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AboutPricing
Drug ReportsElexacaftor
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
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
respiratory tract diseasesD012140
hereditary congenital and neonatal diseases and abnormalitiesD009358
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name
Status
Last Update
trikaftaNew Drug Application2024-12-26
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR / IVACAFTOR, TRIKAFTA (COPACKAGED), VERTEX PHARMS INC
2030-04-26ODE-433
2028-06-08ODE-357
2027-12-21ODE-323
2026-10-21ODE-275
2026-04-26NP
2024-10-21NCE
2024-06-08NPP
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
117521062033-02-27DPU-3696
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
58 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
FibrosisD005355——132312552
Drug interactionsD004347—————1—1
BronchiectasisD001987HP_0002110J47———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cystic fibrosisD003550EFO_0000390E841323—3056
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
Paranasal sinus diseasesD010254——————22
Lung diseasesD008171HP_0002088J98.4————22
Medication adherenceD055118EFO_0006344—————11
Respiratory signs and symptomsD012818——————11
InfectionsD007239EFO_0000544—————11
PneumoniaD011014EFO_0003106—————11
InflammationD007249MP_0001845—————11
Communicable diseasesD003141——————11
Bacterial infectionsD001424—A49————11
Symptom flare upD000067251——————11
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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)Loading
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
RxCUI—
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
No data
Financial
Revenue by drug
$
€
£
â‚£
Trikafta – Vertex Pharmaceuticals
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,574 documents
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Safety
Black-box Warning
Black-box warning for: Trikafta
Adverse Events
Top Adverse Reactions
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11,836 adverse events reported
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