A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Febuxostat 80 mg Film-coated Tablets (INNOXOSTAT) and Reference Product (Feburic 80 mg) in Healthy Thai Volunteers under Fasting Conditions

Start Date01 Jul 2025

Sponsor / Collaborator-

TCTR20240831005 / Not yet recruitingPhase 1IIT

A Bioequivalence study of a randomized, open-label, single dose, two-way crossover design with two-period, two-treatment and two-sequence of Febuxostat Tablets 80 mg relative to Feburic 80 mg (Febuxostat Tablets 80 mg) in healthy Thai volunteers under fasting condition

Start Date04 Feb 2025

Sponsor / Collaborator

Bio-innova Co., Ltd

NCT06653686 / Not yet recruitingNot ApplicableIIT

Study on the Efficacy and Safety of Extracorporeal High-Frequency Hyperthermia in the Treatment of Refractory Gout

Gout is a crystal-related arthropathy caused by purine metabolism disorder or decreased uric acid excretion. It can manifest as acute recurrent arthritis, tophus formation, tophaceous chronic arthritis, and urate nephropathy, with severe cases potentially leading to joint disability, renal insufficiency, and damage to other vital organs.Poor long-term control of uric acid levels may result in the progression of refractory gout in some patients, characterized by persistently elevated serum uric acid levels, recurrent acute arthritis, and multiple or progressive tophi, severely affecting quality of life and imposing a significant economic burden on patients.Currently, clinical research on refractory gout is relatively limited, and both domestic and international guidelines continue to recommend uric acid-lowering therapy to slow disease progression.However, due to poor adherence, intolerance to uric acid-lowering drugs, or dose limitations caused by coexisting chronic kidney disease, achieving target serum uric acid levels in these patients is often difficult, and their clinical symptoms are challenging to alleviate effectively.
In recent years, thermotherapy, as a non-pharmacological treatment modality, has garnered increasing attention for its effects in alleviating chronic pain, promoting blood circulation, and reducing inflammatory responses.Its primary mechanisms include: 1) increasing local temperature to influence the solubility of monosodium urate (MSU) crystals, promoting their dissolution, reducing gout attacks, and accelerating the resolution of gout flares;2) elevated local temperature promotes vasodilation and blood circulation, increasing the supply of oxygen and nutrients, facilitating the clearance of uric acid and inflammatory mediators;3) thermotherapy enhances local immune responses by boosting cellular phagocytic activity; 4) it may act as a stimulus transmitted to the central nervous system alongside pain impulses, disrupting pain transmission pathways and resulting in the attenuation or elimination of pain sensations. In recent years, thermotherapy has been widely used in clinical practice as a non-invasive, adjunctive treatment for various conditions, such as tumors, lumbar disc herniation, chronic prostatitis, pelvic inflammatory disease, endometriosis-associated dysmenorrhea, and osteoarthritis, due to its proven efficacy, non-invasive nature, and minimal adverse effects.A study from China demonstrated that thermotherapy has significant therapeutic effects on patients with acute gout attacks, effectively alleviating acute symptoms and reducing inflammatory responses. In this study, the overall clinical efficacy rate of the treatment group (thermotherapy combined with conventional therapy) was significantly higher at 90.0% compared to 72.5% in the control group. Moreover, on day 1 and day 3 post-treatment, the VAS scores of the treatment group (4.11±0.76, 3.23±0.53) were significantly lower than those of the control group (5.23±1.21, 4.23±0.76), and the treatment group had lower ESR and CRP levels than the control group after treatment (P<0.05).Therefore, the primary aim of this study is to investigate the efficacy of thermotherapy in reducing gout attacks. However, there is currently no large-scale, multicenter clinical research evidence evaluating the clinical effectiveness of thermotherapy in patients with refractory gout.
In summary, considering the critical regulatory role of temperature in the formation and deposition of monosodium urate crystals and the fundamental principles of extracorporeal high-frequency thermotherapy, we hypothesize that extracorporeal high-frequency thermotherapy could reasonably reduce MSU crystal burden, lower uric acid levels, alleviate local inflammation, and decrease the frequency of gout attacks through its thermal effects.This study aims to evaluate the efficacy of extracorporeal high-frequency thermotherapy in patients with refractory gout through a randomized controlled trial, exploring its effects on reducing gout attack frequency, improving uric acid metabolism, and alleviating inflammation. Additionally, the study will assess the impact of thermotherapy on patients' quality of life, physical function, and metabolic parameters, with the goal of providing new effective strategies for the treatment of refractory gout in the future.

Start Date01 Nov 2024

Sponsor / Collaborator

The First Hospital of Jilin University

100 Clinical Results associated with Febuxostat

100 Translational Medicine associated with Febuxostat

100 Patents (Medical) associated with Febuxostat

1,297

Literatures (Medical) associated with Febuxostat

01 Jan 2025·Current drug discovery technologies

A Combination of Pharmacophore Generation, Ligand-based Virtual Screening, Atom-based 3D-QSAR, and Molecular Docking Studies on Febuxostat-based Amides Analogues as Anti-inflammatory Agents

Article

Author: Jagdale, Sakshi M. ; Thorat, Shubhangi B. ; Garud, Dinesh R. ; Asgaonkar, Kalyani D. ; Hirode, Purvaj V. ; Bhatambrekar, Aniket L. ; Hajare, Sayli G. ; Chitre, Trupti S.

Background::

A defence mechanism of the body includes inflammation. It is a process through which the immune system identifies, rejects, and starts to repair foreign and damaging stimuli. In the world, chronic inflammatory disorders are the leading cause of death.

Materials and Methods::

To obtain optimized pharmacophore, previously reported febuxostat- based anti-inflammatory amide derivatives series were subjected to pharmacophore hypothesis, ligand-based virtual screening, and 3D-QSAR studies in the present work using Schrodinger suite 2022-4. QuikProp module of Schrodinger was used for ADMET prediction, and HTVS, SP, and XP protocols of GLIDE modules were used for molecular docking on target protein (PDB ID:3LN1).

Result::

Utilising 29 compounds, a five-point model of common pharmacophore hypotheses was created, having pIC50 ranging between 5.34 and 4.871. The top pharmacophore hypothesis AHHRR_ 1 model consists of one hydrogen bond acceptor, two hydrophobic groups and two ring substitution features. The hypothesis model AHHRR_1 underwent ligand-based virtual screening using the molecules from Asinex. Additionally, a 3D-QSAR study based on individual atoms was performed to assess their contributions to model development. The top QSAR model was chosen based on the values of R2 (0.9531) and Q2 (0.9424). Finally, four potential hits were obtained by molecular docking based on virtual screening.

Conclusion::

The virtual screen compounds have shown similar docking interaction with amino acid residues as shown by standard diclofenac sodium drugs. Therefore, the findings in the present study can be explored in the development of potent anti-inflammatory agents.

01 Jan 2025·BIOCHIMICA ET BIOPHYSICA ACTA-GENERAL SUBJECTS

Computational profiling and pharmacokinetic modelling of Febuxostat: Evaluating its potential as a therapeutic agent for diabetic wound healing

Article

Author: Nirenjen, S ; Narayanan, J

BACKGROUND:

Diabetic wounds, a significant complication of Type 2 Diabetes Mellitus (T2DM), face delayed healing due to impaired inflammation, angiogenesis, and collagen synthesis. This study explores Febuxostat, a xanthine oxidase inhibitor for its therapeutic potential in wound healing. Combining computational approaches and in-vitro assays, the study evaluates its effects on key wound healing pathways, cell viability, migration.

METHODOLOGY:

The potential of Febuxostat in diabetic wound healing was studied using in-silico tools for Molecular docking and ADMET profiling, alongside Molecular dynamics (MD) simulations. Toxicity was assessed with OSIRIS Explorer, and biological activity was predicted using the PASS tool. In-vitro MTT and scratch assays on L929 cells further validated cytotoxicity and wound healing efficacy.

RESULTS:

Docking analysis revealed strong binding affinities to key wound healing targets, including VEGF (-9.11 kcal/mol) and NFKβ (-8.62 kcal/mol). Pharmacokinetic studies highlighted favorable skin permeability, supporting topical applications. Toxicity predictions indicated a safe profile. Molecular dynamics simulations demonstrated stable protein-ligand complexes, particularly with VEGF. Cytotoxicity studies on L929 cells revealed an IC₅₀ of 6.08 μM and the scratch assay demonstrated significant wound healing activity, highlighting its effectiveness in promoting cell migration and closure.

CONCLUSION:

Febuxostat shows remarkable potential in enhancing diabetic wound healing by promoting cell migration, targeting wound-healing proteins, as demonstrated through in-silico and in-vitro studies. This drug is poised to effectively treat diabetic wounds, accelerating healing and reducing complications. Rigorous pre-clinical and clinical evaluations are essential to validate its safety, efficacy, and therapeutic potential.

01 Jan 2025·INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES

Natural polysaccharides in the prevention of hyperuricemia: Source, classification, mechanism, application in food industry

Review

Author: Ren, Likun ; Cui, Fangchao ; Wang, Dangfeng ; Wang, Tian ; Jiang, Yang ; Li, Tingting ; Li, Xuepeng ; Dang, Lingling ; Li, Jianrong ; Liu, Zhiteng

Hyperuricemia (HUA) is one of the major threats to human health. In recent years, with the gradual increase in the incidence rate of Hua, the prevention and treatment of HUA has attracted more and more attention. Clinical pharmaceutical interventions, such as Allopurinol, Febuxostat, and so on, though effective, are usually accompanied by notable adverse effects. Therefore, alternative therapy with high-safety natural components has received more and more attention from scholars. The natural polysaccharides showed a significant potential in HUA therapy and more and more natural polysaccharides for treating HUA were being obtained. Therefore, in this review, the recent progress on natural polysaccharides in preventing HUA was presented focusing on the sources, classification, and biological activities (oxidative stress, anti-inflammatory, and UA-lowering) of natural polysaccharides. Furthermore, this review explores the mechanisms of action and application. It is beneficial to the development of polysaccharides for natural HUA therapy and the results of this review could offer guidance on preventing the occurrence of HUA in daily life.

News (Medical) associated with Febuxostat

03 Dec 2024

·www.businesswire.com

Atom Therapeutics and China Medical System Holdings Enter Exclusive Commercialization Agreement for Lingdolinurad (ABP-671) to Treat Chronic Gout and Hyperuricemia

ZHEJIANG, China--( BUSINESS WIRE )--Atom Therapeutics Co. Ltd (Atom Therapeutics), a clinical stage biotechnology company developing best-in-class treatments for inflammatory and metabolic diseases, announced today the company entered into an exclusive commercialization collaboration agreement with a subsidiary of China Medical System Holdings Ltd (CMS) for lingdolinurad (ABP-671), a novel oral small molecule URAT1 inhibitor for the treatment of chronic gout and hyperuricemia, in mainland China, Hong Kong Special Administrative Region and Macao Special Administrative Region. Atom Therapeutics and CMS will execute a Contract Sales Organization (CSO) business model. Under the agreement, Atom Therapeutics will receive a substantial sum from CMS through upfront and milestone payments, and will pay marketing and sales service fees to CMS. Lingdolinurad is expected to generate substantial income and revenue from the sales collaborated with CMS. This event marks a significant advancement for Atom Therapeutics in the commercialization of ABP-671. Atom Therapeutics is currently conducting multi-center Phase 2b/3 clinical trials of lingdolinurad worldwide, including in China and the United States. Lingolinurad reduces renal re-absorption of uric acid by inhibiting URAT1 (urate anion transporter 1). Results from multiple clinical trials have demonstrated that lingdolinurad is safe and effective at multiple dose levels (from 1 mg to 12 mg). The 2 mg once-daily tablet is expected to be as effective as benzbromarone (80 mg) and febuxostat (80 mg). The efficacy of lingdolinurad is maintained for over 24 hours without significant safety concerns, positioning it as a potentially safer and more effective treatment option for patients with chronic gout and hyperuricemia. CMS is a platform company linking pharmaceutical innovation and commercialization with a strong product lifecycle management capability, outstanding market promotion capabilities, and extensive commercialization experience. Through this collaboration, Atom Therapeutics will leverage the broad market channels and rich commercialization experience of CMS to achieve rapid promotion and broad clinical application of ABP-671 following its launch. Atom Therapeutics CEO, Chairman and Founder William Dongfang Shi, Ph.D., commented, “This collaboration represents a deep integration of our two companies' business operations and strategic initiatives. We look forward to advancing the implementation and application of ABP-671 through this partnership, delivering more effective treatment options for patients with gout and hyperuricemia as soon as possible.” About Atom Therapeutics Atom Therapeutics Co., Ltd (originally named Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd) officially changed its name on October 8, 2024. Atom Therapeutics is a fast-growing innovative drug company focused on development of best-in-class small molecule therapeutics for treatment of inflammatory and metabolic diseases. The company’s lead product, lingdolinurad, is in late-stage clinical development for treatment of chronic gout. Another small molecule ABP-745, for anti-inflammatory and autoimmune conditions, has completed Phase 1 clinical trials in the US and demonstrated good pharmacokinetics and safety, and will enter Phase 2 clinical trials soon. For more information, please visit: https://www.atombp.com or atombp.us . About CMS CMS is a platform company linking pharmaceutical innovation and commercialization with strong product lifecycle management capability, dedicated to providing competitive products and services to meet unmet medical needs. CMS focuses on the global first-in-class and best-in-class innovative products, and efficiently promotes the clinical research, development and commercialization of innovative products, enabling the continuous transformation of scientific research into clinical practices to benefit patients. CMS deeply engages in several specialty therapeutic fields, and has developed proven commercialization capabilities, extensive networks and expert resources, resulting in leading academic and market positions for its major marketed products. CMS continues to promote the in-depth development of its advantageous specialty fields and expand business boundaries. While strengthening the competitiveness of the cardio-cerebrovascular/gastroenterology business, CMS independently operates its dermatology and medical aesthetics business, and ophthalmology business, aiming to gain leading positions in specialty therapeutic fields, whilst enhancing the scale and efficiency. At the same time, CMS has expanded its business territory to the Southeast Asian market, striving to become a "bridgehead" for global pharmaceutical companies to enter the Southeast Asian market, further escorting the sustainable and healthy development of the Group. For more information, please visit: https:/veb.cms.net.cn.

Phase 1License out/inClinical Result

30 Oct 2024

·www.prnewswire.com

Latest Updates of Viva Biotech's Portfolio Companies

HONG KONG, Oct. 30, 2024 /PRNewswire/ -- Even with the ever-changing situation, technological innovation is still the most critical component for biopharmaceutical companies' long-term development. This continuous innovation keeps companies up to date and promotes the evolution of R&D and the success of commercialization. Recently, Viva Biotech's portfolio companies have new updates. Keep reading for more details. Seraxis Announces FDA IND Allowance for Clinical Study of SR-02 Replacement Islets for Type 1 Diabetes October 15, 2024, Germantown, MD. Seraxis Inc., a clinical stage regenerative medicine company invested by Viva BioInnovator (VBI), has received FDA's allowance of an Investigational New Drug (IND) application for a Phase I/II clinical study of its novel islet replacement therapy SR-02. SR-02 is the first reprogrammed stem cell-derived pancreatic product candidate allowed by FDA for testing in humans as a potential functional cure for insulin-requiring diabetes. Arthrosi Therapeutics and ApicHope Pharmaceutical Co-developed Gout Treatment AR882 Achieves Promising Phase II Clinical Results in China and Granted Fast Track Designation by the FDA According to ApicHope Pharmaceutical, Arthrosi Therapeutics, Inc. ("Arthrosi"), a portfolio company incubated by Viva Biotech, has achieved outstanding results in a Phase II clinical trial for the investigational gout treatment AR882. Developed in collaboration with ApicHope Pharmaceutical, this Class I novel drug showed promising outcomes for treating primary gout with hyperuricemia and has now entered Phase II clinical trials in China. The Phase II clinical trial primarily aimed to explore the optimal dosing of AR882 capsules for treating primary gout with hyperuricemia and to preliminarily assess the drug's efficacy and safety. The primary endpoint was the percentage of patients with serum uric acid levels below 360 μmol/L after eight weeks of treatment. By week six, AR882 demonstrated significant efficacy, with the 75mg dose of AR882 showing superiority over Febuxostat (P<0.001). AR882 exhibited an excellent safety profile, with no severe adverse events reported. Mild to moderate side effects observed included diarrhea, headache, and upper respiratory infections. Importantly, AR882 did not interfere with the management of patients' comorbidities, which remained stable throughout the trial. On August 19, Arthrosi Therapeutics announced that it received FDA Fast Track Designation for AR882 in Tophaceous Gout. Antag Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for Lead Molecule, AT-7687 Copenhagen, Denmark – October 9, 2024 – Antag Therapeutics, a leading biopharmaceutical company focused on targeting the Glucose-Dependent Insulinotropic Polypeptide (GIP) receptor to pioneer novel treatments for obesity and invested and incubated by Viva BioInnovator (VBI), announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for its lead molecule, AT-7687. This milestone enables Antag Therapeutics to initiate its Phase I clinical trial, which will evaluate the safety, tolerability, and pharmacokinetics of AT-7687 in both healthy lean and healthy obese subjects. The study will also explore AT-7687 as a monotherapy and in combination with semaglutide, a GLP-1 receptor agonist, in healthy obese individuals. Cybrexa Therapeutics Announces First Patient Dosed with First-in-Class Peptide-Drug Conjugate CBX-12 in Phase 2 Trial in Ovarian Cancer NEW HAVEN, Conn. – October 7, 2024 – Cybrexa Therapeutics, invested and incubated by Viva BioInnovator (VBI), a clinical-stage oncology biotechnology company developing a novel class of tumor-targeting peptide-drug conjugate (PDC) therapeutics, announced that the first patient has been dosed in a Phase 2 clinical trial evaluating CBX-12 in patients with platinum-resistant or refractory ovarian cancer. CBX-12 is a first-in-class PDC that uses Cybrexa's proprietary alphalex™ technology to enhance the delivery of exatecan, a potent, established topoisomerase 1 (TOP1) inhibitor, directly to tumor cells while sparing healthy tissue. This trial initiation follows promising Phase 1 results, which demonstrated CBX-12's broad activity across ovarian, breast, non-small cell lung cancer (NSCLC), thymic, gallbladder, and colorectal cancers, along with a manageable safety profile. Basking Biosciences Doses First Patients in Phase 2 Clinical Trial of Reversible Thrombolytic BB-031 for Acute Ischemic Stroke Columbus, Ohio – Sept. 10, 2024 – Basking Biosciences (Basking), invested and incubated by Viva BioInnovator (VBI), a clinical-stage biopharmaceutical company developing a novel acute thrombolytic therapy, announced that the first patients have been dosed in RAISE, a Phase 2 clinical trial evaluating BB-031 in patients presenting with acute ischemic stroke (AIS). HAYA Therapeutics Announces Collaboration with Lilly to Discover Novel Regulatory Genome Targets for Obesity and Related Metabolic Conditions Using Proprietary RNA Platform LAUSANNE, Switzerland & SAN DIEGO, HAYA Therapeutics, SA, invested and incubated by Viva BioInnovator (VBI), a biotechnology company pioneering precision RNA-guided regulatory genome targeting therapeutics for chronic diseases, announced a multi-year agreement with Eli Lilly and Company to apply HAYA's advanced RNA-guided regulatory genome platform to support preclinical drug discovery efforts in obesity and related metabolic conditions. The partners will identify multiple regulatory genome derived RNA-based drug targets to address these chronic conditions. Under the terms of the collaboration, HAYA will receive an upfront payment, including an equity investment, and is eligible to receive up to an aggregate $1 billion in pre-clinical, clinical and commercial milestone payments, as well as royalties on product sales. About Seraxis Seraxis is bringing transformative therapies to the millions of people worldwide struggling with the management of insulin-requiring diabetes and the associated life-threatening complications. Seraxis' lead program, SR-02, is a novel islet replacement therapy for patients of insulin-requiring diabetes with concurrent immunosuppression therapy. This therapy is the foundation of Seraxis follow-on therapies for patients without immune suppression. Frazier Life Sciences, Polaris Partners, Eli Lilly and Company, the T1D Fund and others are investors in Seraxis. Visit . About Arthrosi Arthrosi Therapeutics, Inc., headquartered in San Diego, CA, is focused on developing AR882, a potentially best-in-class, highly potent and selective next generation URAT1 inhibitor to reduce serum urate levels, flares and tophi in patients with gout. In the U.S., an estimated 13 million individuals are diagnosed with gout and approximately 2 million of those patients have visible tophi. In Phase II studies, AR882 demonstrated encouraging efficacy and safety compared to standard of care (SOC), while Phase IIb results showed impressive success in the complete elimination of tophi. Arthrosi is currently advancing AR882 into Phase III clinical trials. About Antag Therapeutics Antag Therapeutics is a clinical-stage biopharmaceutical company committed to discovering and developing novel therapies for obesity and cardiometabolic diseases through GIP receptor antagonism. As a pioneer in exploring the potential of GIP receptor antagonists, the company is dedicated to advancing science and improving patient outcomes by delivering groundbreaking solutions that address unmet medical needs. For more information, please visit . About Cybrexa Therapeutics Cybrexa is a privately held clinical-stage biotechnology company pioneering novel antigen-independent, tumor-targeting peptide-drug conjugate (PDC) therapeutics. The company is led by a dynamic team of highly successful life science entrepreneurs and veteran drug development scientists. Cybrexa is on a mission to create therapeutics that revolutionize the standard of care in oncology, and its robust pipeline aims to combat breast, ovarian, non-small cell lung cancer, and a range of other tumors. Its assets are built on Cybrexa's alphalex™ technology platform, which enables intracellular delivery of highly potent anti-cancer treatments. Cybrexa is based in New Haven, Connecticut and was founded in 2017. For more information, please visit or follow us on LinkedIn and X. About Basking Biosciences Basking Biosciences, a clinical-stage biopharmaceutical company, was founded to solve the biggest need in acute thrombosis – for a rapid-onset, short-acting thrombolytic drug capable of reopening blocked arteries, and whose activity can be quickly reversed in the event of a bleeding complication. Leveraging RNA aptamer technology, our lead drug candidate, BB-031, targets von Willebrand Factor (vWF), an important structural component of blood clots and driver of the clotting process, and is designed to be safer, more effective, and able to significantly expand the population receiving acute revascularization therapy. About HAYA Therapeutics HAYA Therapeutics is a precision medicines company developing programmable therapeutics targeting regulatory RNAs derived from the dark genome, a cell information processing unit, to reprogram pathological cell states for a broad range of diseases, including cardiovascular and metabolic diseases and cancer. The company is using its innovative platform to gain novel insights into the biology of disease cell states and the long non-coding RNAs (lncRNAs) that regulate them. HAYA's lead therapeutic candidate is HTX-001, in development for the treatment of heart failure. HAYA is also developing a pipeline of lncRNA-targeting precision therapies for the cell-specific treatment of diseases in other tissues. SOURCE Viva Biotech WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Fast TrackClinical Result

05 Aug 2024

·www.prnewswire.com

Shanton Reaches Full Enrollment in Phase 2b Refractory/Tophaceous Gout Study with SAP-001

SAP-001 is Shanton's lead investigational compound with Best-in-Class potential in uncontrolled gout PRINCETON, N.J., Aug. 5, 2024 /PRNewswire/ -- Shanton Pharma, a clinical-stage biotech company developing a groundbreaking treatment for refractory and tophaceous gout patients, today announced full enrollment of a Phase 2b study for its investigational drug SAP-001. "Reaching full enrollment is an important milestone in our 6-month gout study" Shanton's CEO Dr. Bing Li said, "as this sets the clock for topline data readout in Q1 2025. The study aims to show similar good efficacy and safety results that we saw in our Phase 1 and 2a studies in regular gout patients, but now in the more challenging target population of truly refractory patients that often have a more severe form of gout with limited treatment options. The challenge of this study was to just enroll patients that do not respond to a maximum tolerable dose of conventional Xanthine Oxidase Inhibitors such as allopurinol or febuxostat, which we have now accomplished through full enrollment of the Phase 2b study." About Gout Gout is the most common form of inflammatory arthritis, and the second most prevalent metabolic disease caused by too much uric acid in the bloodstream, with over 10 million adult patients diagnosed in the US alone.1 Hyperuricemia, elevated serum uric acid levels, can over time result in gout when urate crystals are deposited in joints (tophi) and other body tissues, causing inflammatory responses and painful gout attacks (flares). Recurrent gout flares are debilitating and can lead to joint destruction and joint disfigurement. About 29% of diagnosed gout patients in the US are treated with urate lowering therapies (ULTs), but only half of those patients sufficiently respond to or can tolerate current treatment options. It is estimated that up to 20% of US gout patients on standard-of-care allopurinol or febuxostat are physiologically refractory to these treatments, and that up to a third of gout patients develop tophi. 2,3,4 About Shanton's Phase 2b Gout Study Shanton's Phase 2b study is a six-month, multi-center, randomized, double-blind, placebo-controlled, dose-ranging clinical study in refractory gout patients with or without tophi, to evaluate the efficacy and safety of a 10, 30, or 60 mg tablet dose of SAP-001. The study has now reached full enrollment with 87 patients from 21 US sites. The Primary objective is to assess the effectiveness of SAP-001 in lowering serum urate levels in gout patients that are refractory to standard-of-care Xanthine Oxidase Inhibitor (XOI) therapy. Secondary study objectives include safety and tolerability assessments, frequency of gout flares, and change in tophi number, size, and mass. About Shanton Pharma Shanton Pharma is a privately held, clinical-stage biotech founded in 2016 by experienced pharma entrepreneurs, with a research focus on unmet needs associated with hyperuricemia and gout. The company is headquartered in the US with research and development activities in the US, China, and Singapore. SAP-001 is Shanton's lead investigational compound for once-a-day oral urate-lowering therapy that targets refractory and tophaceous gout. SAP-001's urate lowering properties are based on a unique mechanism-of-action and the product has shown unparalleled efficacy and safety in Phase 1 and Phase 2a clinical studies in gout patients with hyperuricemia. Based on its clinical profile and mechanism, SAP-001 has the potential to become the Best-in-Class treatment for refractory and tophaceous gout. To learn more about Shanton Pharma, go to . References Chen-Xu, M., Yokose, C., Rai, S.K., Pillinger, M.H. and Choi, H.K. (2019), Contemporary Prevalence of Gout and Hyperuricemia in the United States and Decadal Trends: The National Health and Nutrition Examination Survey, 2007–2016. Arthritis Rheumatol, 71: 991-999. Juraschek SP, Kovell LC, Miller ER 3rd, Gelber AC. Gout, urate-lowering therapy, and uric acid levels among adults in the United States. Arthritis Care Res (Hoboken). 2015 Apr;67(4):588-92. doi: 10.1002/acr.22469. PMID: 25201123; PMCID: PMC4362996. Clarivate Incidence and Prevalence Data Base. Kasper, I.R., Juriga, M.D., Giurini, J.M., Shmerling, R.H., Treatment of tophaceous gout: When medication is not enough, Seminars in Arthritis and Rheumatism, Volume 45, Issue 6, 2016, 669-674. Media Contact Pieter de Ridder VP of Business Development [email protected] SOURCE Shanton Pharma

Phase 2Clinical ResultPhase 1

100 Deals associated with Febuxostat

External Link

KEGG	Wiki	ATC	Drug Bank
D01206	Febuxostat	M04AA03	DB04854

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Arthritis, Gouty	EU	Viatris Ltd. (New Zealand)	15 Jun 2017
Arthritis, Gouty	IS	Viatris Ltd. (New Zealand)	15 Jun 2017
Arthritis, Gouty	LI	Viatris Ltd. (New Zealand)	15 Jun 2017
Arthritis, Gouty	NO	Viatris Ltd. (New Zealand)	15 Jun 2017
HYPERURICEMIA CHRONIC	EU	Viatris Ltd. (New Zealand)	15 Jun 2017
HYPERURICEMIA CHRONIC	IS	Viatris Ltd. (New Zealand)	15 Jun 2017
HYPERURICEMIA CHRONIC	LI	Viatris Ltd. (New Zealand)	15 Jun 2017
HYPERURICEMIA CHRONIC	NO	Viatris Ltd. (New Zealand)	15 Jun 2017
Gout	US	Takeda Pharmaceuticals U.S.A., Inc.	13 Feb 2009
Hyperuricemia	EU	Menarini International Operations Luxembourg SA	21 Apr 2008
Hyperuricemia	IS	Menarini International Operations Luxembourg SA	21 Apr 2008
Hyperuricemia	LI	Menarini International Operations Luxembourg SA	21 Apr 2008
Hyperuricemia	NO	Menarini International Operations Luxembourg SA	21 Apr 2008

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hematologic Neoplasms	Phase 3	-	A. Menarini Industrie Farmaceutiche Riunite SRL	01 Oct 2012
Tumor Lysis Syndrome	Phase 3	-	A. Menarini Industrie Farmaceutiche Riunite SRL	01 Oct 2012
Cardiovascular Diseases	Phase 3	US	Takeda Pharmaceutical Co., Ltd.	23 Apr 2010
Cardiovascular Diseases	Phase 3	MX	Takeda Pharmaceutical Co., Ltd.	23 Apr 2010
Angina, Stable	Phase 2	US	Takeda Pharmaceutical Co., Ltd.	01 Jul 2012
Hypertension	Phase 2	US	Takeda Pharmaceutical Co., Ltd.	01 Feb 2012
Kidney Calculi	Phase 2	US	Takeda Pharmaceutical Co., Ltd.	01 Feb 2010
Nephrolithiasis, Calcium Oxalate	Phase 2	US	Takeda Pharmaceutical Co., Ltd.	01 Feb 2010
Primary gout	Phase 1	-	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	30 Apr 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EULAR2024	Not Applicable	Gout \| Chronic Kidney Diseases serum urate levels	342	Febuxostat (Normal kidney function)	bchcyljecq(yojbjnbmbh) = fwvqzdsmfr oockbxnusm (ujenvevrao )	Positive	05 Jun 2024
				Febuxostat (Chronic kidney disease)	bchcyljecq(yojbjnbmbh) = wzixnswzmr oockbxnusm (ujenvevrao )
SAT641 (ENDO2023)	Not Applicable	-	12	Febuxostat treated water	awrnbftmbm(jgoawmpmwb) = onfvslfink dujmbqvbox (ppeihexzpw, 2.70) View more	Positive	05 Oct 2023
				Febuxostat (Sham-control)	jcqiafhidc(sdtcnhwxay) = mfhrejlxuz rwqdvqbpxt (aqiuvejbhb, 0.1) View more
EASD2023	Not Applicable	Ocular Motility Disorders	-	Febuxostat	jixjqcoroq(rmnpifbaox) = Febuxostat-treated adipocytes exhibited higher UCP1 (p<0.05, vs. febuxostat) and other marker gene mRNA expressions (PRDM16, PPARγ, PGC1a, FABP4) nmwquhexuf (ylzeuqzdol ) View more	Positive	04 Oct 2023
				febuxostat (Control)
TCTR20210224005 (Pubmed \| Sci Rep)	Phase 4	Chronic Kidney Diseases	84	Febuxostat	pxenvolaij(nqxeohtgkb) = dfgqcmmmup ckpgpsxmed (pyqvwsehjw, 0.31 - 3.7)	-	18 Aug 2023
				febuxostat (Control)	pxenvolaij(nqxeohtgkb) = xtolubcgpf ckpgpsxmed (pyqvwsehjw, -1.52 to 1.61)
WCO_IOF_ESCEO2023	Not Applicable	Gout \| Diabetes Mellitus, Type 2 urate-lowering drugs	78	Allopurinol 100 mg/d	ugkxpcrono(twwdfdazql) = qfjbrcnpgy jphhtucplp (eyqqofefml )	Positive	04 May 2023
				Allopurinol 300 mg/d	ugkxpcrono(twwdfdazql) = rfquhphovz jphhtucplp (eyqqofefml )
ASN2022	Not Applicable	Hyperuricemia \| Hypertension \| Chronic Kidney Diseases hyperuricemia \| hypertension	96	Febuxostat	ydndgrppdb(maheghrxbg) = cmfvvgbllk jgyrnrcczq (ncdmjnufkj, -2.00 to 1.55)	Negative	05 Nov 2022
				Benzbromarone	-
Pubmed \| J Clin Pharmacol	Not Applicable	Lesch-Nyhan Syndrome	-	SHR4640 10 mg	getkvgomqt(qfleblavub) = evyonzflnj fxhautdkma (axxsojiugz )	-	21 Sep 2022
				SHR4640 10 mg + Febuxostat 80 mg	getkvgomqt(qfleblavub) = tbkorqnwly fxhautdkma (axxsojiugz )
EULAR2022	Not Applicable	Gout	136	Febuxostat 80mg/day	zivbwcpuro(jecrmxsqzb) = uujwwobcku izvqibdtyf (kznbcgyjsq ) View more	Positive	01 Jun 2022
CARES (EULAR2022)	Not Applicable	Gout serum uric acid	-	Febuxostat	wtlfhzmkdd(fwpfzzvtma) = yjdvcfocec raajqglxyr (jkwjwmftge )	Positive	01 Jun 2022
				Allopurinol	wtlfhzmkdd(fwpfzzvtma) = nhvangevxv raajqglxyr (jkwjwmftge )
EULAR2022	Not Applicable	Gout	-	Febuxostat	yzutnhqmja(xvwccoywox): HR = 1.1 (95% CI, 0.96 - 1.26) View more	-	01 Jun 2022
				Allopurinol

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