Sulindac
Clinoril (sulindac) is a small molecule pharmaceutical. Sulindac was first approved as Clinoril on 1982-01-01. It is used to treat ankylosing spondylitis, bursitis, gouty arthritis, inflammation, and osteoarthritis amongst others in the USA. It is known to target prostaglandin G/H synthase 2, retinoic acid receptor RXR-alpha, and prostaglandin G/H synthase 1.
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Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| musculoskeletal diseases | D009140 |
| hereditary congenital and neonatal diseases and abnormalities | D009358 |
| skin and connective tissue diseases | D017437 |
| nutritional and metabolic diseases | D009750 |
| immune system diseases | D007154 |
| signs and symptoms pathological conditions | D013568 |
| wounds and injuries | D014947 |
| psychological phenomena | D011579 |
| musculoskeletal and neural physiological phenomena | D055687 |
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Sulindac
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CLINORIL | Merck KGaA | N-017911 DISCN | 1982-01-01 | 2 products, RLD |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| sulindac | ANDA | 2023-05-22 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| ankylosing spondylitis | EFO_0003898 | D013167 | M45 |
| bursitis | EFO_1000941 | D002062 | M71.9 |
| gouty arthritis | — | D015210 | — |
| inflammation | MP_0001845 | D007249 | — |
| osteoarthritis | EFO_0002506 | D010003 | M15-M19 |
| rheumatoid arthritis | EFO_0000685 | D001172 | M06.9 |
| shoulder pain | HP_0030834 | D020069 | M25.51 |
| tendinopathy | EFO_1001434 | D052256 | M77.9 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
75 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 4 | — | 2 | 9 | 16 |
| Acne vulgaris | D000152 | EFO_0003894 | L70 | — | — | 1 | 1 | — | 2 |
| Wounds and injuries | D014947 | T14.8 | — | — | — | 1 | — | 1 | |
| Crohn disease | D003424 | EFO_0000384 | K50 | — | — | — | 1 | — | 1 |
| Sentinel lymph node biopsy | D021701 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Brain hypoxia-ischemia | D020925 | EFO_1000846 | P91.6 | — | — | 2 | — | — | 2 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 1 | 1 | — | — | 2 |
| Covid-19 | D000086382 | U07.1 | — | — | 1 | — | — | 1 | |
| Necrotizing enterocolitis | D020345 | EFO_0003928 | K55.3 | — | — | 1 | — | — | 1 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | 1 | — | — | 1 |
| Retinal detachment | D012163 | EFO_0005773 | H33.2 | — | — | 1 | — | — | 1 |
| Proliferative vitreoretinopathy | D018630 | EFO_1001129 | — | — | 1 | — | — | 1 | |
| Brain diseases | D001927 | HP_0001298 | G93.40 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | — | 1 | — | — | 1 | 2 |
| Lymphedema | D008209 | Q82.0 | 1 | 1 | — | — | — | 2 | |
| Portal hypertension | D006975 | EFO_0000666 | K76.6 | — | 1 | — | — | — | 1 |
| Non-small-cell lung carcinoma | D002289 | — | 1 | — | — | — | 1 | ||
| Chronic renal insufficiency | D051436 | N18 | — | 1 | — | — | — | 1 | |
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | 1 | — | — | — | 1 |
| Vesico-ureteral reflux | D014718 | EFO_0007536 | N13.7 | — | 1 | — | — | — | 1 |
| Tetralogy of fallot | D013771 | Q21.3 | 1 | 1 | — | — | — | 1 | |
| Pulmonary valve insufficiency | D011665 | 1 | 1 | — | — | — | 1 | ||
| Renal cell carcinoma | D002292 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 1 | — | — | — | 1 | 2 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | 1 | — | — | — | — | 1 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | 1 | — | — | — | — | 1 |
| Appendicitis | D001064 | EFO_0007149 | K37 | 1 | — | — | — | — | 1 |
| Ciliary motility disorders | D002925 | EFO_0003900 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | — | — | 2 | 2 | ||
| Rectal neoplasms | D012004 | — | — | — | — | 2 | 2 | ||
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | — | — | — | 2 | 2 |
| Head and neck neoplasms | D006258 | — | — | — | — | 2 | 2 | ||
| Neoplasms | D009369 | C80 | — | — | — | — | 1 | 1 | |
| Melanoma | D008545 | — | — | — | — | 1 | 1 | ||
| Squamous cell carcinoma of head and neck | D000077195 | — | — | — | — | 1 | 1 | ||
| Uterine cervical neoplasms | D002583 | — | — | — | — | 1 | 1 | ||
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | — | — | — | — | 1 | 1 |
| Feeding behavior | D005247 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | SULINDAC |
| INN | sulindac |
| Description | Sulindac is a monocarboxylic acid that is 1-benzylidene-1H-indene which is substituted at positions 2, 3, and 5 by methyl, carboxymethyl, and fluorine respectively, and in which the phenyl group of the benzylidene moiety is substituted at the para position by a methylsulfinyl group. It is a prodrug for the corresponding sulfide, a non-steroidal anti-inflammatory drug, used particularly in the treatment of acute and chronic inflammatory conditions. It has a role as a non-steroidal anti-inflammatory drug, an EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor, an antineoplastic agent, a non-narcotic analgesic, an antipyretic, an analgesic, a prodrug, a tocolytic agent and an apoptosis inducer. It is a sulfoxide, a monocarboxylic acid and an organofluorine compound. It is functionally related to an acetic acid. |
| Classification | Small molecule |
| Drug class | anti-inflammatory agents (acetic acid derivatives) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CC1=C(CC(=O)O)c2cc(F)ccc2/C1=C\c1ccc([S+](C)[O-])cc1 |
Identifiers
| PDB | — |
| CAS-ID | 38194-50-2 |
| RxCUI | 10237 |
| ChEMBL ID | CHEMBL15770 |
| ChEBI ID | 9352 |
| PubChem CID | 1548887 |
| DrugBank | DB00605 |
| UNII ID | 184SNS8VUH (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
PTGS2
PTGS2
RXRA
RXRA
PTGS1
PTGS1
Organism
Homo sapiens
Gene name
PTGS2
Gene synonyms
COX2
NCBI Gene ID
Protein name
prostaglandin G/H synthase 2
Protein synonyms
COX-2, cyclooxygenase 2, cyclooxygenase 2b, Cyclooxygenase-2, PGH synthase 2, PGHS-2, PHS II, Prostaglandin H2 synthase 2, Prostaglandin-endoperoxide synthase 2, prostaglandin-endoperoxide synthase 2 (prostaglandin G/H synthase and cyclooxygenase)
Uniprot ID
Mouse ortholog
Ptgs2 (19225)
prostaglandin G/H synthase 2 (Q543K3)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
Black-box warning for: Sulindac
Adverse Events
Top Adverse Reactions
0 adverse events reported
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