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-

CTR20250170

/ RecruitingNot Applicable

非布司他片在健康受试者中空腹/餐后单次口服给药、随机、开放、两制剂、两周期、交叉生物等效性预试验

[Translation] A randomized, open-label, two-dose, two-period, crossover bioequivalence pilot study of febuxostat tablets in healthy subjects after single oral administration on an empty stomach or after a meal

主要目的：通过空腹/餐后预试验研究，考察中国健康受试者在空腹/餐后条件下单剂量口服成都恒瑞制药有限公司生产的非布司他片（规格：40mg）与持证商Teijin Pharma Limited的非布司他片（规格：40mg）制剂的相似程度，考察药物的体内药代动力学特征及个体内变异系数，为能否进入正式试验提供决策依据，并验证正式试验样本量、采血点及试验周期间隔等设置的合理性。次要目的：评价单剂量口服非布司他片（规格：40mg）受试制剂及参比制剂在中国健康受试者中的安全性。

[Translation]

Primary objective: Through a fasting/postprandial pilot study, to investigate the similarity between a single oral dose of febuxostat tablets (specification: 40 mg) produced by Chengdu Hengrui Pharmaceutical Co., Ltd. and a febuxostat tablets (specification: 40 mg) prepared by Teijin Pharma Limited, a licensed manufacturer, in Chinese healthy subjects under fasting/postprandial conditions, to investigate the in vivo pharmacokinetic characteristics and intra-individual coefficient of variation of the drug, to provide a decision basis for whether to enter the formal trial, and to verify the rationality of the formal trial sample size, blood collection points, and trial cycle intervals. Secondary objective: To evaluate the safety of the test and reference preparations of a single oral dose of febuxostat tablets (specification: 40 mg) in healthy Chinese subjects.

Start Date05 Mar 2025

Sponsor / Collaborator

Chengdu Hengrui Pharmaceutical Co. Ltd.

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

100 Clinical Results associated with Febuxostat

100 Translational Medicine associated with Febuxostat

100 Patents (Medical) associated with Febuxostat

2,206

Literatures (Medical) associated with Febuxostat

31 Dec 2025·RENAL FAILURE

Comparative efficacy and safety of febuxostat and allopurinol in chronic kidney disease stage 3–5 patients with asymptomatic hyperuricemia: a network meta-analysis

Review

Author: Chen, Lu ; Zhang, Yanyun ; Wang, Yinglin ; Chen, Jiaojiao

OBJECTIVE:

This study evaluates and compares the effectiveness and safety of febuxostat and allopurinol in chronic kidney disease (CKD) stages 3-5 patients with asymptomatic hyperuricemia using a network meta-analysis.

METHODS:

A systematic review and network meta-analysis were conducted, adhering to PRISMA-NMA guidelines. Searches included PubMed, Embase, Cochrane Library, and Chinese databases up to June 2024. Randomized controlled trials (RCTs) and cohort studies were assessed for methodological rigor using GRADE.

RESULTS:

A total of 12 RCTs and 4 cohort studies (n = 2,423 participants) were included. Febuxostat was associated with greater improvements in estimated glomerular filtration rate compared to allopurinol (MD, 4.99 mL/min/1.73 m²; 95%CI -0.65 to 10.78; certainty: low) and placebo (MD, 4.72 mL/min/1.73 m²; 95%CI 0.67 to 8.82; low). Serum uric acid reduction was also more pronounced with febuxostat (MD, -0.61 mg/dL; 95%CI -1.15 to -0.05; moderate). Safety outcomes, including major cardiovascular events and adverse events, showed no significant differences between febuxostat and allopurinol. Subgroup analyses revealed enhanced effectiveness of febuxostat at six months of treatment.

CONCLUSIONS:

This analysis provides robust evidence that febuxostat might offers greater improvements in kidney function and uric acid levels compared to allopurinol or placebo in asymptomatic hyperuricemia with CKD stage 3-5 patients, without compromising safety. These findings can guide clinical decision-making and treatment optimization.

01 Apr 2025·Contemporary Clinical Trials

Evaluation of the efficacy and safety of a novel xanthine oxidase inhibitor, tigulixostat, in gout patients with hyperuricemia: Design of the EURELIA 1 and EURELIA 2 studies

Article

Author: Hsu, Chi-Yuan ; Kuo, Chang-Fu ; Lee, Yunjung ; Han, Song ; Dalbeth, Nicola ; Perez-Ruiz, Fernando ; White, William B ; Choi, Hyon K ; Hariri, Ali ; Jang, Younghwan ; Nuki, George ; Saag, Kenneth G

BACKGROUND:

Gout is a chronic disease of monosodium urate crystal deposition caused by elevated serum urate (SU). Gout may progress from acute episodic attacks to a disabling chronic deforming arthropathy. Allopurinol and febuxostat are the most widely prescribed urate-lowering drugs, however, these agents have potential adverse events and are seldom titrated to achieve a target SU level. Tigulixostat is a novel non-purine selective xanthine oxidase inhibitor for gout with hyperuricemia which has demonstrated potent in vitro and in vivo urate lowering activity and is being further investigated in humans for regulatory approvals.

METHODS:

The Phase 3 program for tigulixostat consists of two clinical trials: EURELIA 1 and EURELIA 2. EURELIA 1 is a randomized, multi-regional, double-blind, parallel-group, placebo-controlled study to assess the safety and efficacy of 6 months of tigulixostat (100, 200, or 300 mg) in gout patients with hyperuricemia (n = 350). EURELIA 2 is a randomized, multi-regional, double-blind, double-dummy, parallel-group, active comparator (allopurinol titrated up to 800 mg) and placebo-controlled study to assess the safety and efficacy of tigulixostat (100, 200, or 300 mg) up to 12 months in gout patients with hyperuricemia (n = 2542). The primary endpoint for both studies is to determine the proportion of patients with SU levels <6.0 mg/dL sustained at for 3 months (Months 4, 5, and 6).

CONCLUSIONS:

EURELIA 1 and EURELIA 2 studies will be able to adequately determine the efficacy and safety of tigulixostat compared to both placebo and allopurinol.

TRIAL REGISTRATION NUMBER:

For EURELIA 1, the clinicaltrials.gov identifier is NCT05586958. For EURELIA 2, the clinicaltrials.gov identifier is NCT05586971 and the EU CT number is 2022-501421-20-00. The sponsor for both trials is LG Chem, Ltd. (Seoul, South Korea).

30 Mar 2025·JOURNAL OF THE SCIENCE OF FOOD AND AGRICULTURE

Effects of catechins, resveratrol, silymarin components and some of their conjugates on xanthine oxidase‐catalyzed xanthine and 6‐mercaptopurine oxidation

Article

Author: Balázs, Orsolya ; Hetényi, Csaba ; Valentová, Kateřina ; Poór, Miklós ; Bencsik, Tímea ; Zsidó, Balázs Z ; Vida, Róbert G

Abstract:

BACKGROUND:

Over the past two decades, the global incidence of gout has markedly increased, affecting people worldwide. Considering the side effects of xanthine oxidase (XO) inhibitor drugs (e.g. allopurinol and febuxostat) used in the treatment of hyperuricemia and gout, the potential application of phytochemicals has been widely studied. In addition, XO also takes part in the elimination of certain drugs, including 6‐mercaptopurine. In the current explorative study, we aimed to examine the potential effects of tea catechins, resveratrol, silymarin flavonolignans and some of their conjugated metabolites on XO‐catalyzed xanthine and 6‐mercaptopurine oxidation, applying in vitro assays and modeling studies.

RESULTS:

Catechins, resveratrol and resveratrol conjugates exerted no or only weak inhibitory effects on XO. Silybin A, silybin B and isosilybin A were weak, silychristin was a moderate, while 2,3‐dehydrosilychristin was a potent inhibitor of the enzyme. Sulfate metabolites of silybin A, silybin B and isosilybin A were considerably stronger inhibitors compared to the parent flavonolignans, and the sulfation of 2,3‐dehydrosilychristin slightly increased its inhibitory potency. Silychristin was the sole flavonolignan tested, where sulfate conjugation decreased its inhibitory effect.

CONCLUSION:

2,3‐Dehydrosilychristin seems to be a promising candidate for examining its in vivo antihyperuricemic effects, because both the parent compound and its sulfate conjugate are highly potent inhibitors of XO. © 2024 The Author(s). Journal of the Science of Food and Agriculture published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry.

News (Medical) associated with Febuxostat

19 Mar 2025

·www.globenewswire.com

XORTX Announces Update for Discussion with the FDA

● Type B Meeting Discussion to Accelerate XRx-026 for Gout to NDA ● CALGARY, Alberta, March 19, 2025 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late stage clinical pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease and gout, is pleased to provide an update regarding communications with the US Food and Drug Administration (the “FDA”). At the request of the FDA a type B meeting package will be provided by the Company during the next week, and accompanying FDA communications are expected by April 26, 2025. The Company has prepared a broad Type B meeting review at the request of the FDA, including review of chemistry, manufacturing, pharmacology, toxicology and clinical evidence regarding the Company’s XRx-026 program for the treatment of gout. Drug Development of XORLOTM, the Company’s proprietary drug formulation of oxypurinol, has advanced substantially to a state where a Type B meeting and discussion with the FDA to confirm the developmental state of each element of the program is warranted. The purpose of this meeting will be to review the XRx-026 program and its readiness for submission of a New Drug Application (“NDA”) to gain marketing approval for XORLOTM in the US using the FDA 505(b)2 development pathway. The Company believes that a Type B meeting will facilitate a broader discussion toward market approval. Dr. Allen Davidoff, CEO of XORTX commented, “We look forward to FDA feedback the last week in April and advancing the XRx-026 program, thereafter. Many key elements of the XRx-026 program have advanced sufficiently to warrant this robust program review with the FDA to define any additional information needed to complete this marketing approval. We believe that the XRx-026 program provides a much needed therapeutic option for individuals with gout and that advancing with the XRx-026 program will transform XORTX to a revenue positive state.” The Company will provide further updates following communications with the FDA when additional information is available. About Hyperuricemia and Gout In the US it is estimated that approximately 44 million individuals have circulating uric acid above the normal range(1). The prevalence of gout was 3.9% or 9.2 million individuals. Mean serum urate levels were 6.0 mg/dL among men and 4.8 mg/dL among women, with hyperuricemia prevalences of 20.2% and 20.0%, respectively. The prevalence of ULT use among patients with gout was 33% during 2007 to 2014 and remained stable over time (P for trend >0.05)(1). Gout is an inflammatory arthritis that is triggered by the crystallization of monosodium urate inside the joints and is preceded by hyperuricemia. Gout flares lead to substantial morbidity by causing severe pain, reduced quality of life(2), decreased physical function(2,3), increased healthcare costs(4), and lost economic productivity(5). Furthermore, gout is strongly associated with the metabolic syndrome(5), and may contribute to myocardial infarction(6,7), type 2 diabetes mellitus(8), chronic kidney disease(9), and premature mortality(6,10,11). About the XRx-026 Program and XORLOTM The XRx-026 program is developing XORLOTM, a proprietary formulation of oxypurinol to treat individuals suffering from gout. At present, oral xanthine oxidase inhibitors (“XOIs”) are the preferred therapeutic option used to inhibit the production of uric acid and decrease chronically high uric acid in the circulation. Allopurinol is the most commonly prescribed XOI, with approximately 3.3 million prescriptions written per year in North America, however 3 to 5% of patients cannot tolerate Allopurinol. An alternative XOI, Febuxostat, was launched in the US in 2009 with the hope of treating individuals with gout, however while Febuxostat achieved peak sales greater than US$450 million after its launch, a Black Box warning due to its associated risk of sudden cardiovascular death resulted in a decline in its use. XORLOTM can address this unmet medical need and accelerating advancement of the XRx-026 program through an NDA filing is now a priority for XORTX. About Type B Meetings with the FDA Type B meetings for each potential application (e.g., investigational new drug application (IND), NDA, biologics license application (BLA)) or combination of closely related products developed by the same sponsor or applicant (e.g., same active ingredient but different dosage forms being developed concurrently). Typically, it may be appropriate to conduct more than one of some of the Type B meetings for concurrent development of a product for unrelated claims. References: (1) Chen-Xu M_Prevalence of Gout and Hyperuricemia in the US_ArthritisRheumatol_71-6_991-999_2019_nihms-1002533(2) Singh JA. Quality of life and quality of care for patients with gout. Curr Rheumatol Rep. 2009 4;11(2):154–60. [PubMed: 19296889] (3) Burke BT, Köttgen A, Law A, Windham BG, Segev D, Baer AN, et al. Physical Function, Hyperuricemia, and Gout in Older Adults. Arthritis Care Res. 2015 12;67(12):1730–8. (4) Rai SK, Burns LC, De Vera MA, Haji A, Giustini D, Choi HK. The economic burden of gout: A systematic review. Semin Arthritis Rheum. 2015 8;45(1):75–80. [PubMed: 25912932] (5) Choi HK, Ford ES. Prevalence of the metabolic syndrome in individuals with hyperuricemia. Am J Med. 2007 5;120(5):442–7. [PubMed: 17466656] (6) Choi HK, Curhan G. Independent impact of gout on mortality and risk for coronary heart disease. Circulation. 2007 8 21;116(8):894–900. [PubMed: 17698728] (7) Liu S-C, Xia L, Zhang J, Lu X-H, Hu D-K, Zhang H-T, et al. Gout and Risk of Myocardial Infarction: A Systematic Review and Meta-Analysis of Cohort Studies. Pizzi C, editor. PLOS ONE. 2015 7 31;10(7):e0134088. [PubMed: 26230580] (8) Choi HK, De Vera MA, Krishnan E. Gout and the risk of type 2 diabetes among men with a high cardiovascular risk profile. Rheumatology. 2008 8 13;47(10):1567–70. [PubMed: 18710901] (9) Roughley MJ, Belcher J, Mallen CD, Roddy E. Gout and risk of chronic kidney disease and nephrolithiasis: meta-analysis of observational studies. Arthritis Res Ther. 2015 12;17(1). (10) Kuo C-F, See L-C, Luo S-F, Ko Y-S, Lin Y-S, Hwang J-S, et al. Gout: an independent risk factor for all-cause and cardiovascular mortality. Rheumatology. 2010 1;49(1):141–6. [PubMed: 19933595] (11) Fisher MC, Rai SK, Lu N, Zhang Y, Choi HK. The unclosing premature mortality gap in gout: a general population-based study. Ann Rheum Dis. 2017 7;76(7):1289–94. [PubMed: 28122760] About XORTX Therapeutics Inc. XORTX is a pharmaceutical company with three clinically advanced products in development: 1) our lead program XRx-026 program for the treatment of gout; 2) XRx-008 program for ADPKD; and 3) XRx-101 for acute kidney and other acute organ injury associated with respiratory virus infections. In addition, the Company is developing XRx-225, a pre-clinical stage program for Type 2 diabetic nephropathy. XORTX is working to advance products that target aberrant purine metabolism and xanthine oxidase to decrease or inhibit production of uric acid. At XORTX, we are dedicated to developing medications that improve the quality of life and health of individuals with gout and other important diseases. Additional information on XORTX is available at www.xortx.com. For more information, please contact: Allen Davidoff, CEOadavidoff@xortx.com or +1 403 455 7727Nick Rigopulos, Director of Communicationsnick@alpineequityadv.com or +1 617 901 0785 Neither the TSX Venture Exchange nor Nasdaq has approved or disapproved the contents of this news release. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein. Forward Looking Statements This press release contains express or implied forward-looking statements pursuant to applicable securities laws. These forward-looking statements include, but are not limited to, the Company's beliefs, plans, goals, objectives, expectations, assumptions, estimates, intentions, future performance, other statements that are not historical facts and statements identified by words such as "expects", "anticipates", "intends", "plans", "believes", "seeks", "estimates" or words of similar meaning. These forward-looking statements and their implications are based on the current expectations of the management of XORTX only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks, uncertainties, and other factors include, but are not limited to, our ability to obtain additional financing; the accuracy of our estimates regarding expenses, future revenues and capital requirements; the success and timing of our preclinical studies and clinical trials; the performance of third-party manufacturers and contract research organizations; our plans to develop and commercialize our product candidates; our plans to advance research in other kidney disease applications; and, our ability to obtain and maintain intellectual property protection for our product candidates. Except as otherwise required by applicable law and stock exchange rules, XORTX undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. More detailed information about the risks and uncertainties affecting XORTX is contained under the heading “Risk Factors” in XORTX’s Annual Report on Form 20-F filed with the SEC, which is available on the SEC's website, www.sec.gov (including any documents forming a part thereof or incorporated by reference therein), as well as in our reports, public disclosure documents and other filings with the securities commissions and other regulatory bodies in Canada, which are available on www.sedarplus.ca.

NDADrug Approval

24 Jan 2025

·www.fiercepharma.com

Takeda bids adieu to Uloric after gout med's gradual fade from glory

To ease into the discontinuation, Takeda will continue to distribute Uloric to U.S. wholesalers through March 31, 2026, which should provide enough inventory for patients through the end of the year. The journey of Takeda’s gout med Uloric—which turned rocky in recent years—has come to an end in the U.S.This week, the medicine, first approved in 2009, was listed as discontinued on the FDA’s online drug shortage database. The drug, also known as febuxostat, was cleared for chronic management of hyperuricemia—or high uric acid levels in the body—in patients with gout and was previously available in 40-mg and 80-mg tablets.“As a global, R&D-driven biopharmaceutical company, we have taken this decision to help streamline our operational efficiencies and better dedicate our resources where they can provide the most value to patients,” a Takeda spokesperson told Fierce Pharma. Since 2019, multiple generics referencing Uloric have hit the scene in the U.S., with just some 3% of patients using Takeda’s branded product versus generic competitors, the spokesperson added.The move isn’t a total surprise, as the Japanese pharma told the FDA last year it planned to end production of branded Uloric at the end of 2024. To ease into the discontinuation, Takeda will continue to distribute Uloric to U.S. wholesalers through March 31, 2026, which should provide enough inventory for patients through the end of the year, the spokesperson said.Uloric’s sales seem to have peaked in Takeda’s 2019 fiscal year, when the drug brought home 51.1 billion Japanese yen (then around $477 million). The following year, Takeda did not report directly on the drug’s sales, instead noting that revenue beyond its core therapeutic areas dropped 18.5%. The company blamed the issue, in part, on “off-patented products such as Uloric.”Things started to take a turn for Uloric in 2017, when the FDA sent out a drug safety communication to the public signaling the medicine’s potential to cause increased cardiovascular events versus allopurinol—a widely available generic gout drug.Subsequently, safety flags raised in a post-marketing study in 2018 prompted consumer advocacy group Public Citizen to petition the FDA to remove Uloric from the U.S. market. Another blow struck in 2019, when the FDA revoked Uloric’s first-line treatment nod and added a boxed warning that the medication carried an increased risk of death compared to allopurinol.Takeda did not fight the decision, with a spokesperson telling Fierce Pharma at the time that the company found the label updates “appropriate” to ensure doctors and patients had the info to make proper treatment decisions.

Drug ApprovalAccelerated Approval

24 Jan 2025

·endpts.com

Takeda discontinues US supply of gout drug Uloric over generic competition

Takeda has ended the manufacturing and supply of its gout drug Uloric in the US market as more patients turn to generic versions, the company confirmed to Endpoints News . “We have taken this decision to help streamline our operational efficiencies and better dedicate our resources where they can provide the most value to patients,” a Takeda spokesperson said. The two doses of Uloric, 40 mg and 80 mg, were listed as “discontinued” on the FDA’s drug shortage list on Tuesday. Takeda told the FDA in August 2024 it was planning to stop manufacturing and supplying Uloric as of December last year, the spokesperson said. The company will continue to supply Uloric to US wholesalers until March 2026, with supply slated to be available until the end of that year, they added. Takeda won FDA approval for Uloric, the brand name for febuxostat, in February 2009 to lower blood uric acid levels in adult patients with gout. The drug was discovered by Tokyo-based Teijin Pharma and licensed to Takeda to supply the US market. Hello, Reginald Adams You’re an essential part of the biopharma world. Share your voice on this important question to help shape our understanding of the industry. Can you help us out? Hello, Reginald Adams You’re an essential part of the biopharma world. Share your voice on this important question to help shape our understanding of the industry. Can you help us out? Only around 3% of patients in the US taking febuxostat are using Takeda’s Uloric, due to multiple available generic versions, according to Takeda. One of the company’s Uloric patents expired in March 2024, and two more will expire in 2031, according to the FDA Orange Book . “We have continued to see US prescription fill rates transition away from brand-name Uloric year over year,” Takeda added. Uloric sales have been declining, with Takeda’s revenue outside its core therapies dropping by 18.5% in 2021 compared to 2020, due to decreased sales for drugs like Uloric. Takeda’s sales for Uloric were not included in its 2023 and 2022 annual reports. The company has also faced backlash for Uloric in the past, with Public Citizen petitioning the FDA in 2018 to ban the sale of the drug due to increased risk of death.

Drug ApprovalPatent Expiration

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	European Union	Viatris Ltd. (New Zealand)	15 Jun 2017
Arthritis, Gouty	Iceland	Viatris Ltd. (New Zealand)	15 Jun 2017
Arthritis, Gouty	Liechtenstein	Viatris Ltd. (New Zealand)	15 Jun 2017
Arthritis, Gouty	Norway	Viatris Ltd. (New Zealand)	15 Jun 2017
HYPERURICEMIA CHRONIC	European Union	Viatris Ltd. (New Zealand)	15 Jun 2017
HYPERURICEMIA CHRONIC	Iceland	Viatris Ltd. (New Zealand)	15 Jun 2017
HYPERURICEMIA CHRONIC	Liechtenstein	Viatris Ltd. (New Zealand)	15 Jun 2017
HYPERURICEMIA CHRONIC	Norway	Viatris Ltd. (New Zealand)	15 Jun 2017
Gout	United States	Takeda Pharmaceuticals U.S.A., Inc.	13 Feb 2009
Hyperuricemia	European Union	Menarini International Operations Luxembourg SA	21 Apr 2008
Hyperuricemia	Iceland	Menarini International Operations Luxembourg SA	21 Apr 2008
Hyperuricemia	Liechtenstein	Menarini International Operations Luxembourg SA	21 Apr 2008
Hyperuricemia	Norway	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	United States	Takeda Pharmaceutical Co., Ltd.	23 Apr 2010
Cardiovascular Diseases	Phase 3	Mexico	Takeda Pharmaceutical Co., Ltd.	23 Apr 2010
Angina, Stable	Phase 2	United States	Takeda Pharmaceutical Co., Ltd.	01 Jul 2012
Hypertension	Phase 2	United States	Takeda Pharmaceutical Co., Ltd.	01 Feb 2012
Kidney Calculi	Phase 2	United States	Takeda Pharmaceutical Co., Ltd.	01 Feb 2010
Nephrolithiasis, Calcium Oxalate	Phase 2	United States	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)	hqpvzvlihs(ufectawvyx) = zocaxdbhbe lvatjvkfuk (njzdcyngoa )	Positive	05 Jun 2024
				Febuxostat (Chronic kidney disease)	hqpvzvlihs(ufectawvyx) = akiogtrgxw lvatjvkfuk (njzdcyngoa )
SAT641 (ENDO2023)	Not Applicable	-	12	Febuxostat treated water	jmvedmyuxz(xsmgappmeg) = vefwbkfbrm xjvulglzri (tkmkucocvz, 2.70) View more	Positive	05 Oct 2023
				Febuxostat (Sham-control)	huabcxshmg(ddacqoqyjt) = tawzdxxoyz ezjxpzamos (stlqdlawem, 0.1) View more
EASD2023	Not Applicable	Ocular Motility Disorders	-	Febuxostat	pkblgmvkut(ptjxqyvarq) = Febuxostat-treated adipocytes exhibited higher UCP1 (p<0.05, vs. febuxostat) and other marker gene mRNA expressions (PRDM16, PPARγ, PGC1a, FABP4) vvxgzwlykm (quwfrvrjcm ) View more	Positive	04 Oct 2023
				febuxostat (Control)
TCTR20210224005 (Pubmed \| Sci Rep)	Phase 4	Chronic Kidney Diseases	84	Febuxostat	lbghhxgnio(gcmqgtabht) = nfkilehems ywyqhtsvfk (gwwyeddfjp, 0.31 - 3.7)	-	18 Aug 2023
				febuxostat (Control)	lbghhxgnio(gcmqgtabht) = jorusugnrp ywyqhtsvfk (gwwyeddfjp, -1.52 to 1.61)
WCO_IOF_ESCEO2023	Not Applicable	Gout \| Diabetes Mellitus, Type 2 urate-lowering drugs	78	Allopurinol 100 mg/d	abmeohkoqn(ywkoizisuo) = lapoplhbvw ozagwllcmj (prpfhvytfb )	Positive	04 May 2023
				Allopurinol 300 mg/d	abmeohkoqn(ywkoizisuo) = vzakwsirtd ozagwllcmj (prpfhvytfb )
ASN2022	Not Applicable	Hyperuricemia \| Hypertension \| Chronic Kidney Diseases hyperuricemia \| hypertension	96	Febuxostat	zucwvvntkc(curlqecngj) = jfsewtsrky rrfqapgnjm (cwfvwftvhx, -2.00 to 1.55)	Negative	05 Nov 2022
				Benzbromarone	-
NCT04157959 (Pubmed \| J Clin Pharmacol)	Not Applicable	Lesch-Nyhan Syndrome	-	SHR4640 10 mg	nswqgomnuh(hijgxsnopb) = mwnjtdoxxb gbzkvschee (bhgxardjjt )	-	21 Sep 2022
				SHR4640 10 mg + Febuxostat 80 mg	nswqgomnuh(hijgxsnopb) = nkqxnhccyy gbzkvschee (bhgxardjjt )
EULAR2022	Not Applicable	Gout	-	Febuxostat	qngvxnhfyv(edjdbhlhhs): HR = 1.1 (95% CI, 0.96 - 1.26) View more	-	01 Jun 2022
				Allopurinol
EULAR2022	Not Applicable	Gout	136	Febuxostat 80mg/day	ksorlzujpx(autmnammmk) = rsabljwseb dfydysqdoe (kgdiqhdnph ) View more	Positive	01 Jun 2022
NCT01101035 (CARES, EULAR2022)	Phase 3	Gout serum uric acid	-	Febuxostat	uncxjofakn(yowxaudztz) = pgcwvxyzlo skebcjifsf (ftyrftgjcr )	Positive	01 Jun 2022
				Allopurinol	uncxjofakn(yowxaudztz) = huxkormsqb skebcjifsf (ftyrftgjcr )

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Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Febuxostat

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation