Stem definition | Drug id | CAS RN |
---|---|---|
immunomodulators, both stimulant/suppressive and stimulant | 5383 | 1306760-87-1 |
Dose | Unit | Route |
---|---|---|
0.92 | mg | O |
None
Date | Agency | Company | Orphan |
---|---|---|---|
May 20, 2020 | EMA | Bristol-Myers Squibb Pharma EEIG | |
March 25, 2020 | FDA | CELGENE INTL |
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 |
---|---|---|---|---|---|---|
Multiple sclerosis relapse | 220.33 | 35.60 | 86 | 2916 | 42878 | 50559244 |
Fatigue | 134.89 | 35.60 | 185 | 2817 | 707416 | 49894706 |
Headache | 96.69 | 35.60 | 133 | 2869 | 506402 | 50095720 |
COVID-19 | 83.55 | 35.60 | 45 | 2957 | 46617 | 50555505 |
Dizziness | 73.51 | 35.60 | 96 | 2906 | 346273 | 50255849 |
Unevaluable event | 47.16 | 35.60 | 31 | 2971 | 46035 | 50556087 |
COVID-19 pneumonia | 47.12 | 35.60 | 18 | 2984 | 8377 | 50593745 |
Balance disorder | 43.66 | 35.60 | 35 | 2967 | 70555 | 50531567 |
Lymphocyte count decreased | 43.24 | 35.60 | 24 | 2978 | 26283 | 50575839 |
Back pain | 40.40 | 35.60 | 57 | 2945 | 219973 | 50382149 |
Hypoaesthesia | 37.83 | 35.60 | 42 | 2960 | 127215 | 50474907 |
Migraine | 37.60 | 35.60 | 33 | 2969 | 75247 | 50526875 |
Heart rate decreased | 35.98 | 35.60 | 24 | 2978 | 36473 | 50565649 |
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 |
---|---|---|---|---|---|---|
Multiple sclerosis relapse | 88.68 | 43.81 | 25 | 681 | 11394 | 29562427 |
COVID-19 | 57.14 | 43.81 | 24 | 682 | 35990 | 29537831 |
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 |
---|---|---|---|---|---|---|
Fatigue | 150.18 | 42.38 | 171 | 2605 | 748559 | 63747397 |
Multiple sclerosis relapse | 109.25 | 42.38 | 47 | 2729 | 41088 | 64454868 |
Headache | 103.88 | 42.38 | 120 | 2656 | 529347 | 63966609 |
COVID-19 | 85.84 | 42.38 | 46 | 2730 | 65094 | 64430862 |
Dizziness | 70.16 | 42.38 | 89 | 2687 | 430074 | 64065882 |
Back pain | 63.17 | 42.38 | 65 | 2711 | 250106 | 64245850 |
Unevaluable event | 48.45 | 42.38 | 29 | 2747 | 50460 | 64445496 |
Balance disorder | 46.01 | 42.38 | 34 | 2742 | 83892 | 64412064 |
Hypoaesthesia | 44.09 | 42.38 | 41 | 2735 | 139067 | 64356889 |
Heart rate decreased | 43.63 | 42.38 | 28 | 2748 | 55039 | 64440917 |
None
Source | Code | Description |
---|---|---|
ATC | L04AA38 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Selective immunosuppressants |
MeSH PA | D007155 | Immunologic Factors |
MeSH PA | D007166 | Immunosuppressive Agents |
MeSH PA | D000081243 | Sphingosine 1 Phosphate Receptor Modulators |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Multiple sclerosis | indication | 24700007 | DOID:2377 |
Preinfarction syndrome | contraindication | 4557003 | |
Myocardial infarction | contraindication | 22298006 | DOID:5844 |
Mobitz type II atrioventricular block | contraindication | 28189009 | DOID:11312 |
Sick sinus syndrome | contraindication | 36083008 | DOID:13884 |
Sinoatrial block | contraindication | 65778007 | |
Sleep apnea | contraindication | 73430006 | DOID:0050847 |
Heart failure | contraindication | 84114007 | DOID:6000 |
Cerebrovascular accident | contraindication | 230690007 | |
Transient ischemic attack | contraindication | 266257000 | DOID:224 |
None
None
Dissociation level | Dissociation constant | Type (acidic/basic) |
---|---|---|
pKa1 | 8.46 | Basic |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
---|---|---|---|---|---|---|---|---|---|---|
EQ 0.23MG BASE | ZEPOSIA | CELGENE INTL | N209899 | March 25, 2020 | RX | CAPSULE | ORAL | 8481573 | May 14, 2029 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS |
EQ 0.23MG BASE | ZEPOSIA | CELGENE INTL | N209899 | March 25, 2020 | RX | CAPSULE | ORAL | 9382217 | May 14, 2029 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS |
EQ 0.46MG BASE | ZEPOSIA | CELGENE INTL | N209899 | March 25, 2020 | RX | CAPSULE | ORAL | 8481573 | May 14, 2029 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS |
EQ 0.46MG BASE | ZEPOSIA | CELGENE INTL | N209899 | March 25, 2020 | RX | CAPSULE | ORAL | 9382217 | May 14, 2029 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS |
EQ 0.92MG BASE | ZEPOSIA | CELGENE INTL | N209899 | March 25, 2020 | RX | CAPSULE | ORAL | 8481573 | May 14, 2029 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS |
EQ 0.92MG BASE | ZEPOSIA | CELGENE INTL | N209899 | March 25, 2020 | RX | CAPSULE | ORAL | 9382217 | May 14, 2029 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS |
EQ 0.23MG BASE | ZEPOSIA | CELGENE INTL | N209899 | March 25, 2020 | RX | CAPSULE | ORAL | 10239846 | Nov. 15, 2030 | INDICATED FOR THE TREATMENT OF MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS |
EQ 0.46MG BASE | ZEPOSIA | CELGENE INTL | N209899 | March 25, 2020 | RX | CAPSULE | ORAL | 10239846 | Nov. 15, 2030 | INDICATED FOR THE TREATMENT OF MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS |
EQ 0.92MG BASE | ZEPOSIA | CELGENE INTL | N209899 | March 25, 2020 | RX | CAPSULE | ORAL | 10239846 | Nov. 15, 2030 | INDICATED FOR THE TREATMENT OF MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
---|---|---|---|---|---|---|---|---|---|
EQ 0.23MG BASE | ZEPOSIA | CELGENE INTL | N209899 | March 25, 2020 | RX | CAPSULE | ORAL | May 27, 2024 | FOR THE TREATMENT OF MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS IN ADULT PATIENTS |
EQ 0.46MG BASE | ZEPOSIA | CELGENE INTL | N209899 | March 25, 2020 | RX | CAPSULE | ORAL | May 27, 2024 | FOR THE TREATMENT OF MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS IN ADULT PATIENTS |
EQ 0.92MG BASE | ZEPOSIA | CELGENE INTL | N209899 | March 25, 2020 | RX | CAPSULE | ORAL | May 27, 2024 | FOR THE TREATMENT OF MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS IN ADULT PATIENTS |
EQ 0.23MG BASE | ZEPOSIA | CELGENE INTL | N209899 | March 25, 2020 | RX | CAPSULE | ORAL | March 25, 2025 | NEW CHEMICAL ENTITY |
EQ 0.46MG BASE | ZEPOSIA | CELGENE INTL | N209899 | March 25, 2020 | RX | CAPSULE | ORAL | March 25, 2025 | NEW CHEMICAL ENTITY |
EQ 0.92MG BASE | ZEPOSIA | CELGENE INTL | N209899 | March 25, 2020 | RX | CAPSULE | ORAL | March 25, 2025 | NEW CHEMICAL ENTITY |
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
Sphingosine 1-phosphate receptor 1 | GPCR | AGONIST | EC50 | 9.39 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
Sphingosine 1-phosphate receptor 5 | GPCR | AGONIST | EC50 | 7.96 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
Sphingosine 1-phosphate receptor 4 | GPCR | EC50 | 5.38 | CHEMBL | |||||
Sphingosine 1-phosphate receptor 3 | GPCR | EC50 | 5 | CHEMBL | |||||
Sphingosine 1-phosphate receptor 2 | GPCR | EC50 | 5.02 | CHEMBL |
ID | Source |
---|---|
Z80293URPV | UNII |
C4278675 | UMLSCUI |
CHEMBL3707247 | ChEMBL_ID |
52938427 | PUBCHEM_CID |
DB12612 | DRUGBANK_ID |
CHEMBL3707246 | ChEMBL_ID |
D10968 | KEGG_DRUG |
8709 | IUPHAR_LIGAND_ID |
2288235 | RXNORM |
38279 | MMSL |
d09534 | MMSL |
870525003 | SNOMEDCT_US |
871794001 | SNOMEDCT_US |
871800005 | SNOMEDCT_US |
4039423 | VANDF |
4039424 | VANDF |
JEU | PDB_CHEM_ID |
018313 | NDDF |
018314 | NDDF |
C000607776 | MESH_SUPPLEMENTAL_RECORD_UI |
10057 | INN_ID |
1618636-37-5 | SECONDARY_CAS_RN |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
ZEPOSIA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 59572-820 | CAPSULE | 0.92 mg | ORAL | NDA | 29 sections |
ZEPOSIA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 59572-820 | CAPSULE | 0.92 mg | ORAL | NDA | 29 sections |