A Phase 1, Open-Label, Single-Dose, Non-Randomized Study to Evaluate Pharmacokinetics, Pharmacodynamics, and Safety of Betrixaban in Pediatric Patients

This trial was a Phase 1, open-label, multicenter study of the pharmacokinetics (PK), pharmacodynamics (PD), and safety of a single dose of betrixaban in pediatric participants at risk of venous thromboembolism (VTE).

Start Date13 Jul 2018

Sponsor / Collaborator

Alexion Pharmaceuticals, Inc.

[+1]

NCT03397888

/ CompletedPhase 1

The Effect o f Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Betrixiban, an Oral FXa Antagonist

Single center, prospective open label PK and PD study of betrixaban in subjects with mild and moderate hepatic impairment vs healthy volunteers.

Start Date16 Nov 2017

Sponsor / Collaborator

Portola Pharmaceuticals LLC

NCT02596100

/ CompletedPhase 1

A Bioequivalence Study to Compare the Pharmacokinetics of Two Betrixaban Formulations

This is a single center open label randomized 4-period 2-sequence replicated crossover design study. A total of 52 healthy subjects will be randomized.

Start Date01 Sep 2015

Sponsor / Collaborator

Portola Pharmaceuticals LLC

100 Clinical Results associated with Betrixaban

100 Translational Medicine associated with Betrixaban

100 Patents (Medical) associated with Betrixaban

296

Literatures (Medical) associated with Betrixaban

24 Mar 2025·Journal of biomolecular structure & dynamics

Inhibition of respiratory syncytial virus by Daclatasvir and its derivatives: synthesis of computational derivatives as a new drug development

Article

Author: Abdalla, Mohnad ; Mitra, Debanjan ; Afreen, Shagufta ; Das Mohapatra, Pradeep K.

The most common cause of respiratory tract illness in newborns and young children is the respiratory syncytial virus (RSV). There is no approved vaccination or specific antiviral medication for RSV infections. Here, an attempt has been made to explore the potential of currently marketed drugs as well as their probable derivatives to improve the possibility of developing stronger medications against RSV. From the 100 synthetic drug compounds library, the best drug molecule was identified through drug-likeness properties, toxicity, molecular docking and molecular dynamics simulations. Molecular Mechanics Generalized Born Surface Area (MM-GBSA) was also a method that was applied in this study. Daclatasvir showed the highest binding energy and appeared as the best drug to inhibit matrix protein and a fusion protein of RSV. Based on Daclatasvir, 40 computational derivatives were made. D28, D34 and D40 showed far better results than the actual drug. Changes in lipophilicity character increase the binding energy of derivatives. Molecular dynamic simulations showed their non-deviated, non-fluctuated and stable complex formation with target proteins. The high number of amino acid contacts throughout the trajectory increases the stability and effectiveness of derivatives. The key to producing a novel medicine to eradicate RSV is provided by derivatives. Daclatasvir will be employed as a potential RSV inhibitor up until that point.

01 Nov 2024·AMERICAN JOURNAL OF EMERGENCY MEDICINE

Epidemiology of pulmonary embolism diagnosis and management among United States emergency departments over an eight-year period

Article

Author: Moyer, Eric ; Gottlieb, Michael ; Bernard, Kyle

INTRODUCTION:

Pulmonary embolism (PE) is a major cause of morbidity and mortality in the United States. However, as diagnostic imaging, risk stratification tools, and treatment have evolved over time, there is a critical need for current data on the incidence, testing, admission rates, and medical management of PE in the ED setting.

METHODS:

This was a cross-sectional study of ED patients with PE diagnoses from 1/1/2016 to 12/31/2023 using the Epic Cosmos national database. ED visits were identified using ICD-10 codes corresponding to acute PE. Chronic PEs were excluded. Outcomes included total ED visits, admission rates, anticoagulant treatment prescribed from the ED, and thrombolytic therapy. Anticoagulant prescriptions included warfarin, enoxaparin, dabigatran, apixaban, rivaroxaban, edoxaban, and betrixaban. Thrombolytic agents included alteplase, tenecteplase, and urokinase. We also assessed changes in the overall rate of CT pulmonary angiograms (CTPA) performed.

RESULTS:

Out of 186,138,130 total ED encounters, PE represented 531,968 (0.29 %). The overall rate of PE diagnosis rose slowly from 0.20 % in 2016 to a peak of 0.35 % in 2021. Among those with PE, 363,584 (68.3 %) were admitted. The rate of admission declined over time from 75.6 % to 66.1 %. Among those prescribed anticoagulation, the most common medication was apixaban (40.0 %), followed by rivaroxaban (17.3 %), enoxaparin (6.1 %), warfarin (2.6 %), and dabigatran (0.4 %). Thrombolytics were administered in 4.5 % of cases, with the rate of thrombolytics peaking at 5.3 % in 2018 before lowering to 3.5 % in 2023. The overall rate of CTPA increased from 2.4 % to 5.0 %, while the rate of proportion of PEs diagnosed declined from 8.7 % to 6.4 %.

CONCLUSION:

This study highlights significant shifts in the epidemiology and management of PE within the ED setting. Overall rates of PE rose, while a larger proportion were discharged. Direct oral anticoagulants have become the predominant therapy with the majority of patients receiving apixaban. Thrombolytic use occurs in a small subset and has been declining over time. CTPA rates have risen, while the overall diagnostic yield has declined.

01 Nov 2024·Journal of Computational Biophysics and Chemistry

Repurposing FDA-Approved Drugs as Potential Inhibitors of SARS-CoV-2 PLpro: A Comprehensive Computational Study

Author: Metwaly, Ahmed M. ; Elkady, Hazem ; Eissa, Ibrahim H. ; Alsfouk, Aisha A. ; Soliman, Omar A. ; Elkaeed, Eslam B. ; Ibrahim, Ibrahim M.

This study explores the repurposing of Food and Drug Administration (FDA)-approved drugs as potential inhibitors of SARS-CoV-2 papain-like protease (PLpro), a critical enzyme for viral replication. Initially, 3009 FDA approved drugs were screened to identify candidates structurally similar to the co-crystallized ligand XT7 in the SARS-CoV-2 PLpro complex (PDB ID: 7LBR). A fingerprint analysis narrowed the selection to the top 5% )150 drugs) most structurally akin to XT7, followed by a more refined structural similarity test that identified the top 1% (30 drugs). Molecular docking studies highlighted several compounds with strong binding affinities to the SARS-CoV-2 PLpro. Notably, Fedratinib exhibited a particularly robust binding energy of [Formula: see text]kcal/mol and was chosen for further investigation. Subsequent molecular dynamics (MD) simulations over 100 ns confirmed the stability and efficacy of Fedratinib’s binding, as evidenced by favorable energetic and dynamic profiles. The molecular mechanics-generalized born surface area (MM-GBSA) calculations corroborated these findings, revealing a binding energy of [Formula: see text]kcal/mol. Additionally, PLIP, ProLIF, and PCAT analyses further validated the stability and interactions of the PLpro-Fedratinib complex observed during the MD simulations. Overall, our results indicate that Fedratinib, an FDA-approved drug, demonstrates promising potential as an inhibitor of SARS-CoV-2 PLpro, warranting further in vitro and in vivo experimental validation as well as potential clinical evaluation.

News (Medical) associated with Betrixaban

17 Dec 2024

·www.accesswire.com

Esteemed Harvard Medical School Professor Dr. Michael Gibson Appointed Chief Medical Advisor at Lexaria Bioscience

Dr. Gibson joining Lexaria's new scientific advisor board KELOWNA, BC / ACCESSWIRE / December 17, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces the appointment of Dr. Michael Gibson as its new Chief Medical Advisor. Dr. Gibson will collaborate directly with President John Docherty as Lexaria's patented DehydraTECH drug delivery platform continues to expand its applications in GLP-1 and hypertension.C. Michael Gibson M.S., M.D., is an interventional cardiologist, cardiovascular researcher & educator. He is the CEO of the combined non-profit Baim and PERFUSE research institutes at Harvard Medical School. Gibson founded PERFUSE in 1987 which served as the TIMI Data coordinating center that coordinated data for the first 50 TIMI trials. The Baim institute was formerly known as Harvard Clinical Research Institute and was founded in 2000.The combined institutes have led over 1,250 studies, published 5,500 manuscripts in peer review literature (including 144 in the New England Journal of Medicine) and have led 70 FDA submissions from their network of 7,000 sites in 57 countries worldwide. Since 2014, Gibson has consistently been ranked as one of the world's most highly cited authors in all of science by Thomson Reuters. In 2021, he was named one of the Fifty of the Most Influential Voices in Healthcare by Medika Life. His work has been cited over 170,000 times."Lexaria's drug delivery technology offers exciting new pathways towards improving pharmacokinetic drug performance that could unlock a new era of reduced drug waste and adverse side effects combined with enhanced efficacy," said Dr. Gibson. "I'm excited to pursue new and improved applications for this exciting technology.""Dr. Gibson has a wealth of knowledge and experience that will benefit Lexaria, particularly in the area of hypertension which remains an area of intense interest for Lexaria," said John Docherty, President. "On behalf of everyone at Lexaria, I welcome Dr. Gibson's contributions as our new Chief Medial Advisor and member of our scientific advisory board."As Chief Medical Advisor, Dr. Gibson will participate with other scientific and medical experts within Lexaria's newly-formed scientific advisory board in pursuing Lexaria's prioritized objectives in the fields of drug delivery optimization.Dr. Gibson has led phase 1-4 clinical trials, and cardiology megatrials of over 34,000 patients which eventuate in international approval of drugs like prasugrel, rivaroxaban, betrixaban and andexanet as well as devices such as one that alarms to alert a patient to heart attack. He founded WikiDoc.org and WikiPatient.org and is Editor-In-Chief of over 2,200 active contributors who have edited the content of over 100,000 chapters millions of times over the past 15 years. Gibson also founded www.clinicaltrialresults.org. Gibson serves as Chief Medical Correspondent for the American College of Cardiology. Gibson has over 435,000 followers on social media where he is a leading influencer, second only to Sanjay Gupta in some pollsAbout Lexaria Bioscience Corp. & DehydraTECHDehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 46 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.CAUTION REGARDING FORWARD-LOOKING STATEMENTSThis press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.INVESTOR CONTACT:George Jurcic - Head of Investor Relations[email protected]Phone: 250-765-6424, ext 202SOURCE: Lexaria Bioscience Corp.

Executive Change

17 Jan 2024

·pipelinereview.com

Tr1X, Inc. Announces $75 Million Series A Financing to Develop Best-in-Class Universal Allogeneic Regulatory T (Treg) and CAR-Treg Cell Therapies to Treat and Potentially Cure Autoimmune and Inflammatory Diseases

SAN DIEGO, CA, USA I January 17, 2024 I Tr1X, Inc. today announced its emergence from stealth with a $75 million Series A financing to bring universal allogeneic regulatory T (Treg) and CAR-Treg cell therapies to the clinic to treat and potentially cure autoimmune and inflammatory diseases. The financing was led by Bay Area-based The Column Group, with participation from NEVA SGR and Alexandria Ventures. The Company appointed William Lis Chief Executive Officer, strengthened its leadership team with other biopharma industry veterans, and announced members of the Board of Directors and Scientific Advisory Board. "We are thrilled to partner with Bill Lis, Maria Grazia Roncarolo and Tr1X's world-class team to revolutionize the field through its innovative, breakthrough science," said Leon Chen, Ph.D., MBA, Partner at The Column Group and Tr1X Board Member. "With its experienced management team at the helm, we are confident in Tr1X's ability to bring curative cell therapies to patients who currently require life-long treatment and management." Science and Pipeline The Company's science is primarily based on the work of Tr1X's Scientific Founder Maria Grazia Roncarolo, M.D., the discoverer of Type 1 regulatory T (Tr1) cells, which have features that can benefit patients with autoimmune and inflammatory diseases. Tr1 cells, a differentiated subpopulation of regulatory T cells, are crucial for maintaining homeostasis and tolerance in healthy individuals and have several important functions. These include dampening of local inflammation and downregulation of the inflammasome, suppression of pathogenic effector T cell responses, and induction of long-term tolerance as observed in preclinical models and patients. Tr1X's proprietary technology enables the conversion of CD4 + T cells isolated from healthy donors into Treg-like cells that have a similar function and profile to naturally occurring Tr1 cells. These cells can be further engineered to target specific tissues or organs to enable local, targeted immunomodulation. With a proprietary, GMP-grade, closed-loop system that provides consistency, quality and reliability at scale, Tr1X can enable production of its products at commercial volume. Currently, Tr1X is working on its first investigational Tr1 cell therapy, TRX103, which it plans to evaluate in a Phase 1 trial to prevent Graft versus Host Disease (GvHD) in patients undergoing mismatched hematopoietic stem cell transplant. The Company is developing additional pipeline programs to treat inflammatory bowel disease, Type 1 diabetes and multiple B-cell mediated autoimmune diseases. "The ability to develop a pipeline of medicines based on our work on regulatory T cells represents the culmination of decades of discovery and research into the underpinnings of immunological tolerance and autoimmunity," said Dr. Roncarolo, Scientific Founder, President and Head of R&D at Tr1X. "Tr1 cells have unique properties and represent the ideal therapeutic platform from which to develop 'immune reset' products. Our two platforms have the required attributes to address a broad set of indications, including dual targeting of pathogenic T and B cells. These engineered cells have the potential to induce tolerance, which could transform the lives of people living with chronic autoimmune diseases by providing them with a cure instead of ongoing treatment." Proven Leadership Team, Board of Directors and Scientific Advisory Board Tr1X is led by industry veterans with cell therapy expertise who have a track record of discovery, development and commercialization of more than a dozen novel first- or best-in-class medicines. Chief Executive Officer William "Bill" Lis has more than 25 years of biotech executive leadership experience in building companies and product pipelines from R&D stage through commercialization. He most recently served as Chairman and interim CEO of Jasper Therapeutics, Inc., from 2019 to 2022, where he led the company's Series A and follow-on financings and successful brequilimab Phase 1 study readouts in hematopoietic stem cell transplantation. Before that, he served as Chief Executive Officer and a Director of Portola Pharmaceuticals, Inc. from 2008 to 2018 after serving as Chief Operating Officer, where he built the company from a private research-stage startup into a multi-billion dollar public company that launched Andexxa ® and Bevyxxa ® . Portola was acquired by Alexion Pharmaceuticals, Inc. in 2020. Previously, Mr. Lis held executive positions at Scios, Inc. (a Johnson & Johnson company) where he last served as Senior Vice President of New Product Development and Business Development, leading in-licensing efforts, development and commercial P&L operations for Xarelto ® and the company's therapeutics pipeline. Earlier in his career, he held positions at Millennium Pharmaceuticals, Inc., COR Therapeutics, Inc. and Rhone Poulenc Rorer. He is a director of Zai Laboratories, Inc. Scientific Founder, President and Head of R&D Dr. Maria Grazia Roncarolo is the George D. Smith Professor in Stem Cell and Regenerative Medicine, Professor of Pediatrics and Medicine, Founder of the Center for Definitive and Curative Medicine, and former Co-Director of the Institute for Stem Cell Biology and Regenerative Medicine at Stanford University. Dr. Roncarolo has spent her career translating discoveries in immune-mediated diseases and regenerative medicine into novel patient therapies. She and her team were the first to discover Type 1 regulatory T cells in patients and the first to develop curative treatments for ADA-SCID. A pediatric immunologist by training, she was instrumental in bringing novel cell and gene therapies to market, including Strimvelis ® and Libmeldy ® . She is a Co-Founder of the gene-editing companies Graphite Bio and Kamau Therapeutics. Co-Founder and Chief Operating Officer David de Vries has over a decade of experience founding and scaling companies at the intersection of healthcare, biology and technology. Prior to Tr1X, he was Co-Founder and Chief Operating Officer of Arine, a medication intelligence and therapeutic optimization company he helped start, launch and scale to serve millions of patients, working with some of the largest healthcare organizations in the U.S. Previously, he worked at Proteus Digital Health, an innovative drug-device company and the first in the field to obtain FDA approval for a digital medicine, Abilify MyCite ® . "Tr1X is committed to bringing cures to millions of patients suffering from autoimmune diseases through our scalable, universal allogeneic cell therapy process that has been demonstrated to yield billions of cells in a single run," said Mr. Lis, CEO of Tr1X. "In just 18 months, the Tr1X team has successfully closed a Series A financing and extension, assembled an experienced leadership team, board of directors and scientific advisory board, and established a scalable GMP-grade manufacturing process. We are well positioned to advance our pipeline of first-of-their kind allogeneic engineered Treg and CAR-Treg cell therapies that have the potential to address the significant limitations of current cell therapies for autoimmune diseases, which include, among others, poor trafficking, lack of stability, limited persistence and induction of cytokine-associated toxicities, at a fraction of the cost per dose." In addition to Mr. Lis, Dr. Roncarolo and Mr. de Vries, the Tr1X leadership team includes Xavier Paliard, Pharm.D., Ph.D., Chief Scientific Officer; James Adams, MBA, Chief Technical Officer; Jonathan Perrin, J.D., Co-Founder and General Counsel; and Erik Poulsen, M.S., Head of Regulatory Affairs. Joining Mr. Lis and Dr. Roncarolo on Tr1X's Board of Directors are: Tr1X has recruited experts in immunology, stem cell and gene therapy, T-cell biology and immune-mediated diseases to join its Scientific Advisory Board. They include: About Tr1X Tr1X is a privately held biotechnology company focused on engineering cures for immune and inflammatory diseases. Founded by industry veterans, including the scientists behind the discovery of Tr1 cells, the company's pipeline of universal allogeneic cell therapies is being developed for diseases with high unmet medical need. The company is headquartered in San Diego, has developed a robust intellectual property portfolio, and is backed by leading investors, including The Column Group, NEVA SGR and Alexandria Ventures. For more information visit: www.tr1x.bio . SOURCE: Tr1X

Cell TherapyExecutive ChangePhase 1ImmunotherapyGene Therapy

08 Dec 2023

·synapse.patsnap.com

What are factor Xa inhibitors and how do you quickly get the latest development progress?

Factor Xa inhibitors are a class of anticoagulant drugs that work by inhibiting Factor Xa, a key enzyme in the coagulation cascade. The development of Factor Xa inhibitors began in the early 1980s, with the first inhibitor, antistasin, being isolated from the salivary glands of the Mexican leech Haementeria officinalis in 1987. Four drugs from this class are currently marketed worldwide. Rivaroxaban (Xarelto) was the first approved Factor Xa inhibitor, becoming commercially available in Europe and Canada in 2008. This was followed by the approval of apixaban (Eliquis) in Europe in 2011 and in the United States in 2012. Edoxaban (Lixiana, Savaysa) was approved in Japan in 2011 and in Europe and the US in 2015. The most recent addition to this class is betrixaban (Bevyxxa), which was approved in the US in 2017¹ Looking ahead, Factor Xa inhibitors are expected to continue to play a significant role in anticoagulant therapy. They are just as efficacious as low molecular weight heparin (LMWH) and warfarin but are given orally and don't need as strict monitoring. However, the emergence of resistance and the lack of an effective reversal drug when bleeding occurs are challenges that need to be addressed. Ongoing research and development efforts are focused on addressing these issues and expanding the clinical applications of Factor Xa inhibitors The analysis of target factor Xa in the pharmaceutical industry reveals a competitive landscape with multiple companies focusing on its development. Pfizer Inc., Bristol Myers Squibb Co., AstraZeneca PLC, Daiichi Sankyo Co., Ltd., and Bayer AG are among the companies growing the fastest under this target. The indications for drugs targeting factor Xa cover a wide range of cardiovascular and thrombotic conditions, indicating their potential in treating these diseases. Small molecule drugs, chemical drugs, and recombinant coagulation factors are progressing rapidly under this target. The European Union, the United States, and Japan are leading in terms of drug development, but China has also shown progress. Further analysis is required to understand the specific progress in China and its impact on the future development of target factor Xa. Overall, target factor Xa presents a promising opportunity in the pharmaceutical industry with a diverse range of companies, indications, drug types, and countries/locations involved in its development. The mechanism of action of factor Xa inhibitorsFactor Xa inhibitors are a type of medication that specifically target and inhibit the activity of factor Xa, which is a key enzyme involved in the blood clotting process. From a biomedical perspective, factor Xa is a crucial component of the coagulation cascade, a series of reactions that leads to the formation of blood clots. By inhibiting factor Xa, these medications prevent the formation of blood clots and reduce the risk of conditions such as deep vein thrombosis, pulmonary embolism, and stroke. Factor Xa inhibitors work by binding to factor Xa and blocking its ability to activate other clotting factors, ultimately preventing the formation of a stable blood clot. This mechanism of action makes them anticoagulant drugs, meaning they help to prevent the excessive formation of blood clots. These inhibitors are commonly used in the treatment and prevention of thromboembolic disorders, such as atrial fibrillation, venous thromboembolism, and post-operative prophylaxis. Examples of factor Xa inhibitors include rivaroxaban, apixaban, and edoxaban. It's important to note that factor Xa inhibitors carry a risk of bleeding, as they interfere with the normal clotting process. Therefore, their use should be carefully monitored, and patients may require regular blood tests to assess their coagulation status. Additionally, factor Xa inhibitors should be used with caution in individuals with certain medical conditions or those taking other medications that increase the risk of bleeding. Catalog of factor Xa InhibitorsThe currently marketed factor Xa inhibitors include: Andexanet alfaHuman Coagulation Factor X(Bio Products)ApixabanEdoxaban TosylateRivaroxabanArdeparin SodiumCertoparin sodiumParnaparin SodiumDanaparoid SodiumDalteparin SodiumFor more information, please click on the image below. What is the purpose of using factor Xa inhibitors?Factor Xa inhibitors that are used to prevent and treat thromboembolic disorders. For more information, please click on the image below to log in and search. How can I get the most recent advancements in factor Xa inhibitors?In the Synapse database, you can keep abreast of the latest research and development advances of factor Xa inhibitors anywhere and anytime, daily or weekly, through the "Set Alert" function. Click on the image below to embark on a brand new journey of drug discovery!

100 Deals associated with Betrixaban

External Link

KEGG	Wiki	ATC	Drug Bank
D08873	Betrixaban	B01AF	DB12364

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Thromboembolism	United States	Portola Pharmaceuticals LLC	23 Jun 2017
Venous Thromboembolism	United States	Portola Pharmaceuticals LLC	23 Jun 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hemorrhage	Phase 2	United States	Portola Pharmaceuticals LLC	06 Aug 2015
Atrial Flutter	Phase 2	-	Portola Pharmaceuticals LLC	01 Sep 2010
Atrial Fibrillation	Phase 2	United States	Portola Pharmaceuticals LLC	01 Oct 2008
Atrial Fibrillation	Phase 2	Canada	Portola Pharmaceuticals LLC	01 Oct 2008

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03346083 (CTgov)	Phase 1	Venous Thromboembolism	21	Betrixaban (Cohort 1: Betrixaban 40 mg)	blcipwxldn(sglypuhnhz) = buetegooos wsqffudanl (bheonoonnx, sphbbcrqsw - zqlflkpqug) View more	-	12 Jan 2024
				Betrixaban (Cohort 2: Betrixaban 80 mg)	blcipwxldn(sglypuhnhz) = idynuipybn wsqffudanl (bheonoonnx, fwssalcyks - avhcmnwixv) View more
NCT03330457 (CTgov)	Phase 2	Hemorrhage	18	Andexanet alfa (bolus)+Betrixaban 80 mg PO QD (Cohort 1 Bertrixaban/Andexanet)	gevpxtekhz(sksibwlqrg) = wjpqjksyke zxraswyqky (zucggjyrzm, 7.453) View more	-	19 Aug 2020
				Andexanet alfa (bolus)+Betrixaban 80 mg PO QD (Cohort 1 Bertrixaban/Placebo)	gevpxtekhz(sksibwlqrg) = rfxpesfrcr zxraswyqky (zucggjyrzm, 10.090) View more
NCT02111564 \| NCT00571649 \| NCT01583218 (Pubmed \| Crit Pathw Cardiol)	Phase 3	Acute Disease	-	Betrixaban or Rivaroxaban	nfmibxblkl(tjufurtghf) = gjjzgryycl nzrpfajnhr (hbmwitiyta, -2.32% - -0.69%) View more	-	09 Jul 2020
ISTH2019	Not Applicable	-	-	Apixaban	mrcfvuhlgg(uzwmrwqhna) = irwmivrgbc rhqpozrptf (vqjewtfvbb ) View more	-	10 Jun 2019
				Betrixaban	mrcfvuhlgg(uzwmrwqhna) = mvkirishpo rhqpozrptf (vqjewtfvbb ) View more
NCT01583218 (APEX, Pubmed \| Intensive Care Med)	Phase 3	Critical Illness	7,513	Betrixaban	nnjdhwaulh(ptrqrtxsau) = qtipaixmfr dbkoladsha (xmmftosnlg ) View more	-	01 Apr 2019
				Enoxaparin	nnjdhwaulh(ptrqrtxsau) = nedrkrzzdp dbkoladsha (xmmftosnlg ) View more
NCT01583218 (APEX, Pubmed)	Phase 3	Venous Thromboembolism	7,513	Betrixaban	hnjicbbiot(frfpfvttma) = vmnfkteodc cbmjlgnvhe (mhldbuyvjn )	Positive	01 Jan 2018
				Enoxaparin	hnjicbbiot(frfpfvttma) = ntaelnbsyk cbmjlgnvhe (mhldbuyvjn )
NCT00375609 (CTgov)	Phase 2	Thromboembolism	215	Betrixaban (Betrixaban 15 mg)	cmmpvxdeah = wfmrcmtwli tfztlfczqb (flxcdmzmnd, cxrvwzmmeb - oseumrdgrn) View more	-	15 Dec 2017
				Betrixaban (Betrixaban 40 mg)	cmmpvxdeah = tymcqdvudy tfztlfczqb (flxcdmzmnd, gidjyhoesk - cyugirdser) View more
NCT00742859 (EXPLORE-Xa, CTgov)	Phase 2	Atrial Fibrillation	508	Betrixaban (Betrixaban 40 mg)	vtqaaomwlw = duvndbdqxh gbbpmppoqh (crwujbmtsy, qxczinrpzq - uqirylcrol) View more	-	26 Sep 2017
				Betrixaban (Betrixaban 60 mg)	vtqaaomwlw = rcxenumvom gbbpmppoqh (crwujbmtsy, xdfxpfdhrx - koxumhcibu) View more
NCT01583218 (APEX Trial \| APEX, CTgov)	Phase 3	Venous Thromboembolism	7,513	Betrixaban (Betrixaban)	eqlxgtrgwk = wfxqkaybfc xjtdbgbrbf (aydrutgjmj, efhxozcqfm - kjrdfsrbqw) View more	-	20 Sep 2017
				Enoxaparin (Enoxaparin)	eqlxgtrgwk = qgvdmsjeff xjtdbgbrbf (aydrutgjmj, jnpuybwuir - lvobyulmqo) View more
NCT01229254 (CTgov)	Phase 2	Atrial Flutter \| Atrial Fibrillation	189	Amiodarone+Betrixaban (Betrixaban 30 mg (+Amiodarone))	jpiosfgdzy(vcfmysjtji) = fcxdmgbtoj pntycgnrhf (lhnkunwoxo, xmdmsehbll - gyiqybivzj) View more	-	18 Sep 2017
				Betrixaban (Betrixaban 60 mg (<80 kg))	ruambjxiey(hzeomkerzo) = twtnfzsqlf ekyxnfuaix (kbmvsminnj, qpgtjlvcfy - gmqsxmymvm) View more

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