Drugs / Sulfasalazine
Sulfasalazine
also known as
SSZ · Sulphasalazine · Azulfidine · Azulfidine en-tabs · Azulfidine RA · Benzosulfa · Colizine · colosalazine · +18 more
Small molecule targets ALOX5 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | AZULFIDINE EN-TABS | — | 1950-06-20 | fda.gov ↗ |
Trials 33
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT07726368 | Aug → Dec 2026 expected | NAFLD1, hyperlipidemia | Eccogene | Recruiting | No outcome recorded |
| 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 Stop: Enrollment |
| 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 · 1 missed | ||||||
| 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 Stop: Business |
| Phase 4 | NCT01172639 | Feb 2009 → Jun 2015 | rheumatoid arthritis | P. Verschueren | Completed | Missed primary |
| Phase not applicable5 trials · 1 missed | ||||||
| — | 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 | Missed primary |
| — | NCT00554203 | Jul 2003 → Dec 2007 | coronary artery disorder | Boston University | Completed | No outcome recorded |
| Comparator or background therapy55 trials | ||||||
| Phase 0 | NCT02099240 Comparator | Mar 2014 → Nov 2018 | osteomyelitis | University of Louisville | Terminated | No outcome recorded Stop: Enrollment |
| 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 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 | NCT03561584 Comparator | Jul 2018 → Mar 2026 | primary sclerosing cholangitis | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 2 | NCT01033656 Comparator | Dec 2005 → Mar 2010 | adult-onset Still disease | University of Helsinki | Completed | No outcome recorded |
| Phase 2 | NCT00844142 Comparator | Nov 2005 → Jul 2013 | ankylosing spondylitis | Charite University, Berlin, Germany | Unknown | No outcome recorded |
| Phase 2/3 | NCT07730723 Background | Sep 2026 → Jul 2027 expected | rheumatoid arthritis | Ain Shams University | Recruiting | No outcome recorded |
| 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 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 | Met primary |
| 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 | Met primary |
| Phase 3 | NCT02373202 Background | Feb 2015 → Nov 2016 | rheumatoid arthritis | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT02057250 Background | Mar 2014 → Feb 2015 | rheumatoid arthritis | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT01941095 Background | Nov 2013 → Jul 2016 | rheumatoid arthritis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT01768572 Background | Mar 2013 → Oct 2014 | rheumatoid arthritis | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT01709578 Background | Oct 2012 → Mar 2015 | rheumatoid arthritis | Sanofi | Completed | Met primary |
| Phase 3 | NCT01532648 Background | Jan 2012 → Oct 2013 | ulcerative colitis | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01256736 Background | Mar 2010 → Dec 2011 | rheumatoid arthritis | JW Pharmaceutical | Completed | No outcome recorded |
| Phase 3 | NCT01211834 Comparator | Oct 2009 → Oct 2010 | rheumatoid arthritis | JW Pharmaceutical | Completed | No outcome recorded |
| Phase 3 | NCT01870128 Comparator | Aug 2009 → Jun 2011 | rheumatoid arthritis | All India Institute of Medical Sciences | Completed | No outcome recorded |
| Phase 3 | NCT03414502 Comparator | Dec 2007 → Mar 2028 expected | rheumatoid arthritis | University of Nebraska | Recruiting | No outcome recorded |
| Phase 3 | NCT00531817 Background | Oct 2007 → Jun 2009 | rheumatoid arthritis | Hoffmann-La Roche | Completed | Met primary |
| Phase 3 | NCT00521924 Comparator | Jun 2007 → Apr 2008 | rheumatoid arthritis | Merck Sharp & Dohme LLC | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00720798 Background | Sep 2005 → Apr 2013 | rheumatoid arthritis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00579878 Comparator | Mar 2001 → Mar 2010 | rheumatoid arthritis | University of Nebraska | Completed | No outcome recorded |
| 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 4 | NCT03254589 Comparator | Oct 2017 → Dec 2023 | rheumatoid arthritis | Flinders University | Completed | Met primary |
| Phase 4 | NCT02374021 Comparator | Jul 2016 → May 2021 | rheumatoid arthritis | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02714634 Comparator | Mar 2016 → Mar 2029 expected | rheumatoid arthritis | University Hospital, Strasbourg, France | Recruiting | No outcome recorded |
| Phase 4 | NCT02638896 Background | Jan 2016 → Feb 2017 | ankylosing spondylitis | Zhixiang Huang | Unknown | No outcome recorded |
| Phase 4 | NCT02451748 Background | Aug 2015 → Sep 2017 | rheumatoid arthritis | University of Illinois at Chicago | Completed | No outcome recorded |
| Phase 4 | NCT02466581 Comparator | Feb 2015 → Jul 2023 | rheumatoid arthritis | Karolinska Institutet | Unknown | No outcome recorded |
| Phase 4 | NCT01659242 Comparator | Jul → Dec 2012 | rheumatoid arthritis | Singapore General Hospital | Terminated | No outcome recorded |
| Phase 4 | NCT02433184 Comparator | Jul 2011 → Aug 2017 | rheumatoid arthritis | University of Leeds | Completed | Missed primary |
| Phase 4 | NCT01313208 Background | Mar 2011 → Feb 2013 | rheumatoid arthritis | Amgen | Completed | Missed primary |
| Phase 4 | NCT00848354 Comparator | Jun 2009 → Apr 2013 | rheumatoid arthritis | Pfizer | Completed | Met primary |
| Phase 4 | NCT00422227 Comparator | Jun 2007 → Mar 2009 | rheumatoid arthritis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00247962 Comparator | Dec 2005 → Feb 2008 | ankylosing spondylitis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | Met primary |
| Phase 4 | NCT00259610 Comparator | May 2004 → Jun 2009 | rheumatoid arthritis | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 4 | NCT00908089 Comparator | Mar 2003 → May 2007 | rheumatoid arthritis | University of Helsinki | Unknown | No outcome recorded |
| Phase 4 | NCT00764725 Comparator | Dec 2002 → Apr 2007 | rheumatoid arthritis | Karolinska Institutet | Completed | No outcome recorded |
| — | 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. 94 sources stand behind the page.
| Field | Value | Cited 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 ↗79“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 ↗ “Standard-of-care DMARD therapy, including methotrexate, sulfasalazine, leflunomide, minocycline, and/or hydroxychloroquine” NCT01313208 ↗ “including Leflunomide，Hydroxychloroquine,Sulfasalazine,Azathioprine,Tripterygium glycosides and Total glucosides of paeony” NCT04066803 ↗ “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 ↗ |
| 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: sulfasalazine” NCT02456363 ↗ |
| 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 ↗ |
| Known as | Sulphasalazine | “Patients on corticosteroids (plus conventional therapy) will be randomized to receive anakinra (Kineret®), or one of the following: methotrexate, azathioprine, leflunomide,...” NCT01033656 ↗5“Patients who receive standard-therapy (Sulphasalazine, Methotrexate, Leflunomide) are treated with common dosages of these drugs that are deduced from the common treatment of...” NCT00244179 ↗ “Complete cessation of non-biologic DMARD therapy (single or combination of methotrexate, sulphasalazine and/or hydroxychloroquine)” NCT02219347 ↗ “Methotrexate plus Sulphasalazine and Hydroxychloroquine and steroids” NCT01491815 ↗ |
| Known as | Ucine | ChEMBL registry synonym — accepted as the source's own label CHEMBL421 ↗ |
| Action | Inhibit | “We treated patients with coronary artery disease with sulfasalazine, an inhibitor of NFκB, and placebo in a randomized, double-blind, crossover study design.” PMID 22496207 ↗ Apr 20121“Arachidonate 5-lipoxygenase inhibitor” CHEMBL421 ↗ |
| Modality | Small molecule | — CHEMBL421 ↗ |
| Route | Oral | “1.5 g (3 tablets) twice daily orally” NCT00247962 ↗ |
| Target | ALOX5 | “Arachidonate 5-lipoxygenase inhibitor” CHEMBL421 ↗ |