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Drug

Sulfasalazine

Established medicine
ClassCyclooxygenase inhibitorResearchOngoing clinical research
Also known as 2-Hydroxy-5-((4-((2-pyridinylamino)sulfonyl)phenyl)azo)benzoic acid, 4-(Pyridyl-2-amidosulfonyl)-3'-carboxy-4'-hydroxyazobenzene, 5-((p-(2-Pyridylsulfamoyl)phenyl)azo)salicylic acid, 5-(4-(2-Pyridylsulfamoyl)phenylazo)-2-hydroxybenzoic acid+13 more

2-Hydroxy-5-((4-((2-pyridinylamino)sulfonyl)phenyl)azo)benzoic acid, 4-(Pyridyl-2-amidosulfonyl)-3'-carboxy-4'-hydroxyazobenzene, 5-((p-(2-Pyridylsulfamoyl)phenyl)azo)salicylic acid, 5-(4-(2-Pyridylsulfamoyl)phenylazo)-2-hydroxybenzoic acid, 5-(p-(2-Pyridylsulfamyl)phenylazo)salicylic acid, Azulfidine, Azulfidine EN-tabs, Salazosulfapiridina, Salazosulfapyridine, Salazosulfapyridinum, Salicylazosulfapyridine, Sulfazine, 柳氮磺吡啶, Sulfasalazin, Sulfasalazina, Sulphasalazine, Sulfasalazinum.

RxNorm9524ChEMBLCHEMBL421ATCA07EC01UNII3XC8GUZ6CB
6
Active clinical trials
3
Protein targets
65
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Label change: SULFASALAZINE (NDA007073)

Regulatory2026-10-14FDA

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Clinical trial2026-07-09Results expected Q1 2028 · ClinicalTrials.gov

The Effect of Sulfasalazine on CRH Levels in Pregnant Women With a History of Pre-Term Birth: A Randomized Controlled Trial

Clinical trial2026-07-09Results expected Q1 2028 · ClinicalTrials.gov

A Phase Ib/II Randomized, Open Label Drug Repurposing Trial of Glutamate Signaling Inhibitors in Combination With Chemoradiotherapy in Patients With Newly Diagnosed Glioblastoma

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

Treatment of Rheumatoid Arthritis With Disease-modifying Antirheumatic Drugs (DMARDs): Predictors of Response

Clinical trial2026-06-17Results expected Q1 2028 · ClinicalTrials.gov

A Randomized, Placebo-controlled Pilot Study of Sulfasalazine for the Treatment of Primary Sclerosing Cholangitis (PSC)

Clinical trial2026-03-03Completed · ClinicalTrials.gov

Phase I/II Clinical Trial Assessing the Combination of Sulfasalazine With Standard of Care Induction Therapy in Newly Diagnosed Acute Myeloid Leukemias (AML) Patients 60 Years or Older- the SALMA Study

Clinical trial2025-11-30Primary completion · ClinicalTrials.gov

Clinical Effectiveness of Standard Step up Care (Methotrexate) Compared to Early Combination DMARD Therapy With Standard Step up Care Compared to Early Use of TNF Inhibitors With Standard Step up Care for the Treatment of Moderate to Severe Psoriatic Arthritis: a 3-arm Parallel Group Randomised Controlled Trial.

Clinical trial2025-11-26Results posted · ClinicalTrials.gov

Clinical Study Evaluating the Efficacy and Safety of Sulfasalazine in Patients With Metastatic Colorectal Cancer

Clinical trial2025-09-30Primary completion · ClinicalTrials.gov

Label change: SULFASALAZINE (NDA007073)

Regulatory2022-11-16FDA

Label change: SULFASALAZINE (NDA007073)

Regulatory2021-11-01FDA

Label change: SULFASALAZINE (NDA007073)

Regulatory2021-01-15FDA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Sulfasalazine
Aliases & brands
2-Hydroxy-5-((4-((2-pyridinylamino)sulfonyl)phenyl)azo)benzoic acid4-(Pyridyl-2-amidosulfonyl)-3'-carboxy-4'-hydroxyazobenzene5-((p-(2-Pyridylsulfamoyl)phenyl)azo)salicylic acid5-(4-(2-Pyridylsulfamoyl)phenylazo)-2-hydroxybenzoic acid5-(p-(2-Pyridylsulfamyl)phenylazo)salicylic acidAzulfidineAzulfidine EN-tabsSalazosulfapiridinaSalazosulfapyridineSalazosulfapyridinumSalicylazosulfapyridineSulfazine柳氮磺吡啶SulfasalazinSulfasalazinaSulphasalazineSulfasalazinum
RxNorm CUI
9524
ChEMBL ID
CHEMBL421
ATC codes
A07EC01
UNII
3XC8GUZ6CB
Primary mechanism
Cyclooxygenase inhibitor
Regulatory jurisdictions
fda

Pharmacology & targets

3 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Prostaglandin G/H synthase 2
PTGS2 · P35354
INHIBITORCyclooxygenase inhibitor
Prostaglandin G/H synthase 1
PTGS1 · P23219
INHIBITORCyclooxygenase inhibitor
Polyunsaturated fatty acid 5-lipoxygenase
ALOX5 · P09917
INHIBITORArachidonate 5-lipoxygenase inhibitor

Regulatory timeline

65 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
1950-06-20
Latest approval
2015-11-20
Authorities
FDA
Total events
65
fdaU.S. Food and Drug Administration· 65 events
2026-10-14Label change
Label change: SULFASALAZINE (NDA007073)
Evidence ↗
2022-11-16Label change
Label change: SULFASALAZINE (NDA007073)
Evidence ↗
2021-11-01Label change
Label change: SULFASALAZINE (NDA007073)
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

49 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
49
registered trials across all phases
LATEST COMPLETION 2026
6
Active studies
6
Recruiting
30
Late-stage (III+)
31
Completed
12
Discontinued
PHASE DISTRIBUTIONn = 49
Phase 19Phase 1 / 23Phase 27Phase 2 / 31Phase 311Phase 414Phase N / A4

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Clinical Effectiveness of Standard Step up Care (Methotrexate) Compared to Early Combination DMARD Therapy With Standard Step up Care Compared to Early Use of TNF Inhibitors With Standard Step up Care for the Treatment of Moderate to Severe Psoriatic Arthritis: a 3-arm Parallel Group Randomised Controlled Trial.

CompletedPH IVUniversity of Oxfordn=1922024

Methotrexate, Blood Pressure and Arterial Function in Rheumatoid Arthritis

CompletedPH IVFlinders Universityn=1242023

Targeted Treatment Early With Etanercept Plus Methotrexate Versus T2T Care for DMARD-naïve Early RA Patients. A Prospective, Longitudinal Cohort Study With Embedded Pilot Randomised Controlled Trial to Assess Treatment Rationalisation Based on naïve T-cell Stratification.

Unknown statusPH IVUniversity of Leedsn=1062023

Treat-to-target Strategy in Ankylosing Spondylitis Using Etanercept and Conventional Synthetic DMARDs, a Prospective Randomized Controlled Study

Unknown statusPH IVNanfang Hospital, Southern Medical Universityn=1002022

Treatments Against RA and Effect on FDG-PET/CT (The TARGET Trial)

CompletedPH IVBrigham and Women's Hospitaln=1592021

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Randomized, Placebo-controlled Pilot Study of Sulfasalazine for the Treatment of Primary Sclerosing Cholangitis (PSC)

CompletedPH IIBrigham and Women's Hospitaln=322026

Clinical Effectiveness of Standard Step up Care (Methotrexate) Compared to Early Combination DMARD Therapy With Standard Step up Care Compared to Early Use of TNF Inhibitors With Standard Step up Care for the Treatment of Moderate to Severe Psoriatic Arthritis: a 3-arm Parallel Group Randomised Controlled Trial.

CompletedPH IVUniversity of Oxfordn=1922024

Methotrexate, Blood Pressure and Arterial Function in Rheumatoid Arthritis

CompletedPH IVFlinders Universityn=1242023

Double Blind Trial Investigating the Role of Sulfasalazine in Decreasing Opioids Requirements in Breast Cancer Patients

CompletedPH IIUniversity of Arizonan=72023

A Phase 1, Two-part, Open-label, Drug-drug Interaction Study in Healthy Male Adult Participants to Evaluate the Effects of BMS-986371 on the Pharmacokinetics of Methotrexate in the Presence and Absence of Sulfasalazine

CompletedPH IBristol-Myers Squibbn=302022

Phase I Trial Combining Sulfasalazine and Gamma Knife Radiosurgery for Recurrent Glioblastoma

CompletedPH IHaukeland University Hospitaln=242022
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.