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obeticholic acid 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 5155 | 459789-99-2 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
obeticholic acid is an agonist for FXR, a nuclear receptor expressed in the liver and intestine
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 10 | mg | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| S (Water solubility) | 0.01 mg/mL | Bocci G, Oprea TI, Benet LZ |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Bocci G, Oprea TI, Benet LZ |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2B,CDK5,EIF2AK3,ERBB2,GRK2,ITK,MAPK7,NTRK2,PDK1,PDK2,PDK4,PRKDC,TEK | 13 | |||
| kinase-selectivity-class | EIF2AK3,GRK2,MAP2K6 | 3 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 12, 2016 | EMA | Intercept Pharma Ltd | |
| May 27, 2016 | FDA | INTERCEPT PHARMACEUTICALS INC |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Pruritus | 1522.14 | 25.13 | 724 | 5333 | 540801 | 90081589 |
| Blood alkaline phosphatase abnormal | 395.35 | 25.13 | 70 | 5987 | 1298 | 90621092 |
| Therapy cessation | 355.45 | 25.13 | 121 | 5936 | 36240 | 90586150 |
| Hospitalisation | 214.44 | 25.13 | 123 | 5934 | 127977 | 90494413 |
| Product dose omission issue | 213.01 | 25.13 | 167 | 5890 | 291520 | 90330870 |
| Therapy interrupted | 197.05 | 25.13 | 86 | 5971 | 50022 | 90572368 |
| Blood alkaline phosphatase increased | 174.45 | 25.13 | 78 | 5979 | 48001 | 90574389 |
| Hepatic fibrosis | 174.05 | 25.13 | 43 | 6014 | 4132 | 90618258 |
| Gamma-glutamyltransferase abnormal | 125.30 | 25.13 | 23 | 6034 | 524 | 90621866 |
| Aspartate aminotransferase abnormal | 124.23 | 25.13 | 30 | 6027 | 2619 | 90619771 |
| Fatigue | 107.19 | 25.13 | 236 | 5821 | 1153787 | 89468603 |
| Death | 100.21 | 25.13 | 137 | 5920 | 456414 | 90165976 |
| Hepatic cirrhosis | 95.74 | 25.13 | 57 | 6000 | 63196 | 90559194 |
| Portal hypertension | 89.18 | 25.13 | 26 | 6031 | 4675 | 90617715 |
| Varices oesophageal | 81.06 | 25.13 | 23 | 6034 | 3756 | 90618634 |
| Constipation | 71.97 | 25.13 | 91 | 5966 | 280304 | 90342086 |
| Insurance issue | 67.59 | 25.13 | 26 | 6031 | 10932 | 90611458 |
| Alanine aminotransferase abnormal | 56.61 | 25.13 | 19 | 6038 | 5407 | 90616983 |
| Emergency care | 54.46 | 25.13 | 14 | 6043 | 1575 | 90620815 |
| Splenomegaly | 43.74 | 25.13 | 20 | 6037 | 12904 | 90609486 |
| Rehabilitation therapy | 42.27 | 25.13 | 12 | 6045 | 1962 | 90620428 |
| Blood bilirubin increased | 38.40 | 25.13 | 28 | 6029 | 43442 | 90578948 |
| Jaundice | 38.28 | 25.13 | 25 | 6032 | 32492 | 90589898 |
| Bilirubin conjugated abnormal | 35.58 | 25.13 | 6 | 6051 | 82 | 90622308 |
| Therapy change | 34.99 | 25.13 | 15 | 6042 | 8307 | 90614083 |
| Blood bilirubin abnormal | 33.47 | 25.13 | 10 | 6047 | 1954 | 90620436 |
| Dry skin | 33.35 | 25.13 | 35 | 6022 | 88038 | 90534352 |
| Oesophageal variceal ligation | 33.34 | 25.13 | 5 | 6052 | 30 | 90622360 |
| Transplant evaluation | 32.55 | 25.13 | 9 | 6048 | 1337 | 90621053 |
| Liver transplant | 31.84 | 25.13 | 10 | 6047 | 2307 | 90620083 |
| Oesophageal varices haemorrhage | 27.18 | 25.13 | 8 | 6049 | 1484 | 90620906 |
| Scratch | 26.43 | 25.13 | 13 | 6044 | 9853 | 90612537 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Pruritus | 163.42 | 45.02 | 61 | 326 | 188710 | 42432238 |
| Hospitalisation | 48.95 | 45.02 | 20 | 367 | 74310 | 42546638 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Pruritus | 1314.13 | 29.25 | 577 | 4008 | 580983 | 110003731 |
| Blood alkaline phosphatase abnormal | 320.04 | 29.25 | 54 | 4531 | 1233 | 110583481 |
| Therapy cessation | 269.68 | 29.25 | 92 | 4493 | 44765 | 110539949 |
| Product dose omission issue | 169.40 | 29.25 | 125 | 4460 | 321657 | 110263057 |
| Blood alkaline phosphatase increased | 136.48 | 29.25 | 64 | 4521 | 70871 | 110513843 |
| Therapy interrupted | 127.88 | 29.25 | 55 | 4530 | 49767 | 110534947 |
| Gamma-glutamyltransferase abnormal | 124.17 | 29.25 | 23 | 4562 | 904 | 110583810 |
| Aspartate aminotransferase abnormal | 115.71 | 29.25 | 27 | 4558 | 3298 | 110581416 |
| Hepatic fibrosis | 105.33 | 29.25 | 30 | 4555 | 8036 | 110576678 |
| Fatigue | 103.98 | 29.25 | 182 | 4403 | 1215776 | 109368938 |
| Hepatic cirrhosis | 91.36 | 29.25 | 48 | 4537 | 67578 | 110517136 |
| Hospitalisation | 76.13 | 29.25 | 56 | 4529 | 142437 | 110442277 |
| Varices oesophageal | 64.39 | 29.25 | 20 | 4565 | 7195 | 110577519 |
| Portal hypertension | 56.85 | 29.25 | 19 | 4566 | 8618 | 110576096 |
| Death | 52.16 | 29.25 | 99 | 4486 | 698770 | 109885944 |
| Alanine aminotransferase abnormal | 51.54 | 29.25 | 18 | 4567 | 9316 | 110575398 |
| Constipation | 49.16 | 29.25 | 67 | 4518 | 357719 | 110226995 |
| Blood bilirubin abnormal | 43.71 | 29.25 | 11 | 4574 | 1839 | 110582875 |
| Bilirubin conjugated abnormal | 40.18 | 29.25 | 7 | 4578 | 193 | 110584521 |
| Insurance issue | 38.40 | 29.25 | 15 | 4570 | 10597 | 110574117 |
| Splenomegaly | 37.70 | 29.25 | 19 | 4566 | 24479 | 110560235 |
| Blood bilirubin increased | 36.39 | 29.25 | 28 | 4557 | 75944 | 110508770 |
| Jaundice | 35.52 | 29.25 | 25 | 4560 | 59211 | 110525503 |
| Cholelithiasis | 29.56 | 29.25 | 23 | 4562 | 63399 | 110521315 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | A05AA04 | ALIMENTARY TRACT AND METABOLISM BILE AND LIVER THERAPY BILE THERAPY Bile acids and derivatives |
| FDA MoA | N0000192560 | Farnesoid X Receptor Agonists |
| FDA EPC | N0000192561 | Farnesoid X Receptor Agonist |
| CHEBI has role | CHEBI:22587 | antiviral agent |
| CHEBI has role | CHEBI:62868 | hepatoprotective agent |
| CHEBI has role | CHEBI:74518 | anti-obesity agent |
| CHEBI has role | CHEBI:132972 | farnesoid X receptor agonist |
Related Drugs by ATC class:
A05AA Bile acids and derivatives 4 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Primary cholangitis | indication | 17266006 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 4.92 | acidic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 10MG | OCALIVA | INTERCEPT | N207999 | May 27, 2016 | DISCN | TABLET | ORAL | 10047117 | Sept. 6, 2033 | TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) |
| 5MG | OCALIVA | INTERCEPT | N207999 | May 27, 2016 | DISCN | TABLET | ORAL | 10047117 | Sept. 6, 2033 | TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) |
| 10MG | OCALIVA | INTERCEPT | N207999 | May 27, 2016 | DISCN | TABLET | ORAL | 10758549 | April 26, 2036 | TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) IN COMBINATION WITH URSODEOXYCHOLIC ACID (UDCA) IN ADULTS WITH AN INADEQUATE RESPONSE TO UDCA, OR AS MONOTHERAPY IN ADULTS UNABLE TO TOLERATE UDCA |
| 5MG | OCALIVA | INTERCEPT | N207999 | May 27, 2016 | DISCN | TABLET | ORAL | 10758549 | April 26, 2036 | TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) IN COMBINATION WITH URSODEOXYCHOLIC ACID (UDCA) IN ADULTS WITH AN INADEQUATE RESPONSE TO UDCA, OR AS MONOTHERAPY IN ADULTS UNABLE TO TOLERATE UDCA |
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Bile acid receptor | Nuclear hormone receptor | AGONIST | EC50 | 7.00 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
| G-protein coupled bile acid receptor 1 | GPCR | EC50 | 7 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 0462Z4S4OZ | UNII |
| 4035786 | VANDF |
| C1143018 | UMLSCUI |
| CHEBI:43602 | CHEBI |
| CHEMBL566315 | ChEMBL_ID |
| D09360 | KEGG_DRUG |
| 447715 | PUBCHEM_CID |
| DB05990 | DRUGBANK_ID |
| 9084 | INN_ID |
| C464660 | MESH_SUPPLEMENTAL_RECORD_UI |
| 3435 | IUPHAR_LIGAND_ID |
| 1798288 | RXNORM |
| 241391 | MMSL |
| 31698 | MMSL |
| 720257002 | SNOMEDCT_US |
| 763557003 | SNOMEDCT_US |
| CHC | PDB_CHEM_ID |
| IU6 | PDB_CHEM_ID |
| d08442 | MMSL |
| 016875 | NDDF |
| 0462Z4S4OZ | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Ocaliva | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69516-005 | TABLET, FILM COATED | 5 mg | ORAL | NDA | 31 sections |
| Ocaliva | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69516-010 | TABLET, FILM COATED | 10 mg | ORAL | NDA | 31 sections |