Stem definition | Drug id | CAS RN |
---|---|---|
4988 | 83-44-3 |
None
None
Date | Agency | Company | Orphan |
---|---|---|---|
April 29, 2015 | FDA | KYTHERA BIOPHARMS |
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 | 233.50 | 93.58 | 67 | 892 | 41706 | 50562459 |
Facial paresis | 208.13 | 93.58 | 38 | 921 | 3114 | 50601051 |
Injection site nodule | 149.13 | 93.58 | 29 | 930 | 3319 | 50600846 |
Swelling | 128.17 | 93.58 | 66 | 893 | 200806 | 50403359 |
Injection site pain | 128.09 | 93.58 | 55 | 904 | 110969 | 50493196 |
Nerve injury | 117.49 | 93.58 | 28 | 931 | 8322 | 50595843 |
Injection site induration | 96.84 | 93.58 | 24 | 935 | 8373 | 50595792 |
None
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 | 174.37 | 82.00 | 46 | 578 | 41307 | 64456801 |
Facial paresis | 119.76 | 82.00 | 23 | 601 | 4869 | 64493239 |
Swelling | 92.79 | 82.00 | 40 | 584 | 160178 | 64337930 |
Injection site pain | 88.83 | 82.00 | 35 | 589 | 111373 | 64386735 |
Injection site nodule | 84.05 | 82.00 | 16 | 608 | 3214 | 64494894 |
None
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 |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Excess subcutaneous fat | indication | 248302001 |
None
None
Dissociation level | Dissociation constant | Type (acidic/basic) |
---|---|---|
pKa1 | 4.92 | acidic |
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 |
None
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 |
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 |
434444004 | SNOMEDCT_US |
781373006 | SNOMEDCT_US |
78258003 | SNOMEDCT_US |
CHEMBL453873 | ChEMBL_ID |
001205 | NDDF |
010267 | NDDF |
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 |