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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

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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PubMedScientifica2026-08-28

Quality by Design-Driven Formulation Development of Cannabidiol Orally Disintegrating Tablets.

Monton Chaowalit C, Kulvanich Poj P, Sucontphunt Apirada A, Suksaeree Jirapornchai J et al.

The development of cannabidiol (CBD) orally disintegrating tablets (ODTs) is effective in treating anxiety in a patient-friendly manner. The application of Quality by Design (QbD) enhances the efficiency and robustness of the pharmaceutical development of CBD ODTs. The objective of this work was to develop a formulation for CBD ODTs using a QbD-driven approach. Quality target product profile, critical quality attributes, and an initial risk assessment were identified and evaluated. Subsequently, a Box-Behnken design was employed to analyze the effects of varied compression force, the quantity of microcrystalline cellulose, and the quantity of croscarmellose sodium to create a design space and control space. Results indicated that the design and control spaces produced tablets with hardness ranging from 4 to 6 kg-force, a disintegration time (DT) ≤ 30 s, and a friability ≤ 1%. All formulations contained 4% CBD (or 10 mg per tablet). The optimal formulation consisted of 35% microcrystalline cellulose and 1% croscarmellose sodium and was compressed at 1400 pounds per square inch. This formulation exhibited a hardness of approximately 5 kg-force, a DT of 13-15 s, and a friability of approximately 0.3%. Verification data confirmed the accuracy of the predictions made by computer software. The content uniformity and assay determined using validated high-performance liquid chromatography ranged between 90% and 100%. CBD was released from the CBD ODT in 1% sodium lauryl sulfate solution, with approximately 76% dissolved within 3 h in the dissolution study. In conclusion, the QbD-driven approach successfully facilitated the formulation development of CBD ODTs with the desired properties for the treatment of anxiety in a patient-friendly manner.

PMID 42662497
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PubMedPharmaceutics2026-08-27

Texture Analyzer-Derived SeDeM-ODT Extension for Bisoprolol Fumarate Orodispersible Tablets: Formulation Discrimination Within a Pharmacopoeial Disintegration-Compliant Space.

Afşin Çağla Ç, Şahbaz Sevinç S, Özer-Önder Setenay S, Uğurlu Timuçin T

Background/Objectives: Conventional SeDeM-ODT screening relies on physicochemical properties and endpoint disintegration tests, which may have limited discriminatory power among formulations that already meet pharmacopoeial disintegration requirements. This study aimed to extend SeDeM-ODT by incorporating texture analyzer-derived descriptors of low-volume liquid disintegration behavior. Methods: Bisoprolol fumarate was used as a low-dose model drug. Selected excipients were characterized using SeDeM and conventional SeDeM-ODT approaches. Texture analyzer distance-time profiles were used to derive swelling efficiency (SE), residue height (RH), and structural transition efficiency (STE), which were converted into SeDeM-compatible parameters. Orodispersible tablets were developed using a two-factor central composite design and evaluated for mechanical properties, pharmacopoeial disintegration, comparative dissolution performance, texture analyzer behavior, and supportive Heckel parameters. Results: All formulations met the pharmacopoeial disintegration criteria and showed rapid drug release under the applied dissolution conditions. Conventional endpoint-based responses showed limited discriminatory value within the investigated formulation space. In contrast, SE, RH, and STE differentiated formulation-dependent swelling, residual structural persistence, and transition toward structural collapse under low-volume liquid controlled-force conditions. MCC-rich formulations generally retained greater residual structure, whereas lactose-rich and/or higher-superdisintegrant formulations showed lower residual persistence. Comparative kinetic fitting and Heckel analysis supported these interpretations but did not independently establish a definitive disintegration mechanism. Conclusions: Incorporating low-volume liquid texture analyzer-derived parameters into SeDeM-ODT improved the comparative interpretation of excipient and formulation behavior. These findings suggest that pharmacopoeial disintegration compliance may coexist with distinct structural pathways not fully captured by conventional endpoints.

PMID 42654057
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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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