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Last update 06 Dec 2025

Ondansetron Hydrochloride

Last update 06 Dec 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryZOFRAN® (Ondansetron Hydrochloride) is a medication used to prevent nausea and vomiting associated with emetogenic cancer chemotherapy and postoperative nausea and/or vomiting. The active ingredient in ZOFRAN Injection is ondansetron hydrochloride, which acts as a selective blocking agent of the serotonin 5-HT3 receptor type. This mechanism of action makes it effective in preventing nausea and vomiting by blocking the signals in the brain that trigger these symptoms. ZOFRAN Injection is a clear, colorless, nonpyrogenic, sterile solution for intravenous use. It was first approved by Novartis Pharmaceuticals Corp. in the United States in 1991. The pH of the injection solution ranges from 3.3 to 4.0. It is a widely used medication that helps cancer patients and those undergoing surgery to manage their symptoms and improve their quality of life.

Drug Type

Small molecule drug

Synonyms

Ondanseton Hydrochloride, ONDANSETRON, Ondansetron Hydrochloride and Glucose

+ [44]

Target

HTR3

Action

antagonists

Mechanism

5-HT3 receptor antagonists(5-hydroxytryptamine receptors, ionotropic (HTR3) antagonists)

Therapeutic Areas

Other DiseasesInfectious DiseasesNervous System Diseases+ [2]

Active Indication

Chemotherapy-induced nausea and vomitingPostoperative Nausea and VomitingRadiation-induced nausea and vomiting+ [12]

Inactive Indication

Irritable bowel syndrome with diarrheaNauseaObsessive-Compulsive Disorder

Originator Organization

Novartis Pharma AG

Active Organization

Hyloris Pharmaceuticals SA

RedHill Biopharma Ltd.

University of Calgary

+ [8]

Inactive Organization

Aquestive Therapeutics, Inc.Transcept Pharmaceuticals, Inc. (Old)

Sandoz Group AG

+ [2]

License Organization

RedHill Biopharma Ltd.

Chromocell Corp.Hangzhou KangQian Pharmaceutical Technology Co., Ltd.

+ [5]

Drug Highest PhaseApproved

First Approval Date

United States (04 Jan 1991),

Chemotherapy-induced nausea and vomitingPostoperative Nausea and Vomiting

RegulationPriority Review (China)

Structure/Sequence

Molecular FormulaC18H22ClN3O2

InChIKeyWRZJOBREMUDSSV-UHFFFAOYSA-N

CAS Registry103639-04-9

765

Clinical Trials associated with Ondansetron Hydrochloride

ChiCTR2500112585

/ Not yet recruitingPhase 4IIT

Comparison of postoperative Analgesia given Sufentanil or Tegileridine in Laparoscopic Cholecystectomy, a prospective, randomized, controlled, blinded study

Start Date01 Dec 2025

Sponsor / Collaborator-

NCT07246070

/ Not yet recruitingPhase 2IIT

The Efficacy and Safety of Nano-crystalline Megestrol Acetate for the Prevention of Nausea and Vomiting Caused by Emetogenic Chemotherapy: a Randomized, Controlled, Multicenter Clinical Study

The primary objective of this clinical study is to evaluate the efficacy and safety of nanocrystalline megestrol acetate combined with a 5-HT3 receptor antagonist for the prophylaxis of nausea and vomiting caused by moderately emetogenic chemotherapy drugs.
The study population consists of gastric adenocarcinoma patients who are scheduled to receive their first course of moderately emetogenic chemotherapy (PD-1/PD-L1 immune checkpoint inhibitors combined with the CAPOX regimen). This study is divided into two phases. The first phase is a single-arm study design, with the primary objective of preliminarily assessing the efficacy and safety of nanocrystalline megestrol acetate combined with a 5-HT3 receptor antagonist for the full-course management of nausea and vomiting caused by moderately emetogenic chemotherapy drugs. The second phase will adopt a randomized, controlled, multicenter trial design. Based on the efficacy and safety data from the first phase, the investigators will optimize the trial design (primarily including the primary endpoint and sample size calculation) to evaluate the efficacy and safety of nanocrystalline megestrol acetate compared with dexamethasone, each combined with a 5-HT3 receptor antagonist, for the prevention of nausea and vomiting caused by moderately emetogenic chemotherapy drugs.

Start Date01 Dec 2025

Sponsor / Collaborator

Cancer Hospital Chinese Academy of Medical Sciences

[+1]

ChiCTR2500112141

/ Not yet recruitingNot ApplicableIIT

Comparison of postoperative Analgesia given Sufentanil or Tegileridine in Laparoscopic Appendectomy, a prospective, randomized, controlled, blinded study

Start Date01 Dec 2025

Sponsor / Collaborator-

100 Clinical Results associated with Ondansetron Hydrochloride

100 Translational Medicine associated with Ondansetron Hydrochloride

100 Patents (Medical) associated with Ondansetron Hydrochloride

6,333

Literatures (Medical) associated with Ondansetron Hydrochloride

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

The impact of cannabis use on local anesthetic dosing during hair restoration surgery: a case report, proposed mechanisms, and clinical recommendations

Review

Author: Keene, Sharon A. ; Gupta, Aditya K. ; Talukder, Mesbah

Cannabis use has increased significantly in the last decade. This article presents a case where a patient needed more local anesthetic (LA) than usual to induce effective anesthesia during hair transplant surgery. The reason cannabis users often need more LA is poorly understood. One possibility is that cannabis withdrawal effect makes patients more sensitive to pain and stress. Additionally, vasodilatory property of cannabis may speed up LA clearance from the application site. The interactions of two major cannabinoids, cannabidiol (CBD) and tetrahydrocannabinol (THC), with cannabinoid receptor type 1 (CB1), cannabinoid receptor type 2 (CB2), and transient receptor potential vanilloid 1 (TRPV1) receptors are also complex. Furthermore, CBD and THC function as cytochrome P450 enzyme inhibitors potentially impacting systemic metabolism. When planning to administer LA during hair restoration surgery in cannabis users, clinicians should obtain a detailed history of prior consumption (type of cannabis, frequency, dosage). Preoperative planning should consider the anticipated duration of surgery and calculate the maximum safe LA dose to avoid the risk of toxicity. Also, patients should be carefully monitored for vital signs during surgery. If a patient requires frequent re-injection to remain pain free, the surgeon may need to re-assess the surgical plan to avoid toxicity.

01 Nov 2025·JOURNAL OF ARTHROPLASTY

Orally Soluble Pellicles Are More Effective than Intravenous Ondansetron in Prophylaxis of Postoperative Nausea and Vomiting After Primary Total Joint Arthroplasty: A Prospective Randomized Controlled Study

Article

Author: Zhou, Zongke ; Wu, Maojie ; Zhang, Jie ; Zhao, Long ; Ma, Jun ; Xie, Jinwei

BACKGROUND:

Despite the orally soluble pellicle (OSP) of ondansetron emerging as a novel and increasingly prescribed alternative for controlling postoperative nausea and vomiting (PONV), its superiority over its intravenous (IV) counterpart in preventing PONV remains to be definitively established. Herein, we conducted a study to compare the efficacy of OSP versus IV ondansetron in the prophylaxis of PONV following primary total joint arthroplasty (TJA) under general anesthesia.

METHODS:

A total of 150 patients undergoing TJA were randomly assigned to one of three groups: a control group, an OSP ondansetron group (16 mg administered one hour before anesthesia induction, followed by eight mg twice daily for two postoperative days), and an IV ondansetron group (eight mg administered at anesthesia induction, followed by eight mg once daily for two postoperative days). The primary outcome was the incidence and severity of PONV within the first 48 hours postoperatively. Secondary outcomes included the time to resumption of oral intake, the dosage of rescue medications (tramadol and metoclopramide), patient satisfaction scores at discharge, serum levels of inflammatory biomarkers, and the incidence of complications.

RESULTS:

Compared with the control group, both the OSP and IV groups demonstrated significantly lower frequency and severity of PONV within the first six hours postoperatively, as well as earlier resumption of oral intake, lower requirements for rescue antiemetics, and higher patient satisfaction scores. In addition, the OSP group showed a significantly lower frequency of nausea during the 12 to 18 hours postoperatively compared with the control group. Furthermore, the OSP group had significantly higher patient satisfaction scores than those in the IV group.

CONCLUSIONS:

The OSP ondansetron demonstrated comparable efficacy to IV formulations in preventing vomiting following TJA under general anesthesia. Notably, OSP ondansetron not only exhibited superior antinausea effects compared to its IV counterpart but also achieved higher patient satisfaction scores.

01 Nov 2025·PEDIATRIC NEPHROLOGY

Acute interstitial nephritis associated with ondansetron

Article

Author: Goswami, Elizabeth ; Charnaya, Olga

A 16-year-old male presented with seizure to an outside hospital and was found to have severe kidney dysfunction of unknown chronicity. He had dilute urine throughout the hospitalization and a negative serological work-up for acute glomerulonephritis. Exposure history was notable for 1-2 doses of ibuprofen and ondansetron use for nausea for the 3-4 days prior to the admission. All prior medications were discontinued, and he was started on levetiracetam for seizure management. Kidney function markedly improved on hospital day 4, and a planned kidney biopsy was cancelled. Kidney function continued to normalize after discharge. He experienced nausea again 10 days after discharge and took another dose of ondansetron with increased creatinine noted 1 day later. After discontinuation of ondansetron, his kidney function returned to and has remained normal.

264

News (Medical) associated with Ondansetron Hydrochloride

04 Dec 2025

·ir.herontx.com

Heron Therapeutics Announces Inclusion of APONVIE® (aprepitant) Injectable Emulsion in the Newly Released Fifth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting (PONV)

APONVIE, an aprepitant product, highlighted as the only FDA-approved IV formulation Neurokinin-1 (“NK-1”) antagonist indicated for the prevention of PONV in adults, with a long half-life and quicker onset than oral aprepitant Aprepitant alone, or added to a multimodal regimen, recognized as significantly reducing the risk of PONV, and aprepitant monotherapies are noted as more effective compared to 5-HT3 receptor antagonists for postoperative vomiting prevention Post-discharge nausea and vomiting (PDNV) recognized as a significant risk to discharged postoperative patients and the role of long-acting antiemetic strategies highlighted as extending protection beyond the recovery room and into the home setting CARY, N.C., Dec. 04, 2025 (GLOBE NEWSWIRE) -- Heron Therapeutics, Inc. (Nasdaq: HRTX) (“Heron” or the “Company”), a commercial-stage biotechnology company, today announced the inclusion of APONVIE® (aprepitant) injectable emulsion in the newly released Fifth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting: Executive Summary and Full Report as published in Anesthesia and Analgesia (collectively, the “PONV Guidelines”). PONV impacts about 30% of postoperative patients in the general surgical population and up to 80% of high-risk patients1 and is a major cause of patient dissatisfaction after surgery, with patients ranking vomiting as the most undesirable outcome when asked about postsurgical complications.2 The PONV Guidelines name APONVIE as an NK-1 receptor antagonist option for the prevention of PONV in adults and note APONVIE’s long half-life and 30-second IV administration, which provides for quicker onset than oral formulations and a long-acting profile. The PONV Guidelines also provide evidence that aprepitant alone or in combination therapies significantly reduced the risk of PONV and that aprepitant is comparable or superior to ondansetron for PONV prophylaxis. The PONV Guidelines also cite evidence for aprepitant’s significant impact on postoperative vomiting. “The release of the PONV Guidelines comes at a defining moment for surgical care. More procedures than ever are being performed in outpatient and short-stay settings, and patients are going home within hours of anesthesia. Preventing PONV is not just a comfort measure, it is critical to ensuring a safe and satisfying recovery for patients,” said Craig Collard, Chief Executive Officer of Heron. “We see substantial opportunity for APONVIE to help reduce avoidable postoperative complications, enhance patient and caregiver confidence at home, and support clinicians in delivering a smooth and reliable postoperative recovery experience.” The PONV Guidelines continue to recommend and reinforce an algorithmic approach to risk assessment, mitigation, multimodal PONV prophylaxis, and rescue treatment as most adult patients undergoing surgery and anesthesia will have at least one risk factor for PONV. For patients at high risk of PONV (e.g., having three or more PONV risk factors), the PONV Guidelines recommended a multimodal approach to prophylaxis with three or more agents. The PONV Guidelines also discussed risk factors for PDNV and recommended prophylactic, long acting antiemetics before discharge for patients at risk of PDNV. “Importantly, the PONV Guidelines bring renewed attention to the burden that nausea and vomiting place on patients after they leave the hospital,” said Kevin Warner, PharmD, Senior Vice President, Medical Affairs Strategy and Engagement of Heron. “By helping clinicians identify who remains at risk and encouraging the use of long-acting antiemetic options before discharge, the recommendations within the PONV Guidelines give us another chance to protect patients when they are back at home, where support may be more limited. Consistent awareness of the PONV Guidelines and disciplined adherence to its recommendations are essential if we want to translate this progress into safer recoveries, fewer complications, and better overall experiences for patients and their families.” About APONVIE® for Prevention of Postoperative Nausea and Vomiting (“PONV”) Prevention APONVIE is a substance P/neurokinin 1 (NK-1) Receptor Antagonist (RA), indicated for the prevention of postoperative nausea and vomiting (PONV) in adults. Delivered via a 30-second IV push, APONVIE 32 mg was demonstrated to be bioequivalent to oral aprepitant 40 mg with rapid achievement of therapeutic drug levels. APONVIE is the same formulation as Heron's approved drug product CINVANTI. APONVIE is supplied in a single-dose vial that delivers the full 32 mg dose for prevention of PONV. APONVIE was approved by the FDA in September 2022 and became commercially available in the U.S. on March 6, 2023. Please see full prescribing information at www.APONVIE.com. About Heron Therapeutics, Inc. Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients. For more information, visit www.herontx.com. Forward-Looking Statements This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. All statements contained in this news release other than statements of historical facts, including statements regarding our future results of operations and financial position, business and commercialization strategy as well as plans and objectives of management for future operations, are forward-looking statements. Heron cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially. Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding the potential market opportunities for APONVIE. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission, including under the caption "Risk Factors." Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law. References: 1. Gan TJ, Belani KG, Bergese S, et al. Fourth consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2020;131(2):411-448. doi:10.1213/ ane.0000000000004833. 2. Macario A, Weinger M, Carney S, Kim A. Which clinical anesthesia outcomes are important to avoid? The perspective of patients. Anesth Analg. 1999;89(3):652-658. doi:10.1097/00000539-199909000-00022. Investor Relations and Media Contact: Ira Duarte Executive Vice President, Chief Financial Officer Heron Therapeutics, Inc. iduarte@herontx.com 858-251-4400

Drug Approval

01 Dec 2025

·www.globenewswire.com

Adial Pharmaceuticals Announces a Warrant Inducement Transaction for Approximately $2.86 Million in Gross Proceeds

Nov. 26, 2025 -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today announced its entry into a warrant inducement agreement with an existing healthcare-focused institutional investor of the Company for the immediate exercise of existing Series C-1 Warrants (the "Series C-1 Warrants") to purchase up to 4,025,000 shares of the Company’s common stock, par value $0.001 per share (the “Common Stock”), and Series E Warrants (the “Series E Warrants”, and together with the Series C-1 Warrants the “Existing Warrants”) to purchase up to 5,190,675 shares of Common Stock at a reduced exercise price of $0.31 for gross cash proceeds of approximately $2.86 million, before deducting financial advisor fees and other transaction expenses. The Company intends to use the net proceeds from the offering for working capital and other general corporate purposes. A.G.P./Alliance Global Partners is acting as the exclusive financial advisor in this warrant inducement transaction. In consideration for the immediate exercise in full of the Existing Warrants, the investor will receive, in a private placement, new unregistered Series F Warrants to purchase up to 13,823,512 shares of Common Stock (the “New Warrants”). The New Warrants will have an exercise price of $0.31, will be initially exercisable on the date that shareholder approval of the issuance of the New Warrants is obtained (the “Approval Date”), and will expire 24 months following the Approval Date. The closing of the warrant inducement transaction is expected to occur on or about December 1, 2025, subject to satisfaction of customary closing conditions. The private placement of the New Warrants and the shares of Common Stock underlying the New Warrants offered to the institutional investor will be made in reliance on an exemption from registration under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”) and Regulation D promulgated thereunder. Accordingly, the securities issued in the private placement may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. This press release does not constitute an offer to sell or a solicitation of an offer to buy any of the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. Adial is a clinical-stage biopharmaceutical company focused on the development of therapies for the treatment and prevention of addiction and related disorders. The Company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients and was recently investigated in the Company’s ONWARD™ pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes identified using the Company’s proprietary companion diagnostic genetic test. ONWARD showed promising results in reducing heavy drinking in heavy drinking patients, and no overt safety or tolerability concerns. AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity. The content above comes from the network. if any infringement, please contact us to modify.

Clinical Result

01 Dec 2025

·www.prnewswire.com

RedHill Biopharma Successfully Regains Compliance with Nasdaq Stockholders' Equity Requirement

TEL-AVIV, Israel and RALEIGH, N.C., Dec. 1, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that on November 26, 2025, it received confirmation from the Nasdaq Stock Market LLC ("Nasdaq") that the Company has regained compliance with the stockholders' equity requirement set forth in Nasdaq Listing Rule 5550(b)(1)1. This achievement aligns with RedHill's ongoing strategic initiatives in 2025, including the Talicia® partnership with Cumberland Pharmaceuticals and continued focus on operational efficiency. The Company was advised in this process by Donohoe Advisory. About RedHill Biopharma RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the FDA-approved gastrointestinal drug Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults2, with a recent co-commercialization agreement in the U.S. with Cumberland Pharmaceuticals. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anti-inflammatory, antiviral, and anticancer activity, targeting multiple indications with U.S. government and academic collaborations for development for radiation and chemical exposure indications such as GI-Acute Radiation Syndrome (GI-ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 study in prostate cancer in combination with darolutamide; (ii) RHB-204, a next-generation optimized formulation of RHB-104, with a planned Phase 2 study for Crohn's disease (based on RHB-104's positive Phase 3 Crohn's disease study results) and Phase 3-stage for pulmonary nontuberculous mycobacteria (NTM) disease; (iii) RHB-102, with positive results from a U.S. Phase 3 study for acute gastroenteritis and gastritis, positive results from a U.S. Phase 2 study for IBS-D and potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting. RHB-102 is partnered with Hyloris Pharma (EBR: HYL) for worldwide development and commercialization outside North America; and (iv) RHB-107 ( upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19 and is also targeting multiple other cancer and inflammatory gastrointestinal diseases. More information about the Company is available at / X.com/RedHillBio. Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements include statements based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: the risk regarding the Company's ability to maintain compliance with Nasdaq's listing requirements, including the minimum stockholders' equity requirement; the risk that the strategic transaction with Cumberland will not bring the currently anticipated benefits to RedHill's global Talicia business or to RedHill's financial position, costs or its broader strategic objectives; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk of current uncertainty regarding U.S. government research and development funding and that the U.S. government is under no obligation to continue to support development of our products and can cease such support at any time; the risk that acceptance onto the RNCP Product Development Pipeline or other governmental and non-governmental development programs will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for its programs; the risk that the Company's development programs and studies may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional studies may be required; the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of any necessary commercial companion diagnostics; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia; (v) the Company's ability to successfully commercialize and promote Talicia; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 10, 2025. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law. Company contact: Adi Frish Chief Corporate & Business Development Officer RedHill Biopharma +972-54-6543-112 [email protected] Category: Corporate 1 To regain compliance with Nasdaq Listing Rule 5550(b)(1), the Company was required to demonstrate that its stockholders' equity exceeded the minimum $2.5 million stockholders' equity requirement and its ability to sustain compliance with such requirement. 2 Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: . Logo: SOURCE RedHill Biopharma Ltd. 21% more press release views with Request a Demo

Clinical ResultPhase 2Phase 3Drug ApprovalRadiation Therapy

100 Deals associated with Ondansetron Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D00678	Ondansetron Hydrochloride	A04AA01	DB00904

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Radiation-induced nausea and vomiting	Australia	Aspen Pharmacare Australia Pty Ltd.	17 Apr 1991
Chemotherapy-induced nausea and vomiting	United States	Sandoz, Inc.	04 Jan 1991
Postoperative Nausea and Vomiting	United States	Sandoz, Inc.	04 Jan 1991

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Syncope	Phase 3	Canada	University of Calgary	01 Dec 2024
Alcohol Use Disorder	Phase 3	Bulgaria	Adial Pharmaceuticals, Inc.	01 Feb 2020
Alcohol Use Disorder	Phase 3	Croatia	Adial Pharmaceuticals, Inc.	01 Feb 2020
Alcohol Use Disorder	Phase 3	Estonia	Adial Pharmaceuticals, Inc.	01 Feb 2020
Alcohol Use Disorder	Phase 3	Finland	Adial Pharmaceuticals, Inc.	01 Feb 2020
Alcohol Use Disorder	Phase 3	Latvia	Adial Pharmaceuticals, Inc.	01 Feb 2020
Alcohol Use Disorder	Phase 3	Poland	Adial Pharmaceuticals, Inc.	01 Feb 2020
Alcohol Use Disorder	Phase 3	Sweden	Adial Pharmaceuticals, Inc.	01 Feb 2020
Acute gastroenteritis	Phase 3	Canada	University of Calgary	14 Sep 2019
Diarrhea	Phase 3	Canada	University of Calgary	14 Sep 2019

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05819619 (CTgov)	Early Phase 1	Pain \| Nausea	8	misoprostol+ibuprofen+ondansetron (Standard of Care)	akombzgvuv(riibmqdzfp) = ujwtgpsbkq exguurzfqa (yioaupmyek, eugmaoxyxd - yghxklxqdd) View more	-	17 Nov 2025
				misoprostol+ibuprofen+ondansetron (Prophylactic Use)	akombzgvuv(riibmqdzfp) = fezqjqhffg exguurzfqa (yioaupmyek, eyyxwbqpwq - mtovfhnwua) View more
NCT04603066 (CTgov)	Phase 1/2	Neuralgia	24	Ondansetron+Tariquidar (Ondansetron + Tariquidar)	bubeuhcspk(xnsykmkrpp) = fmxnpytntd qfojqvcggz (bkrweomrah, 0.29) View more	-	14 Aug 2025
				Placebo+Ondansetron (Ondansetron + Placebo)	bubeuhcspk(xnsykmkrpp) = xwxlhjjkmc qfojqvcggz (bkrweomrah, 0.45) View more
Pubmed \| N Engl J Med	Not Applicable	Gastroenteritis	1,030	Ondansetron	bkdzkfippm(cqnplagjxu) = qcbiadyzqw cylzuwbvmt (ozzwddjjix )	Positive	17 Jul 2025
				Placebo	bkdzkfippm(cqnplagjxu) = ubelvjpdkt cylzuwbvmt (ozzwddjjix )
NCT04503668 (CTgov)	Phase 3	Female Genital Neoplasms \| Nausea \| Vomiting	62	Compazine+Dexamethasone+Ondansetron+Neurokinin-1 Receptor Antagonist (NK1-RA) (Nk1-RA)	mtjnwjsgnf = colzpxrbfz lxluvceyas (wwochwfohb, wzmlfxhnwl - rqnmxobnwc) View more	-	18 Jun 2025
				Compazine+Olanzapine+Dexamethasone+Ondansetron (Olanzapine)	mtjnwjsgnf = jdraecfgvv lxluvceyas (wwochwfohb, rrnahnvuga - gabzmxrxkh) View more
ASCO2025	Not Applicable	Chemotherapy-induced nausea and vomiting	988	Ondansetron oral soluble film 24 mg	wymqpxfkpe(slyvqkeevk) = lqbngwedup rfdcmpggwq (etebspuzan ) View more	Positive	30 May 2025
NCT05065567 (CTgov)	Phase 3	Hyperemesis Gravidarum \| Familial Cyclic Vomiting Syndrome \| Marijuana Abuse ... View more	32	Haloperidol (Haloperidol)	bldsysualv(imfrxhczph) = dpsgkgqmfo lrbfucfoka (wizxtorkmd, 3.30) View more	-	21 May 2025
				Droperidol (Droperidol)	bldsysualv(imfrxhczph) = aniugjcsxw lrbfucfoka (wizxtorkmd, 3.04) View more
UEGW2024	Not Applicable	Diarrhea	-	Ondansetron 4mg	kubxygbkjo(rifqknvuqe) = Adverse events were significantly higher in non-responders compared to responders (p=0.02) ftpejwzgpb (qbogwevnqa ) View more	-	13 Oct 2024
NCT03435003 (CTgov)	Phase 4	Postoperative Nausea and Vomiting \| Vomiting	83	dexmedetomidine+Total intravenous anesthesia+Fentanyl+scopolamine transdermal+Compazine+sugammadex+Reglan+Propofol+Dexamethasone+Ondansetron+Aprepitant 80 mg Oral Capsule (Intervention Arm)	ccqyoztdgp = envdxntmce oetbqpolpu (whdqpqygrh, wngtolzdbb - fcgzhlvbhe) View more	-	14 Feb 2024
				Compazine+sugammadex+Reglan+Sevoflurane+Dexamethasone+desflurane+Ondansetron (Control Arm)	ccqyoztdgp = xuowjrlhld oetbqpolpu (whdqpqygrh, xouvawbwjw - rxtlajssha) View more
NCT05098067 (CTgov)	Phase 2	Hyperemesis Gravidarum \| Nausea \| Vomiting of pregnancy	30	Lactated Ringers, Intravenous+Capsaicin Topical Cream+Metoclopramide+Ondansetron (Intervention Group)	dmmztljevw(kavpyelpfg) = gjptjdjpmt jmzmftghyj (wkupzwunaq, fommspohnw - ezxurfrsnh) View more	-	07 Feb 2024
				Lactated Ringers, Intravenous+Metoclopramide+Ondansetron (Placebo Group)	dmmztljevw(kavpyelpfg) = zxfciemnqp jmzmftghyj (wkupzwunaq, ldbsohlthr - sqpzlblnfo) View more
NCT04209595 (CTgov)	Phase 1/2	Small Cell Carcinoma \| Small Cell Lung Cancer	10	PLX038+Rucaparib+Ondansetron (Phase I Arm 1 Level 1, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 400 mg)	mscawwompr = nafqrldcre qyyaazmjaa (vvrulszqrs, gqlfqwiumg - dqvwcyzpcj) View more	-	03 Jan 2024
				PLX038+Rucaparib+Ondansetron (Phase I - Arm 1 Level 1A, PLX038 (PEGylated SN38) 1.3 g/m^2 and Rucaparib 300 mg)	mscawwompr = zruicqzhho qyyaazmjaa (vvrulszqrs, qnvlvbuxji - dwwhjknqbj) View more

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