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ondansetron (ondansetron, ODT / Zofran ODT)

✓ Approved

GSK · HTR3A · Small Molecule

What is ondansetron?

ondansetron is a small molecule developed by GSK. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand Namesondansetron, ODT, Zofran ODT
CompanyGSK
Drug ClassSmall Molecule
Molecular TargetHTR3A
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, GSK

Mechanism of Action

Molecular Targets

ondansetron acts on 1 molecular target:

HTR3A5-hydroxytryptamine receptor 3A (5-HT3R, 5-HT-3)
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Related Research Articles

PubMedAsia-Pacific journal of clinical oncology2026-10-15

Selective Serotonin Receptor (5-HT3) Antagonist Prescribing in Cancer Inpatients: A Retrospective Clinical Audit.

Corey Henshaw H, Gray Matthew M, Bui Kim Tam KT, Linton Anthony A

Selective serotonin receptor (5-HT3) antagonists are first-line antiemetics for chemotherapy-induced, radiotherapy-induced, and post-operative nausea and vomiting; other causes of nausea in advanced cancer warrant alternative agents. We aimed to determine patterns of inpatient 5-HT3 antagonist prescribing and its guideline concordance. We retrospectively reviewed electronic medical records of all patients admitted under Medical Oncology at a single metropolitan hospital over 6 months who were prescribed a 5-HT3 antagonist. Data on demographics, cancer, and the prescription (agent, indication, prescriber, duration, administration) were extracted and reviewed for guideline concordance. Analyses were descriptive. Of 210 patients admitted between January and June 2025, 81 (38.6%) were prescribed a 5-HT3 antagonist. Mean age was 64.2 years (range 24-87); 41 (50.6%) were female, and 62 (76.5%) had metastatic cancer. Of 137 prescriptions written, 134 (97.8%) were for ondansetron. Nausea was documented in 104 (75.9%), but a specific cause in only 55/104 (52.9%). The most common prescribers were Emergency (62, 45.3%) and After-Hours (32, 23.4%) doctors. Prescriptions were brief (median 1 day); 82 (59.9%) were administered at least once, and 62/82 (75.6%) were single-dose. Overall, 93 (67.9%) were non-concordant. Concordance was 10/14 (71.4%) in Medical Oncology, 20/21 (95.2%) in anesthetics and intensive care, 4/4 (100%) in Radiation Oncology, and 4/4 (100%) in Palliative Care, but 2/62 (3.2%) in Emergency and 4/32 (12.5%) in After-Hours prescribers. 5-HT3 antagonists were frequently prescribed outside guideline recommendations, particularly by clinicians less familiar with cancer. Targeted education, electronic order-set redesign, and structured documentation of the suspected mechanism of nausea may improve guideline-concordant antiemetic prescribing.

PMID 42878036
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PubMedJournal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners2026-10-11

Add-on oral amisulpride for prevention of chemotherapy-induced nausea and vomiting during highly emetogenic chemotherapy: A randomized double-blind placebo-controlled group sequential trial.

Gr Gayathri G, Ramasubbu Mathan Kumar MK, Mishra Archana A, Hota Debasish D et al.

IntroductionGuideline-based prophylaxis prevents most vomiting during highly emetogenic chemotherapy (HEC), but nausea remains incompletely controlled, especially where NK1 receptor antagonists and olanzapine are inaccessible or ineffective. Amisulpride, a dopamine D2/D3 antagonist, may add benefit with less sedation than olanzapine.MethodsAdults receiving cisplatin-based or anthracycline-cyclophosphamide HEC were studied during a single cycle in this randomized, double-blind, placebo-controlled group sequential trial. All received intravenous ondansetron and dexamethasone on day 1 plus oral dexamethasone 8 mg twice daily on days 2-4, with oral amisulpride (25 mg before chemotherapy, then 12.5 mg nightly for 3 days) or placebo. The primary endpoint was the 4-day (0-96 h) no-nausea responder rate; the planned sample size of 94 targeted an 18 percentage-point improvement. Two interim and one final analysis used O'Brien-Fleming efficacy and futility boundaries.ResultsThe trial stopped for futility at the second interim analysis (70 participants; 35 per arm). No-nausea response was 65.7% with amisulpride versus 57.1% with placebo (risk difference 8.6 percentage points; 95% CI -14.2 to 31.3; p = 0.461). Complete response (no emesis or rescue medication) was 80.0% versus 68.6% (p = 0.274). VAS, FLIE, rescue medication use, and adverse-event frequency were similar, apart from more frequent constipation with amisulpride.ConclusionsThe 8.6 percentage-point difference favored amisulpride but fell short of the 18-point practice-changing MCID, in a well-controlled placebo arm. Without an olanzapine- or NK1-containing comparator, the trial cannot position amisulpride against those regimens, nor exclude a smaller benefit worth having where they are inaccessible.

PMID 42858047
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PubMedClinical pharmacology in drug development2026-10-09

Pharmacokinetic and Bioequivalence of Mirtazapine Orally Disintegrating Tablets: A Randomized, Crossover Study.

Liew Kai Bin KB, Yee Kar Ming KM, Nalaiya Jeyashanthini J, Amran Atiqah A et al.

The study aimed to assess the bioequivalence of a new generic orally disintegrating tablet (ODT) formulation containing mirtazapine 30 mg with the reference formulation, and to support biowaiver for an additional 15 mg strength. Fifty-five healthy Malaysian males completed an open-label, balanced, randomized, 2-treatment, 2-period, single oral dose study with a 14-day washout period under fasting conditions. Each participant received a single 30 mg dose of mirtazapine test or reference ODT. Plasma concentrations of mirtazapine up to 72 h post-dose were quantified using a validated high-performance liquid chromatography-tandem mass spectrometry detection method following a liquid-liquid extraction. Non-compartmental analysis was used to derive the pharmacokinetic parameters, which were then compared between the test and reference formulations using a multivariate analysis of variance. The pharmacokinetic parameters of the test formulation were not statistically different from the reference formulation. The 90% confidence intervals of mirtazapine for AUC0-72 and Cmax concentration were within 80%-125% based on the bioequivalence acceptance range criteria. The test and reference formulations of mirtazapine 30 mg ODT are bioequivalent and well tolerated under fasting conditions. These findings support the extrapolation of bioequivalence and the justification of a biowaiver for the additional mirtazapine ODT 15 mg strength.

PMID 42850927
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PubMedComputer methods in biomechanics and biomedical engineering2026-10-09

Comparing Maximally Collapsing Metric Learning and Optimized Tunable Q-Wavelet Transform for Schizophrenia Identification Using EEG Signals.

Djemili Rafik R

Electroencephalography (EEG) is a noninvasive technique for recording brain electrical activity and supporting the assessment of psychiatric disorders. This study proposes a framework for distinguishing individuals with Schizophrenia (SZ) from healthy subjects using EEG data. The approach employs a transformer based on Maximally Collapsing Metric Learning (MCML) applied to feature-vector matrices and compares it with optimized Tunable Q-Wavelet Transform (TQWT) decomposition. Eight nonlinear features are extracted from both approaches and evaluated using *k*-Nearest Neighbor (*k*-NN), Optimized Decision Tree (ODT), and Deep Neural Network (DNN) classifiers. Results achieve accuracies of 100%, 99.94%, and 99.91%, respectively, using one electrode channel.

PMID 42854099
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PubMedPloS one2026-10-08

Association of 5-hydroxytryptamine 3 receptor antagonists with prognosis in patients with advanced hepatocellular carcinoma: A propensity score-matched study.

Zhang Xiaoge X, Wang Xiaoyun X, Li Na N, Han Qunying Q et al.

5-Hydroxytryptamine and its receptor are involved in hepatocarcinogenesis. This study investigated the effects of 5-hydroxytryptamine 3 receptor antagonists (5-HT3RAs) on the prognosis of patients with advanced hepatocellular carcinoma (HCC). Patients with advanced HCC who received best supportive care were analyzed. Overall survival (OS) between 5-HT3RA users and nonusers was compared. Propensity score matching (PSM) was used to balance variables. Factors associated with prognosis were identified by Cox regression. A total of 1141 patients with advanced HCC were included and 102 of them received 5-HT3RAs. 5-HT3RA treatment was significantly associated with reduced mortality [hazard ratio (HR) = 0.690; 95% confidence interval (CI): 0.546-0.871; p = 0.002]. After 1:2 PSM (n = 89 and n = 161 in 5-HT3RA user and nonuser groups, respectively), 5-HT3RA treatment remained significantly associated with reduced mortality (HR = 0.615; 95% CI: 0.457-0.829; p = 0.001). Subgroup analysis of hepatitis B virus-associated HCC patients yielded similar findings. Subgroup analysis of 5-HT3RAs also yielded similar findings, showing that the 5-year OS was significantly higher in tropisetron users than nonusers (23.7% vs. 10.9%, p = 0.004) after PSM. The use of ondansetron (HR = 0.603; 95% CI: 0.365-0.995; p = 0.048) or tropisetron (HR = 0.477; 95% CI: 0.299-0.759; p = 0.002) was independent factor associated with improved prognosis after PSM. Taken together, this study shows that the use of 5-HT3RAs is associated with improved OS and the use of ondansetron or tropisetron was independently associated with a better prognosis in patients with advanced HCC, indicating a favorable effect of 5-HT3RAs on HCC patients.

PMID 42848747
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PubMedTransfusion2026-10-07

No difference in alloimmunization of pregnant adults with sickle cell disease exposed to chronic versus on-demand transfusions: A two-center retrospective cohort study.

Zarka Clare C, Daniel David D, Menon Vinal V, Choupa Sacha S et al.

Pregnant people with sickle cell disease (SCD) experience high morbidity and mortality, even when RBC transfusion is safe and available. There is a lack of consensus on transfusion use partly due to concern for alloimmunization. This study examined alloimmunization in SCD pregnancies managed with chronic transfusion therapy (CTT) versus on-demand transfusion (ODT). A secondary aim was to quantify the proportion of SCD pregnancies that met guideline indications for CTT that received CTT in pregnancy. This is a two-center, retrospective study of pregnancy in SCD over two decades. We compared alloimmunization between those who received CTT versus ODT by examining the Sickle Cell Pregnancy and Reproductive Knowledge Syndicate database. A secondary analysis applied American Society of Hematology (2020) and/or British Society for Haematology (2021) criteria for CTT in pregnancy to calculate guideline compliance. Among 145 subjects, 26 received CTT and 119 received ODT. Alloimmunization incidence was 4%, with no significant difference by transfusion group (1/26 CTT vs. 5/119 ODT, p = 1.0). Five ODT subjects became alloimmunized (5/46). One CTT subject was alloimmunized (1/26) after receiving an unplanned ODT. Of all pregnancies, 87% met ASH criteria and 65% met BSH criteria for CTT, while 20% received CTT. For patients with SCD in pregnancy, CTT may not pose a greater alloimmunization risk than ODT. CTT may be underutilized for SCD in pregnancy. Our study is limited by incomplete data and variable antigen matching practices. Prospective research will help establish the appropriate role of CTT in SCD pregnancies.

PMID 42841532
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