A prospective, randomised, parallel, controlled interventional study on the impact of hyperuricaemia on the prognosis of patients with heart failure with preserved ejection fraction.

Start Date01 Nov 2025

Sponsor / Collaborator

Chengdu No. 3 People's Hospital

[+1]

ChiCTR2500101365

/ Not yet recruitingNot ApplicableIIT

Study on the Effect of Combined Uric Acid-Lowering Therapy on the Dissolution of Uric Acid Crystals in Toe Joints

Start Date01 May 2025

Sponsor / Collaborator

Self Finance, Inc.

CTR20250762

/ CompletedNot Applicable

苯溴马隆片（50 mg）空腹状态下在健康受试者中的生物等效性试验

[Translation] Bioequivalence study of benzbromarone tablets (50 mg) in healthy subjects under fasting condition

主要目的：在健康男性与女性受试者中于空腹条件下，评价受试制剂苯溴马隆片（规格：50 mg，生产商：浙江华海制药科技有限公司）和トーアエイヨー株式会社为持证商的参比制剂苯溴马隆片（Urinorm，规格：50 mg）的生物等效性。次要目的：观察受试制剂苯溴马隆片与参比制剂苯溴马隆片（Urinorm）在健康受试者中的安全性。

[Translation]

Primary objective: To evaluate the bioequivalence of the test preparation benzbromarone tablets (specification: 50 mg, manufacturer: Zhejiang Huahai Pharmaceutical Technology Co., Ltd.) and the reference preparation benzbromarone tablets (Urinorm, specification: 50 mg) of which Toaieyo Co., Ltd. is the licensee in healthy male and female subjects under fasting conditions. Secondary objective: To observe the safety of the test preparation benzbromarone tablets and the reference preparation benzbromarone tablets (Urinorm) in healthy subjects.

Start Date23 Mar 2025

Sponsor / Collaborator

Zhejiang Huahai Pharmaceutical Technology Co., Ltd.

100 Clinical Results associated with Benzbromarone

100 Translational Medicine associated with Benzbromarone

100 Patents (Medical) associated with Benzbromarone

1,066

Literatures (Medical) associated with Benzbromarone

01 Jan 2026·JOURNAL OF STEROID BIOCHEMISTRY AND MOLECULAR BIOLOGY

Canine aldo-keto reductase 1C3 (AKR1C3/PGFS) exhibits 17β/20α-hydroxysteroid dehydrogenase activity and is inhibited by trilostane

Article

Author: Hayashi, Riri ; Abe, Naohito ; Ueda, Hiroshi ; Morikawa, Yoshifumi ; Sakai, Yuji ; Hara, Akira ; Nakada, Yutaro ; Suenami, Koichi ; Kudo, Yudai ; Matsunaga, Toshiyuki ; Endo, Satoshi

Most members of the aldo-keto reductase (AKR) 1 C subfamily are hydroxysteroid dehydrogenases (HSDs), and their numbers are more than four in many individual mammals. In contrast, there is only one gene for the AKR1C protein (AKR1C3) in dogs, which have been used as a preclinical model for human biomedical research. Here, we report that dog AKR1C3 (known as prostaglandin-F synthase) catalyzes the conversion of the 17-keto group of estrone, 4- and 5-androstenes, and 5α-androstanes to their 17β-hydroxy-metabolites with NADPH as a coenzyme. Dog AKR1C3 also exhibited 20α-HSD activity toward 20-keto-C₂₁-steroids (deoxycorticosterone, its 5α-dihydro- and 5α-tetrahydro-derivatives, and progesterone), but, notably, did not display 3-ketosteroid reductase activity. Additionally, dog AKR1C3 reduced various nonsteroidal carbonyl compounds including endogenous 4-oxo-2-nonenal, all-trans-retinal, and isatin, of which isatin was the most excellent substrate. In the reverse reaction, the enzyme weakly oxidized 17β- and 20α-hydroxysteroids and some alicyclic alcohols. Further site-directed mutagenesis study revealed that residue M55 is responsible for the lack of 3-ketosteroid reductase activity. The enzyme was inhibited by flavonoids, nonsteroidal anti-inflammatory drugs, bile acids, benzbromarone, abiraterone, and trilostane, of which trilostane inhibited most potently (IC₅₀ 0.30 µM), and its inhibition was uncompetitive and competitive with respect to the substrates in the forward and reverse reactions, respectively. Thus, dog AKR1C3 may play a role in the metabolism of steroid hormones (as a reductive 17β/20α-HSD) and nonsteroidal carbonyl compounds, and is a novel target of trilostane that is used to treat Cushing's disease in dogs.

01 Dec 2025·BIOORGANIC & MEDICINAL CHEMISTRY LETTERS

Discovery of novel benzomorpholine derivatives as potent URAT1 inhibitors with hypouricemic effects

Article

Author: Hou, Xianxin ; Xiao, Zhiyan ; Li, Xuechen ; Wang, Yongcheng ; Zhang, Lei ; Ye, Fei ; Yang, Yifan ; Yang, Ying ; Shao, Mengjie

Urate transporter 1 (URAT1) is a clinically validated therapeutic target for hyperuricemia and gout. To obtain structurally novel URAT1 inhibitors, a series of benzomorpholine derivatives were designed by adopting a pharmacophore guided molecular hybridization strategy. Most compounds potently inhibit the human URAT1 in HEK293 cells, and the most active compound 7 exhibited an IC₅₀ of 0.72 μM, which was much more potent than Lesinurad and comparable to Benzbromarone. The possible interaction mode of compound 7 with URAT1 was revealed by molecular modeling. Cell viability assays indicated that compound 7 was less cytotoxic than Benzbromarone in Hep-G2 cells. The urate-lowering effects of compounds 1 and 7 were confirmed in two different hyperuricemia mouse models, and no obvious toxicity was observed in the treated mice. The results provide new chemical prototypes for urate-lowering drug discovery targeting URAT1.

01 Oct 2025·PHYTOMEDICINE

Puerarin-rich compound Puerariae lobatae formulas alleviate hyperuricemia in mice by enhancing renal and intestinal function through regulating gut microbiota

Article

Author: Kang, Kai-Wen ; Wu, Ri-Hui ; Lv, Hui-Qing ; Zheng, Hao ; Gan, Li-She ; Li, Zhi-Xuan ; Xu, Ju-Cai ; Li, Dong-Li

BACKGROUND:

Hyperuricemia, a metabolic disorder strongly associated with gout and cardiorenal diseases, has become a global health threat affecting over 15% of the worldwide population. Current pharmacotherapies face limitations due to adverse effects during prolonged use. Natural medicines like Radix Puerariae Lobatae have demonstrated therapeutic potential with superior safety profiles.

PURPOSE:

This study investigated the anti-hyperuricemic efficacy of compound Puerariae lobatae formulas (PLF1 and PLF2) and their bioactive component puerarin, focusing on their mechanisms for enhancing renal/intestinal uric acid excretion, alleviating pathological damage, and modulating gut microbiota composition.

METHODS:

A hyperuricemic mouse model was established using an adenine/potassium oxonate diet. Mice were treated with PLF1 (250/500 mg/kg), PLF2 (300/600 mg/kg), puerarin (100 mg/kg), or benzbromarone (40 mg/kg, positive control). Plasma and tissue uric acid levels, XOD and ADA activities, and renal/intestinal transporter expression (ABCG2, OAT1) were analyzed. Histopathological examinations were performed using HE staining to assess kidney, liver, and intestinal integrity. Gut microbiota composition was evaluated via PacBio Sequel II 16S rRNA sequencing. Antibiotic-induced microbiota depletion and fecal microbiota transplantation (FMT) approaches were employed to validate microbiota-dependent effects.

RESULTS:

PLF1, PLF2, and puerarin significantly reduced plasma uric acid levels and suppressed XOD/ADA activities. Histopathological analysis demonstrated marked improvements in renal tubular injury, hepatic steatosis, and intestinal structural integrity, including restoration of villus architecture and crypt morphology. The expression of renal ABCG2 and OAT1, as well as intestinal ABCG2, was significantly upregulated, accompanied by enhanced expression of colonic tight junction proteins (ZO-1 and occludin). Antibiotic-induced microbiota depletion abolished the hypouricemic effect of puerarin, while FMT from puerarin-treated donors significantly alleviated hyperuricemia in recipient mice. Gut microbiota analysis revealed that both PLF2 and puerarin selectively enriched the beneficial bacterium Akkermansia muciniphila while simultaneously reducing pathogenic taxa.

CONCLUSION:

This study establishes Puerariae lobatae formulas and puerarin as multi-target therapeutics for hyperuricemia, offering dual advantages over conventional drugs by enhancing renal/intestinal uric acid excretion while also repairing organ damage, and remodeling gut microbiota to enrich probiotics like A. muciniphila. The microbiota-dependent efficacy of puerarin not only underscores its potential as a novel natural therapeutic agent but also provides critical pharmacological evidence for advancing puerarin and Radix Puerariae Lobatae-based formulas in hyperuricemia treatment, bridging traditional herbal medicine with modern microbiota-targeting strategies.

News (Medical) associated with Benzbromarone

08 Sep 2025

·www.fiercebiotech.com

Atom claims phase 3 win shows gout drug can beat competition in efficacy, safety

Atom Therapeutics\' CEO said combined efficacy and safety data position ABP-671 as a “leading candidate for best-in-class therapeutic in this area.”\n Atom Therapeutics is touting data from a phase 2b/3 study as evidence that its gout drug has the efficacy and safety profile to stand out from the competition.The Chinese biotech evaluated the oral URAT1 inhibitor, called lingdolinurad, against placebo or the approved gout drug allopurinol in a trial conducted across the U.S., Europe, Latin America and Australia. The study met all primary and secondary endpoints, Atom explained in a Sept. 8 release.When compared to the allopurinol and placebo cohorts, patients who received ABP-671 experienced a significant reduction in the relative risk of acute gout attacks, with “a maximum risk reduction of 42% within the period of 15-28 weeks,” Atom said.Not only did the study show that patients receiving ABP-671 were more likely to see their serum uric acid levels fall below 6 mg/dL than those on allopurinol, but a higher proportion of the ABP-671 cohort also saw their levels fall below 4 mg/dL.Atom said that an “increasing number of clinical consensus guidelines” now support maintaining uric acid levels at around 4-5 mg/dL, below the 6-mg/dL threshold recommended by the American College of Rheumatology for reducing gout flares and long-term joint damage.Gout can result in small lumps of urate crystals called tophi developing under the skin. Atom said ABP-671 demonstrated “good efficacy” at dissolving tophi over six months of treatment, with a “remarkable reduction in gouty stone compared to baseline levels.”The response rate of a reduction in tophus diameter by Week 28 reached 91%, the company added. Unlike some approved urate-lowering gout drugs like febuxostat and benzbromarone, the trial didn’t link ABP-671 to any cardiovascular risks or liver toxicity, Atom stressed.In a statement, Atom CEO William Dongfang Shi, Ph.D., said the combined efficacy and safety data from the study position ABP-671 as a “leading candidate for best-in-class therapeutic in this area.”“The six-month global phase 2b/3 clinical trial provided compelling evidence that ABP-671 is associated with clinically meaningful improvement in reducing the risk of acute gout attacks and promoting tophus dissolution,” he added. “These findings lay the groundwork for the design and planning of our upcoming pivotal clinical studies.”A relatively recent addition to the gout treatment arsenal was Horizon Therapeutics’ Krystexxa, which Amgen took on through its $27.8 billion acquisition of the drugmaker two years ago. However, Krystexxa hasn’t performed quite as well as expected, with $236 million of sales in the first quarter of 2025 falling $57 million shy of analyst expectations.

Clinical ResultAcquisitionPhase 3

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

16 Oct 2023

·www.biospace.com

Atom Bioscience Raises $83M in a D-Round Financing to Support Global Pivotal Clinical Trials of ABP-671, a New Treatment for Chronic Gout

JIANGSU, China--(BUSINESS WIRE)-- Atom Bioscience (Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.), a clinical stage biotechnology company developing best-in-class treatments for inflammatory and metabolic diseases, announced today completion of a D-round financing of approximately $83 million (CNY 600 million) for completion of global pivotal clinical trials of ABP-671, its unique orally administered URAT1 inhibitor for chronic gout. The funds also will be used to advance to clinical stage the company’s innovative pipeline of drugs for inflammatory and metabolic diseases. This round of financing includes new and existing investors and was led by Kaitai Capital. Other investors include Fortune Capital, Huajin Investment, Unifortune and NNFE Investment. After this round of financing, Atom has raised a total of nearly $165 million. "We appreciate the support of every investment institution involved in the D-round financing and previous investors,” said Dr. William Dongfang Shi, CEO, Chairman and Founder of Atom Bioscience. “We are honored to have their trust as we strive to promote innovative best-in-class drugs benefiting gout patients worldwide.” Chronic gout is caused by long-term hyperuricemia (serum uric acid (sUA) > 7 mg/dL or 420 μmol/L). More than 50 million patients suffer from gout worldwide and nearly 10 million in the U.S. Globally, there are more than 200 million people with hyperuricemia. Aside from the acute painful flare-ups associated with gout, the disease seriously affects people's quality of life and can increase the probability of sudden cardiac death and kidney function injury. The performance of existing gout drugs is far from meeting clinical needs. The drugs have poor efficacy and pose serious safety issues, such as leading to kidney failure, sudden cardiac death, or severe liver toxicity. ABP-671 reduces sUA levels by inhibiting renal urate transporter 1 (URAT1), resulting in normal excretion of urate in urine. Its clinical primary endpoint is to reduce sUA to < 6 mg/dL (360 μmol/L) and in previous clinical trials ABP-671 has demonstrated good efficacy, safety and tolerability. In two Phase 2 clinical trials of ABP-671 at doses ranging from 1 mg to 12 mg once a day, ABP-671 at a dose of 1 mg had showed a substantial reduction of sUA. At doses of 6 mg and 8 mg, 100% of subjects achieved the primary clinical end point of < 6 mg/dL. Notably, 100% of subjects experienced sUA levels of < 5 mg/dL (300 μmol/L), and there were 57% and 87.5% of subjects with sUA levels < 4 mg/dL (240 μmol/L), respectively. Some subjects had sUA levels < 3 mg/dL (180 μmol/L). At a dose of 12 mg of ABP-671, 100% of the subjects achieved sUA levels < 4 mg/dL. The two studies showed efficacy of ABP-671 can be maintained up to 24 hours with once daily dosing, and there were no significant adverse effects (AEs) compared to the placebo group. Maintaining sUA levels of 5 mg/dL to 4 mg/dL in gout patients is recommended by many national gout treatment guidelines. At these levels gout tophi are re-dissolved, tophi size and quantity are reduced and eventually acute gout attacks are reduced. This is difficult for most market drugs to achieve. “In terms of safety, ABP-671 is well tolerated. Its adverse events of ABP-671 were mostly grade 1 (mild and generally not bothersome), and the incidence is comparable to that of the placebo group,” said Dr. Shi. “No severe adverse events have occurred with ABP-671 at the doses tested.” He also observed, “A Human Mass Balance study, which evaluates how drugs are absorbed, metabolized and excreted, showed that ABP-671 is mostly excreted in its original form and does not produce any similar metabolites seen with benzbromarone (a currently marketed drug for gout treatment) which causes severe liver toxicity.” Dr. Shi added, “All subjects taking ABP-671 had a significant decrease in their sUA levels, therefore, we also plan to investigate ABP-671 for the treatment of refractory gout. In addition, we submitted a Pre-IND application to the U.S. FDA in August for ABP-745, which is used to treat inflammation and acute gout. We expect to submit the IND application in the U.S. and China in November.” About Atom Bioscience Atom Bioscience (Jiangsu Atom Bioscience and Pharmaceutical Co. Ltd.) 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, ABP-671, is in clinical development for treatment of chronic gout. Another small molecule ABP-745 has shown significant efficacy and good safety in animal models of anti-inflammation, and is expected to be in Phase 1 clinical trials soon. For more information, please visit: or atombp.us. View source version on businesswire.com: Contacts Business Development Contact: Roy J. Wu, MBA Sr. Vice President, Business Development Atom Bioscience and Pharmaceutical Co., Ltd Email: roy.wu@atombp.com Source: Atom Bioscience View this news release online at:

Clinical ResultPhase 2INDPhase 1

100 Deals associated with Benzbromarone

External Link

KEGG	Wiki	ATC	Drug Bank
D01056	Benzbromarone	M04AB03	DB12319

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Hyperuricemia	Japan	Pfizer Japan, Inc.	04 Nov 1986
Gout	Japan	TOA Eiyo Ltd.	01 Aug 1978
Hypertension	Japan	TOA Eiyo Ltd.	01 Aug 1978

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EULAR/ACR 2015 (EULAR2024)	Not Applicable	Chronic tophaceous gout	15	Benzbromarone	onlrucxeuj(qfnoiftvgo) = rnlagqozsz iqhxxgxavp (fbpotctjrk, 1.2 - 2.9)	Positive	05 Jun 2024
				Febuxostat	onlrucxeuj(qfnoiftvgo) = pgpmovhdlm iqhxxgxavp (fbpotctjrk, 1.1 - 3.6)
ChiCTR1900023033 (Pubmed \| Curr Med Res Opin)	Phase 4	Hyperuricemia \| Hypertension	230	Benzbromarone	bsbdfypyql(ikcijgkvwj) = jspyfpsufq cossqedsru (duaybywohc )	Positive	01 Jul 2023
				benzbromarone (Control (without uric acid-lowering drug))	bsbdfypyql(ikcijgkvwj) = mmhzjqznbm cossqedsru (duaybywohc )
ASN2022	Not Applicable	Hyperuricemia \| Hypertension \| Chronic Kidney Diseases hyperuricemia \| hypertension	96	Febuxostat	ydjagjtzax(txyurvqilv) = jabszlrvkk xcgmdbpexx (ypatkesoaz, -2.00 to 1.55)	Negative	05 Nov 2022
				Benzbromarone	-
RBR-5wvg53s (ERS2022)	Phase 2	Pulmonary Cystic Fibrosis Adjuvant TMEM16A \| CFTR	9	Benzbromarone 100 mg/day	ynkpoclepm(nrxaaynans) = rtvfjzykob zgajoyjofx (dcgzwnlzdw, 3 - 9)	Positive	04 Sep 2022
NCT00422318 (Pubmed \| Circ Heart Fail)	Phase 4	Heart Failure	82	Benzbromarone	eqcapkdaii(ngfvrjcbug) = refatwypxn vqpcbogbgv (yrynvtqtnx ) View more	-	01 Jan 2010
				Placebo	eqcapkdaii(ngfvrjcbug) = xpnngyfemp vqpcbogbgv (yrynvtqtnx ) View more
EULAR2007	Not Applicable	Gout Second line	-	Allopurinol 300 mg	uchncyhgln(xlihlxlmvo) = 10% stopped allopurinol because of adverse drug reactions qmqmtodypt (keeaafqbei )	-	13 Jun 2007

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis