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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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nutritional and metabolic diseases | D009750 |
Trade Name
FDA
EMA
Vyndamax
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Tafamidis
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| VYNDAMAX | FoldRx Pharmaceuticals | N-212161 RX | 2019-05-03 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| vyndamax vyndaqel | New Drug Application | 2025-01-01 |
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
70 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Amyloidosis | D000686 | EFO_1001875 | E85 | — | 4 | 4 | 4 | 16 | 26 |
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | 1 | 1 | 3 | 1 | 11 | 17 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | 11 | 4 | 1 | — | 16 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | 8 | 3 | 1 | — | 12 |
| Polyneuropathies | D011115 | EFO_0009562 | A69.22 | — | 3 | 3 | 3 | 2 | 9 |
| Amyloid neuropathies | D017772 | — | — | — | 2 | 3 | 3 | 2 | 8 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Familial amyloid neuropathies | D028227 | — | E85.1 | — | 2 | 3 | — | 5 | 8 |
| Pain | D010146 | EFO_0003843 | R52 | — | 2 | 2 | — | — | 4 |
| Hip osteoarthritis | D015207 | EFO_1000786 | M16 | — | 2 | 1 | — | — | 3 |
| Shoulder impingement syndrome | D019534 | EFO_1001178 | M75.4 | — | — | 1 | — | — | 1 |
| Injections | D007267 | — | — | — | — | 1 | — | — | 1 |
| Tendinopathy | D052256 | EFO_1001434 | M77.9 | — | — | 1 | — | — | 1 |
| Rotator cuff injuries | D000070636 | — | M75.1 | — | — | 1 | — | — | 1 |
| Inflammation | D007249 | MP_0001845 | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bursitis | D002062 | EFO_1000941 | M71.9 | — | 2 | — | — | — | 2 |
| Nervous system lead poisoning adult | D020265 | — | — | — | 1 | — | — | — | 1 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 1 | — | — | — | 1 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 16 | — | — | — | — | 16 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Disease progression | D018450 | — | — | — | — | — | — | 1 | 1 |
| Immunoglobulin light-chain amyloidosis | D000075363 | — | — | — | — | — | — | 1 | 1 |
| Takotsubo cardiomyopathy | D054549 | EFO_1002000 | I51.81 | — | — | — | — | 1 | 1 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | — | — | 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 | — |
| CAS-ID | 594839-88-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2103837 |
| ChEBI ID | 78538 |
| PubChem CID | 11001318 |
| DrugBank | DB11644 |
| UNII ID | 8FG9H9D31J (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
Variants
No data
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Vyndaqel – Pfizer
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Trends
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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14,080 adverse events reported
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