Stem definition | Drug id | CAS RN |
---|---|---|
enzyme inhibitors | 5214 | 1033805-22-9 |
None
None
Date | Agency | Company | Orphan |
---|---|---|---|
Sept. 18, 2017 | EMA | Ipsen Pharma | |
Feb. 28, 2017 | FDA | LEXICON PHARMA INC |
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 |
---|---|---|---|---|---|---|
Constipation | 51.27 | 34.37 | 37 | 1007 | 185671 | 50418409 |
Abdominal pain | 45.45 | 34.37 | 38 | 1006 | 236190 | 50367890 |
Disease progression | 38.12 | 34.37 | 24 | 1020 | 95842 | 50508238 |
Flushing | 37.70 | 34.37 | 21 | 1023 | 66994 | 50537086 |
Hospice care | 34.47 | 34.37 | 10 | 1034 | 5762 | 50598318 |
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 |
---|---|---|---|---|---|---|
Flushing | 73.46 | 41.29 | 30 | 990 | 28962 | 29544545 |
Abdominal pain | 71.85 | 41.29 | 49 | 971 | 135308 | 29438199 |
Diarrhoea | 57.10 | 41.29 | 63 | 957 | 332635 | 29240872 |
Blood chromogranin A increased | 48.37 | 41.29 | 8 | 1012 | 195 | 29573312 |
Constipation | 48.12 | 41.29 | 36 | 984 | 114124 | 29459383 |
Serum serotonin increased | 46.84 | 41.29 | 7 | 1013 | 86 | 29573421 |
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 |
---|---|---|---|---|---|---|
Flushing | 47.91 | 39.04 | 24 | 1024 | 78624 | 64419060 |
Abdominal pain | 46.16 | 39.04 | 39 | 1009 | 312336 | 64185348 |
Disease progression | 44.58 | 39.04 | 28 | 1020 | 141652 | 64356032 |
Death | 43.93 | 39.04 | 46 | 1002 | 482659 | 64015025 |
None
None
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Diarrhea | indication | 62315008 |
None
None
Dissociation level | Dissociation constant | Type (acidic/basic) |
---|---|---|
pKa1 | 7.14 | Basic |
pKa2 | 2.78 | Basic |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
---|---|---|---|---|---|---|---|---|---|---|
EQ 250MG BASE | XERMELO | TERSERA | N208794 | Feb. 28, 2017 | RX | TABLET | ORAL | 7709493 | Dec. 11, 2027 | THE TREATMENT OF CARCINOID SYNDROME DIARRHEA IN COMBINATION WITH SOMATOSTATIN ANALOG (SSA) THERAPY IN ADULTS INADEQUATELY CONTROLLED BY SSA THERAPY |
EQ 250MG BASE | XERMELO | TERSERA | N208794 | Feb. 28, 2017 | RX | TABLET | ORAL | 7968559 | Dec. 11, 2027 | THE TREATMENT OF CARCINOID SYNDROME DIARRHEA IN COMBINATION WITH SOMATOSTATIN ANALOG (SSA) THERAPY IN ADULTS INADEQUATELY CONTROLLED BY SSA THERAPY |
EQ 250MG BASE | XERMELO | TERSERA | N208794 | Feb. 28, 2017 | RX | TABLET | ORAL | 8653094 | Dec. 19, 2028 | THE TREATMENT OF CARCINOID SYNDROME DIARRHEA IN COMBINATION WITH SOMATOSTATIN ANALOG (SSA) THERAPY IN ADULTS INADEQUATELY CONTROLLED BY SSA THERAPY |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
---|---|---|---|---|---|---|---|---|---|
EQ 250MG BASE | XERMELO | TERSERA | N208794 | Feb. 28, 2017 | RX | TABLET | ORAL | Feb. 28, 2022 | NEW CHEMICAL ENTITY |
EQ 250MG BASE | XERMELO | TERSERA | N208794 | Feb. 28, 2017 | RX | TABLET | ORAL | Feb. 28, 2024 | TREATMENT OF CARCINOID SYNDROME DIARRHEA IN COMBINATION WITH SOMATOSTATIN ANALOG (SSA) THERAPY IN ADULTS INADEQUATELY CONTROLLED BY SSA THERAPY |
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
Tryptophan 5-hydroxylase 1 | Enzyme | INHIBITOR | IC50 | 7.80 | SCIENTIFIC LITERATURE | DRUG LABEL |
ID | Source |
---|---|
8G388563M7 | UNII |
C4317559 | UMLSCUI |
CHEMBL2105695 | ChEMBL_ID |
25181577 | PUBCHEM_CID |
DB12095 | DRUGBANK_ID |
D09974 | KEGG_DRUG |
CHEMBL3348963 | ChEMBL_ID |
C000592493 | MESH_SUPPLEMENTAL_RECORD_UI |
9490 | IUPHAR_LIGAND_ID |
1872441 | RXNORM |
252423 | MMSL |
32389 | MMSL |
d08528 | MMSL |
733879005 | SNOMEDCT_US |
4036470 | VANDF |
017120 | NDDF |
017121 | NDDF |
C000621725 | MESH_SUPPLEMENTAL_RECORD_UI |
1137608-69-5 | SECONDARY_CAS_RN |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
Xermelo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70183-125 | TABLET | 250 mg | ORAL | NDA | 24 sections |
Xermelo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70183-125 | TABLET | 250 mg | ORAL | NDA | 24 sections |
Xermelo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70720-125 | TABLET | 250 mg | ORAL | NDA | 24 sections |