Vanzacaftor
Alyftrek (vanzacaftor) is a small molecule pharmaceutical. Vanzacaftor was first approved as Alyftrek on 2024-12-20. It is used to treat cystic fibrosis in the USA.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Combinations
Alyftrek
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Deutivacaftor
+
Tezacaftor
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Vanzacaftor calcium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ALYFTREK | Vertex Pharmaceuticals | N-218730 RX | 2024-12-20 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| alyftrek | New Drug Application | 2025-09-30 |
| vanzacaftor, tezacaftor, and deutivacaftor | New Drug Application | 2024-12-26 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| cystic fibrosis | EFO_0000390 | D003550 | E84 |
Agency Specific
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ATC Codes
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HCPCS
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Clinical
Clinical Trials
6 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 4 | — | 1 | — | 1 | 6 |
| Fibrosis | D005355 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
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Indications Phases 1
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Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Vanzacaftor |
| INN | vanzacaftor |
| Description | Vanzacaftor/tezacaftor/deutivacaftor, sold under the brand name Alyftrek, is a fixed-dose combination medication used for the treatment of cystic fibrosis. It is a combination of deutivacaftor, a CFTR potentiator; tezacaftor; and vanzacaftor, as the calcium salt, vanzacaftor calcium dihydrate. It is taken by mouth.
|
| Classification | Small molecule |
| Drug class | cystic fibrosis transmembrane regulator (CFTR) protein modulators |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC1(C)C[C@@H]2CCCNc3cccc(n3)S(=O)(=O)NC(=O)c3ccc(-n4ccc(OCCC5C6(CC6)C56CC6)n4)nc3N1C2 |
Identifiers
| PDB | — |
| CAS-ID | 2374124-49-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL5314934 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | COM1POP492 (ChemIDplus, GSRS) |
Target
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Variants
No data
Financial
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Trends
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Safety
Black-box Warning
Black-box warning for: Alyftrek, Vanzacaftor, tezacaftor, and deutivacaftor
Adverse Events
Top Adverse Reactions
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108 adverse events reported
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