Drugs / Sulfasalazine
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Sulfasalazine

Small molecule targets ALOX5 via inhibition

Developed for
rheumatoid arthritis · ankylosing spondylitis · glioblastoma · psoriatic arthritis · acute diarrhea · acute myeloid leukemia · alcohol dependence · brain neoplasm
+15 more · cirrhosis of liver · coronary artery disorder · fibrotic liver disease · juvenile idiopathic arthritis · lichen planus, oral · neuropathy, painful · polyarticular juvenile idiopathic arthritis · pulmonary arterial hypertension · reactive arthritis · spondyloarthropathy · systemic lupus erythematosus · adult-onset Still disease · breast cancer · colorectal cancer · primary sclerosing cholangitis
Investigated by
University of Erlangen-Nürnberg Medical School · Agentschap voor Innovatie door Wetenschap en Technologie · Akebia Therapeutics · Alliance for Clinical Trials in Oncology · Assistance Publique - Hôpitaux de Paris · Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
+41 more · Boston University · Bristol-Myers Squibb · Cairo University · Celgene Corporation · Charite University, Berlin, Germany · Chung Shan Medical University · Foundation for Paediatric Research, Finland · Haukeland University Hospital · Helse Stavanger HF · Helsinki University Central Hospital · Karolinska Institutet · Lakefront Biotherapeutics NV · Massachusetts General Hospital · NYU Langone Health · Nanfang Hospital, Southern Medical University · National Cancer Institute (NCI) · Newcastle University · Newcastle-upon-Tyne Hospitals NHS Trust · Northwell Health · Norwegian Cancer Society · P. Verschueren · Paijat-Hame Hospital District · Pfizer · Päivikki and Sakari Sohlberg Foundation, Finland · Qiong Fu · RenJi Hospital · Rheumatism Foundation Hospital · Rutgers, The State University of New Jersey · Scandinavian Rheumatology Research Foundation · Sun Yat-sen University · Swiss National Science Foundation · Tesaro, Inc. · The Mind Research Network · The Second Affiliated Hospital of Chongqing Medical University · University of Alabama at Birmingham · University of Bergen · University of Oxford · University of Zurich · Weill Medical College of Cornell University · Wellcome Trust · dfg

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) AZULFIDINE EN-TABS 1950-06-20 fda.gov

Trials 32 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 16 trials
Phase 1 NCT05445440 Sep → Nov 2022 Bristol-Myers Squibb Completed No outcome recorded
Phase 1 NCT04720183 Jan → Apr 2021 Lakefront Biotherapeutics NV Completed No outcome recorded
Phase 1 NCT04268394 Mar 2020 → Jun 2021 Celgene Corporation Completed No outcome recorded
Phase 1 NCT04205357 Mar 2020 → Oct 2022 glioblastoma Haukeland University Hospital Completed No outcome recorded
Phase 1 NCT03801733 Jun → Nov 2018 Akebia Therapeutics Completed No outcome recorded
Phase 1 NCT02434861 May → Jul 2015 chemotherapy-induced toxicity Tesaro, Inc. Completed No outcome recorded
Phase 1/23 trials
Phase 1/2 NCT05580861 May 2023 → Nov 2025 overdue acute myeloid leukemia Assistance Publique - Hôpitaux de Paris Recruiting No outcome recorded
Phase 1/2 NCT05664464 Jan 2023 → Jun 2026 overdue glioblastoma University of Zurich Recruiting No outcome recorded
Phase 1/2 NCT04528056 Aug 2020 → Dec 2021 pulmonary arterial hypertension RenJi Hospital Unknown No outcome recorded
Phase 26 trials
Phase 2 NCT07138898 Dec 2025 → Jan 2028 expected rheumatic disorder NYU Langone Health Recruiting No outcome recorded
Phase 2 NCT06360068 May 2024 → May 2025 systemic lupus erythematosus Qiong Fu Unknown No outcome recorded
Phase 2 NCT05703425 Mar 2023 → Jan 2028 expected Rutgers, The State University of New Jersey Recruiting No outcome recorded
Phase 2 NCT01667029 May 2013 → Aug 2017 neuropathy, painful Massachusetts General Hospital Terminated No outcome recorded
Phase 2 NCT02456363 Nov 2009 → Oct 2019 ankylosing spondylitis Chung Shan Medical University Unknown No outcome recorded
Phase 2 NCT00244179 Jan 2003 → ? reactive arthritis Charite University, Berlin, Germany Unknown No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT00889694 Oct 2008 → Jul 2009 ankylosing spondylitis Sun Yat-sen University Unknown No outcome recorded
Phase 36 trials
Phase 3 NCT06060301 Mar 2023 → Sep 2024 overdue lichen planus, oral Cairo University Active not recruiting No outcome recorded
Phase 3 NCT04610476 Oct 2020 → Oct 2024 psoriatic arthritis, substance withdrawal syndrome University of Erlangen-Nürnberg Medical School Unknown No outcome recorded
Phase 3 NCT06985134 Jan 2017 → Dec 2018 spondyloarthropathy Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh Completed No outcome recorded
Phase 3 NCT01198145 Apr 2011 → Jul 2013 acute diarrhea Alliance for Clinical Trials in Oncology Completed No outcome recorded
Phase 3 NCT02779114 Jan 2009 → Dec 2017 rheumatoid arthritis University of Erlangen-Nürnberg Medical School Unknown No outcome recorded
Phase 3 NCT01015547 May 2003 → Nov 2007 polyarticular juvenile idiopathic arthritis Helsinki University Central Hospital Completed No outcome recorded
Phase 45 trials
Phase 4 NCT03739853 May 2019 → Oct 2024 psoriatic arthritis University of Oxford Completed No outcome recorded
Phase 4 NCT03411798 Dec 2017 → Jul 2019 ankylosing spondylitis Nanfang Hospital, Southern Medical University Completed No outcome recorded
Phase 4 NCT01491815 Dec 2012 → Jul 2023 rheumatoid arthritis Karolinska Institutet Unknown No outcome recorded
Phase 4 NCT00637780 Jun 2010 → Jan 2014 juvenile idiopathic arthritis Pfizer Terminated No outcome recorded
Phase 4 NCT01172639 Feb 2009 → Jun 2015 rheumatoid arthritis P. Verschueren Completed No outcome recorded
Phase not applicable5 trials
NCT06293378 Feb 2024 → Oct 2028 expected cirrhosis of liver, fibrotic liver disease The Second Affiliated Hospital of Chongqing Medical University Recruiting No outcome recorded
NCT02219347 Aug 2014 → Aug 2017 rheumatoid arthritis Newcastle-upon-Tyne Hospitals NHS Trust Completed No outcome recorded
NCT01577966 Jan 2012 → Jan 2015 brain neoplasm University of Alabama at Birmingham Completed No outcome recorded
NCT01312129 Mar 2010 → Sep 2011 alcohol dependence The Mind Research Network Completed No outcome recorded
NCT00554203 Jul 2003 → Dec 2007 coronary artery disorder Boston University Completed No outcome recorded
Also used as a comparator or background therapy in 54 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT02099240 Comparator Mar 2014 → Nov 2018 osteomyelitis University of Louisville Terminated No outcome recorded
Phase 13 trials
Phase 1 NCT03012763 Comparator Apr 2016 → Jan 2017 University Medicine Greifswald Completed No outcome recorded
Phase 1 NCT01596764 Comparator May → Jul 2011 intestinal obstruction University Medicine Greifswald Completed No outcome recorded
Phase 1 NCT01596777 Comparator Jan → Mar 2010 intestinal obstruction University Medicine Greifswald Completed No outcome recorded
Phase 28 trials
Phase 2 NCT06753565 Background Dec 2024 → Jun 2025 overdue rheumatoid arthritis German University in Cairo Recruiting No outcome recorded
Phase 2 NCT06640309 Background Dec 2023 → Jun 2025 overdue rheumatoid arthritis Ain Shams University Recruiting No outcome recorded
Phase 2 NCT05447520 Background Dec 2021 → Dec 2022 rheumatoid arthritis Noha Mansour Completed No outcome recorded
Phase 2 NCT03847311 Comparator May 2021 → Oct 2023 breast cancer University of Arizona Completed No outcome recorded
Phase 2 NCT03863405 Background Jan 2019 → Jan 2020 rheumatoid arthritis Ain Shams University Unknown No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT05871086 Background May → Dec 2023 juvenile idiopathic arthritis Nourhan Elsherif Unknown No outcome recorded
Phase 2/3 NCT05671497 Background Nov 2022 → Oct 2024 rheumatoid arthritis Ain Shams University Completed No outcome recorded
Phase 319 trials
Phase 3 NCT06134388 Comparator Sep 2023 → Sep 2025 overdue colorectal cancer Tanta University Recruiting No outcome recorded
Phase 3 NCT06594822 Comparator Aug 2023 → Jan 2024 rheumatoid arthritis King Edward Medical University Completed No outcome recorded
Phase 3 NCT03660059 Background Sep 2018 → Apr 2021 rheumatoid arthritis Astellas Pharma Inc Completed No outcome recorded
Phase 3 NCT02930343 Comparator Sep 2016 → Aug 2018 rheumatoid arthritis Jawaharlal Institute of Postgraduate Medical Education & Research Terminated No outcome recorded
Phase 3 NCT02873936 Background Jul 2016 → Mar 2018 rheumatoid arthritis Gilead Sciences Completed No outcome recorded
Phase 420 trials
Phase 4 NCT04077957 Background Oct 2019 → Oct 2021 ankylosing spondylitis Nanfang Hospital, Southern Medical University Unknown No outcome recorded
Phase 4 NCT03797872 Comparator Apr 2019 → Jul 2020 psoriatic arthritis University of Oxford Completed No outcome recorded
Phase 4 NCT03813771 Background Mar 2019 → Feb 2023 rheumatoid arthritis University of Leeds Unknown No outcome recorded
Phase 4 NCT04066803 Background Aug 2018 → Jul 2020 rheumatoid arthritis Sun Yat-sen University Unknown No outcome recorded
Phase 4 NCT03449758 Background Mar 2018 → Jul 2019 rheumatoid arthritis Sanofi Completed No outcome recorded
Phase not applicable1 trial
NCT00405275 Comparator Jul 2007 → Dec 2011 rheumatoid arthritis US Department of Veterans Affairs Completed No outcome recorded

Evidence & citations 31 cited values

Every value below carries the sentence it was read from. 92 sources stand behind the page.

FieldValueCited text
Known as Sulfasalazine “Yisaipu® was introduced only during the active state and was switched to DMARDs, methotrexate(MTX), sulfasalazine(SSZ) and hydroxychloroquine(HCQ), after disease remission (ESR...” NCT03411798
77

“csDMARDs may include one or two of the following: methotrexate (MTX), hydroxychloroquine or chloroquine, sulfasalazine, and/or leflunomide (combination of leflunomide and MTX...” NCT02873936

“The following DMARDs were permitted in this study: methotrexate (MTX), chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide.” NCT00531817

“Disease-modifying anti-rheumatic drugs included methotrexate, chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide.” NCT00720798

“methotrexate 10-25 mg/week, sulfasalazine 1-2 g/day, hydroxychloroquine 35 mg/kg/week, prednisolone 7.5 mg/day, and infliximab 3 mg/kg during first 6 months” NCT00908089

“methotrexate 7.5-15 mg once weekly hydroxychloroquine 200 mg twice daily sulfasalazine 500 mg to 3 g once daily leflunomide 20 mg once daily” NCT05671497

“Methotrexate(MTX) and/or 1 DMARDs(chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide)” NCT01211834

“including Leflunomide,Hydroxychloroquine,Sulfasalazine,Azathioprine,Tripterygium glycosides and Total glucosides of paeony” NCT04066803

“Standard-of-care DMARD therapy, including methotrexate, sulfasalazine, leflunomide, minocycline, and/or hydroxychloroquine” NCT01313208

“diclofenac 50 mg twice a day, prednisone 5mg once daily, methotrexate 10mg once weekly or sulfasalazine 500 twice daily” NCT06594822

“DMARDs(chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide)” NCT01256736

“conventional DMARD (hydroxychloroquine or sulfasalazine) plus methotrexate for 24 weeks.” PMID 27006728 Feb 2016

“Azulfidine® (generic: sulfasalazine), minimum daily dose ≥4.0 g” NCT01532648

“methotrexate, leflunomide, hydroxychloroquine or sulfasalazineNCT05447520

“methotrexate, leflunomide, hydroxychloroquine or sulfasalazineNCT03863405

“methotrexate- leflunomide- sulfasalazine- hydroxychloroquine” NCT06640309

“* Sulfasalazine - 30 to 50 mg/kg/day in 2 divided doses” NCT05871086

“methotrexate, sulfasalazine, plus hydroxychloroquine” NCT01015547

“additional sulfasalazine and hydroxychloroquine” PMID 22464340 Mar 2012

Sulfasalazine 2000 to 3000 mg per day” NCT01870128

sulfasalazine(colosalazine®)” NCT06753565

SulfasalazineNCT02099240

NCT06985134

NCT04720183

NCT01577966

NCT01596764

NCT03797872

NCT07138898

NCT01596777

NCT05445440

NCT01941095

NCT03739853

NCT04205357

NCT02374021

NCT03801733

NCT02434861

NCT06134388

NCT01312129

NCT04528056

NCT01198145

NCT00579878

NCT00422227

NCT03813771

NCT00637780

NCT02451748

NCT02373202

NCT00405275

NCT04268394

NCT03847311

NCT02456363

NCT01709578

NCT03561584

NCT00521924

NCT02433184

NCT05664464

NCT00259610

NCT00844142

NCT03254589

NCT06360068

NCT04610476

NCT02714634

NCT03012763

NCT03449758

NCT02638896

NCT01659242

NCT01768572

NCT00889694

NCT05703425

NCT01667029

NCT01172639

NCT00554203

NCT02057250

NCT04077957

NCT05580861

NCT06293378

NCT02930343

NCT06060301

NCT03414502

Known as Azulfidine Azulfidine® (generic: sulfasalazine), minimum daily dose ≥4.0 g” NCT01532648
Known as Azulfidine en-tabs ChEMBL registry synonym — accepted as the source's own label CHEMBL421
Known as Azulfidine RA “Sulfasalazin (e.g. Azulfidine RA®, Pleon RA®)” NCT02779114
Known as Benzosulfa ChEMBL registry synonym — accepted as the source's own label CHEMBL421
Known as Colizine ChEMBL registry synonym — accepted as the source's own label CHEMBL421
Known as colosalazine “sulfasalazine(colosalazine®)” NCT06753565
Known as Drug: sulfasalazine Drug: sulfasalazineNCT02456363
Known as NSC-203730 ChEMBL registry synonym — accepted as the source's own label CHEMBL421
Known as NSC-667219 ChEMBL registry synonym — accepted as the source's own label CHEMBL421
Known as Pleon RA “Sulfasalazin (e.g. Azulfidine RA®, Pleon RA®)” NCT02779114
Known as POLYMER OF SULFASALAZINE ChEMBL registry synonym — accepted as the source's own label CHEMBL421
Known as S.a.s.-500 ChEMBL registry synonym — accepted as the source's own label CHEMBL421
Known as Salazopyrin ChEMBL registry synonym — accepted as the source's own label CHEMBL421
Known as Salazopyrin e.c. ChEMBL registry synonym — accepted as the source's own label CHEMBL421
Known as Salazopyrin-en ChEMBL registry synonym — accepted as the source's own label CHEMBL421
Known as salazosulfapyridine “hydroxychloroquine, salazosulfapyridine, gold (injection or oral), D-penicillamine, lobenzarit, actarit, bucillamine and iguratimod.” NCT03660059
Known as Salicylazosulfapyridine ChEMBL registry synonym — accepted as the source's own label CHEMBL421
Known as SAS “Here, we demonstrated that although inhibition of xCT either by pharmacological inhibitor (sulfasalazine [SAS]), approved by US Food and Drug Administration (FDA) for...” PMID 33744468 Mar 2021
Known as SSZ “Yisaipu® was introduced only during the active state and was switched to DMARDs, methotrexate(MTX), sulfasalazine(SSZ) and hydroxychloroquine(HCQ), after disease remission (ESR...” NCT03411798
6

“Sulfasalazine (SSZ) is a broadly available, well tolerated anti-inflammatory medicine approved for the treatment of ulcerative colitis and rheumatoid arthritis.” NCT05580861

“patients with axSpA were randomized to treatment with ETN (n = 40) versus sulfasalazine (SSZ; n = 36)” PMID 25028375 Jul 2014

“infliximab (IFX) versus sulfasalazine (SSZ) plus hydroxychloroquine (HCQ)” PMID 32433827 Aug 2021

“MTX + sulfasalazine (SSZ) + hydroxychloroquine (HCQ) triple therapy” PMID 27483410 Jan 2017

“ARM 1(Methotrexate(MTX) plus Sulfasalazine(SSZ))” NCT01659242

“sulphasalazine (SSZ)” NCT00247962

Known as Sulfasalazin Sulfasalazin (e.g. Azulfidine RA®, Pleon RA®)” NCT02779114
Known as Sulfasalazina ChEMBL registry synonym — accepted as the source's own label CHEMBL421
Known as sulfasalazine(SSZ) sulfasalazine(SSZ)NCT03411798
Known as Sulfasalazinum ChEMBL registry synonym — accepted as the source's own label CHEMBL421
Known as Sulfasalazopyridine ChEMBL registry synonym — accepted as the source's own label CHEMBL421