Azulfidine

(Sulfasalazine)

ApprovedSmall molecule

Sulfasalazine is an anti-inflammatory medication used to treat ulcerative colitis by reducing swelling and sores in the colon and rectum. It's also used to treat rheumatoid arthritis and childhood arthritis in patients who haven't responded to other treatments, working by decreasing inflammation in the body.[2] Azulfidine is currently approved and in use across 24 indications[4].[1]

Azulfidine is one of 619 small molecule programs targeting Ulcerative Colitis. It is currently in Approved.

Indications

Total Trials

Active Trials

618

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Ulcerative ColitisActive, not recruiting

Alcohol DependenceActive, not recruiting

Irritable Bowel SyndromeActive, not recruiting

Coronary Artery DiseaseActive, not recruiting

Brain NeoplasmActive, not recruiting

Intestinal ObstructionApproved

Premature BirthApproved

Acute Myeloid LeukemiaApproved

OsteomyelitisApproved

GliomaActive, not recruiting

Ulcerative ColitisApproved

Active, not recruiting

Alcohol DependencePreclinical

Active, not recruiting

Irritable Bowel SyndromeApproved

Active, not recruiting

Coronary Artery DiseasePreclinical

Active, not recruiting

Brain NeoplasmPreclinical

Active, not recruiting

Intestinal ObstructionApproved

Approved

Premature BirthApproved

Approved

Acute Myeloid LeukemiaApproved

Approved

OsteomyelitisApproved

Approved

GliomaPreclinical

Active, not recruiting

Showing 10 of 24 indications

Competition

Competitive Landscape

255 competitors in Acute Myeloid Leukemia

#DrugCompanyPhaseTrials

Azulfidine

Pfizer

Approved

53 2

Novantrone

Pfizer

Phase 3

34 3

Xospata

Astellas

Phase 3

24 4

Fludara

Sanofi

Phase 3

17 5

Cerubidine

EEastern Cooperative Oncology Group

Phase 3

42 6

Vepesid

AAvyxa

Phase 3

52 7

Mylotarg

WWyeth-Lederle Vaccines

Phase 3

38 8

Vanflyta

Daiichi Sankyo

Phase 3

14 9

Neupogen

EEastern Cooperative Oncology Group

Phase 3

31 10

Cerubidine

HHikma Pharmaceuticals LLC

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1/2Recruiting

Glioblastoma

NCT05664464

Phase 1/2Recruiting

Elderly Patients

NCT05580861

Phase 1Recruiting

Non-Alcoholic Fatty Liver Disease (NAFLD)

NCT07726368

Q1 2028

Phase 2Recruiting

Rheumatic Disease

NCT07138898

Q2 2028

Phase 2Recruiting

Preterm Birth

NCT05703425

Q4 2028

N/ARecruiting

Cirrhosis

NCT06293378

Clinical

Trials by Indication[1]

Rheumatoid Arthritis10 trials

Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis.

Completed·PP. Verschueren·Phase 4·NCT01172639·400 enrolled

Methotrexate, Blood Pressure and Arterial Function in Rheumatoid Arthritis

Completed·FFlinders University·Phase 4·NCT03254589·124 enrolled

Rheumatoid Arthritis: Comparison of Active Therapies in Patients With Active Disease Despite Methotrexate Therapy

Completed·UUS Department of Veterans Affairs·N/A·NCT00405275·353 enrolled

Show 7 more trials

A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid Arthritis

Completed· Roche logo

Roche·Phase 3·NCT01941095·100 enrolled

Effects of Antirheumatic Treatment on Levels of Survivin in Rheumatoid Arthritis Patients

Unknown status·VVastra Gotaland Region··NCT03440892·2,500 enrolled

Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid Arthritis

Completed· Sanofi logo

Sanofi·Phase 4·NCT03449758·84 enrolled

Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)

Completed·UUniversity of Alabama at Birmingham·Phase 4·NCT00259610·755 enrolled

Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response

Recruiting·UUniversity of Nebraska·Phase 3·NCT03414502·400 enrolled

A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA)

Completed· Sanofi logo

Sanofi·Phase 3·NCT02373202·91 enrolled

To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis

Completed· Sanofi logo

Sanofi·Phase 3·NCT02057250·217 enrolled

Methotrexate3 trials

Comparison of Disease Modifying Antirheumatic Drugs Therapy in Patients With RA Failing Methotrexate Monotherapy

Terminated·JJawaharlal Institute of Postgraduate Medical Education & Research·Phase 3·NCT02930343·136 enrolled

A Study to Assess the Effects of BMS-986371 on the Drug Levels of Methotrexate in the Presence and Absence of Sulfasalazine

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT05445440·30 enrolled

Targeted Treatment Early With Etanercept + Methotrexate vs.T2T Care for DMARD-naïve Early RA Patients Based on naïve T-cell Stratification

Unknown status·UUniversity of Leeds·Phase 4·NCT03813771·106 enrolled

Ankylosing Spondylitis3 trials

Treat-to-target Strategy in Ankylosing Spondylitis Using Etanercept and Conventional Synthetic DMARDs

Unknown status·NNanfang Hospital, Southern Medical University·Phase 4·NCT04077957·100 enrolled

Dose Reduction of Etanercept in Patients With Ankylosing Spondylitis

Unknown status·ZZhixiang Huang·Phase 4·NCT02638896·100 enrolled

Clinical Study of Tripterygium Capsule to Treat Early Ankylosing Spondylitis

Unknown status·SSun Yat-sen University·Phase 2/3·NCT00889694·80 enrolled

Arthritis2 trials

Psoriatic Oligoarthritis Intervention With Symptomatic thErapy

Completed·UUniversity of Oxford·Phase 4·NCT03797872·1 enrolled

Enbrel-Sulfasalazin-Early-Axial Spondyloarthritis (AS)

Unknown status·—·Phase 2·NCT00844142·80 enrolled

Glioblastoma2 trials

Sulfasalazine and Stereotactic Radiosurgery for Recurrent Glioblastoma

Completed·HHaukeland University Hospital·Phase 1·NCT04205357·24 enrolled

Glutamate Inhibitors in Glioblastoma

Recruiting·UUniversity of Zurich·Phase 1/2·NCT05664464·120 enrolled

30 more indications

Psoriatic Arthritis2 trials

Impact of Tapering Immunosuppressants on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis

Unknown status·UUniversity of Erlangen-Nürnberg Medical School·Phase 3·NCT04610476·270 enrolled

Severe Psoriatic Arthritis - Early intervEntion to Control Disease: the SPEED Trial

Completed·UUniversity of Oxford·Phase 4·NCT03739853·192 enrolled

Interaction2 trials

A Study to Evaluate Potential Cytochrome P450 and Transporter Protein Interactions With CC-99677

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04268394·48 enrolled

Drug-drug Interaction Study with GLPG3970 and Sulfasalazine in Adult, Healthy Subjects

Completed·GGalapagos NV·Phase 1·NCT04720183·8 enrolled

MPA1 trial

Effects of Methylnaltrexone in Comparison to Naloxone on Loperamide-induced Delay of the Oro-cecal, Whole-gut and Colon Transit Time.

Completed·UUniversity Medicine Greifswald·Phase 1·NCT01596764·16 enrolled

Breast Cancer1 trial

Sulfasalazine in Decreasing Opioids Requirements in Breast Cancer Patients

Completed·UUniversity of Arizona·Phase 2·NCT03847311·7 enrolled

ESS1 trial

IL-7 and IL-7R Expression in RA Patients With Active vs. Inactive Disease Treated With DMARD or CIMZIA

Completed·UUniversity of Illinois at Chicago·Phase 4·NCT02451748·32 enrolled

Osteomyelitis1 trial

CHronic Nonbacterial Osteomyelitis International Registry

Recruiting·SSeattle Children's Hospital··NCT04725422·2,000 enrolled

Pulmonary Arterial Hypertension1 trial

Pilot Study of the Safety and Efficacy of Sulfasalazine in Pulmonary Arterial Hypertension

Unknown status·RRenJi Hospital·Phase 1/2·NCT04528056·80 enrolled

Oral1 trial

Oral Pharmacokinetics of Sulfasalazine, Paracetamol, Fexofenadine and Valsartan Using Different Administration Mediums

Completed·UUniversity Medicine Greifswald·Phase 1·NCT03012763·9 enrolled

Tocilizumab1 trial

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

Completed· Sanofi logo

Sanofi·Phase 3·NCT01768572·202 enrolled

Oral Lichen Planus1 trial

Topical Sulfasalazine and Oral Lichen Planus

Active, not recruiting·—·Phase 3·NCT06060301·46 enrolled

Cirrhosis1 trial

Safety and Effectiveness of Sulfasalazine in the Treatment of Liver Fibrosis/Cirrhosis.

Recruiting·TThe Second Affiliated Hospital of Chongqing Medical University·N/A·NCT06293378·330 enrolled

Systemic Lupus Erythematosus1 trial

A Prospective, Single Arm, Open Label, Proof of Concept Clinical Study of Sulfasalazine in the Treatment of Active Systemic Lupus Erythematosus

Not yet recruiting·QQiong Fu·Phase 2·NCT06360068·20 enrolled

Acute Diarrhea1 trial

Sulfasalazine in Preventing Acute Diarrhea in Patients With Cancer Who Are Undergoing Pelvic Radiation Therapy

Completed·AAlliance for Clinical Trials in Oncology·Phase 3·NCT01198145·87 enrolled

Neuropathy1 trial

Study of Sulfasalazine in Treating Painful Neuropathy

Terminated·MMassachusetts General Hospital·Phase 2·NCT01667029·8 enrolled

Atorvastatin1 trial

Drug-Drug Interaction Study of Vadadustat With Rosuvastatin, Sulfasalazine, Pravastatin, Atorvastatin and Simvastatin

Completed·AAkebia Therapeutics·Phase 1·NCT03801733·134 enrolled

Glioma1 trial

Pilot Study Effect of Sulfasalazine on Glutamate Levels by(Magnetic Resonance Spectroscopy)MRS in Patients With Glioma

Completed·UUniversity of Alabama at Birmingham·N/A·NCT01577966·9 enrolled

Metastatic Colorectal Cancer1 trial

Sulfasalazine in Patients With Metastatic Colorectal Cancer

Recruiting·TTanta University·Phase 3·NCT06134388·50 enrolled

Alcohol1 trial

Effects of Sulfasalazine on BOLD Response to Alcohol Cues

Completed·TThe Mind Research Network·N/A·NCT01312129·23 enrolled

Juvenile Idiopathic Arthritis1 trial

Study To Determine The Pharmacokinetics Of Sulfasalazine In Children With Juvenile Idiopathic Arthritis

Terminated· Pfizer logo

Pfizer·Phase 4·NCT00637780·2 enrolled

Gastrointestinal1 trial

Gastrointestinal Nutrient Transit and Enteroendocrine Function After Upper Gastrointestinal Surgery

Completed·SSt. James's Hospital, Ireland··NCT03734627·40 enrolled

Drug1 trial

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

Completed· Sanofi logo

Sanofi·Phase 3·NCT01709578·546 enrolled

Treatment1 trial

Treatments Against RA and Effect on FDG-PET/CT

Completed·—·Phase 4·NCT02374021·159 enrolled

Sclerosing Cholangitis1 trial

Sulfasalazine for the Treatment of Primary Sclerosing Cholangitis

Completed·—·Phase 2·NCT03561584·32 enrolled

Single Dose1 trial

An Open Label, Single Dose, Three Part Study to Assess the Effects of Rolapitant (2 mg/mL IV Solution) on the Pharmacokinetics of Digoxin; Sulfasalazine; and the Cooperstown Cocktail (Midazolam, Omeprazole, Warfarin, Caffeine, and Dextromethorphan in Healthy Subjects

Completed·TTesaro, Inc.·Phase 1·NCT02434861·102 enrolled

Endothelial Function1 trial

Sulfasalazine and Endothelial Function

Completed·—·N/A·NCT00554203·60 enrolled

Elderly Patients1 trial

Sulfasalazine in AML Treated by Intensive Chemotherapy: Elderly Patients-first Line Treatment

Recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 1/2·NCT05580861·64 enrolled

Non-alcoholic Fatty Liver Disease (NAFLD)1 trial

A Phase 1, Open-Label, Fixed-Sequence, Single-Center, Two-Period, Drug-Drug Interaction Trial in Healthy Adult Participants to Evaluate the Effect of Steady-State ECC4703 on the Pharmacokinetics of Sulfasalazine (BCRP Probe Substrate) and Pitavastatin (OATP1B1/OATP1B3 Probe Substrate)

Recruiting·EEccogene·Phase 1·NCT07726368·40 enrolled

Rheumatic Disease1 trial

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Recruiting·NNYU Langone Health·Phase 2·NCT07138898·80 enrolled

Preterm Birth1 trial

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

Recruiting·RRutgers, The State University of New Jersey·Phase 2·NCT05703425·50 enrolled

Unspecified2 trials

Effects of 500 mg Immediate Release and Extended Release Methylnaltrexone on Loperamide-induced Delay of the Oro-cecal and Whole-gut Transit Time in Healthy Subjects

Completed·UUniversity Medicine Greifswald·Phase 1·NCT01596777·15 enrolled

Very Early Versus Delayed Etanercept in Patients With RA

Completed·UUniversity of Leeds·Phase 4·NCT02433184·120 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

AZULFIDINE

NDA NDA018605

Apr 6, 1983

AZULFIDINE EN-TABS

NDA NDA007073

Sources

References

[1]
ClinicalTrials.gov — 53 trial records for Sulfasalazine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Azulfidine drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Sulfasalazine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Sulfasalazine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA007073). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Arachidonate 5-Lipoxygenase Inhibitor; Cyclooxygenase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Pfizer

Azulfidine

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2028

Q2 2028

Q4 2028

Trials by Indication[1]

Rheumatoid Arthritis10 trials

Methotrexate3 trials

Ankylosing Spondylitis3 trials

Arthritis2 trials

Glioblastoma2 trials

Psoriatic Arthritis2 trials

Interaction2 trials

MPA1 trial

Breast Cancer1 trial

ESS1 trial

Osteomyelitis1 trial

Pulmonary Arterial Hypertension1 trial

Oral1 trial

Tocilizumab1 trial

Oral Lichen Planus1 trial

Cirrhosis1 trial

Systemic Lupus Erythematosus1 trial

Acute Diarrhea1 trial

Neuropathy1 trial

Atorvastatin1 trial

Glioma1 trial

Metastatic Colorectal Cancer1 trial

Alcohol1 trial

Juvenile Idiopathic Arthritis1 trial

Gastrointestinal1 trial

Drug1 trial

Treatment1 trial

Sclerosing Cholangitis1 trial

Single Dose1 trial

Endothelial Function1 trial

Elderly Patients1 trial

Non-alcoholic Fatty Liver Disease (NAFLD)1 trial

Rheumatic Disease1 trial

Preterm Birth1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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