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eluxadoline 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| analgesics | 5001 | 864821-90-9 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Eluxadoline is a mu-opioid receptor agonist; eluxadoline is also a delta opioid receptor antagonist and a kappa opioid receptor agonist. The binding affinities (Ki) of eluxadoline for the human mu and delta opioid receptors are 1.8 nM and 430 nM, respectively. The binding affinity (Ki) of eluxadoline for the human kappa opioid receptor has not been determined; however, the Ki for guinea pig cerebellum kappa opioid receptor is 55 nM. In animals, eluxadoline interacts with opioid receptors in the gut.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.20 | g | O |
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2B,AXL,CAMK2D,CDK5,CDK9,EIF2AK3,ERBB2,GRK2,ITK,MAPK10,MAPK7,PDK1,PDK2,PDK4,PRKDC | 15 | |||
| kinase-selectivity-class | AXL,BRAF,EIF2AK3,GRK2,STK33 | 5 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Sept. 19, 2016 | EMA | Allergan Pharmaceuticals International Limited | |
| May 27, 2015 | FDA | FURIEX PHARMA 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 |
|---|---|---|---|---|---|---|
| Pancreatitis | 110.02 | 28.56 | 39 | 1114 | 69787 | 90557507 |
| Abdominal pain | 77.81 | 28.56 | 53 | 1100 | 395668 | 90231626 |
| Sphincter of Oddi dysfunction | 64.57 | 28.56 | 10 | 1143 | 446 | 90626848 |
| Constipation | 48.93 | 28.56 | 35 | 1118 | 280360 | 90346934 |
| Contraindicated product prescribed | 45.76 | 28.56 | 9 | 1144 | 1613 | 90625681 |
| Abdominal pain upper | 45.74 | 28.56 | 36 | 1117 | 332638 | 90294656 |
| Pancreatitis acute | 39.55 | 28.56 | 15 | 1138 | 32100 | 90595194 |
| Diarrhoea | 35.64 | 28.56 | 51 | 1102 | 939139 | 89688155 |
FDA Adverse Event Reporting System (Male)
None
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 |
|---|---|---|---|---|---|---|
| Pancreatitis | 116.07 | 28.62 | 41 | 1054 | 93492 | 110494712 |
| Sphincter of Oddi dysfunction | 64.54 | 28.62 | 10 | 1085 | 578 | 110587626 |
| Abdominal pain | 58.99 | 28.62 | 45 | 1050 | 512944 | 110075260 |
| Abdominal pain upper | 36.44 | 28.62 | 29 | 1066 | 349082 | 110239122 |
| Constipation | 35.81 | 28.62 | 29 | 1066 | 357757 | 110230447 |
| Pancreatitis acute | 34.06 | 28.62 | 15 | 1080 | 60259 | 110527945 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | A07DA06 | ALIMENTARY TRACT AND METABOLISM ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS ANTIPROPULSIVES Antipropulsives |
| MeSH PA | D005765 | Gastrointestinal Agents |
| FDA MoA | N0000191866 | Opioid mu-Receptor Agonists |
| FDA EPC | N0000191867 | mu-Opioid Receptor Agonist |
| CHEBI has role | CHEBI:53784 | antispasmodic drug |
| CHEBI has role | CHEBI:55322 | μ-opioid receptor agonist |
| CHEBI has role | CHEBI:55324 | gastrointestinal drug |
| CHEBI has role | CHEBI:59282 | κ-opioid receptor agonist |
| CHEBI has role | CHEBI:59283 | δ-opioid receptor antagonist |
Related Drugs by ATC class:
A07DA Antipropulsives 5 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Irritable bowel syndrome with diarrhea | indication | 197125005 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 3.68 | acidic |
| pKa2 | 12.56 | acidic |
| pKa3 | 13.17 | acidic |
| pKa4 | 8.27 | Basic |
| pKa5 | 5.63 | Basic |
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 100MG | VIBERZI | ABBVIE | N206940 | May 27, 2015 | RX | TABLET | ORAL | 8691860 | July 7, 2028 | TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE). |
| 100MG | VIBERZI | ABBVIE | N206940 | May 27, 2015 | RX | TABLET | ORAL | 9115091 | July 7, 2028 | TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE) |
| 100MG | VIBERZI | ABBVIE | N206940 | May 27, 2015 | RX | TABLET | ORAL | 9364489 | July 7, 2028 | TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE). |
| 100MG | VIBERZI | ABBVIE | N206940 | May 27, 2015 | RX | TABLET | ORAL | 9789125 | July 7, 2028 | TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE). |
| 100MG | VIBERZI | ABBVIE | N206940 | May 27, 2015 | RX | TABLET | ORAL | 9789125 | July 7, 2028 | TREATMENT OF PAIN ASSOCIATED WITH IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE) |
| 75MG | VIBERZI | ABBVIE | N206940 | May 27, 2015 | RX | TABLET | ORAL | 8691860 | July 7, 2028 | TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE). |
| 75MG | VIBERZI | ABBVIE | N206940 | May 27, 2015 | RX | TABLET | ORAL | 9115091 | July 7, 2028 | TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE) |
| 75MG | VIBERZI | ABBVIE | N206940 | May 27, 2015 | RX | TABLET | ORAL | 9364489 | July 7, 2028 | TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE). |
| 75MG | VIBERZI | ABBVIE | N206940 | May 27, 2015 | RX | TABLET | ORAL | 9789125 | July 7, 2028 | TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE). |
| 75MG | VIBERZI | ABBVIE | N206940 | May 27, 2015 | RX | TABLET | ORAL | 9789125 | July 7, 2028 | TREATMENT OF PAIN ASSOCIATED WITH IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE) |
| 100MG | VIBERZI | ABBVIE | N206940 | May 27, 2015 | RX | TABLET | ORAL | 11484527 | March 14, 2033 | REDUCTION OF THE FREQUENCY OF ABDOMINAL PAIN AND DIARRHEA, IN AN INFLAMMATORY BOWEL DISEASE WITH DIARRHEA (IBS-D) PATIENT, WITH ELUXADOLINE TWICE DAILY WITH FOOD |
| 75MG | VIBERZI | ABBVIE | N206940 | May 27, 2015 | RX | TABLET | ORAL | 12097187 | March 14, 2033 | REDUCTION OF THE FREQUENCY OF ABDOMINAL PAIN AND DIARRHEA, IN AN INFLAMMATORY BOWEL DISEASE WITH DIARRHEA (IBS-D) PATIENT, WITH ELUXADOLINE TWICE DAILY WITH FOOD |
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 |
|---|---|---|---|---|---|---|---|---|---|
| Mu-type opioid receptor | GPCR | AGONIST | Ki | 8.77 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
| Delta-type opioid receptor | GPCR | ANTAGONIST | Ki | 8.89 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
| Kappa-type opioid receptor | GPCR | AGONIST | Ki | 7.26 | SCIENTIFIC LITERATURE | ||||
| Kappa-type opioid receptor | GPCR | AGONIST | Ki | 7.26 | DRUG LABEL | ||||
| Mu-type opioid receptor | GPCR | Ki | 9.05 | CHEMBL | |||||
| Delta-type opioid receptor | GPCR | Ki | 8.89 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| D10403 | KEGG_DRUG |
| 4035123 | VANDF |
| CHEBI:85980 | CHEBI |
| CHEMBL2159122 | ChEMBL_ID |
| C583636 | MESH_SUPPLEMENTAL_RECORD_UI |
| 7691 | IUPHAR_LIGAND_ID |
| DB09272 | DRUGBANK_ID |
| 1653781 | RXNORM |
| 237230 | MMSL |
| 31303 | MMSL |
| d08401 | MMSL |
| 016415 | NDDF |
| 716119001 | SNOMEDCT_US |
| 763582003 | SNOMEDCT_US |
| C3712232 | UMLSCUI |
| 9749 | INN_ID |
| 11250029 | PUBCHEM_CID |
| 864825-13-8 | SECONDARY_CAS_RN |
| 45TPJ4MBQ1 | UNII |
| 45TPJ4MBQ1 | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Viberzi | HUMAN PRESCRIPTION DRUG LABEL | 1 | 61874-075 | TABLET, FILM COATED | 75 mg | ORAL | NDA | 34 sections |
| Viberzi | HUMAN PRESCRIPTION DRUG LABEL | 1 | 61874-100 | TABLET, FILM COATED | 100 mg | ORAL | NDA | 34 sections |