Drugs / Febuxostat
Febuxostat
also known as
FBX · Adenuric · Febuxostat XR · Febuxostat (Adenuric, Uloric) · febuxostat extended- release (XR) · Febuxostat krka · Febuxostat mylan · Febuxostat viatris (previously febuxostat mylan) · +5 more
Small molecule targets ABCG2, XDH via inhibition
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | ULORIC | — | 2017-08-15 – 2019-02-21 | fda.gov ↗ |
| Approved | US (FDA) | ULORIC | — | 2009-02-13 | fda.gov ↗ |
| Approved | EU (EMA) | Adenuric | — | 2008-04-21 | europa.eu ↗ |
Trials 63 · started per year
today
EU approved 2008
US approved 2009
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06525974 | Sep 2024 → Sep 2026 overdue | ulcerative colitis | Tanta University | Not yet recruiting | No outcome recorded |
| Phase 113 trials | ||||||
| Phase 1 | NCT07181265 | Oct 2025 → Apr 2026 overdue | autosomal dominant polycystic kidney disease | Jemincare | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07170475 | Jun 2025 → Mar 2026 overdue | Parkinson disease | Fujita Health University | Recruiting | No outcome recorded |
| Phase 1 | NCT06233162 | Sep → Oct 2024 | — | Bio-innova Co., Ltd | Unknown | No outcome recorded |
| Phase 1 | NCT05575297 | Dec 2021 → May 2022 | — | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 1 | NCT05324423 | Oct 2021 → Aug 2022 | gout | The Affiliated Hospital of Qingdao University | Unknown | No outcome recorded |
| Phase 1 | NCT04157959 | Oct 2019 → Jun 2020 | — | Jiangsu HengRui Medicine Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT04347005 | Jan → Jul 2019 | — | Arthrosi Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT03131583 | Feb 2017 → Jan 2018 | gout | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02504320 | Aug → Sep 2015 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT02382640 | Mar → May 2015 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT02374164 | Feb → Mar 2015 | gout | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT01883167 | Jun → Sep 2013 | — | Ardea Biosciences, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01563432 | Jan → Feb 2012 | gout | SK Chemicals Co., Ltd. | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT03605212 | Feb 2017 → Jul 2018 | tumor lysis syndrome | Menarini Group | Terminated | No outcome recorded |
| Phase 1/2 | NCT02317861 | Dec 2014 → Jun 2015 | gout | AstraZeneca | Completed | No outcome recorded |
| Phase 216 trials · 4 met primary · 3 missed | ||||||
| Phase 2 | NCT07485452 | Jun 2026 → Jun 2027 expected | non-small cell lung carcinoma | Maastricht University Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07701512 | Nov 2025 → Oct 2026 expected | hemorrhagic stroke | Tanta University | Recruiting | No outcome recorded |
| Phase 2 | NCT04772352 | Mar → Aug 2021 | NAFLD1 | Ningbo No. 1 Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04155918 | Feb → Sep 2020 | gout | Arthrosi Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT04180982 | Dec 2019 → Jul 2020 | — | Jiangsu HengRui Medicine Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT04804111 | Jan 2019 → Sep 2020 | gout | JW Pharmaceutical | Completed | Met primary |
| Phase 2 | NCT03118739 | May 2017 → Aug 2018 | proteinuria, type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 2 | NCT02246673 | Oct 2014 → Jul 2015 | gout | Ardea Biosciences, Inc. | Completed | Mixed |
| Phase 2 | NCT02252835 | Aug → Dec 2014 | gout | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT01549977 | Jul → Nov 2012 | — | Takeda | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT01496469 | Feb 2012 → Aug 2014 | hypertensive disorder | Takeda | Completed | Missed primary |
| Phase 2 | NCT01082640 | Apr 2010 → May 2012 | impaired renal function disease | Takeda | Completed | Missed primary |
| Phase 2 | NCT01078389 | Mar 2010 → Sep 2013 | — | Takeda | Completed | Missed primary |
| Phase 2 | NCT01077284 | Feb 2010 → Nov 2011 | nephrolithiasis, calcium oxalate | Takeda | Completed | Met primary |
| Phase 2 | NCT00174941 | Mar 2001 → Dec 2006 | gout | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT00174967 | Jan → Jul 2001 | gout | Takeda | Completed | Met primary |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02866214 | Aug → Oct 2016 | end stage renal failure | Ain Shams University | Completed | No outcome recorded |
| Phase 310 trials · 5 met primary | ||||||
| Phase 3 | NCT05109936 | Aug 2023 → Jan 2027 expected | gout | University Hospital, Rouen | Recruiting | No outcome recorded |
| Phase 3 | NCT01808144 | Mar 2013 → Aug 2016 | gout | Ardea Biosciences, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01724528 | Oct 2012 → Oct 2013 | tumor lysis syndrome | Menarini Group | Completed | Mixed |
| Phase 3 | NCT02082769 | Jul 2011 → Oct 2013 | gout | Xijing Hospital | Completed | Met primary |
| Phase 3 | NCT01736514 | Mar 2011 → Feb 2012 | gout | Astellas Pharma Taiwan, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01101035 | Apr 2010 → May 2017 | cardiovascular disorder | Takeda | Completed | Met primary |
| Phase 3 | NCT00430248 | Feb 2007 → Mar 2008 | gout | Takeda | Completed | Met primary |
| Phase 3 | NCT00175019 | Jul 2003 → Feb 2007 | gout | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00174915 | Feb 2003 → Apr 2004 | gout | Takeda | Completed | Met primary |
| Phase 3 | NCT00102440 | Jul 2002 → Feb 2004 | gout | Takeda | Completed | Met primary |
| Phase 412 trials · 2 missed | ||||||
| Phase 4 | NCT05474560 | Jan 2022 → Jan 2023 | metabolic dysfunction-associated steatotic liver disease | Ain Shams University | Completed | No outcome recorded |
| Phase 4 | NCT04398251 | Apr 2020 → Mar 2022 | hypouricemia, renal, urolithiasis | Xuhui Central Hospital, Shanghai | Unknown | No outcome recorded |
| Phase 4 | NCT03534037 | Feb 2020 → Dec 2021 | diastolic heart failure, metabolic syndrome X | National Defense Medical Center, Taiwan | Unknown | No outcome recorded |
| Phase 4 | NCT03200210 | Jul 2017 → Dec 2022 | — | Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 4 | NCT02500641 | Aug 2015 → May 2017 | gout | Menarini International Operations Luxembourg SA | Completed | Missed primary |
| Phase 4 | NCT02279342 | Oct 2014 → Mar 2017 | coronary artery disorder | Yokohama City University Medical Center | Terminated | No outcome recorded |
| Phase 4 | NCT02600780 | Nov 2013 → Dec 2014 | — | Getz Pharma | Completed | No outcome recorded |
| Phase 4 | NCT02752633 | May 2013 → May 2015 | adenine phosphoribosyltransferase deficiency | Landspitali University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01763996 | May 2013 → Mar 2015 | coronary artery disorder | Takeda | Completed | Missed primary |
| Phase 4 | NCT02344602 | Dec 2012 → Sep 2015 | type 1 diabetes mellitus | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 4 | NCT01654276 | May 2012 → Mar 2015 | gout | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT01112982 | May 2010 → Dec 2014 | gout | University of South Florida | Completed | No outcome recorded |
| Phase not applicable8 trials · 1 met primary | ||||||
| — | NCT07850713 | May → Nov 2026 expected | chronic kidney disease | Nishtar Medical University | Active not recruiting | No outcome recorded |
| — | NCT05264584 | Dec 2020 → Sep 2021 | chronic kidney disease | Ain Shams University | Completed | No outcome recorded |
| — | NCT03395977 | Jan 2018 → Dec 2019 | essential hypertension | Erasme University Hospital | Completed | No outcome recorded |
| — | NCT03149939 | Jan → Apr 2017 | — | Benha University | Completed | No outcome recorded |
| — | NCT02944214 | Oct 2016 → Dec 2019 | chronic kidney disease, impaired renal function disease | Shanghai 10th People's Hospital | Unknown | No outcome recorded |
| — | NCT02338323 | Jan 2015 → Dec 2018 | chronic kidney disease, impaired renal function disease | Shanghai 10th People's Hospital | Completed | No outcome recorded |
| — | NCT01984749 | Nov 2013 → Oct 2017 | — | Freed Study Group | Unknown | Met primary |
| — | NCT01701622 | Jan 2010 → Oct 2011 | gout, hypertensive disorder | University of Mississippi Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Comparator or background therapy42 trials | ||||||
| Phase 1 | NCT06997952 Comparator | May → Aug 2024 | — | Ain Shams University | Completed | No outcome recorded |
| Phase 1 | NCT05347498 Comparator | Apr → Jul 2022 | gout | Jiangsu HengRui Medicine Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT07323095 Comparator | Jun 2026 → Oct 2027 expected | chronic kidney disease | Atom Therapeutics Co., Ltd | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07498647 Comparator | Apr → Oct 2026 expected | gout | BioRay Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07362355 Comparator | Feb 2026 → Jul 2027 expected | gout | Jiangsu HengRui Medicine Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT06995339 Comparator | May → Dec 2025 | gout | Mostafa Bahaa | Completed | No outcome recorded |
| Phase 2 | NCT06501534 Comparator | Jul → Dec 2024 | gout | Innovent Biologics (Suzhou) Co. Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT05513976 Background | Sep 2022 → May 2023 | gout | Jiangsu HengRui Medicine Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT05574036 Comparator | Aug 2022 → May 2026 overdue | metabolic dysfunction-associated steatohepatitis | Tanta University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03767322 Comparator | Dec 2018 → Oct 2019 | acute kidney injury | Instituto Nacional de Cardiologia Ignacio Chavez | Unknown | No outcome recorded |
| Phase 2 | NCT03316131 Background | Oct 2017 → Jul 2018 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT02287818 Background | Dec 2014 → Oct 2016 | gout | TWi Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02128490 Comparator | May 2014 → Sep 2015 | gout | Takeda | Completed | Met primary |
| Phase 2 | NCT01712204 Background | Jan → Sep 2013 | gout | TWi Biotechnology, Inc. | Completed | Missed primary |
| Phase 2 | NCT01416402 Background | Aug → Oct 2011 | gout | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT00995618 Comparator | Sep 2009 → Apr 2010 | gout | Nuon Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2/3 | NCT06603142 Comparator | Apr 2024 → Apr 2026 overdue | gout | Guangzhou Ruianbo Pharmaceutical Technology Co., Ltd | Active not recruiting | No outcome recorded |
| Phase 3 | NCT07414394 Comparator | Mar 2026 → Apr 2027 expected | gout | Innovent Biologics Technology Limited (Shanghai R&D Center) | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06414837 Comparator | Jun 2024 → Jun 2026 | gout | Jiangsu HengRui Medicine Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT06139393 Comparator | Dec 2023 → Aug 2025 | gout | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT05815901 Comparator | Mar 2023 → Mar 2024 | gout | JW Pharmaceutical | Completed | No outcome recorded |
| Phase 3 | NCT05007392 Comparator | Dec 2021 → Jun 2023 | gout | Eisai Inc. | Completed | Met primary |
| Phase 3 | NCT03372200 Comparator | Jan → Jun 2018 | gout | Mochida Pharmaceutical Company, Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT01510769 Background | Jan 2012 → Jun 2014 | gout | Ardea Biosciences, Inc. | Completed | Mixed |
| Phase 3 | NCT00821392 Comparator | Aug 2006 → Sep 2007 | gout | SK Chemicals Co., Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT07369622 Comparator | Jan 2026 → Jun 2027 expected | gout | Haiphong University of Medicine and Pharmacy | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06622603 Comparator | Sep 2025 → Feb 2027 expected | gout | Seoul National University Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06834230 Comparator | Mar 2025 → Jul 2027 expected | gout, hypertensive disorder | Saga University | Recruiting | No outcome recorded |
| Phase 4 | NCT06966635 Background | Apr 2024 → Dec 2025 overdue | gout, nephrolithiasis | Huashan Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT03336203 Comparator | Oct 2017 → Dec 2022 | chronic kidney disease, gout | Medical Practice Prof D. Ivanov | Unknown | No outcome recorded |
| Phase 4 | NCT03226899 Comparator | Jul 2017 → Feb 2019 | chronic kidney disease, gout | Ironwood Pharmaceuticals, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT02579096 Comparator | Mar 2017 → Feb 2021 | chronic kidney disease, gout | VA Office of Research and Development | Completed | No outcome recorded |
| Phase 4 | NCT03425708 Comparator | Jan 2017 → Dec 2018 | chronic kidney disease | The Affiliated Hospital of Xuzhou Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT02060552 Background | Jan 2013 → Mar 2014 | gout | Tongji Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01472692 Comparator | Oct 2011 → Mar 2014 | gout, hypertensive disorder | University of California, San Diego | Completed | No outcome recorded |
| Phase 4 | NCT01328769 Comparator | Mar 2011 → Sep 2013 | hypertensive disorder | Paul N. Hopkins | Completed | No outcome recorded |
| — | NCT07326839 Background | Dec 2025 → Nov 2027 expected | gout, obesity disorder | XueMei Guo | Not yet recruiting | No outcome recorded |
| — | NCT06653686 Comparator | Nov 2024 → Jul 2026 overdue | gout | The First Hospital of Jilin University | Not yet recruiting | No outcome recorded |
| — | NCT04697602 Comparator | Jan 2021 → Aug 2023 | gout | National Taiwan University Hospital | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT04352153 Background | Apr → Sep 2020 | urolithiasis | Ai Peng | Unknown | No outcome recorded |
| — | NCT04069325 Background | Sep 2019 → Jul 2020 | gout | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Unknown | No outcome recorded |
| — | NCT01350388 Comparator | May 2011 → Oct 2013 | chronic kidney disease, type 2 diabetes mellitus | University of Utah | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2024-01-18 | Lupin Limited | Regulatory Lupin Receives Approval from U.S. FDA for Febuxostat Tablets lupin.com ↗ |
| 2023-06-26 | Teijin Pharma Limited | Regulatory 痛風・高尿酸血症治療剤「フェブリク錠」が小児適応追加の承認を取得 teijin-pharma.co.jp ↗ |
| 2023-01-10 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Febuxostat Tablets zyduslife.com ↗
Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited) has received final approval from the United States Food and Drug Administration (USFDA) to market Febuxostat Tablets, 40 mg and 80 mg (USRLD: Uloric Tablets). |
| 2019-10-30 | AstraZeneca | Results AstraZeneca to present pivotal roxadustat Phase III data at the American Society of Nephrology Kidney Week 2019 astrazeneca.com ↗
CITRINE: Verinurad Plus Febuxostat Rapidly Reduces Albuminuria in Type 2 Diabetes Independent of Pre-existing Kidney Disease |
| 2018-12-24 | Zydus Lifesciences Limited | Regulatory Zydus receives approvals from the USFDA for Doxycycline Hyclate Delayed-Release Tablets and Febuxostat Tablets zyduslife.com ↗
The group also received a tentative approval for Febuxostat Tablets (US RLD – Uloric), 40 mg and 80 mg . |
| 2014-08-13 | AstraZeneca | Results AstraZeneca announces top-line results from the Phase III programme of lesinurad in combination with xanthine oxidase inhibitors in gout patients astrazeneca.com ↗
In the CRYSTAL trial, lesinurad 400mg in combination with febuxostat met the primary endpoint, with a statistically significant higher proportion of patients reaching the target sUA goal of <5.0mg/dL at month 6 compared to febuxostat alone (p<0.0001). |
| 2014-02-11 | Menarini Group | Results Leukemia: a refuse-collecting drug which can reduce the risks posed by chemotherapy. menarini.com ↗
From the first day of treatment, febuxostat is reduces the uric acid levels with a global superiority of approximately 30% compared to the standard therapy which has been in use for more than thirty years. |
All press releases naming this drug 9 releases
Evidence & citations 19 cited values
Every value below carries the sentence it was read from. 110 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Febuxostat | “This study was designed to compare and evaluate the pharmacokinetic characteristics of febuxostat after single oral administration of TMX-67 (test drug) and Feburic® tablet in...” NCT01563432 ↗103“Traditional uric acid-lowering treatment plans include drugs that reduce uric acid production such as febuxostat and allopurinol, and drugs that increase uric acid excretion...” NCT06966635 ↗ “Participants in this group receive Febuxostat tablets together with dummy tablets matching Tigulixostat once daily during the 24-week core treatment period.” NCT07414394 ↗ “Randomized patients will receive orally once daily fixed dose of febuxostat in 2 treatment sequences AB or BA for 7 consecutive days.” NCT03316131 ↗ “ABP-671 Dose 1 + Febuxostat Dose 1-tablets(PO)” NCT07323095 ↗ “Febuxostat 40 mg Oral Tablet” NCT05324423 ↗ “Febuxostat 80 mg” NCT04804111 ↗ “febuxostat” NCT03226899 ↗ |
| Known as | Adenuric | “Febuxostat film-coated tablets 1x80 mg/QD for 7-9 days (Adenuric® 80 mg)” NCT03605212 ↗ |
| Known as | FBX | “An open-label, randomized, 4-treatment, 6-sequence, 4-period crossover study was conducted to investigate the effects of rifampicin (RFP), an inhibitor of organic anionic...” PMID 38860384 ↗ Jun 20242“ARH plus febuxostat (FBX) were evaluated in subjects with gout for serum uric acid (SUA) lowering, drug interaction, and safety.” PMID 27980008 ↗ Dec 2016 “Group 1: AR882 Alone and in Combination with Febuxostat (FBX)” NCT04155918 ↗ |
| Known as | Febuxostat (Adenuric, Uloric) | “Febuxostat (Adenuric®, Uloric®)” NCT04155918 ↗ |
| Known as | febuxostat extended- release (XR) | “The drug being tested in this study is called febuxostat extended- release (XR).” NCT02374164 ↗ |
| Known as | Febuxostat krka | ChEMBL registry synonym — accepted as the source's own label CHEMBL1164729 ↗ |
| Known as | Febuxostat mylan | ChEMBL registry synonym — accepted as the source's own label CHEMBL1164729 ↗ |
| Known as | Febuxostat viatris (previously febuxostat mylan) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1164729 ↗ |
| Known as | Febuxostat XR | “The drug being tested is this study is febuxostat XR.” NCT02504320 ↗1“Febuxostat XR capsules” NCT02374164 ↗ |
| Known as | FXT | “Febuxostat (FXT) is a medication used in management hyperuricemia espicially in gout, a condition characterized by joints pain as result of deposition of uric acid crystals due...” NCT06525974 ↗ |
| Known as | NSC-758874 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1164729 ↗ |
| Known as | TEI-6720 | “Febuxostat (TEI-6720, TMX-67) is a potent, non-purine inhibitor of XO, currently under clinical evaluation for the treatment of hyperuricemia and gout.” PMID 15698861 ↗ Jan 2005 |
| Known as | TMX-67 | “Febuxostat (TEI-6720, TMX-67) is a potent, non-purine inhibitor of XO, currently under clinical evaluation for the treatment of hyperuricemia and gout.” PMID 15698861 ↗ Jan 2005 |
| Known as | Uloric | “Febuxostat was recently approved by the FDA as Uloric.” NCT01328769 ↗ |
| Action | Inhibit | “Febuxostat, a novel nonpurine selective inhibitor of xanthine oxidase” PMID 16339094 ↗ Dec 20051“Xanthine dehydrogenase inhibitor” CHEMBL1164729 ↗ |
| Modality | Small molecule | — CHEMBL1164729 ↗ |
| Route | Oral | “Febuxostat 80 mg, orally, once daily for up to 52 weeks.” NCT00102440 ↗ |
| Target | ABCG2 | “combine osimertinib with febuxostat, a strong selective ABCG2 transporter inhibitor” NCT07485452 ↗ |
| Target | XDH | “Xanthine dehydrogenase inhibitor” CHEMBL1164729 ↗ |