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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
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
respiratory tract diseasesD012140
hereditary congenital and neonatal diseases and abnormalitiesD009358
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)
Elexacaftor
+
ivacaftor
+
tezacaftor
+
Ivacaftor
Tradename
Company
Number
Date
Products
TRIKAFTA (COPACKAGED)Vertex PharmaceuticalsN-212273 RX2019-10-21
2 products, RLD, RS
TRIKAFTA (COPACKAGED)Vertex PharmaceuticalsN-217660 RX2023-04-26
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
trikaftaNew Drug Application2020-12-22
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
cystic fibrosisEFO_0000390D003550E84
Agency Specific
FDA
EMA
Expiration
Code
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR / IVACAFTOR, TRIKAFTA (COPACKAGED), VERTEX PHARMS INC
2028-06-08ODE-357
2027-12-21ODE-323
2026-10-21ODE-275
2026-04-26NP
2024-10-21NCE
2024-06-08NPP
2023-02-12NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Elexacaftor, Ivacaftor, Tezacaftor / Ivacaftor, Trikafta (Copackaged), Vertex Pharms Inc
107935472037-12-08DS, DPU-2645, U-3028, U-3144, U-3588
111793672037-12-08DPU-3253, U-3597
114536552037-12-08DS, DP
115175642037-12-08DPU-3498, U-3586
107585342035-10-06DS, DPU-2645, U-3028, U-3144, U-3589
114264072035-10-06DS, DPU-3425, U-3595
90124962033-07-15U-2649, U-3154
88832062033-02-27DP
102720462033-02-27DPU-3599
111477702033-02-27DPU-3598
100816212031-03-25DPU-2652, U-3032, U-3157, U-3600
115780622031-03-25DPU-3544, U-3584
106464812029-08-13DP
115649162029-08-13U-3525, U-3585
84153872027-11-12U-2645, U-3028, U-3144, U-3589
83242422027-08-05U-2645, U-3028, U-3144, U-3589
77769052027-06-03DS, DP
74951032027-05-20DS, DP
76457892027-05-01DS, DP
85981812027-05-01U-2645, U-3028, U-3144, U-3589
86239052027-05-01DS, DP
99747812027-04-09DPU-2645, U-3028, U-3144, U-3589
100223522027-04-09DPU-2651, U-3156, U-3596
102398672027-04-09DS, DPU-2653, U-3033, U-3158, U-3590
116393472027-04-09DS, DPU-3583, U-3587
84102742026-12-28DP
87542242026-12-28DS, DP
96701632026-12-28DPU-2650, U-3031, U-3155, U-3591
99313342026-12-28DPU-2650, U-3031, U-3155, U-3591
83544272026-07-06U-2646, U-3029, U-3145, U-3593
86291622025-06-24U-2648, U-3030, U-3146, U-3592
ATC Codes
R: Respiratory system drugs
— R07: Other respiratory system products in atc
— R07A: Other respiratory system products in atc
— R07AX: Other respiratory system products in atc
— R07AX32: Ivacaftor, tezacaftor and elexacaftor
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 fibrosisD003550EFO_0000390E841232916
Drug interactionsD004347———1—1
Gastrointestinal diseasesD005767———1—1
Medication adherenceD055118EFO_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 diseasesD008171EFO_0003818J98.4————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameELEXACAFTOR
INNelexacaftor
Description
Elexacaftor is a medication that acts as cystic fibrosis transmembrane conductance regulator (CFTR) corrector.
Classification
Small molecule
Drug classcystic 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-ID2216712-66-0
RxCUI2256951
ChEMBL IDCHEMBL4298128
ChEBI ID—
PubChem CID134587348
DrugBankDB15444
UNII IDRRN67GMB0V (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
CFTR
CFTR
Organism
Homo sapiens
Gene name
CFTR
Gene synonyms
ABCC7
NCBI Gene ID
1080
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
Q2I102
Mouse ortholog
Cftr (12638)
cystic fibrosis transmembrane conductance regulator (Q9JKQ6)
Variants
Clinical Variant
No data
Financial
Trikafta - Vertex Pharmaceuticals
$
€
£
₣
Mock data
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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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