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

NCT06622603 / Not yet recruitingPhase 4IIT

A Prospective, Multicenter, Randomized Investigator Initiative Clinical Trial Study on the Effects of Febuxostat Dose Tapering in Gout Patients Optimally Controlled for 5 Years or More

The goal of this clinical trial is to compare the changes in serum urate levels and symptom recurrence after reducing or suspending urate-lowering agents in well-controlled gout patients (the 'after dishes are clean' state in the Dirty Dish hypothesis)
Researchers will compare three randomized groups: the reducing group takes febuxostat 20 mg once daily for 12 months, the discontinuing group takes a placebo once daily for 6 months, followed by febuxostat 20 mg once daily for the next 6 months, and the maintaining group continues their pre-study urate-lowering agents for 12 months, serving as an observational reference group.
During the 12-month study period, participants will visit every 3 months for laboratory evaluations including serum urate levels, and for checking symptomatic status using questionnaires and diaries. Additionally, musculoskeletal ultrasonography and serum sample collection will be performed at baseline to study predictors for maintaining serum urate levels <7.0 mg/dL after reducing or suspending urate-lowering therapy.

Start Date15 Oct 2024

Sponsor / Collaborator

Seoul National University Hospital

[+6]

100 Clinical Results associated with Febuxostat

100 Translational Medicine associated with Febuxostat

100 Patents (Medical) associated with Febuxostat

1,319

Literatures (Medical) associated with Febuxostat

01 Mar 2025·Current Radiopharmaceuticals

Response of Male Reproductive System Against Ionizing Radiation and Available Radio-protective Agents: Cellular and Molecular Insight

Article

Author: Jheeta, Kuldeep S ; Saini, Priya ; Parashar, Ronit ; Meena, Priyadarshi ; Patel, Dev Dutt ; Kumar, Raj ; Yadav, Sanwar Mal

Background:The reproductive organ, housing spermatogonial stem cells (SSCs), undergoes ongoing division impacted by the irradiation dosage and exposure duration. Within the male reproductive organ, germ stem cells (spermatogonia) and somatic cells (Sertoli and Leydig cells) are present. Lower doses of ionizing (>4-6 Gy) and non-ionizing radiation (radiofrequency and microwave range 900 MHz - 2.45 GHz) may cause sperm-related issues, while higher doses (15 Gy) may affect Leydig cells and testosterone production. Response to radiation varies with age and pubescence. Spermatogonial stem cells, crucial for regenerating the spermatogenic lineage, express molecular markers like Estrogen receptor, FSH (Follicular Stimulating Hormone) receptor, TLR-4 (Toll-like Receptor-4), TLR-5 (Toll-like Receptor-5), FGF2 (Fibroblast Growth Factor-2), KIT (Receptor Tyrosine Kinase), AT-1 (Angiotensin II Type-1 Receptor), LXRs-γ (Liver X Receptor-γ), TNF-β (Tumor Necrosis Factor-β), and PCNA (Proliferating Cell Nuclear Antigen), influencing stem cell activity in testes.Objective:This study aimed to review the various available radioprotective agents and their efficacy in targeting the male reproductive system from the available literature.Result:Various radioprotective herbal/synthetic/microbial/metallic extracts/formulations/ drugs [Septilin, Silymarin, Organic Turmeric, Oestrogen, Melatonin, Febuxostat, SQGD (Semiquinone glucoside derivative), Rapamycin, Entolimod, Zinc, Selenium, etc.] have been investigated up to exposure, but owing to effectiveness issues, they are unable to fulfil the aim to the fullest of restoring male fertility and normal testosterone levels during such eventuality.Conclusion:Further study is needed to optimize these tactics and fill knowledge gaps. Also, the effective components of herbal, synthetic drugs, etc., should be isolated and tested up to clinical levels, paving the way for successful radioprotection and radiomitigation strategies in the male reproductive system.

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

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.

31 Dec 2024·Annals of Medicine

Febuxostat provides renoprotection in patients with hyperuricemia or gout: a systematic review and meta-analysis of randomized controlled trials

Review

Author: Fu, Shun Kun ; Zhang, Bao Long ; Yang, Xiu Hong ; Jin, Hui Min ; Cheng, Yun

PURPOSEIt is unknown whether febuxostat can delay the progression of kidney dysfunction and reduce kidney endpoint events. The aim was to evaluate the renoprotective effect of febuxostat in patients with hyperuricemia or gout by performing a meta-analysis of randomized controlled trials (RCTs).METHODSMEDLINE, Web of science, EMBASE, ClinicalTrials.gov, and the Cochrane Central Register for Randomized Controlled Trials were searched. The main outcomes included kidney events (serum creatinine doubling or progression to end-stage kidney disease or dialysis). The secondary outcomes were the rate of change in the estimated glomerular filtration rate (eGFR) and changes in the urine protein or urine albumin to creatinine ratio from baseline to the end of follow-up. We used random-effects models to calculate the pooled risk estimates and 95% CIs.RESULTSA total of 16 RCTs were included in the meta-analysis. In comparison with the control group, the patients who received febuxostat showed a reduced risk of kidney events (RR = 0.56, 95% CI 0.37-0.84, p = 0.006) and a slower decline in eGFR (WMD = 0.90 mL/min/1.73 m², 95% CI 0.31-1.48, p = 0.003). The pooled results also revealed that febuxostat use reduced the urine albumin to creatinine ratio (SMD = -0.21, 95% CI -0.41 to -0.01, p = 0.042).CONCLUSIONFebuxostat use is associated with a reduced risk of kidney events and a slow decline in eGFR. In addition, the urine albumin to creatinine ratio decreased in febuxostat users. Accordingly, it is an effective drug for delaying the progression of kidney function deterioration in patients with gout.Systematic review registration: PROSPERO CRD42021272591.

News (Medical) associated with Febuxostat

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

28 Mar 2024

·www.fiercepharma.com

Amneal pulls 4 lots of antibiotic vancomycin due to potentially overfilled, extra-potent bottles

The antibiotic is used to treat intestine and colon inflammation caused by bacterial infections. Amneal Pharmaceuticals is recalling four lots of an antibacterial after a manufacturing error may have resulted in overfilled bottles. The recall covers four different packaging formats of the company’s generic vancomycin hydrochloride for oral solution, which treats intestine inflammation (or enterocolitis) caused by bacteria, plus colon inflammation (pseudomembranous colitis) caused by antibiotic-related C. difficile infection. Some bottles “may have been overfilled” during the manual bottle-filling stage of manufacturing, the FDA noted in its recall announcement. Overfilled bottles may lead to dosing that exceeds the recommended maximum daily allowance, the agency said. That limit is set at up to 2 mg per day, but the bottling mistake could cause patients to receive double that dose. Taking too much vancomycin can lead to worsening renal function, which in turn could cause electrolyte concerns such as high potassium, a risk factor for cardiac arrest. So far, the company has not received any reports of adverse events linked to the recall, the FDA said. The impacted lots contained pack sizes of 80 mL, 300 mL and two batches at 150 mL. The lots all expire in September 2025. Amneal is alerting customers of the recall via mail and is arranging for a return of the products. Retailers, customers and consumers are instructed to check to see whether they possess any affected bottles. Meanwhile, other recent recalls across the industry include Sun Pharma’s withdrawal of 5,000 bottles of febuxostat tablets due to a report of microbial contamination at the company’s manufacturing facility. Pfizer last January recalled a batch of its vancomycin hydrochloride, although in injection vial form, due to the possible presence of glass particles in the vials.

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	LI	Viatris, Inc.	15 Jun 2017
Arthritis, Gouty	EU	Viatris, Inc.	15 Jun 2017
Arthritis, Gouty	NO	Viatris, Inc.	15 Jun 2017
Arthritis, Gouty	IS	Viatris, Inc.	15 Jun 2017
HYPERURICEMIA CHRONIC	LI	Viatris, Inc.	15 Jun 2017
HYPERURICEMIA CHRONIC	NO	Viatris, Inc.	15 Jun 2017
HYPERURICEMIA CHRONIC	IS	Viatris, Inc.	15 Jun 2017
HYPERURICEMIA CHRONIC	EU	Viatris, Inc.	15 Jun 2017
Gout	US	Takeda Pharmaceuticals U.S.A., Inc.	13 Feb 2009
Hyperuricemia	NO	Menarini International Operations Luxembourg SA	21 Apr 2008
Hyperuricemia	LI	Menarini International Operations Luxembourg SA	21 Apr 2008
Hyperuricemia	EU	Menarini International Operations Luxembourg SA	21 Apr 2008
Hyperuricemia	IS	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
Hyperuricemia	Discovery	CN	Astellas Pharma China, Inc.	11 Apr 2013
Hematologic Neoplasms	Discovery	-	A. Menarini Industrie Farmaceutiche Riunite SRL	01 Oct 2012
Hematologic Neoplasms	Discovery	-	A. Menarini Industrie Farmaceutiche Riunite SRL	01 Oct 2012
Tumor Lysis Syndrome	Discovery	-	A. Menarini Industrie Farmaceutiche Riunite SRL	01 Oct 2012
Tumor Lysis Syndrome	Discovery	-	A. Menarini Industrie Farmaceutiche Riunite SRL	01 Oct 2012
Cardiovascular Diseases	Discovery	MX	Takeda Pharmaceutical Co., Ltd.	23 Apr 2010
Cardiovascular Diseases	Discovery	US	Takeda Pharmaceutical Co., Ltd.	23 Apr 2010
Kidney Calculi	Discovery	US	Takeda Pharmaceutical Co., Ltd.	01 Feb 2010
Nephrolithiasis, Calcium Oxalate	Discovery	US	Takeda Pharmaceutical Co., Ltd.	01 Feb 2010
Gout	Discovery	-	Takeda Pharmaceutical Co., Ltd.	01 Jul 2002

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05513976 (EULAR2024) Manual	Phase 2	Hyperuricemia \| Primary gout	151	ruzinurad 10 mg+FEBUXOSTAT	(gzcwtxknvl) = iwvzvcacll ntkrgzpsxh (xbnnrkyzrn ) View more	Positive	12 Jun 2024
				ruzinurad 5 mg+FEBUXOSTAT	(gzcwtxknvl) = nqmtizqyzw ntkrgzpsxh (xbnnrkyzrn ) View more
EULAR2024	Not Applicable	Gout \| Chronic Kidney Diseases serum urate levels	342	Febuxostat (Normal kidney function)	wjlftawfgz(trerxhxyit) = beohduldxr xqyilgfegg (atvulmxvbe )	Positive	05 Jun 2024
				Febuxostat (Chronic kidney disease)	wjlftawfgz(trerxhxyit) = gjkhonjspb xqyilgfegg (atvulmxvbe )
EULAR2024	Not Applicable	Chronic tophaceous gout	15	Benzbromarone	bcnvllicgw(dvicgsciii) = qdftrckkut pcopxfdxqd (wtjbqnniux, 1.2 - 2.9)	Positive	05 Jun 2024
				Febuxostat	bcnvllicgw(dvicgsciii) = jmynjjlqni pcopxfdxqd (wtjbqnniux, 1.1 - 3.6)
EULAR2024	Not Applicable	fractional excretion of uric acid (FEUA)	1,465	Allopurinol	xytllkztkp(angfxbwfig) = qlsotwhezj ehdqvmnntb (vmhwwrlbbh ) View more	Positive	05 Jun 2024
				Febuxostat	xytllkztkp(angfxbwfig) = vsdphqqntb ehdqvmnntb (vmhwwrlbbh )
EASD2023	Not Applicable	Ocular Motility Disorders	-	Febuxostat	easdtzxbey(emchpqehod) = Febuxostat-treated adipocytes exhibited higher UCP1 (p<0.05, vs. febuxostat) and other marker gene mRNA expressions (PRDM16, PPARγ, PGC1a, FABP4) zvanluuebk (eqczmfopeg ) View more	Positive	04 Oct 2023
				febuxostat
TCTR20210224005 (Pubmed)	Phase 4	Chronic Kidney Diseases	84	Febuxostat	(rrnwjxblvk) = tykfzyrpnp udfztdgkls (kqktesebnf, 0.31 - 3.7)	-	18 Aug 2023
				febuxostat (Control)	(rrnwjxblvk) = kwnzfdmcrr udfztdgkls (kqktesebnf, -1.52 to 1.61)
ASN2022	Not Applicable	Hyperuricemia \| Hypertension \| Chronic Kidney Diseases hyperuricemia \| hypertension	96	Febuxostat	(fvwflfvtas) = uhebqvpbpx tpgirvysyv (dnuzcvvrht, -2.00 to 1.55)	Negative	05 Nov 2022
				Benzbromarone	-
Pubmed	Not Applicable	Lesch-Nyhan Syndrome	-	SHR4640 10 mg	(ybfabiajuk) = gidsrcolqa bxfqudzcgi (mxexxzdhec )	-	21 Sep 2022
				SHR4640 10 mg + Febuxostat 80 mg	(ybfabiajuk) = bajnlvvtec bxfqudzcgi (mxexxzdhec )
EULAR2022	Not Applicable	Gout	-	Febuxostat	jnoeamyulk(ikrduceqyk): HR = 1.1 (95% CI, 0.96 - 1.26) View more	-	01 Jun 2022
				Allopurinol
EULAR2022	Not Applicable	Gout	136	Febuxostat 80mg/day	bxsdxugiyo(rmtitlfjdc) = wxrytpqsmu hanrxafsfw (bgrjeqalhk ) View more	Positive	01 Jun 2022

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