CDEK
← All drugs Report issue

sulfasalazine

Trade name: azulfidine

Small moleculeapproved

Approved

Aug 11, 1941

Sulfasalazine is an anti-inflammatory indicated for the treatment of ulcerative colitis and rheumatoid arthritis. The mode of action of Sulfasalazine or its metabolites, 5-aminosalicylic acid (5-ASA) and sulfapyridine (SP), is still under investigation, but may be related to the anti-inflammatory and/or immunomodulatory properties that have been observed in animal and in vitromodels, to its affinity for connective tissue, and/or to the relatively high concentration it reaches in serous fluids, the liver and intestinal walls, as demonstrated in autoradiographic studies in animals. In ulcerative colitis, clinical studies utilizing rectal administration of Sulfasalazine, SP and 5-ASA have indicated that the major therapeutic action may reside in the 5-ASA moiety. The relative contribution of the parent drug and the major metabolites in rheumatoid arthritis is unknown. Sulfasalazine is used for the treatment of Crohn's disease and rheumatoid arthritis as a second-line agent. Sulfasalazine is marketed under the trade name Azulfidine among others. — NCATS

Clinical trial activity

77 trials · 95 clinical orgs · 17 marketing orgs

Phase 1
14
Phase 2
39
Phase 3
20
Phase 4
21

Earliest trial started Dec 1, 1999 (NCT00579878)

Timeline

1940s

  1. Aug 11, 1941

    Earliest FDA Approval

  2. Aug 11, 1941

    Lederle — NDA Secondary Org

  3. Aug 11, 1941

    American Cyanamid — NDA Secondary Org

1950s

  1. Jun 20, 1950

    Pharmacia & Upjohn — NDA Secondary Org

  2. Jun 20, 1950

    Pfizer — Marketing Organization

  3. Jun 20, 1950

    Pfizer — NDA Secondary Org

1970s

  1. Nov 12, 1973

    Chartwell Pharmaceuticals — Marketing Organization

  2. Nov 12, 1973

    Heritage Pharma — Marketing Organization

  3. Apr 9, 1974

    Solvay — Marketing Organization

  4. May 12, 1976

    Watson Pharmaceuticals — Marketing Organization

1980s

  1. Dec 29, 1980

    Pharmacia & Upjohn — Marketing Organization

  2. May 15, 1981

    Sandoz — Marketing Organization

  3. Apr 1, 1983

    Epic Pharma Llc — Marketing Organization

  4. Oct 19, 1987

    Sun Pharmaceuticals — Marketing Organization

1990s

  1. Jan 1, 1999

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Aug 18, 2000

    Pharmacia — NDA Secondary Org

  2. Jan 11, 2002

    Vintage — Marketing Organization

  3. Jan 11, 2002

    Nuvo Research Inc. — Marketing Organization

  4. Jan 1, 2005

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2010

    Earliest Phase 1 Sponsor(trial)

2020s

  1. Nov 4, 2025

    Rising Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAug 11, 1941

Chemistry & pharmacology

Loading structure…

SMILES

OC(=O)C1=C(O)C=CC(=C1)\N=N\C2=CC=C(C=C2)S(=O)(=O)NC3=NC=CC=C3
Mol. weight
398.393 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Discontinued

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • 1,1'-(sulfonylbis(p-phenyleneimino))bis(3-phenyl- 1,3-propanedisulfonic acid) tetrasodium salt
  • 2-hydroxy-5-((4-((2-pyridinylamino)sulfonyl)phenyl)azo)benzoic acid
  • 2-hydroxy-5-((4-((2-pyridinylamino)sulfonyl)phenyl)azo)benzoic acid
  • 2-hydroxy-5-[4-(pyridin-2-ylsulfamoyl)-phenylazo]-benzoic acid
  • 2-hydroxy-5-[4-(pyridin-2-ylsulfamoyl)-phenylazo]-benzoic acid
  • 4-(pyridyl-2-amidosulfonyl)-3'-carboxy-4'-hydroxyazobenzene
  • 4-(pyridyl-2-amidosulfonyl)-3'-carboxy-4'-hydroxyazobenzene
  • 5-(4-(2-pyridylsulfamoyl)phenylazo)-2-hydroxybenzoic acid
  • 5-(4-(2-pyridylsulfamoyl)phenylazo)-2-hydroxybenzoic acid
  • 5-((p-(2-pyridylsulfamoyl)phenyl)azo)salicylic acid
  • 5-((p-(2-pyridylsulfamoyl)phenyl)azo)salicylic acid
  • 5-(p-(2-pyridylsulfamyl)phenylazo)salicylic acid
  • 5-(p-(2-pyridylsulfamyl)phenylazo)salicylic acid
  • azopyrin
  • azopyrin
  • azulfidine
  • azulfidine
  • azulfidine
  • azulfidine
  • azulfidine en
  • azulfidine en
  • azulfidine en-tabs
  • azulfidine en-tabs
  • colizine
  • phenopryldiasulfone
  • phenopryldiasulfone sodium
  • phenopyrldiasulfone
  • salazopyrin
  • salazopyrin
  • salazopyrin
  • salazopyrin, azopyrin
  • salazopyrine
  • salazopyrine
  • salazopyrin e.c.
  • salazopyrin-en
  • salazosulfapiridina
  • salazosulfapiridina
  • salazosulfapyridine
  • salazosulfapyridine
  • salazosulfapyridine
  • salazosulfapyridine
  • salazosulfapyridine
  • salazosulfapyridine
  • salazosulfapyridinum
  • salazosulfapyridinum
  • salicylazosulfapyridine
  • salicylazosulfapyridine
  • salicylazosulfapyridine
  • salicylazosulfapyridine
  • salicylazsulfapyridine
  • s.a.s.
  • s.a.s.
  • s.a.s.-500
  • s.a.s.-500
  • sas-500
  • sas-500
  • solapsone
  • solapsone
  • solasulfone
  • solasulfone
  • solasulfone
  • solasulfone
  • solasulfone
  • solasulfone
  • soliusulfon
  • solusulfone
  • sufalalazine
  • sulfadiazin
  • sulfadiazine sodium
  • sulfadiazine sodium
  • sulfadiazine sodium
  • sulfadiazine sodium
  • sulfadiazine sodium
  • sulfadiazine sodium
  • sulfadiazine sodium
  • sulfasalazin
  • sulfasalazin
  • sulfasalazina
  • sulfasalazina
  • sulfasalazine
  • sulfasalazine
  • sulfasalazine
  • sulfasalazine
  • sulfasalazine
  • sulfasalazine
  • sulfasalazine
  • sulfasalazine
  • sulfasalazine
  • sulfasalazinum
  • sulfasalazinum
  • sulfazine
  • sulfetrone
  • sulfonazina
  • sulfonazine
  • sulphasalazine
  • sulphasalazine
  • sulphasalazine
  • sulphasalazine
  • sulphetrone
  • sulphetrone
  • sulphonazine
  • sulusulfone
  • ucine
  • ucine

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07138898Phase 2Sep 30, 2025New York University
NCT06360068Phase 2May 6, 2024Jiao Tong University
NCT06293378N/AFeb 1, 2024Chongqing Medical University
NCT06010342Phase 2Jan 31, 2024Suzhou Teligene Ltd.
NCT06134388Phase 3Sep 1, 2023Tanta University
NCT05703425Phase 2Mar 1, 2023Rutgers University
NCT06060301Phase 3Mar 1, 2023Cairo University
NCT05664464Phase 1/Phase 2 (Phase 2)Jan 31, 2023Swiss National Science Foundation, University of Zurich
NCT05580861Phase 1/Phase 2 (Phase 2)Oct 31, 2022Assistance Publique - Hôpitaux de Paris
NCT05445440Phase 1Sep 6, 2022Bristol-Myers Squibb
NCT05447520Phase 2Jul 31, 2022Mansoura University
NCT05322707Phase 3Apr 15, 2022Cipla
NCT04720183Phase 1Jan 11, 2021Galapagos NV
NCT04610476Phase 3Oct 31, 2020University of Erlangen-Nuremberg
NCT04528056Phase 1/Phase 2 (Phase 2)Aug 1, 2020Jiao Tong University
NCT04268394Phase 1Feb 15, 2020Celgene
NCT04205357Phase 1Jan 1, 2020Cornell University, Northwell Health, Norwegian Cancer Society, University of Bergen, University of Stavanger
NCT04080206Phase 2Oct 31, 2019Therapeutics, Inc.
NCT04077957Phase 4Sep 10, 2019Southern Medical University
NCT03847311Early Phase 1 (Phase 1)Jul 15, 2019University of Arizona
Showing 20 of 77 trials
Page 1 / 4

Organizations

Research & Development (95)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
PfizerFor profit5412004
SanofiFor profit4422012
Harvard UniversityAcademic/Hospital3322013
RegeneronFor profit3022013
RocheFor profit3312005
Tiltan PharmaFor profit3312009
University of GreifswaldAcademic/Hospital3312010
University of HelsinkiAcademic/Hospital3332003
WyethFor profit3022005
AmgenFor profit2012004
Galapagos NVFor profit2122016
Government of FinlandGovernment2022003
Jiao Tong UniversityAcademic/Hospital2212020
Karolinska InstituteAcademic/Hospital2212002
Kuopio University HospitalAcademic/Hospital2022003
Rheumatism Foundation HospitalAcademic/Hospital2022003
Sun Yat-Sen UniversityAcademic/Hospital2122008
University of Alabama, BirminghamAcademic/Hospital2222004
University of Erlangen-NurembergAcademic/Hospital2212009
University of LeedsAcademic/Hospital2212011
95 organizations
Page 1 / 5

Marketing (21)

OrganizationOrg typeRelationshipDate
American CyanamidFor profitNDA2Aug 11, 1941
Chartwell PharmaceuticalsFor profitMKTGNov 12, 1973
Epic Pharma LlcFor profitMKTGApr 1, 1983
Epic Pharma LlcFor profitSYNApr 1, 1983
Heritage PharmaFor profitMKTGNov 12, 1973
KabiFor profitNDA—
LederleFor profitNDA2Aug 11, 1941
Nuvo Research Inc.For profitMKTGJan 11, 2002
PfizerFor profitMKTGJun 20, 1950
PfizerFor profitNDA2Jun 20, 1950
PharmaciaFor profitNDA2Aug 18, 2000
Pharmacia & UpjohnFor profitNDA2Jun 20, 1950
Pharmacia & UpjohnFor profitSYNAug 18, 2000
Pharmacia & UpjohnFor profitMKTGDec 29, 1980
Rising PharmaceuticalsFor profitMKTGNov 4, 2025
SandozFor profitMKTGMay 15, 1981
SolvayFor profitMKTGApr 9, 1974
Sun PharmaceuticalsFor profitMKTGOct 19, 1987
SuperpharmFor profitMKTG—
VintageFor profitMKTGJan 11, 2002
Watson PharmaceuticalsFor profitMKTGMay 12, 1976