deoxycholic acid 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 4988 | 83-44-3 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A bile acid formed by bacterial action from cholate. It is usually conjugated with glycine or taurine. Deoxycholic acid acts as a detergent to solubilize fats for intestinal absorption, is reabsorbed itself, and is used as a choleretic and detergent.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| April 29, 2015 | FDA | KYTHERA BIOPHARMS |
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 |
|---|---|---|---|---|---|---|
| Injection site swelling | 331.83 | 92.56 | 93 | 1255 | 47479 | 63440195 |
| Facial paresis | 263.56 | 92.56 | 48 | 1300 | 3450 | 63484224 |
| Injection site nodule | 202.34 | 92.56 | 39 | 1309 | 3796 | 63483878 |
| Nerve injury | 175.85 | 92.56 | 41 | 1307 | 9905 | 63477769 |
| Swelling | 167.40 | 92.56 | 91 | 1257 | 275287 | 63212387 |
| Injection site pain | 164.19 | 92.56 | 71 | 1277 | 129729 | 63357945 |
| Injection site induration | 126.54 | 92.56 | 31 | 1317 | 9195 | 63478479 |
| Injection site mass | 100.54 | 92.56 | 30 | 1318 | 18626 | 63469048 |
| Facial asymmetry | 93.58 | 92.56 | 16 | 1332 | 789 | 63486885 |
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 |
|---|---|---|---|---|---|---|
| Injection site swelling | 260.40 | 79.26 | 65 | 709 | 47067 | 79696547 |
| Facial paresis | 141.51 | 79.26 | 27 | 747 | 5499 | 79738115 |
| Injection site nodule | 132.01 | 79.26 | 24 | 750 | 3756 | 79739858 |
| Injection site pain | 100.55 | 79.26 | 40 | 734 | 129798 | 79613816 |
| Swelling | 99.29 | 79.26 | 46 | 728 | 216665 | 79526949 |
| Nerve injury | 93.61 | 79.26 | 21 | 753 | 9371 | 79734243 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | D11AX24 | DERMATOLOGICALS OTHER DERMATOLOGICAL PREPARATIONS OTHER DERMATOLOGICAL PREPARATIONS Other dermatologicals |
| FDA PE | N0000008476 | Decreased Cell Membrane Integrity |
| MeSH PA | D002756 | Cholagogues and Choleretics |
| MeSH PA | D005765 | Gastrointestinal Agents |
| FDA EPC | N0000191548 | Cytolytic Agent |
| CHEBI has role | CHEBI:77746 | Homo sapiens metabolite |
| CHEBI has role | CHEBI:85234 | human blood serum metabolites |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Excess subcutaneous fat | indication | 248302001 |
🐶 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 20MG/2ML (10MG/ML) | KYBELLA | KYTHERA BIOPHARMS | N206333 | April 29, 2015 | RX | SOLUTION | SUBCUTANEOUS | 8846066 | Feb. 8, 2025 | METHOD FOR REDUCTION OF SUBMENTAL FAT |
| 20MG/2ML (10MG/ML) | KYBELLA | KYTHERA BIOPHARMS | N206333 | April 29, 2015 | RX | SOLUTION | SUBCUTANEOUS | 8298556 | Aug. 3, 2025 | METHOD FOR REDUCTION OF SUBMENTAL FAT |
| 20MG/2ML (10MG/ML) | KYBELLA | KYTHERA BIOPHARMS | N206333 | April 29, 2015 | RX | SOLUTION | SUBCUTANEOUS | 7622130 | Dec. 10, 2027 | METHOD FOR REDUCTION OF SUBMENTAL FAT |
| 20MG/2ML (10MG/ML) | KYBELLA | KYTHERA BIOPHARMS | N206333 | April 29, 2015 | RX | SOLUTION | SUBCUTANEOUS | 7754230 | Dec. 10, 2027 | METHOD FOR REDUCTION OF SUBMENTAL FAT |
| 20MG/2ML (10MG/ML) | KYBELLA | KYTHERA BIOPHARMS | N206333 | April 29, 2015 | RX | SOLUTION | SUBCUTANEOUS | 8546367 | Feb. 21, 2028 | METHOD FOR REDUCTION OF SUBMENTAL FAT |
| 20MG/2ML (10MG/ML) | KYBELLA | KYTHERA BIOPHARMS | N206333 | April 29, 2015 | RX | SOLUTION | SUBCUTANEOUS | 9522155 | Feb. 21, 2028 | IMPROVEMENT IN THE APPEARANCE OF MODERATE TO SEVERE CONVEXITY OR FULLNESS ASSOCIATED WITH SUBMENTAL FAT IN ADULTS BY MEANS OF REDUCING SUBMENTAL FAT VOLUME AS DESCRIBED IN THE APPROVED LABELING |
| 20MG/2ML (10MG/ML) | KYBELLA | KYTHERA BIOPHARMS | N206333 | April 29, 2015 | RX | SOLUTION | SUBCUTANEOUS | 9636349 | Feb. 21, 2028 | IMPROVEMENT IN THE APPEARANCE OF MODERATE TO SEVERE CONVEXITY OR FULLNESS ASSOCIATED WITH SUBMENTAL FAT IN ADULTS BY MEANS OF REDUCING SUBMENTAL FAT VOLUME AS DESCRIBED IN THE APPROVED LABELING |
| 20MG/2ML (10MG/ML) | KYBELLA | KYTHERA BIOPHARMS | N206333 | April 29, 2015 | RX | SOLUTION | SUBCUTANEOUS | 9949986 | Feb. 21, 2028 | IMPROVEMENT IN THE APPEARANCE OF MODERATE TO SEVERE CONVEXITY OR FULLNESS ASSOCIATED WITH SUBMENTAL FAT IN ADULTS BY MEANS OF REDUCING SUBMENTAL FAT VOLUME AS DESCRIBED IN THE APPROVED LABELING |
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 |
|---|---|---|---|---|---|---|---|---|---|
| fMet-Leu-Phe receptor | GPCR | ANTAGONIST | Ki | 4 | IUPHAR | ||||
| Bile acid receptor | Nuclear hormone receptor | EC50 | 4.35 | CHEMBL | |||||
| G-protein coupled bile acid receptor 1 | GPCR | AGONIST | EC50 | 6.20 | IUPHAR | ||||
| Steroid Delta-isomerase | Unclassified | Kd | 4.80 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 005990WHZZ | UNII |
| 4018928 | VANDF |
| 4035848 | VANDF |
| C0011479 | UMLSCUI |
| CHEBI:28834 | CHEBI |
| DHO | PDB_CHEM_ID |
| CHEMBL406393 | ChEMBL_ID |
| 222528 | PUBCHEM_CID |
| DB03619 | DRUGBANK_ID |
| CHEMBL412272 | ChEMBL_ID |
| CHEMBL1208257 | ChEMBL_ID |
| CHEMBL514674 | ChEMBL_ID |
| D003840 | MESH_DESCRIPTOR_UI |
| 9540 | INN_ID |
| 610 | IUPHAR_LIGAND_ID |
| DB05780 | DRUGBANK_ID |
| 1367220 | RXNORM |
| 14975 | MMSL |
| 234529 | MMSL |
| d08364 | MMSL |
| 001205 | NDDF |
| 010267 | NDDF |
| 434444004 | SNOMEDCT_US |
| 781373006 | SNOMEDCT_US |
| 78258003 | SNOMEDCT_US |
| CHEMBL453873 | ChEMBL_ID |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| KYBELLA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 61168-101 | INJECTION, SOLUTION | 20 mg | SUBCUTANEOUS | NDA | 27 sections |
| KYBELLA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 61168-101 | INJECTION, SOLUTION | 20 mg | SUBCUTANEOUS | NDA | 27 sections |
| KYBELLA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 61168-101 | INJECTION, SOLUTION | 20 mg | SUBCUTANEOUS | NDA | 27 sections |