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Symdeko (copackaged), Symkevi(tezacaftor)
Kaftrio, Symdeko, Symkevi (tezacaftor) is a small molecule pharmaceutical. Tezacaftor was first approved as Symdeko (copackaged) on 2018-02-12. 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
Symdeko
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ivacaftor
+
Ivacaftor
+
tezacaftor
Tradename
Company
Number
Date
Products
SYMDEKO (COPACKAGED)Vertex PharmaceuticalsN-210491 RX2018-02-12
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
symdekoNew Drug Application2020-12-21
trikaftaNew Drug Application2022-12-16
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
IVACAFTOR / IVACAFTOR, TEZACAFTOR, SYMDEKO (COPACKAGED), VERTEX PHARMS INC
2027-12-21ODE-335
2026-06-21ODE-247
2025-02-12ODE-173
2023-02-12NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Ivacaftor / Ivacaftor, Tezacaftor, Symdeko (Copackaged), Vertex Pharms Inc
102068772035-04-14DPU-2498, U-2570, U-3026, U-3027
90124962033-07-15U-2248
100585462033-07-15U-2399, U-2572, U-3022, U-3023
100816212031-03-25DPU-2420, U-2571, U-3024, U-3025
115780622031-03-25DPU-3545
106464812029-08-13DP
115649162029-08-13U-3527
84153872027-11-12U-2246
83242422027-08-05U-2246
77769052027-06-03DS, DP
74951032027-05-20DS, DP
76457892027-05-01DS, DP
85981812027-05-01U-2246
86239052027-05-01DS, DP
99747812027-04-09DPU-2318, U-2574
100223522027-04-09DPU-2343, U-2573
102398672027-04-09DS, DPU-2512, U-2569
116393472027-04-09DS, DPU-2569
84102742026-12-28DP
87542242026-12-28DS, DP
96701632026-12-28DPU-2246
99313342026-12-28DPU-2275, U-2575
83544272026-07-06U-3021
86291622025-06-24U-2247
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
23 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_0000390E843552823
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
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)
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
RxCUI1999382
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
Clinical Variant
Identifier
Target mutation
Effect
Evaluation
Status
VCV000007105CFTR, 1521_1523del, Phe508delPathogenic2004-03-031A
Financial
Symdeko - Vertex Pharmaceuticals
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,239 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,265 adverse events reported
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