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 | 51.87 | 34.34 | 37 | 1012 | 201906 | 56089112 |
Abdominal pain | 45.80 | 34.34 | 38 | 1011 | 258767 | 56032251 |
Flushing | 38.82 | 34.34 | 21 | 1028 | 70079 | 56220939 |
Disease progression | 38.32 | 34.34 | 24 | 1025 | 105149 | 56185869 |
Hospice care | 34.80 | 34.34 | 10 | 1039 | 6170 | 56284848 |
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 | 74.21 | 41.72 | 30 | 995 | 30098 | 31666221 |
Abdominal pain | 71.36 | 41.72 | 49 | 976 | 145903 | 31550416 |
Diarrhoea | 61.01 | 41.72 | 65 | 960 | 352344 | 31343975 |
Blood chromogranin A increased | 48.06 | 41.72 | 8 | 1017 | 217 | 31696102 |
Constipation | 47.53 | 41.72 | 36 | 989 | 123955 | 31572364 |
Serum serotonin increased | 47.22 | 41.72 | 7 | 1018 | 87 | 31696232 |
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 | 48.99 | 38.21 | 24 | 1028 | 82148 | 70845244 |
Abdominal pain | 46.17 | 38.21 | 39 | 1013 | 342088 | 70585304 |
Death | 45.32 | 38.21 | 46 | 1006 | 510015 | 70417377 |
Disease progression | 44.33 | 38.21 | 28 | 1024 | 156644 | 70770748 |
Hospice care | 38.72 | 38.21 | 11 | 1041 | 8194 | 70919198 |
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 | 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 |
EQ 250MG BASE | XERMELO | TERSERA | N208794 | Feb. 28, 2017 | RX | TABLET | ORAL | 7709493 | Feb. 28, 2031 | 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 |
1137608-69-5 | SECONDARY_CAS_RN |
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 |
252423 | MMSL |
32389 | MMSL |
d08528 | MMSL |
017120 | NDDF |
017121 | NDDF |
733879005 | SNOMEDCT_US |
4036470 | VANDF |
C000621725 | MESH_SUPPLEMENTAL_RECORD_UI |
1872441 | RXNORM |
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 | 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 | 25 sections |
Xermelo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70720-125 | TABLET | 250 mg | ORAL | NDA | 25 sections |