Last update 12 Dec 2024

Ondansetron Hydrochloride

Last update 12 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

651

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]

NCT06727201 / Not yet recruitingPhase 2/3IIT

The Effect of Ondansetron on the Total Consumption of Norepinephrine Infusion Used to Prevent Spinal Anaesthesia Induced Hypotention in Cesarean Section.

The objective of this study is to determine the effect of ondansetron on the total consumption of norepinephrine infusion needed to prevent spinal anaesthesia induced hypotension in cesarean section.

Start Date01 Jan 2025

Sponsor / Collaborator

Assiut University

100 Clinical Results associated with Ondansetron Hydrochloride

100 Translational Medicine associated with Ondansetron Hydrochloride

100 Patents (Medical) associated with Ondansetron Hydrochloride

5,107

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·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.

01 Jan 2025·JOURNAL OF CLINICAL ANESTHESIA

Comparative efficacy of intravenous treatments for perioperative shivering in patients undergoing caesarean delivery under neuraxial anaesthesia: A systematic review and Bayesian network meta-analysis of randomised-controlled trials

Review

Author: Blake, Lindsay ; Sultan, Pervez ; Ferrea, Guillermina ; Singh, Preet Mohinder ; Fedoruk, Kelly ; Carvalho, Brendan ; Singh, Narinder Pal ; Monks, David T

INTRODUCTION:

Shivering affects 52 % of patients undergoing caesarean delivery under neuraxial anaesthesia. Despite extensive research focused on its prevention, there is still no consensus regarding optimal pharmacological treatment. This systematic review and network meta-analysis aims to compare available intravenous treatments of perioperative shivering in patients undergoing caesarean delivery under neuraxial anaesthesia.

METHODS:

We searched seven databases (PubMed MEDLINE, Scopus, Web of Science, Embase, LILACS, Cochrane CRCT and clinicaltrials.gov) for randomised controlled trials comparing intravenous treatments of perioperative shivering during caesarean delivery and performed a Bayesian model network meta-analysis. We assessed study quality using the Cochrane risk of bias assessment tool. The primary outcome evaluated in this meta-analysis was shivering control (cessation or significant reduction in intensity), and secondary outcomes included time to shivering control, shivering recurrence, and incidence of maternal nausea.

RESULTS:

Twenty randomised controlled trials, with a total of 1983 patients, were included in this analysis. Network estimates of odds ratios (OR [95 % Credible Interval]) of effective treatment of shivering compared with saline were: dexmedetomidine (38.1 [14.2 to 111.5]), tramadol (33.6 [15.1 to 81.8]), nalbuphine (26.2 [10.8 to 80.2]), meperidine (20.9 [6.2 to 73.1]), ondansetron (6.6 [2.2 to 23.2]), and clonidine (3.2 [0.6 to 14.9]). The rank order of interventions by surface area under the cumulative ranking curve scores (in parenthesis) for shivering control was dexmedetomidine (0.87) > tramadol (0.85) > nalbuphine (0.74) > meperidine (0.66) > ondansetron (0.41) > clonidine (0.3) > amitriptyline (0.03). Dexmedetomidine was also the top-ranked intervention for time to shivering control, shivering recurrence and maternal nausea. We judged the certainty in the evidence to be moderate for dexmedetomidine and nalbuphine, and low for all other interventions.

CONCLUSION:

This network meta-analysis identified four effective intravenous treatments for shivering in patients undergoing caesarean delivery under neuraxial anaesthesia: dexmedetomidine, tramadol, nalbuphine and meperidine. Dexmedetomidine was the top-ranked intervention for all outcomes.

121

News (Medical) associated with Ondansetron Hydrochloride

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

14 Nov 2024

·www.globenewswire.com

Adial Pharmaceuticals Announces Positive Topline Results from the AD04-103 Pharmacokinetics Study of AD04 for the Treatment of Alcohol Use Disorder

Confirmed relative bioavailability to the reference standard, dose proportional increases in pharmacokinetic exposure, and no food effect Marks final study needed for the upcoming FDA meeting for the Phase 3 study design and ongoing partnership discussions Continued excellent safety and tolerability findings, consistent with extensive human use experience with ondansetron GLEN ALLEN, Va., Nov. 14, 2024 (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, announced that it has completed a pharmacokinetics (PK) study of AD04, the Company's lead investigational genetically targeted, serotonin-3 receptor antagonist, and therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients (defined as less than 10 drinks/drinking day). This data will help the Company optimize study design elements needed for the upcoming Phase 3 clinical trial of AD04. Completion of this study also satisfied an FDA requirement for the upcoming Phase 3 clinical trials of AD04. The study, a single-center, relative bioavailability, open label study, enrolled a total of 30 healthy adult volunteers in two cohorts. Cohort 1 (n=6) was a randomized, open-label, 2-sequence, 2-period crossover study to evaluate the PK variability of ondansetron from AD04 0.33 and 0.99mg. Cohort 2 (n=24) was a randomized, open-label, 6-sequence, 4-period crossover study to evaluate the relative bioavailability of the AD04 0.33mg tablet to a marketed ondansetron 4mg tablet, dose proportionality of ondansetron PK between AD04 0.33 and 0.99mg, and the effect of food on the bioavailability of ondansetron administered as the AD04 0.33mg tablet. The results of this study showed that, as a result of the lower dose, AD04 0.33mg delivered lower ondansetron PK exposure than the marketed reference standard ondansetron 4mg tablet; ondansetron pharmacokinetic exposure increased in proportion to dose across a 3–fold AD04 dose range; and AD04 can be taken in fed or fasted states. Cary Claiborne, President and Chief Executive Officer of Adial commented, "Completion of this study achieves our goal to obtain the data we needed to design a more precise and informed Phase 3 trial protocol, including evaluating the optimal dosing regimen to maximize the efficacy and safety of AD04 in patients with AUD. Its completion is in accord with previous guidance provided by the FDA and is intended to enhance the likelihood of success in our upcoming Phase 3 trial. This relatively short and low-cost study was a key element of our strategy to advance ongoing partnership discussions. Additionally, the study will provide data necessary to support an application for approval of AD04 under a 505(b)(2) regulatory pathway with the FDA. We plan to engage with the FDA during Q4 2024 with the results of this pharmacokinetics study and obtain feedback which will assist with the AD04 Phase 3 study program. This meeting is an important next step to further advancing AD04 towards regulatory approval." About AD04AD04 (0.33mg ondansetron taken orally twice daily) acts upon the 5HT3 pathway and is thought to reduce alcohol craving. This mode of action is distinct from, but complimentary to, the currently approved therapies for AUD. Post-hoc analyses of Adial's prior clinical studies have indicated that patients with mutations in the 5HT3 receptor experience substantial and clinically meaningful reductions in alcohol consumption. The specific mutations that appear to respond to AD04 are single nucleotide polymorphisms (SNPs) on rs1150226-AG ("AG") or rs1176713-GG ("GG") genotypes in the gene that encodes the 5-HT3A receptor subunit. These genes are thought to affect the binding of AD04 to the 5HT3 receptor and its function. Furthermore, in both previous clinical trials, AD04 had similar adverse events to placebo, which further supports that it is likely to be extremely safe and tolerable. Adial has already developed a companion diagnostic test (CDx) to identify the specific genotypes that benefit from AD04. This test was used in its Phase 3 ONWARD study, will be used in future clinical studies, and will be commercially available at the time of AD04's launch. About Adial Pharmaceuticals, Inc.Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions 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 companion diagnostic genetic test. ONWARD showed promising results in reducing 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. Forward-Looking StatementsThis 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 the pharmacokinetics study data helping the Company optimize study design elements needed for the upcoming Phase 3 clinical trial of AD04, designing a more precise and informed Phase 3 trial protocol, completion of the study providing the data needed to design a more precise and informed Phase 3 trial protocol, including evaluating the optimal dosing regimen to maximize the efficacy and safety of AD04 in patients with AUD, completion of the study enhancing the likelihood of success in the Company’s upcoming Phase 3 trial, advancing ongoing partnership discussions, the study providing data necessary to support an application for approval of AD04 under a 505(b)(2) regulatory pathway with the FDA, plans to engage with the FDA during Q4 2024 with the results of the pharmacokinetics study and obtain feedback which will assist with the AD04 Phase 3 study program, further advancing AD04 towards regulatory approval 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, 2023, 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

Clinical ResultPhase 3

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	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

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


UEGW	Not Applicable	Diarrhea	-	Ondansetron 4mg	afhcwajztp(rlmbuvpegf) = Adverse events were significantly higher in non-responders compared to responders (p=0.02) vwxndsddke (wxfwikmzcd ) View more	-	13 Oct 2024
ASCO2024	Not Applicable	-	-	ondansetron (Medicare Part D Prescription Drug Plans (PDPs))	zyhdwkackl(ofwsmmslnd) = gqrworfsxl jpdiknfaxi (keatcbamhx ) View more	-	24 May 2024
				ondansetron (Medicare Advantage plans (MADPs))	zyhdwkackl(ofwsmmslnd) = rtzmtbhuue jpdiknfaxi (keatcbamhx ) 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)	akxczvnpro(xzjzkesyqk) = bryspvfwqq rlbkitipud (llnzaiyhmc, wwwhcuhggh - ltvjxxtxiv) View more	-	14 Feb 2024
				Compazine+sugammadex+Reglan+Sevoflurane+Desflurane+Ondansetron+Dexamethasone (Control Arm)	akxczvnpro(xzjzkesyqk) = fjtzwwaxhf rlbkitipud (llnzaiyhmc, ozpniyatbo - vssinecjqk) View more
NCT05098067 (CTgov)	Phase 2	Hyperemesis Gravidarum \| Nausea \| Vomiting of pregnancy	30	Lactated Ringers, Intravenous+Metoclopramide+Capsaicin Topical Cream+Ondansetron (Intervention Group)	lgyyctlwkw(ungqvagplc) = vfytzpxyoo shwtjqepnf (tuwurnaejd, bakqjadisk - odkwyjajnt) View more	-	07 Feb 2024
				Lactated Ringers, Intravenous+Metoclopramide+Ondansetron (Placebo Group)	lgyyctlwkw(ungqvagplc) = swlmyjyebi shwtjqepnf (tuwurnaejd, jnlsszafeg - ecszyduudh) View more
NCT03237611 (CTgov)	Phase 2	Chemotherapy-induced nausea and vomiting	15	Ondansetron 16 MG+Aprepitant 125 mg+Dexamethasone+Fosaprepitant 115 MG	msvcjrqwzb(gzrrnhyndj) = kfqonuokpi qqtbcjqnox (ryrpceydvi, ylggzczbof - szejrbwprm) View more	-	13 Nov 2023
NCT02991456 (CTgov)	Phase 2	Radiation-induced nausea and vomiting \| Glioma	48	Ondansetron+Rolapitant (Sequence A)	wevnnjarag(loubtewysz) = fdztccangy jaabrqfcwa (dthtyhwhqh, rdvyxmphfk - giumtfoiwx) View more	-	11 Jul 2023
				Ondansetron+Rolapitant (Sequence B)	wevnnjarag(loubtewysz) = sajipceovs jaabrqfcwa (dthtyhwhqh, qqlmcgfyui - zdhmjyildp) View more
NCT03239210 (CTgov)	Phase 4	Tourette Syndrome \| Obsessive-Compulsive Disorder	110	Ondansetron (Ondansetron (OND))	mqabrzpckz(zzddabhhhi) = oshghwhbgb qcbdyhfewv (ypyuqdgksw, xaynluvcms - dmxxuyyzsf) View more	-	03 Jul 2023
				Placebo (Placebo (PL))	mqabrzpckz(zzddabhhhi) = epvoigqfwr qcbdyhfewv (ypyuqdgksw, aihiakguym - fbtzihihvw) 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))	khvtkxyegz(cdfedglrbq) = uazzjwvqri kujqyqotdx (imkctbzjzc, riuuuepuga - nholyzniqq) View more	-	08 May 2023
				Placebo+Olanzapine+Palonosetron Hydrochloride+Ondansetron Hydrochloride+Dexamethasone (Arm II (Placebo, Olanzapine))	khvtkxyegz(cdfedglrbq) = jacojmqfki kujqyqotdx (imkctbzjzc, pcsfnpsucx - jucsuqujwn) View more
ISRCTN17508514 (Pubmed \| Aliment Pharmacol Ther)	Phase 3	Irritable bowel syndrome with diarrhea	400	Ondansetron 4 mg	(nawdaqymsn) = szjecrlonn shwmewnajh (jwbigzjotq, 24.7% - 56.4%) View more	-	03 Mar 2023
				Placebo	(nawdaqymsn) = zdqmgwushh shwmewnajh (jwbigzjotq, 14.5% - 41.3%) View more
NCT03817970 (ASN2022)	Phase 3	Nephrotoxicity	23	Ondansetron 8 mg p.o.	hjxucyvsrx(yibcxpvvan) = rfqiwlppsr mastwqoyjq (fihjdngibj ) View more	Negative	04 Nov 2022
				Palonosetron 0.25 mg i.v.	hjxucyvsrx(yibcxpvvan) = iizgbnkdfe mastwqoyjq (fihjdngibj ) View more

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