at UPMC (UPMC REMAP): Core Protocol - Enhanced Recovery Protocols (ERP)

CompletedPH IIIKey trialJennifer Holder-Murrayn=3,3952025

Phase I/II Trial of PLX038 (PEGylated SN38) and Rucaparib in Solid Tumors and Small Cell Cancers

CompletedPH I/IINational Cancer Institute (NCI)n=102025

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Major research themes3
Functional Neuroimaging1Magnetic Resonance Imaging1Reward1
Journals, researchers & institutions
Top journals
  • Clinical pharmacology and therapeutics1
  • Drug and alcohol dependence1
Leading researchers
  • Alva H1
  • Carvalho B1
  • Chu LF1
  • Clark JD1
  • Clavijo C1
  • Clemenson A1
  • Drover DR1
  • Elkomy MH1
Leading institutions
free-text, unnormalised
  • Stanford University1
  • Stanford University School of Medicine1
  • University of Alabama at Birmingham1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.