Last update 27 Dec 2024

Ondansetron Hydrochloride

Last update 27 Dec 2024

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

5-HT3 receptor

Mechanism

5-HT3 receptor antagonists(Serotonin 3 (5-HT3) receptor antagonists)

Therapeutic Areas

Other DiseasesInfectious DiseasesNervous System Diseases+ [1]

Active Indication

Chemotherapy-induced nausea and vomitingNauseaVomiting+ [8]

Inactive Indication

Obsessive-Compulsive Disorder

Originator Organization

Novartis Pharma AG

Active Organization

Fuan Pharmaceutical (Group) Co., Ltd.

University of CalgaryAspen Pharmacare Australia Pty Ltd.

+ [2]

Inactive Organization

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

+ [2]

Drug Highest PhaseApproved

First Approval Date

US (04 Jan 1991),

Chemotherapy-induced nausea and vomitingPostoperative Nausea and Vomiting

RegulationPriority Review (CN)

Structure

Molecular FormulaC18H22ClN3O2

InChIKeyWRZJOBREMUDSSV-UHFFFAOYSA-N

CAS Registry103639-04-9

655

Clinical Trials associated with Ondansetron Hydrochloride

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.

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 Date15 Jan 2025

Sponsor / Collaborator

Indiana University

[+2]

NCT06729307 / Not yet recruitingPhase 4IIT

Ondansetron Combined with Dyclonine Hydrochloride to Improve Patient Experience in Unsedated Esophagogastro-duodenoscopy

The goal of this clinical trial is to learn if administering ondansetron prior to esophagogastroduodenoscopy (EGD) can alleviate the gagging reflex, nausea and vomiting in Chinese patients undergoing unsedated diagnostic EGD. The main questions it aims to answer are:
Does taking ondansetron prior to EGD reduce the discomfort of patients during the endoscopic process? Does taking ondansetron prior to EGD reduce the intensity of patient gagging and nausea, and the incidence of vomiting ? Researchers will compare premedication of oral ondasetron and topical pharyngeal anesthesia (dyclonine hydrochloride mucilage) with topical pharyngeal anesthesia only to see if ondansetron can exert the above-mentioned effects.
Participants will be treated with one of the following regimens according to the randomization result:
* Oral ondansetron of 8 mg 2 hours prior to endoscopic process and dyclonine hydrochloride mucilage to be gurgled 15 minutes prior to endoscopic process;
* dyclonine hydrochloride mucilage to be gurgled 15 minutes prior to endoscopic process.
After the endoscopic process is finished, patients will be asked to fill in a questionnaire that contains the following items, all measured by NRS 0-10:
* Overall discomfort;
* Intensity of gagging;
* Willingness to undergo unsedated EGD again if indicated.

Start Date01 Jan 2025

Sponsor / Collaborator

Peking Union Medical College Hospital

100 Clinical Results associated with Ondansetron Hydrochloride

100 Translational Medicine associated with Ondansetron Hydrochloride

100 Patents (Medical) associated with Ondansetron Hydrochloride

5,114

Literatures (Medical) associated with Ondansetron Hydrochloride

01 Jan 2025·ARCHIVES OF MICROBIOLOGY

Biopolymer-based oral films integrated with probiotic active compounds for improved health applications

Article

Author: Tunçer Çağlayan, Sinem

Orally dissolving films (ODFs) have emerged as a versatile platform that combines convenience, efficacy, and patient compliance. In this study, the cell-free supernatant of the oral probiotic Streptococcus salivarius M18 was incorporated into various biopolymer-based ODF formulations, evaluated for demolding, fragility, and flexibility. The combination of carboxymethyl cellulose, sodium alginate, and glycerol successfully formed stable films. The films were characterized by weight, thickness, pH, and disintegration times. Fourier-transform infrared spectroscopy (FTIR) was used to analyze ODF content and release profiles in simulated saliva. Unique absorption peaks in the cell-free product-incorporated ODF samples confirmed the integration of bacterial proteins, lipids, and nucleic acids into the ODF matrix. The biological activity of the ODF carrying M18 bioactive products was assessed by its inhibitory effect on the growth of Streptococcus mutans, a pathogen linked to dental plaque and cavities. Additionally, the anti-proliferative effect on cancer epithelial cells was demonstrated. This study show that probiotic products can be integrated into bio-based thin films without losing activity, making this delivery platform promising for local and potentially systemic effects.

01 Jan 2025·CLINICAL PHARMACOLOGY & THERAPEUTICS

Value of Pharmacogenetic Testing Assessed with Real‐World Drug Utilization and Genotype Data

Article

Author: Cajanus, Kristiina ; Sistonen, Johanna ; Lindstedt, Mats ; Tarkiainen, E. Katriina ; Kytö, Ville ; Khan, Sofia ; Orpana, Arto ; Falkenbach, Petra ; Korhonen, Mari ; Niemi, Mikko ; Turpeinen, Miia ; Perola, Markus ; Kristiansson, Kati ; Nyrönen, Tommi ; Ukkola‐Vuoti, Liisa ; Tornio, Aleksi ; Litonius, Kaisa ; Kulla, Noora

Implementation of pharmacogenetic testing in clinical care has been slow and with few exceptions is hindered by the lack of real‐world evidence on how to best target testing. In this retrospective register‐based study, we analyzed a nationwide cohort of 1,425,000 patients discharged from internal medicine or surgical wards and a cohort of 2,178 university hospital patients for purchases and prescriptions of pharmacogenetically actionable drugs. Pharmacogenetic variants were obtained from whole genome genotype data for a subset (n = 930) of the university hospital patients. We investigated factors associated with receiving pharmacogenetically actionable drugs and developed a literature‐based cost–benefit model for pre‐emptive pharmacogenetic panel testing. In a 2‐year follow‐up, 60.4% of the patients in the nationwide cohort purchased at least one pharmacogenetically actionable drug, most commonly ibuprofen (25.0%) and codeine (19.4%). Of the genotyped subset, 98.8% carried at least one actionable pharmacogenetic genotype and 23.3% had at least one actionable gene‐drug pair. Patients suffering from musculoskeletal or cardiovascular diseases were more prone to receive pharmacogenetically actionable drugs during inpatient episode. The cost–benefit model included frequently dispensed drugs in the university hospital cohort, comprising ondansetron (19.4%), simvastatin (7.4%), clopidogrel (5.0%), warfarin (5.1%), (es)citalopram (5.3%), and azathioprine (0.5%). For untargeted pre‐emptive pharmacogenetic testing of all university hospital patients, the model indicated saving €17.49 in direct healthcare system costs per patient in 2 years without accounting for the cost of the test itself. Therefore, it might be reasonable to target pre‐emptive pharmacogenetic testing to patient groups most likely to receive pharmacogenetically actionable drugs.

01 Jan 2025·Methods in molecular biology (Clifton, N.J.)

Proteogenomics for Non-model Ocean-Derived Fungi

Article

Author: Kumar, Abhishek

Most biological and biomedical experiments are designed and studied using the most common model organisms (MOs) like humans, mice, Escherichia coli, Saccharomyces cerevisiae, Neurospora crassa, worms, fruit flies, zebrafish, and Arabidopsis thaliana. These model organisms have been extensively studied and have a well-established set of genetic, physiological, and other tools available for research. In contrast, non-model organisms (NMOs) are those that are not traditionally used in scientific research and do not have a well-established set of genetic or other biological tools available for their study. The majority of MOs are associated with land habitats but rarely with ocean environments. The ocean forms the largest portion of our planet, yet ocean-derived organisms are the least explored, and these organisms are primarily NMOs. However, these are thrilling living entities, such as ocean-derived fungi (ODF). These ODFs are a diverse group of fungi that live in different ocean sectors, including the ocean, estuaries, and coastal ecosystems. These fungi are found to colonize and adapt to different substrates. They are important decomposers in marine ecosystems, breaking down dead organic matter and recycling nutrients. ODFs have adapted to survive in the unique and challenging conditions of the ocean environment, including high salt concentrations, low nutrient availability, and exposure to waves and currents. ODFs are potent producers of natural compounds with pharmaceutical and industrial applications, such as antibiotics, anticancer agents, antivirals, and enzymes for industrial processes. ODFs are an exciting group of fungi; however, these are the least studied because of the nonavailability of MOs from this group. Hence, there is a massive scope of expanding our current knowledge about ODFs, their genetic traits, potential future drug-producing capabilities, and lifestyle traits.With the advent of next-generation DNA sequencing, there is huge potential for the characterization of the genetic material of ODF as NMOs. Parallel proteomic methods also pose huge potential. A marriage of NGS and proteomic methods generates a new avenue called proteogenomics, which focuses on better annotation of existing genomic data. Both methods are getting cheaper and accessible to the research community for studying the proteogenomics of NMOs. Herein, the proteogenomic protocol development and data analyses are illustrated for the ocean-derived fungus Scopulariopsis brevicaulis.

123

News (Medical) associated with Ondansetron Hydrochloride

18 Dec 2024

·www.businesswire.com

Valink Therapeutics Appoints Biopharmaceutical Veteran Martin D. Williams as Chair of the Board of Directors and Names Scientific Advisory Board

BOSTON--( BUSINESS WIRE )--Valink Therapeutics, a biopharmaceutical company focused on discovering and developing innovative bispecific antibody-drug conjugates (bsADCs) to transform the treatment of cancer and other diseases, has appointed Martin D. Williams as Chair of its Board of Directors. The company also named its Scientific Advisory Board, which assembles experts in the discovery, development, manufacture and commercialization of ADCs and bispecific therapeutics. “ We are thrilled to welcome Martin, whose expertise in strategy, development and partnering, and track record of leading multiple U.S. biopharmaceutical companies, will be instrumental to the next stages of Valink. He brings deep experience advancing a wide range of therapeutics from early development through regulatory approval and commercialization and developing industry partnerships that move promising medicines closer to patients. Martin’s career journey, which began in the UK before his move to the U.S. over 30 years ago, mirrors Valink’s roots as a University of Oxford spinout based in the U.S., with a strong UK presence,” said Arne Scheu, DPhil, Co-founder and Chief Executive Officer of Valink. “ Furthermore, I am excited to announce our Scientific Advisory Board, which brings together a distinguished group of advisors who have been at the forefront of ADC and bispecific innovation and development.” Mr. Williams brings to Valink more than 35 years of experience in the global biopharmaceutical business, having closed more than $5 billion worth of corporate transactions, including numerous partnerships, M&A, and public and private financings. He recently served as Chief Executive Officer of Caraway Therapeutics, a venture-backed company developing therapeutics to modulate lysosomal function for neurodegenerative and rare diseases, through the company’s acquisition by Merck & Co. at the end of 2023. Previously, he was President and Chief Executive Officer of Tokai Pharmaceuticals, a clinical-stage oncology company; Chief Business Officer at Dicerna Pharmaceuticals, a leading RNAi company with programs in oncology; and Chief Business Officer and Senior Vice President for commercial and business development at Synta Pharmaceuticals, a clinical-stage public company focused on oncology and inflammation. Earlier in his career, he held various leadership positions and directed the development, commercialization and launch of several flagship brands for GSK, Hoffmann-La Roche and Lederle/Wyeth (now Pfizer), including GSK’s blockbusters Zantac® and Zofran®; Hoffmann La-Roche’s Xenical®; and Lederle/Wyeth’s global anti-infective portfolio, including Zosyn®/Tazocin®. He holds an MBA from Harvard Business School and an MS from the University of Manchester, UK. “ Valink has developed a compelling approach to realizing the unmet potential of ADCs to improve outcomes for patients with cancer and other diseases, which has been restricted by dose-limiting toxicities and the range of suitable targets. Their technology addresses a significant challenge to ADC innovation by enabling rapid and cost-effective generation and screening of bispecific ADCs, unlocking a vast range of target synergy and potentially bringing previously undruggable space within reach,” said Mr. Williams. “ I am excited to work closely with the Valink executive team and Board as the company builds on its discoveries and pursues its clinical aspirations.” Valink also announced the formation of its Scientific Advisory Board, initially consisting of: Sonia Quaratino, MD, PhD is Executive Vice President and Chief Medical Officer at Innate Pharma, a clinical-stage biotech utilizing monoclonal antibodies, multi-specific NK cell engagers and ADCs to develop immunotherapies for cancer. Her career spans over 25 years in basic research, clinical development and translational medicine across academia, biotech and global pharmaceuticals. She has held numerous leadership positions, including serving as CMO at Kymab (until its acquisition by Sanofi) and Georgiamune Inc, and was Professor of Immunology at the University of Southampton. Marc Damelin, PhD is Chief Scientific Officer at Alphina Therapeutics and an expert in oncology drug discovery and development. Previously he served as VP and Head of Biology at Mersana Therapeutics, a clinical-stage biotech developing ADCs to treat cancer. Prior to that he worked for a decade in ADC discovery and development in Pfizer's Oncology Research Unit. Robert Lutz, PhD , Chief Scientific Officer at leading ADC company Iksuda Therapeutics, is a recognized expert in ADC discovery and development. As VP of Translational R&D at ImmunoGen, he was responsible for bringing eight ADC product candidates into development and was the research lead for Kadcyla®, the first ADC to be approved for solid tumor indications. Antoine Awad , Principal Executive Officer of Synlogic, has extensive experience in CMC, bispecific drug development and partnerships. Prior to Synlogic, he held leadership positions at various biotechs, including Merrimack Pharmaceuticals, where he led CMC development, manufacturing and approval of ONIVYDE® for treatment of advanced pancreatic cancer and transitioned to Ipsen Bioscience to lead global commercial manufacturing of ONIVYDE®. Mihriban Tuna, PhD is Chief Executive Officer of Immutrin and Entrepreneur-in-Residence at Cambridge Innovation Capital, a leading UK-based venture company focused on deep tech and life sciences. She previously served as Chief Scientific Officer at Adaptate Biotherapeutics (acquired by Takeda) and SVP, Drug Discovery at F-star Therapeutics, and was an early employee at Domantis Ltd. (acquired by GSK). Alexey A. Lugovskoy, PhD is President and Chief Executive Officer of Diagonal Therapeutics, Entrepreneur-in-Residence at Atlas Ventures and Associate Editor of mAbs . He formerly served as Chief Operating Officer at Dragonfly, Chief Development Officer at Morphic, Vice President of Therapeutics at Merrimack Pharmaceuticals and Associate Director of Drug Discovery at Biogen. He joined Valink’s Board of Directors in 2023, and this additional appointment highlights a close collaboration between the Scientific Advisory Board, Board of Directors and leadership team. About Valink Therapeutics Valink Therapeutics Inc. is a biopharmaceutical company focused on the discovery and development of first-in-class bispecific antibody-drug conjugates (bsADCs) to transform the treatment of cancer and other diseases. Valink’s technology platform utilizes a modular assembly approach to rapidly generate bsADCs with therapeutic potential, testing drugs at unparalleled scale and speed to improve on the payload delivery and selectivity of conventional ADCs. The company is based in Boston, Massachusetts and has research and development operations in London, UK. For more information, visit the company’s website at www.valinktx.com or contact the company at connect@valinktx.com .

Executive ChangeADCAcquisitionDrug Approval

02 Dec 2024

·www.prnewswire.com

RedHill Biopharma Awarded Judgment of Approximately $8 Million Plus Costs by New York Supreme Court

RedHill has been awarded a judgment of approximately $8 million plus costs in a summary judgment by the New York Supreme Court in its legal proceedings against Kukbo Co. Ltd The Court dismissed the entirety of Kukbo's counterclaims, ruling in favor of RedHill's demonstrated good faith commitment to the spirit and the letter of the agreements TEL-AVIV, Israel and RALEIGH, N.C., Dec. 2, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the Company has been awarded approximately $8 million (consisting of $6.5 million plus interest amounting to approximately $1.5 million), plus costs in a summary judgment by the Supreme Court of the State of New York, New York County (the "Court"), in its legal proceedings (Index number: 653200/2022) against Kukbo Co. Ltd. ("Kukbo"), domiciled in South Korea. The case refers to Kukbo's failure to make agreed payments to RedHill, pursuant to a Subscription Agreement (the "SA"), dated October 25, 2021, and a subsequent Exclusive License Agreement (the "ELA" and together with the SA, the "Agreements"), dated March 14, 2022, entered into by the two companies. Dror Ben-Asher, RedHill's CEO: "RedHill thanks the Court for this crystal-clear judgment, affirming the Company's just position from the beginning of the relationship, and in making correct provision for full reparation for the contractual breaches. The Company is also grateful to Haynes and Boone, LLP for their expert counsel and legal representation in this case." Upon entry, Kukbo has a right to seek an appeal of the judgment, which may or may not be granted. RedHill intends to pursue its attorneys' fees and collection of the judgment. About RedHill Biopharma RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on U.S commercialization and development of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the gastrointestinal drug Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults[1]. 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 a U.S. government collaboration for development for Acute Radiation Syndrome (ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 program in oncology; (ii) 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, with non-dilutive external funding covering the entirety of the RHB-107 arm of the 300-patient Phase 2 adaptive platform trial, and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; (iii) 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; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-204, a Phase 3-stage program for pulmonary nontuberculous mycobacteria (NTM) disease. 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 legal process going forward including Kukbo's rights to appeal. 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: market and other conditions; the risk that the Court's ruling will not be upheld in any subsequent appeal or that the provisions for reparation for the contractual breaches will not be honored; 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 that acceptance onto the RNCP Product Development Pipeline 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 opaganib for any indication; the risk that observations from preclinical studies are not indicative or predictive of results in clinical trials; the risk that the FDA pre-study requirements will not be met and/or that the Phase 3 study of RHB-107 in COVID-19 outpatients will not be approved to commence or if approved, will not be completed or, should that be the case, that we will not be successful in obtaining alternative non-dilutive development funding for RHB-107; the risk that RHB-107's late-stage development for non-hospitalized COVID-19 will not benefit from the resources redirected from the terminated RHB-204 Phase 3 study, and that the Phase 2/3 COVID-19 study for RHB-107 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 COVID-19 studies for opaganib and RHB-107 are likely to 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 a commercial companion diagnostic for the detection of MAP; (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® and Aemcolo®; (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. Category: Corporate Logo: [1] Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: . SOURCE RedHill Biopharma Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Clinical ResultLicense out/inPhase 3

27 Nov 2024

·www.globenewswire.com

Advantage Therapeutics Inc. Announces Formation of Klothea Bio, Inc. to Advance Research and Development of Klotho Protein for Age-Related Therapeutics

Klothea Bio Secures Funding from Longevitytech.fund as a lead investor to Pioneer Breakthrough Treatments for Metabolic Syndrome and several Aging-Associated DiseasesMIAMI, Nov. 25, 2024 (GLOBE NEWSWIRE) -- Advantage Therapeutics Inc., a leader in developing therapies targeting age-related diseases, announced today the formation of its new subsidiary, Klothea Bio, Inc., which will focus exclusively on the research and development of Klotho-based therapies to prevent and treat various age-associated conditions. The new subsidiary is backed by seed funding led by Longevitytech.fund (“LTF”), a prominent venture capital fund managed by Petr Sramek that invests in biotechnology startups focused on healthy lifespan extension globally. Klothea Bio, Inc. will build upon Advantage Therapeutics’ proprietary IP portfolio centered around Klotho, a protein renowned for its significant anti-aging properties, including neuroprotection, antioxidative effects, and tumor suppression. Klotho levels decrease with age to dangerous levels. Initial studies will target metabolic disease syndrome, with subsequent research aimed at expanding therapeutic applications to cancer, Alzheimer’s disease, obesity, and other age-related indications. Jeffrey Madden, Chairman of Klothea Bio, said, “As we embark on this exciting journey, we expect to demonstrate that our mRNA therapy will increase significantly the levels of Klotho to those found in young and healthy individuals and will offer the potential for longer-lasting therapeutic effects which may delay or prevent certain age-related diseases.” Mr. Madden then expressed gratitude for the investment and highlighted the strategic focus that Longevitytech.fund will bring to the company's anti-aging research. “We are thrilled to partner with Longevitytech.fund as our lead investor, advancing our mission to realize the transformative potential of Klotho protein therapies for aging-related diseases. This collaboration strengthens Klothea Bio’s laser focus on developing safe and effective treatments as we prepare for our upcoming clinical trial, bringing us closer to a future where significantly extending healthy human lifespan is achievable." Petr Sramek, Managing Partner of Longevitytech.fund and Klothea Board Member, expressed enthusiasm for supporting Klothea Bio’s mission. "Longevitytech.fund is committed to advancing solutions that address the hallmarks of aging, and we see Klotho as a critical protein in a molecular pathway to enhance human health and longevity. By supporting Klothea Bio, we aim to enable pioneering science that holds the promise of reducing the burden of age-associated diseases." Dr. Carmela Abraham, ADvantage’s Chief Science Officer, who studied Klotho for over 20 years as Professor of Biochemistry, Pharmacology and Experimental Therapeutics at Boston University School of Medicine and co-founded Klogenix, where she developed a number of modalities to increase Klotho levels, added, “Klotho is a protein possessing multiple beneficial and unique pleotropic functions by protecting organs against inflammation, oxidative stress, tumor growth, while its absence leads to age-related diseases and early death.” Dr. Abraham is delighted to work with Petr Sramek and his team and transform Klotho boosting into a therapy for a better healthspan and lifespan. About Klothea Bio Inc.Klothea is a subsidiary of Advantage Therapeutics dedicated to research and development surrounding Klotho, a protein recognized for its significant anti-aging properties. Expressed in various cells, particularly in the kidneys and brain, Klotho acts as a circulating hormone with numerous health benefits, including neuroprotection, antioxidative effects, and tumor suppression. Declining Klotho levels with age are linked to age-related disorders such as cognitive decline, chronic kidney disease, and cancer. Klothea Bio is pioneering a novel approach using mRNA technology to enhance the body’s own Klotho production, potentially enabling sustained therapeutic expression that could revolutionize anti-aging therapies. About Advantage Therapeutics Inc.Advantage Therapeutics, Inc. is at the forefront of developing next-generation therapies aimed at modifying the course of Alzheimer’s disease and other age-related conditions. The company is committed to addressing the unmet medical needs of patients through cutting-edge science and innovative treatment approaches, which it believes will ultimately have a significant impact on healthspan and longevity. The Company’s lead compound AD04™ is a subcutaneous injectable therapy with planned confirmatory Phase 2b clinical trials in Europe and the UK, to evaluate its safety and efficacy in early AD patients. AD04™ may function as an immunomodulator, stimulating and regulating the immune system to reduce AD pathology, rather than limiting therapy to attack the misfolded proteins, beta amyloid and tau. About AD04™ ADvantage Therapeutics is developing AD04™ as a new class of therapeutic for mild Alzheimer’s disease that exhibits durable multifaceted effects, including both immediate symptomatic relief and long-term disease-modification. The compound has been used extensively as an adjuvant in human and animal vaccination programs. In a previous trial, AD04™ serving as a control against another compound appeared to demonstrate statistically significant slower decline in cognitive and quality of life clinical measures compared to other treatment groups. AD04™ also showed slower decline in hippocampal volume as a biomarker. The Company believes that rather than being limited to a specific aspect of AD pathology, such as amyloid beta or tau, AD04™ may restore expression of genes in lipid metabolism, improve phagocytosis and reduce inflammation. Through multiple mechanisms AD04™ functions as an immunomodulator, stimulating and/or regulating the immune system to reduce AD pathology. About ADvantage Therapeutics GmbH ADvantage Therapeutics GmbH, founded in 2021, is the Vienna BioCenter-based subsidiary of ADvantage Therapeutics, Inc., where the Company conducts early preclinical research and drug development. About Longevitytech.fundLongevitytech.fund (“LTF”) is a venture capital fund focused on pre-seed and seed-stage investments in early-stage biotech startups and university spinoffs worldwide. Through close cooperation with top scientists in aging research, biotechnology, bioinformatics, agetech, and AI, LTF offers an active, supportive approach with commercialization assistance and a longevity program for its limited partners (LPs).

Clinical Study

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
Nausea	CN	Fuan Pharmaceutical (Group) Co., Ltd.	01 Jan 1996
Vomiting	CN	Fuan Pharmaceutical (Group) Co., Ltd.	01 Jan 1996
Radiation-induced nausea and vomiting	AU	Aspen Pharmacare Australia Pty Ltd.	17 Apr 1991
Chemotherapy-induced nausea and vomiting	US	Sandoz, Inc.	04 Jan 1991
Postoperative Nausea and Vomiting	US	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	CA	University of Calgary	01 Dec 2024
Alcohol Use Disorder	Phase 3	BG	Adial Pharmaceuticals, Inc.	01 Feb 2020
Alcohol Use Disorder	Phase 3	HR	Adial Pharmaceuticals, Inc.	01 Feb 2020
Alcohol Use Disorder	Phase 3	EE	Adial Pharmaceuticals, Inc.	01 Feb 2020
Alcohol Use Disorder	Phase 3	FI	Adial Pharmaceuticals, Inc.	01 Feb 2020
Alcohol Use Disorder	Phase 3	LV	Adial Pharmaceuticals, Inc.	01 Feb 2020
Alcohol Use Disorder	Phase 3	PL	Adial Pharmaceuticals, Inc.	01 Feb 2020
Alcohol Use Disorder	Phase 3	SE	Adial Pharmaceuticals, Inc.	01 Feb 2020
Acute gastroenteritis	Phase 3	CA	University of Calgary	04 Sep 2019
Diarrhea	Phase 3	CA	University of Calgary	04 Sep 2019

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


UEGW	Not Applicable	Diarrhea	-	Ondansetron 4mg	znjzwmrpsq(vlrpytnxbg) = Adverse events were significantly higher in non-responders compared to responders (p=0.02) woulzgcfpa (cpknmvpvly ) View more	-	13 Oct 2024
ASCO2024	Not Applicable	-	-	ondansetron (Medicare Part D Prescription Drug Plans (PDPs))	iinwwcalez(gmxztybjip) = dzhrihenbg djezhboomi (hezshxdduu ) View more	-	24 May 2024
				ondansetron (Medicare Advantage plans (MADPs))	iinwwcalez(gmxztybjip) = epqygjjynz djezhboomi (hezshxdduu ) View more
NCT03435003 (CTgov)	Phase 4	Postoperative Nausea and Vomiting \| Vomiting	83	dexmedetomidine+Compazine+Total intravenous anesthesia+scopolamine transdermal+sugammadex+Reglan+Propofol+Fentanyl+Ondansetron+Aprepitant 80 mg Oral Capsule+Dexamethasone (Intervention Arm)	amzzhrqkxi(nrlpjiwsko) = sqhmtppqun cznxqbncqc (wuyygxktsp, cxxfhwznba - xcsoudllnt) View more	-	14 Feb 2024
				Compazine+sugammadex+Reglan+Sevoflurane+Desflurane+Ondansetron+Dexamethasone (Control Arm)	amzzhrqkxi(nrlpjiwsko) = tkqleiuqgv cznxqbncqc (wuyygxktsp, wrtlkblrrz - oshbekvqtr) View more
NCT05098067 (CTgov)	Phase 2	Hyperemesis Gravidarum \| Nausea \| Vomiting of pregnancy	30	Lactated Ringers, Intravenous+Metoclopramide+Capsaicin Topical Cream+Ondansetron (Intervention Group)	nkxxzmgewf(gcfcfeqvmz) = spncqzraoy dynwzrzkux (zostcrzrmy, vejyfubuef - ctcphnqfkm) View more	-	07 Feb 2024
				Lactated Ringers, Intravenous+Metoclopramide+Ondansetron (Placebo Group)	nkxxzmgewf(gcfcfeqvmz) = qnfrfhenha dynwzrzkux (zostcrzrmy, irgzzpggrd - adkdhyprmk) View more
Pubmed \| Int J Surg	Not Applicable	Hypotension	-	Ondansetron 0.1 mg/kg	oyksgenrac(mmtztlgyze) = derwwnggde ctjbuzitwm (uxjbtmqnls, 0.013 - 0.029) View more	Positive	01 Feb 2024
				Saline Control	oyksgenrac(mmtztlgyze) = mccicmcorl ctjbuzitwm (uxjbtmqnls, 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	uqeyjogjar(gkdeksmuul) = ygyhpmdvxg fimppgvxtx (yjxufcfnll, eolhqeqakn - glqxviqxor) View more	-	13 Nov 2023
NCT02991456 (CTgov)	Phase 2	Radiation-induced nausea and vomiting \| Glioma	48	Ondansetron+Rolapitant (Sequence A)	qtoqhjfpdd(nnpapiczrm) = udtrlzogna qgstpgelmn (kcmhwlnron, bmgximvaef - jtxqzitgvy) View more	-	11 Jul 2023
				Ondansetron+Rolapitant (Sequence B)	qtoqhjfpdd(nnpapiczrm) = xxvinvispl qgstpgelmn (kcmhwlnron, yozeqvzznc - cjuibbrykh) View more
NCT03239210 (CTgov)	Phase 4	Tourette Syndrome \| Obsessive-Compulsive Disorder	110	Ondansetron (Ondansetron (OND))	dquauzeqox(xiydmiaaou) = fromqgvsiv lhahtiyaax (nrixdjuuji, khnczspjyx - dtzsabulzz) View more	-	03 Jul 2023
				Placebo (Placebo (PL))	dquauzeqox(xiydmiaaou) = uhxesmseye lhahtiyaax (nrixdjuuji, vrpnaljxou - emdztsdckw) View more
NCT03578081 (CTgov)	Phase 3	Nausea \| Chemotherapy-induced nausea and vomiting \| Neoplasms ... View more	690	Olanzapine+Palonosetron Hydrochloride+Ondansetron Hydrochloride+Dexamethasone+Fosaprepitant Dimeglumine (Arm I (Fosaprepitant Dimeglumine, Olanzapine))	afmgupsnlb(szukhqwjtr) = kycderlpsr whvndsetbs (hosvdhymsh, vxpqazuthn - pibpowlfvm) View more	-	08 May 2023
				Placebo+Olanzapine+Palonosetron Hydrochloride+Ondansetron Hydrochloride+Dexamethasone (Arm II (Placebo, Olanzapine))	afmgupsnlb(szukhqwjtr) = vodpawlrcj whvndsetbs (hosvdhymsh, fbymiuklxg - yrzznyxljh) View more
ISRCTN17508514 (Pubmed \| Aliment Pharmacol Ther)	Phase 3	Irritable bowel syndrome with diarrhea	400	Ondansetron 4 mg	bgpjrteojr(rfaxrayzxj) = kcmgdoznqm nuvjazycwq (rgukfzbsuk, 24.7% - 56.4%) View more	-	03 Mar 2023
				Placebo	bgpjrteojr(rfaxrayzxj) = tgobirzzmj nuvjazycwq (rgukfzbsuk, 14.5% - 41.3%) View more

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