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Last update 16 May 2025

Ondansetron Hydrochloride

Last update 16 May 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

+ [43]

Target

HTR3

Action

antagonists

Mechanism

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

Therapeutic Areas

Other DiseasesInfectious DiseasesNervous System Diseases+ [1]

Active Indication

Chemotherapy-induced nausea and vomitingNauseaVomiting+ [10]

Inactive Indication

Irritable bowel syndrome with diarrheaObsessive-Compulsive Disorder

Originator Organization

Novartis Pharma AG

Active Organization

University of Calgary

TAHO Pharmaceuticals Ltd.

RedHill Biopharma Ltd.

+ [4]

Inactive Organization

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

Algorithme Pharma, Inc.

+ [2]

License Organization

RedHill Biopharma Ltd.

Chromocell Corp.SpePharm AG

+ [3]

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

703

Clinical Trials associated with Ondansetron Hydrochloride

NCT05784350

/ Not yet recruitingNot ApplicableIIT

Preoperative Point of Care Ultrasound Guided Fluid Optimization and Intravenous Ondansetron to Prevent General Anesthesia-Induced Hypotension: A Randomized Controlled Trial

Hypotension is a common side-effect of general anesthesia induction and is related to adverse outcomes including significantly increasing risk of one-year mortality. Even short durations of intraoperative hypotension have been associated with acute kidney injury (AKI) and myocardial injury.Half of all the patients were fluid-responsive, pointing to volume status as a significant risk factor. Ultrasound measurements of inferior vena cava (IVC) diameter with respiration, including the maximal diameter of the IVC (dIVCmax) at the end of expiration during spontaneous respiration and the collapsibility index (CI), have been recommended as rapid and noninvasive methods for estimating volume status.
In attempt to prevent hypotension after spinal anesthesia induction, Ondansetron, a serotonin receptor antagonist, has been used effectively .
Research Question Can preoperative IVC-US guided fluid optimization and intravenous ondansetron reduce the incidence of general anesthesia-induced hypotension in adult patients undergoing elective non-cardiac non-obstetric surgery?

Start Date01 Aug 2025

Sponsor / Collaborator

Meir Medical Center

NCT05844501

/ RecruitingPhase 4IIT

Inhibition of Small Conductance Calcium-Activated Potassium Current: A New Therapeutic Approach for Atrial Fibrillation

"Afib" is a common irregular heartbeat. Afib can cause stroke, blood clots, dementia and death. Medicines used to treat Afib often do not work well and can cause serious side effects. Clinicians need medicines that work better for Afib. Medicines for Afib work by blocking a current in the heart called a potassium current. There is a newer potassium current called IKas that can contribute to Afib. A medicine called ondansetron is used to keep people with cancer from getting sick to their stomach and throwing up. The investigators have found that ondansetron blocks IKas, and the investigators think that this means that ondansetron may work well to treat Afib. So, in this study the investigators want to find out if ondansetron can: 1) Reduce the amount of time that people have Afib, and 2) Slow down the heart rate when people have Afib. The investigators will study 80 people who are scheduled to have an AF ablation. Several weeks prior to undergoing the ablation procedure, these AF patients will be assigned by chance (like flipping a coin) to one of two groups: ondansetron 8 mg by mouth twice daily or a sugar pill (placebo), which they will take for 28 days. The people in the study will not know whether they are receiving ondansetron or placebo. The investigators will find out if ondansetron reduces the percentage of time that people are in Afib. Also, the investigators will find out if ondansetron slows the heart rate while people are having Afib. The investigators will compare the people in the study who take ondansetron with the people in the study who take placebo. This research will help the investigators to find out if ondansetron can be used as a medicine for people who have Afib.

Start Date01 Jul 2025

Sponsor / Collaborator

Indiana University

[+2]

NCT05876585

/ Not yet recruitingPhase 3

A Randomized, Double-Blinded, Placebo-Controlled, Phase III Clinical Trial to Investigate the Efficacy and Safety of Ondansetron (Danset - Adwia) Versus Placebo Plus the Standard of Care in the Treatment of Nausea and Vomiting in Adult Patients With Acute Gastroenteritis

A Randomized, Open-label, Active-Controlled Clinical Trial to Investigate the Efficacy and Safety of Ondansetron compared to Metoclopramide in the management of Nausea and Vomiting in Adult Patients with Acute Gastroenteritis.

Start Date01 Jun 2025

Sponsor / Collaborator

Adwia Pharmaceuticals Co.

100 Clinical Results associated with Ondansetron Hydrochloride

100 Translational Medicine associated with Ondansetron Hydrochloride

100 Patents (Medical) associated with Ondansetron Hydrochloride

7,086

Literatures (Medical) associated with Ondansetron Hydrochloride

01 Aug 2025·Current Drug Safety

Carbamazepine-induced Stevens-Johnson Syndrome: A Case Report with Review of the Literature

Article

Author: S, Nirenjen ; T., Tamilanban ; Manavalan, Mohankumar ; Raja, Sangeetha ; Subramanian, Arunkumar ; Haitharali, Rajamohamed ; Gnanasekaran, Sabariakilesh ; Dhanasekaran, Sivaraman

Background::

Stevens-Johnson Syndrome (SJS) is an infrequent yet severe mucocutaneous reaction that involves less than 10% of the Body Surface Area (BSA). It is predominantly induced by certain medications, including anticonvulsants (e.g., Lamotrigine, Carbamazepine, Phenytoin, Phenobarbitone), Allopurinol at doses above 100 mg per day, and sulphonamides (e.g., Cotrimoxazole, Sulfasalazine). Genetic predispositions, particularly the presence of the HLA-B*1502 allele, significantly increase the risk of developing SJS. This case report discusses a unique presentation of SJS in a young female patient, emphasizing the critical need for genetic screening and careful monitoring when prescribing Carbamazepine, especially in populations at higher genetic risk.

Case Presentation::

A 19-year-old female patient, who had been on Phenytoin and Sodium Valproate for epilepsy management over the past year, was newly prescribed Carbamazepine. Within a week of initiating Carbamazepine, the patient experienced a seizure, followed by the sudden onset of fever, painful sores, and blisters covering the upper body, along with mucous discharge from both eyes. These symptoms rapidly worsened. Based on clinical presentations and the extent of epidermal detachment, the patient was diagnosed with SJS. The severity and mortality risks were assessed using the SCORTEN score. Therapeutic interventions included intravenous Ranitidine, Ondansetron, Paracetamol, Midazolam, Levetiracetam, and Dexamethasone, along with oral Fluconazole, Chlorpheniramine tablets, and Ciprofloxacin eye drops. The patient showed significant improvement and was discharged after fourteen days with followup advice.

Conclusion::

This case underscores the critical importance of performing genetic testing for the HLA-B*1502 allele and conducting baseline blood tests before initiating Carbamazepine therapy. Such precautionary measures can significantly mitigate the risk of severe adverse reactions like SJS. This report adds to the scientific literature by highlighting the potential dangers associated with anticonvulsant therapies and the necessity for personalized medicine approaches in preventing life-threatening conditions. The main takeaway is the pivotal role of genetic screening and vigilant monitoring in the management of patients requiring anticonvulsant medications to prevent serious adverse reactions.

04 May 2025·Expert Opinion On Drug Safety

Safety profile of lasmiditan: a retrospective post-marketing pharmacovigilance study based on the real-world data of FAERS database

Article

Author: Zhang, Hongrui ; Zhang, Shuohan ; Jiang, Cheng ; Wan, Xiaochen

BACKGROUND:

Lasmiditan offers a promising option for the treatment of migraines, particularly for individuals with cardiovascular concerns. It is crucial to gather comprehensive safety information of lasmiditan through large-scale post market monitoring.

RESEARCH DESIGN AND METHODS:

This study assessed the safety profile of lasmiditan based on real-world data of FDA Adverse Event Reporting System (FAERS) database. Four disproportionality analysis methods were applied to mining the significant signals. The differences in adverse event signals among different subgroups were investigated concerning race, sex, age, weight, dose, and concomitant drug.

RESULTS:

A total of 820 reports and 1,661 adverse events with lasmiditan as the primary suspected drug were identified. Two new adverse event signals related to nervous system disorders emerged. Females and males were more likely to develop paresthesia and dizziness, respectively. Most common adverse events were more likely to occur in the elderly patients and at high doses.

CONCLUSIONS:

It is essential to be vigilant about the relation of potential nervous system disorders with lasmiditan. The importance of heightened clinical vigilance regarding paresthesia in females and dizziness in males was underscored. Additionally, it is advised to administer a lower initial dose for elderly patients.

01 May 2025·INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES

Design and development of Ondansetron-loaded polysaccharide-based buoyant formulation for improved gastric retention and drug release, using both natural and semi-synthetic polymers

Article

Author: Ali, Kazi Asraf ; Roy, Sanjit Kr ; Ghosal, Kajal ; Chakraborty, Rideb

Extended gastric residence of drugs can enhance the therapeutic effect, increase bioavailability, improve efficacy, and reduce the number of required doses by prolonging the retention of the drug delivery system. A new floating drug delivery for Ondansetron was designed and evaluated. Pre-formulation studies included the assessment of powder flow properties and drug-excipient compatibility. In-vitro release studies and a buoyancy test were performed to characterize the performance of the system. The study evaluated the properties of Ondansetron tablets. The optimized batches had compressibility index values ranging from 7.272 % to 25 %, with percentage weight fluctuation ranging from 0 to 1.05 %. The tablets were 2.92 and 3.52 mm thick, hardness between 3.50 and 4.65 kg/cm², and loss percentages between 0.12 and 0.68 %, except batch T8, which had high friability index values of 1.02. Thermo-gravimetric analysis and Differential scanning Calorimetry showed no interaction between the drug and other polymers. Formulations showed a sustained release of the drug for periods of >12 h for several compositions, while some showed a release of >90 %. The formulations with HPMC K4M showed slower drug release due to a strong hydro layer. Citric acid content increased drug release, suggesting modulation of drug release kinetics. Kinetic modeling revealed that some of the formulations exhibited zero-order release kinetics, which means that the drug is released at a constant rate to maintain a steady level of the drug in the body. This project aims to improve the therapeutic effect of Class I Biopharmaceutical Classification System (BCS I) drug ondansetron by using a stomach-retaining, floating drug delivery system. Promising results are indicative of better bioavailability and sustained therapeutic doses. Findings may influence the development of delivery methods for similar substances facing gastrointestinal absorption challenges.

222

News (Medical) associated with Ondansetron Hydrochloride

15 May 2025

·www.globenewswire.com

Adial Pharmaceuticals Reports First Quarter 2025 Financial Results and Provides Business Update

GLEN ALLEN, Va., May 15, 2025 (GLOBE NEWSWIRE) -- 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 provided a business update and reported its financial results for the first quarter of 2025. Cary Claiborne, CEO of Adial Pharmaceuticals, commented, “We made meaningful progress during the first quarter of 2025, completing foundational steps that position us to advance swiftly toward the initiation of our Phase 3 clinical trial for AD04, our lead investigational drug for Alcohol Use Disorder (AUD).” “One of the key achievements this quarter was the successful completion of our pharmacokinetics bridging study, AD04-103, which confirmed that AD04 delivers favorable and consistent bioavailability, with or without food. This reinforces a flexible and patient-friendly dosing regimen that supports real-world use. Following this milestone, we have commenced manufacturing of our clinical trial supply, ensuring we are operationally ready to enter the next stage of development.” “We were also pleased to receive confirmation from the FDA supporting our proposed 505(b)(2) in vitro bridging strategy. This strategy leverages data from the AD04-103 study, along with in vitro dissolution data demonstrating equivalence between the formulation used in our prior Phase 3 ONWARD trial and the planned commercial formulation of AD04. This regulatory alignment represents a significant validation of our development plan and enables a more streamlined and efficient path into our next pivotal study. In parallel, we continue to strengthen our intellectual property portfolio with multiple granted patents that broaden and extend protection around AD04’s formulation, method of use, and its genetically guided patient targeting strategy—further enhancing the value and defensibility of our program.” “Looking ahead, we are preparing for our End of Phase 2 meeting with the FDA in July to finalize key aspects of our Phase 3 trial design and protocol. This engagement represents a pivotal milestone, offering regulatory clarity and ensuring alignment on our development plans. Given the strong progress made across clinical, regulatory, and operational fronts, we believe we are well-positioned to proceed efficiently. The foundation we have built gives us confidence in our ability to advance AD04 through late-stage development and bring a much-needed treatment option to patients living with AUD.” Other Developments Adovate, LLC On May 13, 2025, Adial announced that it has received a six-figure development milestone payment from Adovate, LLC, following the commencement of a Phase 1 clinical trial evaluating Adovate’s lead compound for asthma, ADO-5030. This milestone payment follows Adovate’s exercise of its option to acquire the assets and business of Purnovate, Inc., a wholly owned subsidiary of Adial Pharmaceuticals, as previously disclosed. Under the terms of the agreement with Adovate, Adial is eligible to receive more than $50 million in commercial milestone payments plus an additional $11 million in development and approval milestone payments per compound, for a total consideration of up to $83 million for the first three compounds alone if such milestones are achieved. In addition, Adial is entitled to low single-digit royalties on net sales should the program advance to commercialization. Adial also retains a significant equity stake in Adovate of over 10%, positioning the Company to participate in the long-term upside as the asthma candidate advances through clinical development and toward potential commercialization. Intellectual Property On May 1, 2025, Adial announced patent number 12,274,692 was issued on April 15, 2025, by the United States Patent and Trademark Office covering the administration of AD04, the Company’s investigational drug, as a precision medicine approach for patients with specific genetic markers. The patent claims a method of treating addiction by administering a therapeutically effective amount of AD04 to patients with serotonin-related gene variations, including specific genotypes of HTR3A, HTR3B, and SLC6A4, such as the LL genotype of 5-HTTLPR in combination with variations in rs1150226, rs17614942, and rs1176713. Warrants On May 2, 2025, Adial 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 B Warrants to purchase 1,418,440 shares of the Company’s common stock, par value $0.001 per share, and Series C Warrants to purchase 2,300,000 shares of Common Stock at a reduced exercise price of $0.74 for gross cash proceeds of approximately $2.75 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. First Quarter 2025 Financial Results Cash and cash equivalents were $2.4 million as of March 31, 2025, compared to $3.8 million as of December 31, 2024. Including the proceeds from the warrant exercises, the Company believes that its existing cash and cash equivalents will fund its operating expenses into the fourth quarter of 2025 based on currently committed development plans. Research and development expenses increased by approximately $293 thousand (65%) during the three months ended March 31, 2025, compared to the three months ended March 31, 2024. The key drivers of the increase were increased chemistry, manufacturing, and controls (CMC) expenses to develop clinical supplies for the upcoming program and consulting expenses as we continue to progress and advance AD04 to a Phase 3 trial. General and administrative expenses increased by approximately $129 thousand (9%) during the three months ended March 31, 2025, compared to the three months ended March 31, 2024. This modest increase was mainly due to higher compensation and consulting. Net Loss was $2.2 million for the three months ended March 31, 2025, compared to a net loss of $6.5 million for the three months ended March 31, 2024. The decrease in net loss was primarily driven by non-cash charges of $4.5 million for an inducement expense in 2024 which was not incurred in 2025 and partially offset by increases in R&D and G&A spending. About Adial Pharmaceuticals, Inc. Adial Pharmaceuticals 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. Additional information is available at www.adial.com. If you are interested in exploring partnership opportunities with Adial, we invite you to reach out to us (BD@adialpharma.com) to discuss how our joint efforts can bring about positive change to the millions of patients who are struggling with addiction. Forward-Looking Statements This communication contains certain "forward-looking statements" within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words "believes," "expects," "anticipates," "intends," "projects," "estimates," "plans" and similar expressions or future or conditional verbs such as "will," "should," "would," "may" and "could" are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. The forward-looking statements include statements regarding being positioned to advance swiftly toward the initiation of the Phase 3 clinical trial for AD04, the regulatory alignment with the FDA enabling a more streamlined and efficient path into the next pivotal study, continuing to strengthen the Company’s intellectual property portfolio, enhancing the value and defensibility of the Company’s program, preparing for the End of Phase 2 meeting with the FDA in July to finalize key aspects of our Phase 3 trial design and protocol, the engagement with the FDA offering regulatory clarity and ensuring alignment on the Company’s development plans, being well-positioned to proceed efficiently given the strong progress made across clinical, regulatory, and operational fronts, advancing AD04 through late-stage development, bringing a much-needed treatment option to patients living with AUD, positioning the Company to participate in the long-term upside of Adovate as its asthma candidate advances through clinical development and toward potential commercialization, using the net proceeds from the warrant inducement transaction for working capital and other general corporate purposes, existing cash and cash equivalents funding operating expenses into the fourth quarter of 2025 and the potential of AD04 to treat other addictive disorders such as opioid use disorder, gambling, and obesity. Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, our ability to pursue our regulatory strategy, our ability to advance ongoing partnering discussions, our ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, our ability to develop strategic partnership opportunities and maintain collaborations, our ability to obtain or maintain the capital or grants necessary to fund our research and development activities, our ability to complete clinical trials on time and achieve desired results and benefits as expected, regulatory limitations relating to our ability to promote or commercialize our product candidates for specific indications, acceptance of our product candidates in the marketplace and the successful development, marketing or sale of our products, our ability to maintain our license agreements, the continued maintenance and growth of our patent estate and our ability to retain our key employees or maintain our Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the other cautionary statement included in our Annual Report on Form 10-K for the year ended December 31, 2024, subsequent Quarterly Reports on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law. Contact:Crescendo Communications, LLCDavid Waldman / Alexandra SchiltTel: 212-671-1020Email: ADIL@crescendo-ir.com

Financial StatementPhase 1License out/inPhase 3

13 May 2025

·www.globenewswire.com

Adial Pharmaceuticals Receives Milestone Payment from Adovate Following Initiation of Phase 1 Study

Milestone Achieved as Adovate Initiates First-in-Human Study for Novel Asthma Therapy Targeting Underserved, Multi-Billion Dollar MarketGlen Allen, Va., May 13, 2025 (GLOBE NEWSWIRE) -- 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 that it has received a six-figure development milestone payment from Adovate, LLC, following the commencement of a Phase 1 clinical trial evaluating Adovate’s lead compound for asthma, ADO-5030. This milestone payment follows Adovate’s exercise of its option to acquire the assets and business of Purnovate, Inc., a wholly owned subsidiary of Adial Pharmaceuticals, as previously disclosed. The ongoing Phase 1 study is a Single Ascending Dose (SAD) clinical trial designed to evaluate the safety, tolerability, and pharmacokinetics of Adovate’s novel adenosine receptor antagonist in healthy volunteers. The compound is being developed as a potential first-line therapy for asthma, a large and underserved global market with substantial unmet medical needs, with a differentiated mechanism of action and the potential to shift the treatment paradigm for asthma patients globally. Cary Claiborne, CEO of Adial Pharmaceuticals, said “This milestone highlights the value of our strategic decision to monetize the Purnovate assets while retaining meaningful upside. The structure of the deal provides non-dilutive capital and a strong equity position, allowing us to focus our resources on advancing AD04 while continuing to benefit from the progress Adovate is making in asthma and other indications.” Under the terms of the agreement with Adovate, Adial is eligible to receive more than $50 million in commercial milestone payments plus an additional $11 million in development and approval milestone payments per compound, for a total consideration of up to $83 million for the first three compounds alone if such milestones are achieved. In addition, Adial is entitled to low single-digit royalties on net sales should the program advance to commercialization. Adial also retains a significant equity stake in Adovate of over 10%, positioning the Company to participate in the long-term upside as the asthma candidate advances through clinical development and toward potential commercialization. About Adial Pharmaceuticals, Inc. Adial Pharmaceuticals 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. Additional information is available at www.adial.com. If you are interested in exploring partnership opportunities with Adial, we invite you to reach out to us (BD@adialpharma.com) to discuss how our joint efforts can bring about positive change to the millions of patients who are struggling with addiction. Forward-Looking Statements This communication contains certain "forward-looking statements" within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words "believes," "expects," "anticipates," "intends," "projects," "estimates," "plans" and similar expressions or future or conditional verbs such as "will," "should," "would," "may" and "could" are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. The forward-looking statements include statements regarding Adovate’s development of the ADO-5030 as a first-line therapy for asthma, the potential to shift the treatment paradigm for asthma patients globally, Adial advancing AD04 while continuing to benefit from the progress Adovate is making in asthma and other indications, receiving more than $50 million in commercial milestone payments plus an additional $11 million in development and approval milestone payments per compound, for a total consideration of up to $83 million for the first three compounds alone, positioning Adial to participate in the long-term upside as Adovate’s asthma candidate advances through clinical development and toward potential commercialization and the potential of AD04 to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity. Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, Adovate’s ability to develop ADO-5030 as a first-line therapy for asthma, Adovate’s ability to achieve the milestones under the terms of the agreement with us, Adovate’s ability to advance its asthma candidate through clinical development and toward potential commercialization; our ability to pursue our regulatory strategy, our ability to advance ongoing partnering discussions, our ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, our ability to develop strategic partnership opportunities and maintain collaborations, our ability to obtain or maintain the capital or grants necessary to fund our research and development activities, our ability to complete clinical trials on time and achieve desired results and benefits as expected, regulatory limitations relating to our ability to promote or commercialize our product candidates for specific indications, acceptance of our product candidates in the marketplace and the successful development, marketing or sale of our products, our ability to maintain our license agreements, the continued maintenance and growth of our patent estate and our ability to retain our key employees or maintain our Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the other cautionary statement included in our Annual Report on Form 10-K for the year ended December 31, 2024, subsequent Quarterly Reports on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law. Contact:Crescendo Communications, LLCDavid Waldman / Alexandra SchiltTel: 212-671-1020Email: ADIL@crescendo-ir.com

Phase 3Phase 1Clinical ResultLicense out/in

13 May 2025

·www.prnewswire.com

RedHill Biopharma Secures Kukbo Asset Freeze Following RedHill's $8.25 Million Plus Legal Fees New York Supreme Court Summary Judgment Win

Korea's Incheon District Court attachment grant prevents asset disposal by Kukbo prior to enforcement, following the New York Supreme Court's approximately $8.25 million plus legal fees and costs summary judgment in favor of RedHill -- The New York Supreme Court dismissed all Kukbo's counterclaims -- Latest Court victory demonstrates RedHill's commitment to collection of the court-mandated award, upon which 9% interest continues to be accruable RALEIGH, N.C. and TEL-AVIV, Israel, May 13, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it had won its attachment petition to the Court in South Korea on Kukbo Co. Ltd's ("Kukbo") assets, following the approximately $8.25 million plus legal fees and costs summary judgment ruling in RedHill's favor by the New York Supreme Court. An attachment petition in South Korea refers to a court-ordered seizure (attachment) of a debtor's assets to secure a claim before or during a lawsuit, designed to prevent the debtor from disposing of assets before the creditor can enforce a judgment. RedHill's approximately $8.25 million summary judgment win includes approximately $1.75 million in accrued interest at 9%, emanating from Kukbo's failure to pay RedHill according to the terms of subscription and licensing agreements signed by the two companies in October 2021 and March 2022, respectively. Additionally, and in accordance with the court's ruling, a motion has been filed to recover legal fees and costs. Kukbo has a right to seek an appeal of the judgment, and on December 4, 2024, filed a notice of appeal, upon which they may or may not choose to act. Kukbo has six months from filing of the notice, until June 4, 2025, to perfect its appeal, subject to potential extension. 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 adults[1], with submission planned for marketing authorization in other territories. 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 anticancer, anti-inflammatory and antiviral activity, targeting multiple indications with U.S. government and academic collaborations for development for radiation and chemical exposure indications such as Gastrointestinal-Acute Radiation Syndrome (GI-ARS), a Phase 2 study in prostate cancer in combination with Bayer's darolutamide and a Phase 2/3 program for hospitalized COVID-19 patients; (ii) RHB-204 with a planned Phase 2 study for Crohn's disease and Phase 3-stage for pulmonary nontuberculous mycobacterial (NTM) disease; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (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; and (v) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D. RHB-102 is partnered with Hyloris Pharma (EBR: HYL) for worldwide development and commercialization outside North America. 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 and include, among others, statements regarding the potential outcome of litigation against Kukbo Co. Ltd. Forward-looking statements are 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 that the Company's attempts to receive the judgment awarded against Kukbo by the New York Supreme Court may not be successful; the risk that the Company may not submit a UK MAA for Talicia and if it does that submission may not be successful; the risk that the development of RHB-204 for Crohn's disease may not be completed and if completed may not be successful; the risk that the Company will not benefit from its agreement with Hyloris as currently anticipated; the Company's ability to maintain compliance with the Nasdaq Capital Market's listing requirements; 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 observations from preclinical studies are not indicative or predictive of results in clinical trials; 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 of market and other conditions and 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 8, 2024. 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] 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. 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Phase 2Clinical ResultPhase 3Drug Approval

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.

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Indication	Country/Location	Organization	Date
Nausea	China	Fuan Pharmaceutical (Group) Co., Ltd.	01 Jan 1996
Vomiting	China	Fuan Pharmaceutical (Group) Co., Ltd.	01 Jan 1996
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.

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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
Diarrhea	Phase 3	Canada	University of Calgary	14 Sep 2019
Norovirus Infections	Phase 3	Canada	University of Calgary	14 Sep 2019

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


UEGW2024	Not Applicable	Diarrhea	-	Ondansetron 4mg	uchmwfswij(nyhserozar) = Adverse events were significantly higher in non-responders compared to responders (p=0.02) nyljnrrhrm (ncaectlopv ) View more	-	13 Oct 2024
ASCO2024	Not Applicable	-	-	ondansetron (Medicare Part D Prescription Drug Plans (PDPs))	jxkhbbzlla(gmwehxabjd) = topnediqic khwexekoki (kazokvittg ) View more	-	24 May 2024
				ondansetron (Medicare Advantage plans (MADPs))	jxkhbbzlla(gmwehxabjd) = orfpvwopmu khwexekoki (kazokvittg ) View more
NCT03435003 (CTgov)	Phase 4	Postoperative Nausea and Vomiting \| Vomiting	83	dexmedetomidine+Compazine+Total intravenous anesthesia+Fentanyl+scopolamine transdermal+sugammadex+Reglan+Propofol+Ondansetron+Aprepitant 80 mg Oral Capsule+Dexamethasone (Intervention Arm)	xzmyirdywp = sdoicunuaw attmdlgjpq (uzjvuoaeix, vwqceoseqo - dxgmonnkkm) View more	-	14 Feb 2024
				Compazine+sugammadex+Reglan+Sevoflurane+Desflurane+Ondansetron+Dexamethasone (Control Arm)	xzmyirdywp = fkrptnbymx attmdlgjpq (uzjvuoaeix, gsrhyizhmb - jxddxdkzkq) View more
NCT05098067 (CTgov)	Phase 2	Hyperemesis Gravidarum \| Nausea \| Vomiting of pregnancy	30	Lactated Ringers, Intravenous+Capsaicin Topical Cream+Metoclopramide+Ondansetron (Intervention Group)	jysbpowgvl(fjettzoedy) = axmwvakhrk neolhxoksj (gityujyagv, imzywyrqwn - bktrcgfreh) View more	-	07 Feb 2024
				Lactated Ringers, Intravenous+Metoclopramide+Ondansetron (Placebo Group)	jysbpowgvl(fjettzoedy) = cajirbpjwu neolhxoksj (gityujyagv, ieulbwcwqi - krlmzadhqw) View more
Pubmed \| Int J Surg	Not Applicable	Hypotension	-	Ondansetron 0.1 mg/kg	yavayotzfm(ejzbbtquco) = uhdagrfffq jndvlojnlm (bhtgptfocl, 0.013 - 0.029) View more	Positive	01 Feb 2024
				Saline Control	yavayotzfm(ejzbbtquco) = uhscwacgde jndvlojnlm (bhtgptfocl, 0.024 - 0.043) View more
NCT03237611 (CTgov)	Phase 2	Chemotherapy-induced nausea and vomiting	15	Ondansetron 16 MG+Aprepitant 125 mg+Dexamethasone+Fosaprepitant 115 MG	ggaqnymxey = bfixkrwdqe wloeujdswy (gtkhqpguro, clqpiirfqg - hrwufoipgl) View more	-	13 Nov 2023
NCT02991456 (CTgov)	Phase 2	Astrocytoma \| Gliosarcoma \| Glioblastoma ... View more	48	Ondansetron+Rolapitant (Sequence A)	jfhfruhxlh = bdelpiqylr cbotmjcsld (qplbrlogst, lcemwhiotz - yroawnlzme) View more	-	11 Jul 2023
				Ondansetron+Rolapitant (Sequence B)	jfhfruhxlh = phpjkhazmv cbotmjcsld (qplbrlogst, xpofnxiqph - ujnbrrionm) View more
NCT03239210 (CTgov)	Phase 4	Tourette Syndrome \| Obsessive-Compulsive Disorder	110	Ondansetron (Ondansetron (OND))	rufupoooai(ttgwuuitkx) = qvpzpavhmq irznkengri (jbqeuvgrps, 0.21) View more	-	03 Jul 2023
				Placebo (Placebo (PL))	rufupoooai(ttgwuuitkx) = spqpqkfftn irznkengri (jbqeuvgrps, 0.23) View more
NCT03578081 (CTgov)	Phase 3	Chemotherapy-induced nausea and vomiting \| Nausea \| Neoplasms ... View more	690	Olanzapine+Palonosetron Hydrochloride+Ondansetron Hydrochloride+Fosaprepitant Dimeglumine+Dexamethasone (Arm I (Fosaprepitant Dimeglumine, Olanzapine))	qjbtknqodi = skvqusvjhu jdbfaymmso (ujnngbgblh, zxortpvbbs - idpfllubuf) View more	-	08 May 2023
				Placebo+Olanzapine+Palonosetron Hydrochloride+Ondansetron Hydrochloride+Dexamethasone (Arm II (Placebo, Olanzapine))	qjbtknqodi = ehgdxffwsc jdbfaymmso (ujnngbgblh, bzwjrdarqo - wzsuxmfoax) View more
ISRCTN17508514 (Pubmed \| Aliment Pharmacol Ther)	Phase 3	Irritable bowel syndrome with diarrhea	400	Ondansetron 4 mg	ugjgkbwtwq(xxaksmwnzl) = kfbnjkpkph wepdijocmo (nxqbjgyscd, 24.7% - 56.4%) View more	-	03 Mar 2023
				Placebo	ugjgkbwtwq(xxaksmwnzl) = zftzywmein wepdijocmo (nxqbjgyscd, 14.5% - 41.3%) View more

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