Trikafta (copackaged), Kaftrio(elexacaftor)
Kaftrio, Trikafta (elexacaftor) is a small molecule pharmaceutical. Elexacaftor was first approved as Trikafta (copackaged) on 2019-10-21. It is used to treat cystic fibrosis in the USA. It has been approved in Europe to treat cystic fibrosis. It is known to target cystic fibrosis transmembrane conductance regulator.
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FDA Novel Drug Approvals 2019
Commercial
Trade Name
FDA
EMA
Combinations
Trikafta
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 |
---|---|---|
trikafta | New Drug Application | 2020-12-22 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
cystic fibrosis | EFO_0000390 | D003550 | E84 |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR / IVACAFTOR, TRIKAFTA (COPACKAGED), VERTEX PHARMS INC | |||
2028-06-08 | ODE-357 | ||
2027-12-21 | ODE-323 | ||
2026-10-21 | ODE-275 | ||
2026-04-26 | NP | ||
2024-10-21 | NCE | ||
2024-06-08 | NPP | ||
2023-02-12 | NCE |
Patent Expiration
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Elexacaftor, Ivacaftor, Tezacaftor / Ivacaftor, Trikafta (Copackaged), Vertex Pharms Inc | |||
10793547 | 2037-12-08 | DS, DP | U-2645, U-3028, U-3144, U-3588 |
11179367 | 2037-12-08 | DP | U-3253, U-3597 |
11453655 | 2037-12-08 | DS, DP | |
11517564 | 2037-12-08 | DP | U-3498, U-3586 |
10758534 | 2035-10-06 | DS, DP | U-2645, U-3028, U-3144, U-3589 |
11426407 | 2035-10-06 | DS, DP | U-3425, U-3595 |
9012496 | 2033-07-15 | U-2649, U-3154 | |
8883206 | 2033-02-27 | DP | |
10272046 | 2033-02-27 | DP | U-3599 |
11147770 | 2033-02-27 | DP | U-3598 |
10081621 | 2031-03-25 | DP | U-2652, U-3032, U-3157, U-3600 |
11578062 | 2031-03-25 | DP | U-3544, U-3584 |
10646481 | 2029-08-13 | DP | |
11564916 | 2029-08-13 | U-3525, U-3585 | |
8415387 | 2027-11-12 | U-2645, U-3028, U-3144, U-3589 | |
8324242 | 2027-08-05 | U-2645, U-3028, U-3144, U-3589 | |
7776905 | 2027-06-03 | DS, DP | |
7495103 | 2027-05-20 | DS, DP | |
7645789 | 2027-05-01 | DS, DP | |
8598181 | 2027-05-01 | U-2645, U-3028, U-3144, U-3589 | |
8623905 | 2027-05-01 | DS, DP | |
9974781 | 2027-04-09 | DP | U-2645, U-3028, U-3144, U-3589 |
10022352 | 2027-04-09 | DP | U-2651, U-3156, U-3596 |
10239867 | 2027-04-09 | DS, DP | U-2653, U-3033, U-3158, U-3590 |
11639347 | 2027-04-09 | DS, DP | U-3583, U-3587 |
8410274 | 2026-12-28 | DP | |
8754224 | 2026-12-28 | DS, DP | |
9670163 | 2026-12-28 | DP | U-2650, U-3031, U-3155, U-3591 |
9931334 | 2026-12-28 | DP | U-2650, U-3031, U-3155, U-3591 |
8354427 | 2026-07-06 | U-2646, U-3029, U-3145, U-3593 | |
8629162 | 2025-06-24 | U-2648, U-3030, U-3146, U-3592 |
HCPCS
No data
Clinical
Clinical Trials
18 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Cystic fibrosis | D003550 | EFO_0000390 | E84 | 1 | 2 | 3 | 2 | 9 | 16 |
Drug interactions | D004347 | — | — | — | 1 | — | 1 | ||
Gastrointestinal diseases | D005767 | — | — | — | 1 | — | 1 | ||
Medication adherence | D055118 | EFO_0006344 | — | — | — | 1 | — | 1 |
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Lung diseases | D008171 | EFO_0003818 | J98.4 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | ELEXACAFTOR |
INN | elexacaftor |
Description | Elexacaftor is a medication that acts as cystic fibrosis transmembrane conductance regulator (CFTR) corrector.
|
Classification | Small molecule |
Drug class | cystic fibrosis transmembrane regulator (CFTR) protein modulators |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | Cc1nn(C)cc1S(=O)(=O)NC(=O)c1ccc(-n2ccc(OCC(C)(C)C(F)(F)F)n2)nc1N1C[C@@H](C)CC1(C)C |
Identifiers
PDB | — |
CAS-ID | 2216712-66-0 |
RxCUI | 2256951 |
ChEMBL ID | CHEMBL4298128 |
ChEBI ID | — |
PubChem CID | 134587348 |
DrugBank | DB15444 |
UNII ID | RRN67GMB0V (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
CFTR
CFTR
Organism
Homo sapiens
Gene name
CFTR
Gene synonyms
ABCC7
NCBI Gene ID
Protein name
cystic fibrosis transmembrane conductance regulator
Protein synonyms
ATP-binding cassette sub-family C member 7, cAMP-dependent chloride channel, Channel conductance-controlling ATPase, cystic fibrosis transmembrane conductance regulating, cystic fibrosis transmembrane conductance regulator (ATP-binding cassette sub-family C, member 7)
Uniprot ID
Mouse ortholog
Cftr (12638)
cystic fibrosis transmembrane conductance regulator (Q9JKQ6)
Variants
Clinical Variant
No data
Financial
Trikafta - Vertex Pharmaceuticals
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 942 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4,391 adverse events reported
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