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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

PubMedFrontiers in pharmacology2026-07-17

Dexmedetomidine-flurbiprofen axetil-based opioid-free analgesia attenuates postoperative melatonin suppression and improves sleep quality after thyroidectomy: a randomized controlled trial.

Guo Rui R, Luo Xin X, Chen Li L, Rao Pan-Guo PG et al.

To determine whether an opioid-free patient-controlled intravenous analgesia (PCIA) regimen based on dexmedetomidine and flurbiprofen axetil improves postoperative sleep quality and affects nocturnal melatonin secretion compared to a sufentanil-based regimen in patients undergoing thyroidectomy. In this prospective, randomized, double-blind controlled trial, 96 patients undergoing thyroidectomy were randomly assigned to receive either opioid-free PCIA (dexmedetomidine, flurbiprofen axetil, and ondansetron) or opioid PCIA (sufentanil and ondansetron). PCIA was initiated 5 min before the end of surgery. The primary outcome was postoperative sleep quality, assessed using the Richards-Campbell Sleep Questionnaire (RCSQ). Secondary outcomes included urinary 6-sulfatoxymelatonin (6-SMT) excretion normalized to creatinine, detailed sleep parameters, anxiety levels, pain intensity, sedation levels, and postoperative adverse events. Assessments of sleep quality, urinary 6-SMT excretion, and anxiety levels were performed preoperatively (T0) and on postoperative days 1 (T1) and 2 (T2). Pain intensity (assessed by the Visual Analog Scale, VAS) and sedation levels (assessed using the Ramsay Sedation Scale) were measured at postoperative hours 1, 6, 24, and 48. Patients in the opioid-free group exhibited significantly higher RCSQ scores at T1 and T2, indicating improved postoperative sleep quality (all P < 0.001). Correspondingly, urinary 6-SMT excretion was significantly higher in the opioid-free group at both postoperative time points (P < 0.001), suggesting better preservation of nocturnal melatonin secretion. Detailed sleep parameters showed shorter sleep latency, fewer nocturnal awakenings, and longer total sleep time in the opioid-free group (all P < 0.01). Anxiety levels were significantly lower in the opioid-free group (P < 0.001). Postoperative pain intensity and sedation levels were comparable between groups at all time points (all P > 0.05). The incidences of nausea, vomiting, and pruritus were significantly reduced in the opioid-free group (P < 0.05). An opioid-free PCIA regimen based on dexmedetomidine and flurbiprofen axetil provides non-inferior postoperative analgesia while attenuating postoperative melatonin suppression, improving sleep quality, reducing anxiety, and decreasing opioid-related adverse events. This opioid-sparing strategy may represent an effective approach to enhance postoperative recovery after thyroidectomy. https://www.chictr.org.cn, identifier ChiCTR2400079949. 01/17/2024.

PMID 42465992
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PubMedBMC anesthesiology2026-07-17

Comparison of ultrasound-guided erector spinae plane block to intrathecal morphine for postoperative analgesia in patients undergoing elective lumbar fusion operations under general anesthesia: a randomized controlled trial.

Ashoor Tarek Mohamed TM, Abdelaal Hany Abdelnaby Shehata HAS, Elewa Gamal Eldin Mohammad GEM, Esmat Ibrahim Mamdouh IM et al.

Postoperative (PO) pain management after spine surgery is challenging. For such surgeries, erector spinae plane block (ESPB) and intrathecal morphine (ITM) may offer effective PO analgesia. However, the lack of availability of US machines in low-resource settings and proper dose of ITM that confine the side effects may limit the use of either. Nalbuphine presents an effective approach for managing opioid-induced pruritus without diminishing PO pain relief. In first 24 h after lumbar fusion operations under general anesthesia, the researchers examined effectiveness of bilateral ultrasound (US)-guided ESPB on PO pain and analgesic intake in comparison with ITM. One hundred twenty patients premedicated with 4 mg intravenous ondansetron were randomized into group E; bilateral US-guided ESPB, group M; ITM (0.2 mg) or group C; control group. Time to first rescue analgesic (ketorolac) was the primary outcome while parameters of PO analgesic regimen and side effects were considered as secondary outcomes. Compared to C group, E & M groups had longer duration to first rescue analgesic and reduced analgesic consumption within 24 h postoperatively (P < 0.001). Twenty-four hours after surgery, the M group had lower pain scores (P < 0.001) and higher rates of nausea and pruritus (P < 0.001) than the other two groups without any cases of respiratory depression. The analgesic effect of 0.2 mg intrathecal morphine after lumbar fusion operation under general anesthesia provided lower pain scores and lower analgesic demands than erector spinae plane block at the expense of a higher incidence of manageable side effects of intrathecal morphine within the first 24 h postoperatively. IRB: FMASU MD 102/2022. ClinicalTrials.gov Identifier: NCT05338320. The date that the clinical trial was registered in the ClinicalTrials.gov. : April 14, 2022.

PMID 42464120
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PubMedJournal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses2026-07-15

Utilization of Aromatherapy as First Line Treatment for Nausea and Vomiting in Post Anesthesia Recovery.

Oratz Temima T, Liu Katie K, Jackson Pam P, Gettis Margaret M

Post operative patients often have break through nausea and vomiting (PONV) despite receiving ondansetron and/or dexamethasone intraoperatively. Studies show aromatherapy is effective in reducing PONV in the adult population and the use of aromatherapy in children is increasing. This evidence-based quality improvement initiative was implemented in a pediatric setting to measure aromatherapy usage for PONV to minimize antiemetic medication usage. The Pediatric Post Anesthesia Care Unit (PACU) employed aromatherapy as a first line treatment for PONV. The Nurse Scientist, EBP Coordinator, and the PACU project investigator developed an EBP initiative to look at the feasibility and effectiveness in utilizing aromatherapy prior to offering the patients rescue antiemetic medication. PACU Staff received education through multiple in-service opportunities. Monthly aromatherapy usage was tracked via a report of staff removal for peppermint aromatherapy sticks from the automated dispensing cabinet. A data report generated from electronic medical records was created to track patients who received antiemetic medications in the PACU. All data was audited by the project investigator to verify accuracy. Data was collected over 18 months and trends were reported to staff and management. Trends and associations between aromatherapy, antiemetic use, and costs were analyzed using Spearman correlation and linear regression. Data indicated a downward trend in antiemetic medication use as aromatherapy use increased. The number of patients who received aromatherapy significantly increased by 0.19 each month (p=0.017), while the number of patients who received antiemetic medication significantly decreased by 0.35 each month (p<0.001). The spearman correlation coefficient is -0.21 and did not reach statistical significance (p=0.406). However, this initiative led to monthly cost savings which significantly increased by $0.09 per month (p=0.002). Aromatherapy can be an effective, feasible and low-cost option for pediatric patients experiencing nausea and vomiting in the PACU. Aromatherapy should be offered as a first-line treatment for post-operative patients, prior to rescue antiemetic therapy.

PMID 42455084
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PubMedCancer management and research2026-07-14

Chlorpromazine versus Metoclopramide for Neurogenic Nausea and Vomiting in Incurable Patients with Gastrointestinal Tumors: A Prospective Observational Cohort Study.

Konysheva Anna A, Myasoyedov Stanislav S

Nausea and vomiting are prevalent symptoms in incurable patients with gastrointestinal (GI) tumors. While standard antiemetic protocols are widely used, evidence supporting mechanism-based treatment selection in palliative patients remains limited. This study compared outcomes of individualized, mechanism-based antiemetic therapy with standard treatment in this population. A prospective observational cohort study was conducted at the Palliative Medicine Department of Kyiv City Clinical Oncological Center (2022-2024). In this non-randomized design, treatment was allocated by the treating physician based on clinical judgment of the predominant pathophysiological mechanism. One hundred patients with incurable GI tumors and nausea received standard therapy (metoclopramide plus dexamethasone; n=41) or individualized therapy: ondansetron plus dexamethasone for hepatic-related nausea, or chlorpromazine plus dexamethasone for neurogenic vomiting (n=59). The primary outcome was clinical improvement (≥50% reduction in Visual Analog Scale [VAS] score or vomiting frequency) at day 7. Baseline characteristics were largely comparable between groups (VAS: 7.7±0.9 vs 7.6±0.8, p=0.747; ECOG: 3.8±0.4 vs 3.8±0.4, p=0.635), although hepatic metastases were more prevalent in the individualized group (78.0% vs 51.2%, p=0.005), reflecting mechanism-based allocation. Overall improvement rates were 75.6% (standard) and 88.1% (individualized) (p=0.171). In the neurogenic subgroup, chlorpromazine achieved significantly higher improvement rates than metoclopramide (100% [13/13] vs 55.0% [11/20]; Fisher's exact test, p=0.005), with lower post-treatment VAS scores (4.2±0.6 vs 5.5±0.8; p<0.001). Adverse events were not systematically assessed; however, no treatment discontinuations due to adverse effects were recorded. While overall improvement rates were comparable, chlorpromazine was associated with higher improvement rates than metoclopramide in the neurogenic subgroup. Given the observational, non-randomized design and the small subgroup, these findings are hypothesis-generating and require confirmation in adequately powered randomized controlled trials. They suggest that pathophysiology-guided antiemetic selection, particularly for neurogenic symptoms, warrants further evaluation in palliative GI cancer patients.

PMID 42445222
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PubMedAnnals of medicine and surgery (2012)2026-07-11

Route-specific adverse effects of ondansetron: an overlooked concern in Asian clinical practice.

Ur Rehman Muhammad Ubaid MU, Nisa Noor Un NU, Hotak Rafiullah R

PMID 42433771
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PubMedMedicine2026-07-11

Comparative effectiveness and safety of ondansetron-based dual versus triple antiemetic regimens for chemotherapy-induced nausea and vomiting.

Yu Xiang X, Yuan Ying Y, Qiao Guanglei G, Zheng Wei W et al.

Chemotherapy-induced nausea and vomiting remains a frequent complication of cytotoxic therapy and can compromise treatment tolerance and adherence. This retrospective propensity score-matched cohort study evaluated the comparative effectiveness and safety of ondansetron-based dual versus triple antiemetic regimens in patients receiving chemotherapy for malignant tumors. Consecutive patients treated between January 2022 and July 2023 who underwent at least 2 chemotherapy cycles were identified from hospital records. Patients received either a dual regimen (ondansetron plus dexamethasone or aprepitant) or a triple regimen (ondansetron plus dexamethasone plus aprepitant). Propensity score matching (1:1) was conducted using sex, age, tumor type, metastatic status, Karnofsky performance status score, and history of motion sickness to reduce confounding, yielding 319 matched pairs. Across the first 2 chemotherapy cycles, the triple regimen achieved higher control rates for nausea and vomiting than the dual regimen, with statistically significant differences in overall efficacy in both cycles. Subgroup analyses suggested the greatest benefit of triple therapy among patients receiving highly emetogenic chemotherapy, whereas both strategies achieved high efficacy in moderately emetogenic settings. Adverse reactions were more frequent with the triple regimen in the first cycle, while between-group differences were attenuated in the second cycle. These findings support a risk-adapted approach that prioritizes triple therapy for highly emetogenic regimens with attention to tolerability.

PMID 42432981
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