Stem definition | Drug id | CAS RN |
---|---|---|
4192 | 594839-88-0 |
Dose | Unit | Route |
---|---|---|
20 | mg | O |
None
Date | Agency | Company | Orphan |
---|---|---|---|
Sept. 20, 2013 | PMDA | PFIZER | |
March 5, 2019 | FDA | FOLDRX PHARMS | |
Nov. 16, 2011 | EMA |
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 |
---|---|---|---|---|---|---|
Cardiac failure | 206.03 | 35.77 | 76 | 1268 | 82017 | 56208706 |
Death | 175.10 | 35.77 | 105 | 1239 | 341321 | 55949402 |
Cardiac failure chronic | 92.17 | 35.77 | 21 | 1323 | 4046 | 56286677 |
Cardiac amyloidosis | 71.77 | 35.77 | 13 | 1331 | 794 | 56289929 |
Congenital coronary artery malformation | 40.76 | 35.77 | 6 | 1338 | 98 | 56290625 |
Hereditary neuropathic amyloidosis | 38.58 | 35.77 | 4 | 1340 | 0 | 56290723 |
Pyelonephritis acute | 35.86 | 35.77 | 10 | 1334 | 4319 | 56286404 |
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 |
---|---|---|---|---|---|---|
Death | 680.69 | 23.38 | 531 | 5050 | 360038 | 31331725 |
Cardiac failure | 488.45 | 23.38 | 256 | 5325 | 85697 | 31606066 |
Cardiac amyloidosis | 378.64 | 23.38 | 75 | 5506 | 940 | 31690823 |
Cardiac failure chronic | 377.28 | 23.38 | 109 | 5472 | 7194 | 31684569 |
Off label use | 99.92 | 23.38 | 200 | 5381 | 347074 | 31344689 |
Atrial fibrillation | 98.10 | 23.38 | 110 | 5471 | 113673 | 31578090 |
Amyloidosis | 83.40 | 23.38 | 26 | 5555 | 2210 | 31689553 |
Dyspnoea exertional | 66.71 | 23.38 | 55 | 5526 | 38782 | 31652981 |
Essential hypertension | 63.47 | 23.38 | 22 | 5559 | 2605 | 31689158 |
Product use in unapproved indication | 61.12 | 23.38 | 81 | 5500 | 99090 | 31592673 |
Amyloidosis senile | 51.02 | 23.38 | 7 | 5574 | 3 | 31691760 |
Cardiac failure congestive | 47.57 | 23.38 | 64 | 5517 | 79323 | 31612440 |
Left ventricular hypertrophy | 47.48 | 23.38 | 24 | 5557 | 7308 | 31684455 |
Chronic left ventricular failure | 43.50 | 23.38 | 11 | 5570 | 433 | 31691330 |
N-terminal prohormone brain natriuretic peptide increased | 40.36 | 23.38 | 15 | 5566 | 2169 | 31689594 |
Disease progression | 37.02 | 23.38 | 61 | 5520 | 90403 | 31601360 |
Dyspnoea | 36.87 | 23.38 | 138 | 5443 | 343341 | 31348422 |
Atrial flutter | 32.15 | 23.38 | 24 | 5557 | 14631 | 31677132 |
Bendopnoea | 30.58 | 23.38 | 4 | 5577 | 0 | 31691763 |
Carpal tunnel syndrome | 30.37 | 23.38 | 15 | 5566 | 4346 | 31687417 |
Cardiac failure acute | 28.44 | 23.38 | 19 | 5562 | 9722 | 31682041 |
Acquired haemophilia | 26.94 | 23.38 | 9 | 5572 | 952 | 31690811 |
Hereditary neuropathic amyloidosis | 26.92 | 23.38 | 4 | 5577 | 6 | 31691757 |
Drug ineffective | 26.20 | 23.38 | 19 | 5562 | 395554 | 31296209 |
Hyperlipidaemia | 25.45 | 23.38 | 20 | 5561 | 13140 | 31678623 |
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 |
---|---|---|---|---|---|---|
Death | 1000.59 | 27.00 | 608 | 6152 | 509453 | 70412231 |
Cardiac failure | 687.18 | 27.00 | 313 | 6447 | 143228 | 70778456 |
Cardiac failure chronic | 478.49 | 27.00 | 124 | 6636 | 10145 | 70911539 |
Cardiac amyloidosis | 378.72 | 27.00 | 73 | 6687 | 1512 | 70920172 |
Atrial fibrillation | 126.98 | 27.00 | 119 | 6641 | 184229 | 70737455 |
Off label use | 125.90 | 27.00 | 240 | 6520 | 742820 | 70178864 |
Amyloidosis | 107.51 | 27.00 | 29 | 6731 | 2750 | 70918934 |
Dyspnoea exertional | 81.14 | 27.00 | 64 | 6696 | 78366 | 70843318 |
Essential hypertension | 80.08 | 27.00 | 27 | 6733 | 5457 | 70916227 |
Cardiac failure congestive | 66.65 | 27.00 | 73 | 6687 | 135384 | 70786300 |
Left ventricular hypertrophy | 63.77 | 27.00 | 27 | 6733 | 10175 | 70911509 |
Product use in unapproved indication | 63.50 | 27.00 | 88 | 6672 | 207390 | 70714294 |
Dyspnoea | 54.82 | 27.00 | 179 | 6581 | 769881 | 70151803 |
Amyloidosis senile | 54.65 | 27.00 | 7 | 6753 | 4 | 70921680 |
Chronic left ventricular failure | 53.65 | 27.00 | 13 | 6747 | 802 | 70920882 |
Cardiac failure acute | 44.41 | 27.00 | 25 | 6735 | 17462 | 70904222 |
Atrial flutter | 43.50 | 27.00 | 26 | 6734 | 20301 | 70901383 |
Hereditary neuropathic amyloidosis | 43.31 | 27.00 | 6 | 6754 | 11 | 70921673 |
Drug ineffective | 41.48 | 27.00 | 19 | 6741 | 939733 | 69981951 |
Disease progression | 37.14 | 27.00 | 59 | 6701 | 156613 | 70765071 |
N-terminal prohormone brain natriuretic peptide increased | 37.10 | 27.00 | 14 | 6746 | 3910 | 70917774 |
Congenital coronary artery malformation | 34.65 | 27.00 | 6 | 6754 | 66 | 70921618 |
Bendopnoea | 33.45 | 27.00 | 5 | 6755 | 19 | 70921665 |
Hyperlipidaemia | 32.52 | 27.00 | 23 | 6737 | 23840 | 70897844 |
Chronic kidney disease | 31.90 | 27.00 | 34 | 6726 | 61023 | 70860661 |
Oedema peripheral | 28.07 | 27.00 | 65 | 6695 | 228026 | 70693658 |
None
Source | Code | Description |
---|---|---|
ATC | N07XX08 | NERVOUS SYSTEM OTHER NERVOUS SYSTEM DRUGS OTHER NERVOUS SYSTEM DRUGS Other nervous system drugs |
CHEBI has role | CHEBI:35470 | central nervous system agents |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Wild-type transthyretin cardiac amyloidosis | indication | 16573007 | |
Amyloidosis | indication | 17602002 | DOID:9120 |
Transthyretin related familial amyloid cardiomyopathy | indication | 715655000 |
None
None
Dissociation level | Dissociation constant | Type (acidic/basic) |
---|---|---|
pKa1 | 3.55 | acidic |
pKa2 | 1.19 | Basic |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
---|---|---|---|---|---|---|---|---|---|---|
20MG | VYNDAQEL | FOLDRX PHARMS | N211996 | May 3, 2019 | RX | CAPSULE | ORAL | 7214696 | Dec. 19, 2023 | TREATMENT OF THE CARDIOMYOPATHY OF WILD TYPE OR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM) |
61MG | VYNDAMAX | FOLDRX PHARMS | N212161 | May 3, 2019 | RX | CAPSULE | ORAL | 7214696 | Dec. 19, 2023 | TREATMENT OF THE CARDIOMYOPATHY OF WILD TYPE OR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM) |
20MG | VYNDAQEL | FOLDRX PHARMS | N211996 | May 3, 2019 | RX | CAPSULE | ORAL | 8653119 | Jan. 28, 2024 | TREATMENT OF THE CARDIOMYOPATHY OF WILD TYPE OR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM) |
61MG | VYNDAMAX | FOLDRX PHARMS | N212161 | May 3, 2019 | RX | CAPSULE | ORAL | 9770441 | Aug. 31, 2035 | TREATMENT OF THE CARDIOMYOPATHY OF WILD TYPE OR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM) |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
---|---|---|---|---|---|---|---|---|---|
20MG | VYNDAQEL | FOLDRX PHARMS | N211996 | May 3, 2019 | RX | CAPSULE | ORAL | May 3, 2024 | NEW CHEMICAL ENTITY |
61MG | VYNDAMAX | FOLDRX PHARMS | N212161 | May 3, 2019 | RX | CAPSULE | ORAL | May 3, 2024 | NEW CHEMICAL ENTITY |
20MG | VYNDAQEL | FOLDRX PHARMS | N211996 | May 3, 2019 | RX | CAPSULE | ORAL | May 3, 2026 | TREATMENT OF THE CARDIOMYOPATHY OF WILD TYPE OR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM) IN ADULTS TO REDUCE CARDIOVASCULAR MORTALITY AND CARDIOVASCULAR-RELATED HOSPITALIZATION |
61MG | VYNDAMAX | FOLDRX PHARMS | N212161 | May 3, 2019 | RX | CAPSULE | ORAL | May 3, 2026 | TREATMENT OF THE CARDIOMYOPATHY OF WILD TYPE OR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM) IN ADULTS TO REDUCE CARDIOVASCULAR MORTALITY AND CARDIOVASCULAR-RELATED HOSPITALIZATION |
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
Transthyretin | Secreted | BINDING AGENT | Kd | 6.81 | DRUG LABEL | DRUG LABEL | |||
ATP-binding cassette sub-family G member 2 | Transporter | INHIBITOR | IC50 | 5.94 | DRUG LABEL | ||||
Solute carrier family 22 member 6 | Transporter | INHIBITOR | IC50 | 5.54 | DRUG LABEL | ||||
Solute carrier family 22 member 8 | Transporter | INHIBITOR | IC50 | 5.63 | DRUG LABEL |
ID | Source |
---|---|
D09673 | KEGG_DRUG |
951395-08-7 | SECONDARY_CAS_RN |
4038378 | VANDF |
4038379 | VANDF |
C2745274 | UMLSCUI |
CHEBI:78538 | CHEBI |
3MI | PDB_CHEM_ID |
CHEMBL2103837 | ChEMBL_ID |
CHEMBL2105675 | ChEMBL_ID |
DB11644 | DRUGBANK_ID |
C547076 | MESH_SUPPLEMENTAL_RECORD_UI |
8378 | IUPHAR_LIGAND_ID |
9094 | INN_ID |
8FG9H9D31J | UNII |
11001318 | PUBCHEM_CID |
DB05352 | DRUGBANK_ID |
1545063 | RXNORM |
199417 | MMSL |
29344 | MMSL |
37371 | MMSL |
d08073 | MMSL |
015816 | NDDF |
015819 | NDDF |
703348000 | SNOMEDCT_US |
703349008 | SNOMEDCT_US |
703810000 | SNOMEDCT_US |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
Vyndaqel | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-1975 | CAPSULE, LIQUID FILLED | 20 mg | ORAL | NDA | 27 sections |
Vyndaqel | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-1975 | CAPSULE, LIQUID FILLED | 20 mg | ORAL | NDA | 27 sections |
Vyndamax | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-8730 | CAPSULE, LIQUID FILLED | 61 mg | ORAL | NDA | 27 sections |
Vyndamax | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-8730 | CAPSULE, LIQUID FILLED | 61 mg | ORAL | NDA | 27 sections |