Deutivacaftor
Alyftrek (deutivacaftor) is a small molecule pharmaceutical. Deutivacaftor was first approved as Alyftrek on 2024-12-20.
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FDA approval date
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Study first post date
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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
+
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
FDA
EMA
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Patent Expiration
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ATC Codes
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HCPCS
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Clinical
Clinical Trials
19 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 | 7 | 5 | 5 | — | 1 | 17 |
| Fibrosis | D005355 | — | — | 1 | 5 | 4 | — | — | 9 |
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Deutivacaftor |
| INN | deutivacaftor |
| Description | Deutivacaftor is a small molecule pharmaceutical. It is currently being investigated in clinical studies. |
| Classification | Small molecule |
| Drug class | cystic fibrosis transmembrane regulator (CFTR) protein modulators; deuterated compounds |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | [2H]C([2H])([2H])C(c1cc(C(C)(C)C)c(NC(=O)c2c[nH]c3ccccc3c2=O)cc1O)(C([2H])([2H])[2H])C([2H])([2H])[2H] |
Identifiers
| PDB | — |
| CAS-ID | 1413431-07-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4297603 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | SHA6U5FJZL (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 58 documents
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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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