Vyndamax, Vyndaqel(tafamidis)
Vyndamax, Vyndaqel (tafamidis) is a small molecule pharmaceutical. Tafamidis was first approved as Vyndaqel on 2011-11-16. It has been approved in Europe to treat amyloidosis. It is known to target transthyretin.
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FDA Novel Drug Approvals 2019
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Therapeutic Areas
Therapeutic Area | MeSH |
---|---|
nutritional and metabolic diseases | D009750 |
Trade Name
FDA
EMA
Vyndamax, Vyndaqel
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
vyndamax vyndaqel | New Drug Application | 2020-04-22 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
TAFAMIDIS, VYNDAMAX, FOLDRX PHARMS | |||
2026-05-03 | ODE-237 | ||
2024-05-03 | NCE | ||
TAFAMIDIS MEGLUMINE, VYNDAQEL, FOLDRX PHARMS | |||
2026-05-03 | ODE-237 | ||
2024-05-03 | NCE |
HCPCS
No data
Clinical
Clinical Trials
33 clinical trials
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Indications Phases 4
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Cardiomyopathies | D009202 | EFO_0000318 | I42 | — | 1 | — | — | — | 1 |
Nervous system lead poisoning adult | D020265 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Healthy volunteers/patients | — | 14 | — | — | — | — | 14 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Takotsubo cardiomyopathy | D054549 | EFO_1002000 | I51.81 | — | — | — | — | 1 | 1 |
Polyneuropathies | D011115 | EFO_0009562 | A69.22 | — | — | — | — | 1 | 1 |
Hereditary amyloidosis transthyretin-related | C567782 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | TAFAMIDIS |
INN | tafamidis |
Description | Tafamidis is a member of the class of 1,3-benzoxazoles that is 1,3-benzoxazole-6-carboxylic acid in which the hydrogen at position 2 is replaced by a 3,5-dichlorophenyl group. Used (as its meglumine salt) for the amelioration of transthyretin-related hereditary amyloidosis. It has a role as a central nervous system drug. It is a member of 1,3-benzoxazoles, a monocarboxylic acid and a dichlorobenzene. It is a conjugate acid of a tafamidis(1-). |
Classification | Small molecule |
Drug class | antimyloidotics |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | O=C(O)c1ccc2nc(-c3cc(Cl)cc(Cl)c3)oc2c1 |
Identifiers
PDB | 6E72 |
CAS-ID | 594839-88-0 |
RxCUI | 1545063 |
ChEMBL ID | CHEMBL2103837 |
ChEBI ID | 78538 |
PubChem CID | 11001318 |
DrugBank | DB11644 |
UNII ID | 8FG9H9D31J (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
Variants
Clinical Variant
No data
Financial
Vyndaqel - Pfizer
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,397 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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29,624 adverse events reported
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