Sulfasalazine
Azulfidine, Sulfasalazine (sulfasalazine) is a small molecule pharmaceutical. Sulfasalazine was first approved as Azulfidine on 1982-01-01. It is used to treat juvenile arthritis, rheumatoid arthritis, and ulcerative colitis in the USA. It is known to target proton-coupled folate transporter.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Azulfidine en-tabs, Sulfasalazine (discontinued: Azulfidine, S.a.s, Sulfasalazine)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| azulfidine | New Drug Application | 2025-04-08 |
| sulfasalazine | NDA authorized generic | 2025-04-08 |
| sulfasalazine delayed-release | 2007-08-31 | |
| sulfazalazine | 2007-08-31 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
135 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Arthritis | D001168 | EFO_0005856 | M05-M14 | — | 10 | 24 | 23 | 9 | 63 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | 9 | 21 | 20 | 8 | 56 |
| Spondylarthritis | D025241 | — | — | 1 | 3 | 3 | 7 | 3 | 16 |
| Spondylitis | D013166 | — | M46.9 | 1 | 3 | 3 | 7 | 3 | 16 |
| Ankylosing spondylitis | D013167 | EFO_0003898 | M45 | 1 | 2 | 2 | 7 | 3 | 14 |
| Psoriatic arthritis | D015535 | EFO_0003778 | L40.5 | — | — | 1 | 2 | 2 | 5 |
| Juvenile arthritis | D001171 | EFO_1002007 | M08 | — | 1 | 2 | 1 | — | 3 |
| Inflammation | D007249 | MP_0001845 | — | — | 1 | 1 | 1 | 1 | 3 |
| Axial spondyloarthritis | D000089183 | — | — | — | 1 | — | 1 | — | 2 |
| Diarrhea | D003967 | — | R19.7 | — | — | 1 | 1 | — | 2 |
Show 8 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | — | — | 1 | — | 2 | 3 |
| Covid-19 | D000086382 | — | U07.1 | — | 1 | 1 | — | 1 | 2 |
| Colitis | D003092 | EFO_0003872 | K52.9 | — | — | 1 | — | 1 | 2 |
| Ulcer | D014456 | MPATH_579 | — | — | — | 1 | — | 1 | 2 |
| Premature birth | D047928 | EFO_0003917 | O60 | — | 1 | 1 | — | — | 2 |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | 1 | 1 | — | — | 1 |
| Spondylarthropathies | D025242 | EFO_0000706 | M47 | — | — | 1 | — | — | 1 |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | — | 1 | — | — | 1 |
| Newborn respiratory distress syndrome | D012127 | — | P22 | — | — | 1 | — | — | 1 |
| Neoplasms | D009369 | — | C80 | — | — | 1 | — | — | 1 |
Show 4 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diabetic foot | D017719 | EFO_1001459 | — | — | 3 | — | — | — | 3 |
| Necrosis | D009336 | — | — | — | 1 | — | — | 1 | 2 |
| Glioblastoma | D005909 | EFO_0000515 | — | 2 | 1 | — | — | — | 2 |
| Systemic lupus erythematosus | D008180 | EFO_0002690 | M32 | — | 1 | — | — | 1 | 2 |
| Vasculitis | D014657 | EFO_0006803 | M31 | 1 | 1 | — | — | — | 1 |
| Cryoglobulinemia | D003449 | EFO_0005846 | D89.1 | 1 | 1 | — | — | — | 1 |
| Hypertension | D006973 | EFO_0000537 | I10 | 1 | 1 | — | — | — | 1 |
| Pulmonary arterial hypertension | D000081029 | — | — | 1 | 1 | — | — | — | 1 |
| Familial primary pulmonary hypertension | D065627 | — | I27.0 | 1 | 1 | — | — | — | 1 |
| Ischemia | D007511 | EFO_0000556 | — | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 4 | — | — | — | 1 | 5 |
| Osteomyelitis | D010019 | EFO_0003102 | M86 | 1 | — | — | — | 1 | 2 |
| Recurrence | D012008 | — | — | 1 | — | — | — | 1 | 2 |
| Therapeutic equivalency | D013810 | — | — | 2 | — | — | — | — | 2 |
| Intestinal obstruction | D007415 | — | K56.60 | 2 | — | — | — | — | 2 |
| Magnetic resonance imaging | D008279 | — | — | 1 | — | — | — | — | 1 |
| Oral administration | D000284 | — | — | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 1 | — | — | — | — | 1 |
| Vomiting | D014839 | — | R11.1 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Psoriasis | D011565 | EFO_0000676 | L40 | — | — | — | — | 2 | 2 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | — | — | — | — | 2 | 2 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | — | — | — | 2 | 2 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | — | — | — | — | 1 | 1 |
| Localized scleroderma | D012594 | EFO_1001361 | L94.0 | — | — | — | — | 1 | 1 |
| Diffuse scleroderma | D045743 | EFO_0000404 | — | — | — | — | — | 1 | 1 |
| Papillomavirus infections | D030361 | — | — | — | — | — | — | 1 | 1 |
| Disease attributes | D020969 | — | — | — | — | — | — | 1 | 1 |
| Esophageal neoplasms | D004938 | — | C15 | — | — | — | — | 1 | 1 |
| Gastroparesis | D018589 | EFO_1000948 | K31.84 | — | — | — | — | 1 | 1 |
Show 16 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Sulfasalazine |
| INN | sulfasalazine |
| Description | Sulfasalazine is an azobenzene consisting of diphenyldiazene having a carboxy substituent at the 4-position, a hydroxy substituent at the 3-position and a 2-pyridylaminosulphonyl substituent at the 4'-position. It has a role as a non-steroidal anti-inflammatory drug, an antiinfective agent, a gastrointestinal drug, an EC 2.5.1.18 (glutathione transferase) inhibitor, a drug allergen and a ferroptosis inducer. It is a sulfonamide, a member of pyridines and a member of azobenzenes. It is functionally related to a sulfanilamide. |
| Classification | Small molecule |
| Drug class | antiarrhythmic/antianginal/antihypertensive agents, phthalazine like structure; anti-inflammatory agents (salicylic acid derivatives); antimicrobials (sulfonamides derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C(O)c1cc(/N=N/c2ccc(S(=O)(=O)Nc3ccccn3)cc2)ccc1O |
Identifiers
| PDB | — |
| CAS-ID | 599-79-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL421 |
| ChEBI ID | 9334 |
| PubChem CID | 5339 |
| DrugBank | DB00795 |
| UNII ID | 3XC8GUZ6CB (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
SLC46A1
SLC46A1
Organism
Homo sapiens
Gene name
SLC46A1
Gene synonyms
G21, HCP1, PCFT
NCBI Gene ID
Protein name
proton-coupled folate transporter
Protein synonyms
Heme carrier protein 1, PCFT/HCP1, solute carrier family 46 (folate transporter), member 1, Solute carrier family 46 member 1
Uniprot ID
Mouse ortholog
Slc46a1 (52466)
proton-coupled folate transporter (Q9D1P1)
Variants
No data
Financial
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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57,709 adverse events reported
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