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Ocaliva(obeticholic acid)
Ocaliva (obeticholic acid) is a small molecule pharmaceutical. Obeticholic acid was first approved as Ocaliva on 2016-05-27. It is used to treat cholangitis in the USA. It has been approved in Europe to treat biliary liver cirrhosis. The pharmaceutical is active against bile acid receptor.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Ocaliva (generic drugs available since 2023-05-30)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Obeticholic acid
Tradename
Company
Number
Date
Products
OCALIVAIntercept PharmaceuticalsN-207999 RX2016-05-27
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
ocalivaNew Drug Application2020-02-07
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
cholangitisHP_0030151D002761K83.0
Agency Specific
FDA
EMA
Expiration
Code
OBETICHOLIC ACID, OCALIVA, INTERCEPT PHARMS INC
2023-05-27ODE-119
Patent Expiration
Patent
Expires
Flag
FDA Information
Obeticholic Acid, Ocaliva, Intercept Pharms Inc
100523372036-04-26DP
107513492036-04-26DP
107585492036-04-26U-2945
100471172033-09-06U-1854
92386732033-06-17DP
101740732033-06-17DP
RE482862027-02-21DS, DP
ATC Codes
A: Alimentary tract and metabolism drugs
— A05: Bile and liver therapy drugs
— A05A: Bile therapy drugs
— A05AA: Bile acids and derivatives for bile therapy
— A05AA04: Obeticholic acid
HCPCS
No data
Clinical
Clinical Trials
34 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Biliary liver cirrhosisD008105K74.31532314
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-alcoholic fatty liver diseaseD065626EFO_0003095K75.81—22—15
Liver cirrhosisD008103EFO_0001422K74.0——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ObesityD009765EFO_0001073E66.911———2
Familial partial lipodystrophyD052496—1———1
GallstonesD042882EFO_0004210—1———1
Type 2 diabetes mellitusD003924EFO_0001360E11—1———1
Fatty liverD005234—1———1
Sclerosing cholangitisD015209EFO_0004268K83.01—1———1
Alcoholic hepatitisD006519EFO_1001345K70.1—1———1
Barrett esophagusD001471EFO_0000280K22.7—1———1
Colorectal neoplasmsD015179—1———1
Duodenal neoplasmsD004379—1———1
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hepatic insufficiencyD0485501————1
CholestasisD002779K83.11————1
PruritusD011537HP_0000989L291————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Alcohol drinkingD000428EFO_0004329————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameOBETICHOLIC ACID
INNobeticholic acid
Description
Obeticholic acid is a dihydroxy-5beta-cholanic acid that is chenodeoxycholic acid carrying an additional ethyl substituent at the 6alpha-position. A semi-synthetic bile acid which acts as a farnesoid X receptor agonist and is used for treatment of primary biliary cholangitis. It has a role as a farnesoid X receptor agonist and a hepatoprotective agent. It is a dihydroxy-5beta-cholanic acid, a 3alpha-hydroxy steroid and a 7alpha-hydroxy steroid. It is functionally related to a chenodeoxycholic acid.
Classification
Small molecule
Drug class—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CC[C@@H]1[C@@H]2C[C@H](O)CC[C@]2(C)[C@H]2CC[C@@]3(C)[C@@H](CC[C@@H]3[C@H](C)CCC(=O)O)[C@@H]2[C@@H]1O
Identifiers
PDB1OSV
CAS-ID459789-99-2
RxCUI1798288
ChEMBL IDCHEMBL566315
ChEBI ID—
PubChem CID447715
DrugBankDB05990
UNII ID0462Z4S4OZ (ChemIDplus, GSRS)
Target
Agency Approved
NR1H4
NR1H4
Organism
Homo sapiens
Gene name
NR1H4
Gene synonyms
BAR, FXR, HRR1, RIP14
NCBI Gene ID
9971
Protein name
bile acid receptor
Protein synonyms
farnesoid X nuclear receptor, Farnesoid X-activated receptor, Farnesol receptor HRR-1, Nuclear receptor subfamily 1 group H member 4, Retinoid X receptor-interacting protein 14, RXR-interacting protein 14
Uniprot ID
Q96RI1
Mouse ortholog
Nr1h4 (20186)
bile acid receptor (Q60641)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Ocaliva - Intercept Pharmaceuticals
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,866 documents
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Safety
Black-box Warning
Black-box warning for: Ocaliva
Adverse Events
Top Adverse Reactions
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4,232 adverse events reported
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