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Drug ReportsEtodolac
Etodolac
Etodolac (etodolac) is a small molecule pharmaceutical. Etodolac was first approved as Lodine on 1991-01-31. It is used to treat osteoarthritis, pain, and rheumatoid arthritis in the USA. The pharmaceutical is active against prostaglandin G/H synthase 2.
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FDA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
skin and connective tissue diseasesD017437
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
psychological phenomenaD011579
musculoskeletal and neural physiological phenomenaD055687
Trade Name
FDA
EMA
Etodolac (discontinued: Etodolac, Lodine)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Etodolac
Tradename
Company
Number
Date
Products
LODINEWyethN-018922 DISCN1991-01-31
4 products, RLD
LODINE XLWyethN-020584 DISCN1996-10-25
3 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
antiseptic povidone-lodine prep padC2002632024-10-11
etodolacANDA2024-10-18
lodineANDA2021-05-04
lodine xlANDA2021-02-12
povidone-lodine prep padC2002632024-08-19
povidone-lodine swabsticks tripleC2002632023-11-10
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
M: Musculo-skeletal system drugs
— M01: Antiinflammatory and antirheumatic products
— M01A: Antiinflammatory and antirheumatic products, non-steroids
— M01AB: Acetic acid derivatives and related substances
— M01AB08: Etodolac
HCPCS
No data
Clinical
Clinical Trials
29 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Acute painD059787—R52——1113
HypersensitivityD006967HP_0012393T78.40———1—1
EdemaD004487HP_0000969R60.9———1—1
TrismusD014313—————1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Low back painD017116HP_0003419M54.5——1—12
Back painD001416HP_0003418M54——1—12
Colorectal neoplasmsD015179———11——2
MyalgiaD063806HP_0003326M79.1——1—12
Postoperative painD010149—G89.18——1——1
RecurrenceD012008————1——1
Ankle injuriesD016512—S93.4——1——1
Sprains and strainsD013180————1——1
BursitisD002062EFO_1000941M71.9——1——1
TendinopathyD052256EFO_1001434M77.9——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pancreatic neoplasmsD010190EFO_0003860C25—1———1
LeukemiaD007938—C95—1———1
B-cell chronic lymphocytic leukemiaD015451—C91.1—1———1
Lymphoid leukemiaD007945—C91—1———1
Hepatocellular carcinomaD006528—C22.0—1———1
Prostatic neoplasmsD011471—C61—1———1
Wasting syndromeD019282———1———1
CachexiaD002100HP_0004326R64—1———1
Multiple myelomaD009101—C90.0—1———1
Plasma cell neoplasmsD054219———1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
FastingD005215EFO_0002756—4————4
MalnutritionD044342EFO_0008572E40-E463————3
Dry eye syndromesD015352—H04.121————1
Healthy volunteers/patients———1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
OsteoarthritisD010003EFO_0002506M15-M19————22
Knee osteoarthritisD020370EFO_0004616M17————11
Breast neoplasmsD001943EFO_0003869C50————11
Rheumatoid arthritisD001172EFO_0000685M06.9————11
ArthritisD001168HP_0001369M05-M14————11
PeriarthritisD010489EFO_1001097M77.9————11
Dental occlusionD003766——————11
CarcinomaD002277—C80.0————11
Ovarian neoplasmsD010051EFO_0003893C56————11
Fallopian tube neoplasmsD005185——————11
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameEtodolac
INNetodolac
Description
Etodolac is a monocarboxylic acid that is acetic acid in which one of the methyl hydrogens is substituted by a 1,8-diethyl-1,3,4,9-tetrahydropyrano[3,4-b]indol-1-yl moiety. A preferential inhibitor of cyclo-oxygenase 2 and non-steroidal anti-inflammatory, it is used for the treatment of rheumatoid arthritis and osteoarthritis, and for the alleviation of postoperative pain. Administered as the racemate, only the (S)-enantiomer is active. It has a role as a non-steroidal anti-inflammatory drug, a cyclooxygenase 2 inhibitor, a non-narcotic analgesic and an antipyretic. It is a monocarboxylic acid and an organic heterotricyclic compound.
Classification
Small molecule
Drug classanti-inflammatory agents (acetic acid derivatives)
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Structure (InChI/SMILES or Protein Sequence)
CCc1cccc2c3c([nH]c12)C(CC)(CC(=O)O)OCC3
Identifiers
PDB—
CAS-ID41340-25-4
RxCUI—
ChEMBL IDCHEMBL622
ChEBI ID4909
PubChem CID3308
DrugBankDB00749
UNII ID2M36281008 (ChemIDplus, GSRS)
Target
Agency Approved
PTGS2
PTGS2
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)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
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Estimated US medical usage
Etodolac
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,522 documents
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Safety
Black-box Warning
Black-box warning for: Etodolac
Adverse Events
Top Adverse Reactions
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1,557 adverse events reported
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