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ondansetron (Zuplenz / ondansetron OFDS)

✓ Approved

Galena Biopharma, Inc. · HTR3A · Small Molecule

What is ondansetron?

ondansetron is a small molecule developed by Galena Biopharma, Inc.. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand NamesZuplenz, ondansetron OFDS
CompanyGalena Biopharma, Inc.
Drug ClassSmall Molecule
Molecular TargetHTR3A
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, Galena Biopharma, Inc.

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

PubMedBMJ supportive & palliative care2026-08-28

Cost-effectiveness analysis of fosaprepitant versus aprepitant-based antiemetic regimens in children receiving highly emetogenic chemotherapy: individual patient-level analysis of a randomised trial.

Kumar Rahul R, Sra Manraj Singh MS, Rasheed Azgar Abdul AA, Sasi Archana A et al.

To assess the trial-based cost-effectiveness of an intravenous fosaprepitant-based antiemetic regimen compared with oral aprepitant, in combination with ondansetron and dexamethasone, among children receiving highly emetogenic chemotherapy in India and the USA using individual patient-level data. Costs were estimated from a private payer perspective in India and the USA. Health outcomes were expressed as quality-adjusted life-years (QALYs). Incremental cost-utility ratio (ICUR) and incremental net monetary benefit (iNMB) were calculated. Uncertainty was evaluated through one-way deterministic sensitivity analyses. A total of 140 and 139 children were enrolled in the fosaprepitant and aprepitant groups, respectively. Mean QALYs were marginally higher in the aprepitant group (0.0118 vs 0.0116; difference: 0.0002). In India, mean costs were $33.94 in the fosaprepitant arm vs $19.73 in the aprepitant arm (difference: $14.21). In the USA, mean costs were $615.92 vs $809.73, respectively, in the two arms (difference: $193.81), favouring fosaprepitant. iNMB values of fosaprepitant compared with aprepitant were -$15.59 in India and $173.81 in the USA, indicating lack of cost-effectiveness for fosaprepitant in India but cost-effectiveness in the USA. In sensitivity analyses, the ICUR was most sensitive to the cost of fosaprepitant in India and to the utility value of the complete protection health state in the USA. Intravenous fosaprepitant, administered in combination with ondansetron and dexamethasone, was not cost-effective compared with oral aprepitant-based combination therapy in India but demonstrated cost-effectiveness in the USA.

PMID 42660630
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PubMedPediatric annals2026-08-26

Structured Approach to Pediatric Acute Gastroenteritis: Discussion of Diagnostics and Treatment of Acute Gastroenteritis in Children.

Traisman Benjamin B, Kilaru Raga R, Parikh Sonia S, Listernick Zoe Z

Pediatric acute gastroenteritis remains a leading global cause of mortality and malnutrition, accounting for 1.7 billion annual cases. Despite its prevalence, management remains variable. This article advocates for a transition from unstructured clinical "gestalt" to evidence-based frameworks in order to improve outcomes. Diagnostic evaluation should prioritize validated tools, like the Clinical Dehydration Scale and the Gorelick Scale, as physician intuition often lacks precision. Laboratory diagnostics and polymerase chain reaction testing should be reserved for severe cases or patients with high risk to avoid over testing. Management emphasizes oral rehydration therapy as the gold standard for mild-to-moderate dehydration, supported by single-dose ondansetron to reduce intravenous (IV) fluid reliance and hospitalization. Antimicrobials are indicated only for specific pathogens (eg, Shigella, Vibrio cholerae) or immunocompromised hosts. Finally, there is discussion on systemic health disparities-noting that children who are Black and not Hispanic and children who are Hispanic are statistically less likely to receive IV fluids or admission-underscoring the role of standardized guidelines in ensuring equitable, high-value care.

PMID 42644700
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PubMedNaunyn-Schmiedeberg's archives of pharmacology2026-08-25

Ondansetron versus gabapentin in preventing postoperative nausea and vomiting after laparoscopic sleeve gastrectomy: a randomized study.

Moussa Aya Gamal AG, El-Haggar Sahar Mohammed SM, El-Mahdy Tamer Mosaad TM, Mostafa Tarek Mohamed TM

Despite the use of costly serotonin (5-HT3) receptor antagonists, preventing postoperative nausea and vomiting (PONV) particularly after laparoscopic sleeve gastrectomy (LSG) remains challenging. This study was aimed at evaluating the impact of ondansetron versus gabapentin in preventing PONV in morbidly obese patients underwent LSG. In this double-blind placebo controlled parallel study, 100 morbidly obese patients who were scheduled for LSG were randomized into two groups; group 1 (n = 50) which received intravenous ondansetron 8 mg before surgery and group 2 (n = 50) which received 600 mg oral gabapentin an hour before the anticipated time of surgery. The severity of PONV using the Rhodes index and the percentage of complete response as well as intensity of pain using visual analogue scale (VAS) scores during the first 48 h were evaluated alongside with the assay of serum levels of substance P, serotonin, and vasopressin at baseline, and 24 h after surgery. The severity of PONV was comparable between both groups during the first 2 h and from 2 to 24 h postoperatively. However, fewer patients in the gabapentin group required rescue antiemetics within 24 h (P = 0.001). Gabapentin was also associated with significantly lower serum levels of both vasopressin (P = 0.001) and substance P (P = 0.014), with no difference in serotonin levels between groups. Pain intensity was significantly lower in gabapentin group at 0-2 h, 6 h, and 12 h, but not at 24 or 48 h. Based on the safety profile and known analgesic property, gabapentin could represent a cost-effective prophylactic agent for PONV in patients undergoing LSG. Clinical trial registration: ClinicalTrials.gov Identifier: NCT05620641 (11/11/2022).

PMID 42637866
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PubMedJournal of pediatric gastroenterology and nutrition2026-08-25

Food protein-induced enterocolitis syndrome in Spanish children: Results from a multicentre prospective study.

Rodríguez-Manchón Silvia S, Espín Beatriz B, Segarra Cantón Oscar O, Domínguez-Ortega Gloria G et al.

Food protein-induced enterocolitis syndrome (FPIES) is a non-immunoglobulin E (IgE)-mediated gastrointestinal food allergy characterized by delayed repetitive vomiting, often accompanied by pallor, lethargy, diarrhoea, dehydration and occasionally hypotension. Its pathophysiology remains unclear and diagnosis relies on clinical criteria. We aimed to describe the clinical characteristics, trigger profile, diagnostic pathway and management of FPIES cases in Spain. Prospective multicentre registry study conducted in Spain, including children born in 2019 diagnosed with acute or chronic FPIES according to international consensus criteria. Thirty-two FPIES episodes were recorded in 28 children; 18/28 (64%) were male. Most cases were acute (26/28, 92.8%), with mild-to-moderate severity (26/28, 92.8%). Cow's milk (CM) (19/32, 59.4%), hen's egg (5/32, 15.6%) and fish (3/32, 9.4%) were the most common food triggers, and most children reacted to a single food. Almost a third (6/19) of the CM-FPIES cases presented during exclusive breastfeeding. Despite 16/28 (57.1%) patients experiencing two or more vomiting episodes prior to diagnosis, median diagnostic delay was only 6.5 days (interquartile range 0.25-13.5). Diagnostic oral food challenge was performed in 6/26 (23%) of acute FPIES and 1/2 (50%) of chronic FPIES. Acute management included intravenous fluids, ondansetron and oral rehydration. In CM-FPIES, extensively hydrolyzed formulas were the main choice, while rice hydrolysates and elemental formulas were used less frequently. Most children reacted to a single offending food. CM remains the most frequent trigger, although hen's egg and fish are also relevant. Improved clinical awareness may have contributed to earlier diagnosis.

PMID 42638421
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PubMedLeukemia & lymphoma2026-08-24

Incidence of clinically significant chemotherapy induced nausea and vomiting with brentuximab vedotin and AVD in comparison with ABVD using standard anti-emetic prophylaxis.

Kassouf Alyssa A, Welkie Rina Li RL, Sawalha Yazeed Y, Sigmund Audrey A et al.

Chemotherapy-induced nausea and vomiting (CINV) is an important side effect of the ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) and BV-AVD (brentuximab, vedotin, doxorubicin, vinblastine, dacarbazine) regimens for classical Hodgkin lymphoma (cHL). The same anti-emetic prophylaxis strategies are commonly used for both; however, the comparative incidence of CINV between regimens is not well described. We conducted a retrospective cohort study of cHL patients treated with ABVD (n = 87) or BV-AVD (n = 57) given standard anti-emetic prophylaxis with dexamethasone and palonosetron or ondansetron. Clinically significant nausea was more frequent in the BV-AVD cohort (44% vs 20%, p < 0.01), alongside higher rates of hospitalization or emergency department visits for CINV (18% vs 2.3%, p < 0.01) and significant weight loss (40% vs 7.0%, p < 0.0001). Multivariable analysis showed BV-AVD treatment was the only variable independently associated with clinically significant CINV. These findings suggest BV-AVD is more emetogenic than ABVD and that two drug anti-emetic prophylaxis is suboptimal for AVD-based regimens.

PMID 42636147
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PubMedDrug safety2026-08-18

Antiemetic Combination Use During the First Trimester and Adverse Circulatory Outcomes in Newborn Infants: A Data-Mining Analysis.

Thai Thuy N TN, Maro Judith C JC, Brown Joshua J, Schmidt Stephan S et al.

Pregnant women sometimes need antiemetic combination therapy to control severe nausea and vomiting during pregnancy. Because promethazine, ondansetron, and metoclopramide have QT-prolonging effects, combination use may potentiate arrhythmic effects in mothers and cause circulatory conditions in infants, with promethazine combinations expected to exert stronger effects than metoclopramide combinations. We implemented tree-based scan statistics to screen for signals of adverse circulatory-related conditions in newborn infants following maternal exposure to promethazine-ondansetron combination compared to metoclopramide-ondansetron combination. We used Merative® Marketscan® Commercial Claims 2005-19 and Medicaid Analytic eXtract data 2005-15 to identify pregnant women aged 12-55 years with a live birth. To define combination use, pregnant women had to fill a prescription for a second antiemetic during the active days' supply of the first antiemetic and then refill the first antiemetic during the active days' supply of the second antiemetic. Our outcomes included circulatory diseases, individually and clustered within a hierarchical tree structure. We adjusted for potential confounders using propensity score quartile stratification and used Poisson tree-based scan statistics to screen for signals (p < 0.05). A total of 6865 and 4186 live birth deliveries with first-trimester exposure to promethazine-ondansetron combination or metoclopramide-ondansetron combination, respectively, met our inclusion criteria. After multiplicity adjustment for over 300 outcome clusters, we found three significant signals: unspecified hypotension (relative risk = 3.71, p < 0.001), chest pain (relative risk = 2.01, p < 0.001), and essential hypertension (relative risk = 1.76, p = 0.002) among infants with maternal promethazine-ondansetron combination exposure. Unspecified hypotension likely reflects neonatal conditions, whereas unspecified chest pain and essential hypertension may represent maternal conditions based on the claims origin. By scanning more than 300 infant circulatory-related outcomes, we identified unspecified hypotension as a potential safety signal among newborns whose mothers were exposed to promethazine-ondansetron combination rather than metoclopramide-ondansetron combination during the first trimester. This finding warrants further investigation and illustrates the utility of tree-based scan statistics as a hypothesis-generating tool for pregnancy medication safety research.

PMID 42611119
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