ondansetron / Generic mfg. - LARVOL DELTA

BARPHS: Brisbane-based Anti-Emetic Randomised Controlled Trial in the Prehospital Setting (ANZCTR) - P4 | N=172 | Recruiting | Sponsor: Queensland Ambulance Service | N=1000 ➔ 172

Enrollment change

A randomized placebo-controlled Phase 1 trial in healthy volunteers investigating safety, pharmacokinetics and pharmacodynamics of a novel menin inhibitor, balomenib (ZE63-0302): Interim analysis. (ASH 2025) - "This interim analysis focuses on the 7 SADcohorts (20, 100, 300 mg, 600 mg, 300 mg with food, 300 mg with food in high BMI participants, and 600with itraconazole) and the 3 MAD cohorts (600 mg QD, 300 mg BID, and 300/600 mg BID for 7 days).Results...The most frequent TEAE was nausea(Grade 1 or Grade 2, controllable with ondansetron)...Dose-proportional systemic exposure wasobserved, and target engagement was established. The safety of balomenib in both pre-clinical andclinical studies thus far suggest it will be an exceptional therapeutic to combine with other agents inKMT2A/MEN1 dependent malignancies."

Clinical • P1 data • PK/PD data • KMT2A • MEIS1 • NPM1

Primary analysis of the phase 3 randomized trial of selinexor and lenalidomide versus lenalidomide alone as maintenance therapy post autologous stem cell transplant for patients with newly diagnosed multiple myeloma (ALLG MM23; SEALAND) (ASH 2025) - P3 | "Introduction:Selinexor (S) is an oral selective exportin 1 inhibitor approved in relapsed multiple myeloma (MM) incombination with bortezomib (V) and dexamethasone (d)...Patients received ondansetron 8mg immediately prior to, and 8-hours following each S dose.Additional ondansetron and low-dose olanzapine were used as required for break-through nausea andvomiting...In this randomized phase III study, the addition of low-dose S to R maintenance following ASCT did notresult in a significant PFS benefit compared to R alone in NDMM. Although a higher CR rate was observedwith SR, this came at the cost of increased toxicity, including more infections, cytopenias andgastrointestinal AEs. Quality of life, as assessed by EORTC QLQ-C30 and MY20, was comparable betweenarms."

Clinical • P3 data • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Thrombocytopenia • Transplantation • XPO1

A prospective randomized, double-blind controlled trial of olanzapine versus placebo in addition to ondansetron plus dexamethasone as antiemetic prophylaxis in patients receiving moderately emetogenic chemotherapy (ESMO Asia 2025) - "Given the comparable efficacy of olanzapine, this study evaluated the effectiveness of 5 mg olanzapine (OLN) in combination with ondansetron and dexamethasone in preventing chemotherapy-induced nausea and vomiting (CINV) in patients undergoing MEC. This double-blind, randomized controlled trial included patients receiving their first cycle of oxaliplatin-, carboplatin-, or irinotecan-based chemotherapy. Olanzapine (5 mg) combined with ondansetron and dexamethasone significantly improved prevention of CINV in patients receiving MEC. This regimen may serve as a new standard of care."

Clinical • Chemotherapy-Induced Nausea and Vomiting • Oncology

Ondansetron: A Novel Treatment to Reduce the Severity of Neonatal Opioid Withdrawal Syndrome? (PubMed, Neonatal Netw) - "Could ondansetron be an answer? This column provides a brief review of a meta-analysis supporting the benefits of a behavioral approach to NOWS, a discussion about why ondansetron may be useful in NOWS, an overview of a pharmacokinetic study of ondansetron in mother-infant dyads, and a review of a recently published clinical trial of ondansetron for NOWS."

Journal

General Ondansetron Exposure and ICU Outcomes: A Comprehensive Analysis of 85,229 Critically Ill Adults Using the Medical Information Mart for Intensive Care IV (MIMIC-IV). (PubMed, Cureus) - "Conclusions Ondansetron exposure during ICU admission was independently associated with reduced in-hospital mortality. These findings suggest a potential survival benefit of a commonly used, well-tolerated antiemetic and support further prospective evaluation of ondansetron as an adjunctive therapy in critical care."

Journal • Critical care

Opportunities and challenges for the implementation of pharmacogenomics in supportive care for gastrointestinal cancer patients in Zimbabwe. (PubMed, Pharmacogenomics) - "PGX guidelines were fully implemented for tramadol, codeine, omeprazole, and ondansetron; partially for ibuprofen and celecoxib; and unimplementable for amitriptyline. There is an opportunity to improve supportive care in gastrointestinal cancer patients through pharmacogenomics though some specific medicines challenges to full implementations are due to limited registered medicines."

Biomarker • Journal • Gastrointestinal Cancer • Oncology • Solid Tumor

Does Propofol-based or Remimazolam-based Anesthesia Impact the Incidence of Postoperative Nausea and Vomiting When Used In Combination With Prophylactic Dexamethasone and Ondansetron? (PubMed, Anesth Prog) - "The incidence of PONV during 24 hours after orthognathic surgery was not significantly different when using remimazolam-based anesthesia vs propofol-based anesthesia in combination with dexamethasone and ondansetron. There were also no significant differences in the severity of PONV or the quality of recovery between the 2 groups."

Clinical • Journal • Anesthesia • Orthopedics

High-Throughput Screening Using the Self-Controlled Tree-Based Scan Statistic to Identify Medications Associated With Hospitalization for Severe Acute Liver Injury. (PubMed, Pharmacoepidemiol Drug Saf) - "High-throughput screening using tree-based scan statistics detected potentially hepatotoxic drugs for investigation in future pharmacoepidemiology studies."

Journal • CNS Disorders • Gastroenterology • Hepatology • Liver Failure • Pain

Oral Ondansetron to Improve Patient Experience of Unsedated Esophagogastroduodenoscopy Pilot Study (clinicaltrials.gov) - P4 | N=40 | Active, not recruiting | Sponsor: Peking Union Medical College Hospital

New P4 trial

Incidence of Post-Sedation Emesis in Cynomolgus (Macaca fascicularis) and Rhesus (Macaca mulatta) Macaques, and Evaluation of Prophylactic Antiemetic Efficacy. (PubMed, Animals (Basel)) - "Emesis is one of the most common side effects of ketamine sedation; however, predictors like species and sex have not been studied in macaques. Prophylactic oral administration of maropitant appears ineffective in preventing emesis in cynomolgus macaques. In contrast, prophylactic oral ondansetron is a more effective alternative in preventing emesis in these animals."

Journal • Anesthesia

Kirsten rat sarcoma G12C inhibitor treatment for a patient with relapsed metastatic lung adenocarcinoma: A case report. (PubMed, World J Clin Cases) - "After multiple-line treatment including chemotherapy, targeted therapy, and immunotherapy, disease control was achieved in a case of advanced pulmonary adenocarcinoma carrying the KRAS G12C mutation by mutation-specific inhibitor therapy, and the adverse reactions to the therapy were tolerable."

IO biomarker • Journal • Preclinical • Cough • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Respiratory Diseases • Sarcoma • Solid Tumor • KRAS

Antiemetic use during pregnancy and child neurodevelopment: population-based birth cohort study. (PubMed, BMC Med) - "This large-scale study found no association between antiemetic exposure during pregnancy and the risk of neurodevelopmental disorders or delays in children, providing reassurance for the use of antiemetics in pregnancy to treat nausea and vomiting. However, the slightly elevated risks observed in certain subgroups warrant further investigation. Meanwhile, these findings may assist in guiding decisions when considering antiemetic treatment during pregnancy."

Journal • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • Autism Spectrum Disorder • Cerebral Palsy • CNS Disorders • Developmental Disorders • Epilepsy • Genetic Disorders • Movement Disorders • Pediatrics • Psychiatry

Exploration of neural mechanisms underlying antidepressant-like property of Ziziphora clinopodioides Lam. essential oil using mouse forced swimming test: Involvement of the monoaminergic systems. (PubMed, Curr Res Physiol) - "Moreover, naloxone (non-selective antagonist for opioid receptor subtypes, 1 mg/kg), prazosin (α1-adrenergic receptor antagonist, 1 mg/kg), yohimbine (α2-adrenergic receptor antagonist, 1 mg/kg), propranolol (β-adrenergic receptor antagonist, 2 mg/kg), WAY100635 (selective 5-HT1A receptor antagonist, 0.1 mg/kg), ondansetron (5-HT3 receptor antagonist, 1 mg/kg), haloperidol (non-selective dopamine receptor blocker, 0.2 mg/kg), SCH23390 (selective dopamine D1 receptor blocker, 0.05 mg/kg), sulpiride (selective dopamine D2 receptor blocker, 50 mg/kg) and flumazenil (GABAA/BDZ receptor antagonist, 10 mg/kg) were used to ascertain the neural pathways implicated in the antidepressant-like response of EOZC. However, this effect remained unaffected by naloxone, propranolol and flumazenil. These findings indicate that EOZC elicits antidepressant-like response, which relies on its interaction with noradrenergic, serotonergic and..."

Journal • Preclinical • Addiction (Opioid and Alcohol) • DRD2

Comparison of the Effects of Hyoscine-N-Butylbromide and Ondansetron on Postoperative Nausea-Vomiting after Laparoscopic Cholecystectomy: A Prospective Randomized Study. (PubMed, Niger J Clin Pract) - "The effects of hyoscine-n-butylbromide and ondansetron on PONV and pain are similar in laparoscopic cholecystectomy. In laparoscopic cholecystectomies, hyoscine-n-butylbromide is a good alternative for PONV prophylaxis in eligible patients."

Clinical • Journal • Pain

The correlation between the use of ondansetron and mortality in sepsis associated encephalopathy patients: a retrospective ICU cohort study. (PubMed, Front Pharmacol) - "In SAE patients, OND use is associated with significantly lower short- and long-term mortality, suggesting its potential as an adjunct therapy. However, further prospective randomized controlled trials are warranted to validate these results."

Journal • Retrospective data • CNS Disorders • Critical care • Infectious Disease • Septic Shock

The Role of the Serotonergic Projection from the Dorsal Raphe Nucleus to the Insular Cortex in SUDEP (AES 2025) - "Activation of the 5-HTergic projection from the DRN to the IC significantly improves survival, reduces seizure burden, and alleviates respiratory suppression in Scn1a⁺/⁻ mice subjected to heat-induced SUDEP. This projection plays a key protective role in the pathophysiology of SUDEP."

CNS Disorders • Epilepsy • FOS

Preoperative Aprepitant Decreases Postoperative Nausea After Laparoscopic Sleeve Gastrectomy. (PubMed, R I Med J (2013)) - "The addition of preoperative aprepitant to a multimodal protocol can reduce nausea after laparoscopic sleeve gastrectomy."

Journal • Retrospective data • Gastrointestinal Disorder

A novel Ondansetron extended release injectable suspension (OERIS): evaluation of Safety, tolerability and pharmacokinetics in a phase I trial. (PubMed, Cancer Chemother Pharmacol) - "OERIS is a promising, convenient, safe anti-emetic therapy effective for acute and delayed phases (lasts for 5-days) of CINV in patients receiving chemotherapy with a single dose."

Journal • P1 data • PK/PD data • Chemotherapy-Induced Nausea and Vomiting • Oncology

Evaluation of Postoperative Pain Control in Ear Surgery (clinicaltrials.gov) - P=N/A | N=56 | Recruiting | Sponsor: Kocaeli University | Not yet recruiting ➔ Recruiting

Enrollment open • Otorhinolaryngology • Pain

Cardiotoxicity of different 5-HT3 receptor antagonists analyzed using the FAERS database and pharmacokinetic study. (PubMed, Sci Rep) - "Ondansetron concentration in cardiac tissue far exceeded that in plasma, which might partially explain the observed cardiotoxicity. In conclusion, it suggested to prioritize low cardiac toxicity 5-HT3RAs for patients especially for those with heart diseases, and to strengthen the monitoring and management of cardiac toxicity furtherly."

Journal • PK/PD data • Cardiovascular • Heart Failure • Oncology

The Nonirritating Concentrations of Midazolam, Ketamine, and Ondansetron (clinicaltrials.gov) - P4 | N=60 | Recruiting | Sponsor: Mayo Clinic | Not yet recruiting ➔ Recruiting

Enrollment open • Allergy • Immunology

PIONFORM: Peritoneal Lavage Using Saline or Saline With Ondansetron for Pain Control After Laparoscopic Cholecystectomy (clinicaltrials.gov) - P4 | N=40 | Enrolling by invitation | Sponsor: Instituto Mexicano del Seguro Social | Not yet recruiting ➔ Enrolling by invitation | Trial completion date: Dec 2025 ➔ Mar 2026 | Trial primary completion date: Dec 2025 ➔ Mar 2026

Enrollment open • Trial completion date • Trial primary completion date • Pain

Prophylactic Analgesic and Antiemetic Regimen for Medical Abortion < 70 Days (clinicaltrials.gov) - P1 | N=8 | Terminated | Sponsor: Hackensack Meridian Health | N=168 ➔ 8 | Recruiting ➔ Terminated; Inability to recruit and staffing changes

Enrollment change • Trial termination • Pain

KetHead: Multi-center RCT of IV Ketamine Efficacy and Safety in Chronic Daily Headaches (clinicaltrials.gov) - P3 | N=56 | Recruiting | Sponsor: University Health Network, Toronto | Trial completion date: Feb 2026 ➔ Jun 2026 | Trial primary completion date: Oct 2025 ➔ Feb 2026

Trial completion date • Trial primary completion date • Pain