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AboutPricing
Drug ReportsTezacaftor
Symdeko (copackaged), Symkevi(tezacaftor)
Alyftrek, Kaftrio, Symkevi (tezacaftor) is a small molecule pharmaceutical. Tezacaftor was first approved as Symkevi on 2018-10-31. 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
Combinations
Alyftrek, Symdeko, Trikafta
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
ALYFTREKVertex PharmaceuticalsN-218730 RX2024-12-20
2 products, RLD, RS
Ivacaftor
+
Ivacaftor
+
tezacaftor
Tradename
Company
Number
Date
Products
SYMDEKO (COPACKAGED)Vertex PharmaceuticalsN-210491 RX2018-02-12
2 products, RLD, RS
Elexacaftor
+
ivacaftor
+
tezacaftor
+
Ivacaftor
Tradename
Company
Number
Date
Products
TRIKAFTA (COPACKAGED)Vertex PharmaceuticalsN-212273 RX2019-10-21
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
alyftrekNew Drug Application2025-01-31
symdekoNew Drug Application2024-02-09
trikaftaNew Drug Application2024-12-26
vanzacaftor, tezacaftor, and deutivacaftorNew Drug Application2024-12-26
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
cystic fibrosisEFO_0000390D003550E84
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
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
— R07AX31: Ivacaftor and tezacaftor
— R07AX32: Ivacaftor, tezacaftor and elexacaftor
HCPCS
No data
Clinical
Clinical Trials
105 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cystic fibrosisD003550EFO_0000390E84101139—664
FibrosisD005355——41139—557
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTezacaftor
INNtezacaftor
Description
Tezacaftor is a drug used for the treatment of cystic fibrosis (CF) in people six years and older, who have a F508del mutation, the most common type of mutation in the CFTR gene. It is sold as a fixed-dose combination with ivacaftor under the brand name Symdeko. It was approved by the U.S. FDA in 2018. The combination of elexacaftor, tezacaftor, and ivacaftor is being sold as Trikafta.
Classification
Small molecule
Drug classcystic fibrosis transmembrane regulator (CFTR) protein modulators
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC(C)(CO)c1cc2cc(NC(=O)C3(c4ccc5c(c4)OC(F)(F)O5)CC3)c(F)cc2n1C[C@@H](O)CO
Identifiers
PDB—
CAS-ID1152311-62-0
RxCUI—
ChEMBL IDCHEMBL3544914
ChEBI ID—
PubChem CID46199646
DrugBankDB11712
UNII ID8RW88Y506K (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
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,025 documents
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Safety
Black-box Warning
Black-box warning for: Alyftrek, Trikafta, Vanzacaftor, tezacaftor, and deutivacaftor
Adverse Events
Top Adverse Reactions
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17,218 adverse events reported
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