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 62 · 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 expected | 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 | ||||||
| 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 | No outcome recorded |
| Phase 2 | NCT03118739 | May 2017 → Aug 2018 | proteinuria, type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT02246673 | Oct 2014 → Jul 2015 | gout | Ardea Biosciences, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02252835 | Aug → Dec 2014 | gout | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT01549977 | Jul → Nov 2012 | — | Takeda | Terminated | No outcome recorded |
| Phase 2 | NCT01496469 | Feb 2012 → Aug 2014 | hypertensive disorder | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT01082640 | Apr 2010 → May 2012 | impaired renal function disease | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT01078389 | Mar 2010 → Sep 2013 | — | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT01077284 | Feb 2010 → Nov 2011 | nephrolithiasis, calcium oxalate | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT00174941 | Mar 2001 → Dec 2006 | gout | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT00174967 | Jan → Jul 2001 | gout | Takeda | Completed | No outcome recorded |
| 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 | ||||||
| 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 | No outcome recorded |
| Phase 3 | NCT02082769 | Jul 2011 → Oct 2013 | gout | Xijing Hospital | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT00430248 | Feb 2007 → Mar 2008 | gout | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00175019 | Jul 2003 → Feb 2007 | gout | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00174915 | Feb 2003 → Apr 2004 | gout | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00102440 | Jul 2002 → Feb 2004 | gout | Takeda | Completed | No outcome recorded |
| Phase 412 trials | ||||||
| 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 | No outcome recorded |
| 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 | NCT01763996 | May 2013 → Mar 2015 | coronary artery disorder | Takeda | Completed | No outcome recorded |
| Phase 4 | NCT02752633 | May 2013 → May 2015 | adenine phosphoribosyltransferase deficiency | Landspitali University Hospital | Completed | No outcome recorded |
| 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 applicable7 trials | ||||||
| — | 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 | No outcome recorded |
| — | NCT01701622 | Jan 2010 → Oct 2011 | gout, hypertensive disorder | University of Mississippi Medical Center | Terminated | No outcome recorded |
Also used as a comparator or background therapy in 42 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 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 214 trials | ||||||
| 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 2025 → Aug 2026 overdue | gout | Mostafa Bahaa | Recruiting | 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 | No outcome recorded |
| Phase 2 | NCT01712204 Background | Jan → Sep 2013 | gout | TWi Biotechnology, Inc. | Completed | No outcome recorded |
| 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 2/31 trial | ||||||
| Phase 2/3 | NCT06603142 Comparator | Apr 2024 → Apr 2026 overdue | gout | Guangzhou Ruianbo Pharmaceutical Technology Co., Ltd | Active not recruiting | No outcome recorded |
| Phase 38 trials | ||||||
| Phase 3 | NCT07414394 Comparator | Mar 2026 → Apr 2027 expected | gout | Innovent Biologics Technology Limited (Shanghai R&D Center) | 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 | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT00821392 Comparator | Aug 2006 → Sep 2007 | gout | SK Chemicals Co., Ltd. | Completed | No outcome recorded |
| Phase 411 trials | ||||||
| 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 |
| 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 |
| Phase not applicable6 trials | ||||||
| — | 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 |
| — | 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 |
Evidence & citations 19 cited values
Every value below carries the sentence it was read from. 109 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 ↗102“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 ↗ |