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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Commercial
Therapeutic Areas
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 Pharmaceuticals | N-210491 RX | 2018-02-12 | 2 products, RLD, RS |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| cystic fibrosis | EFO_0000390 | D003550 | E84 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
IVACAFTOR / IVACAFTOR, TEZACAFTOR, SYMDEKO (COPACKAGED), VERTEX PHARMS INC | |||
| 2027-12-21 | ODE-335 | ||
| 2026-06-21 | ODE-247 | ||
| 2025-02-12 | ODE-173 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Ivacaftor / Ivacaftor, Tezacaftor, Symdeko (Copackaged), Vertex Pharms Inc | |||
| 10206877 | 2035-04-14 | DP | U-2498, U-2570, U-3026, U-3027 |
| 9012496 | 2033-07-15 | U-2248 | |
| 10058546 | 2033-07-15 | U-2399, U-2572, U-3022, U-3023 | |
| 10081621 | 2031-03-25 | DP | U-2420, U-2571, U-3024, U-3025 |
| 11578062 | 2031-03-25 | DP | U-3545 |
| 10646481 | 2029-08-13 | DP | |
| 11564916 | 2029-08-13 | U-3527 | |
| 8415387 | 2027-11-12 | U-2246 | |
| 8324242 | 2027-08-05 | U-2246 | |
| 7776905 | 2027-06-03 | DS, DP | |
| 7495103 | 2027-05-20 | DS, DP | |
| 7645789 | 2027-05-01 | DS, DP | |
| 8598181 | 2027-05-01 | U-2246 | |
| 8623905 | 2027-05-01 | DS, DP | |
| 9974781 | 2027-04-09 | DP | U-2318, U-2574 |
| 10022352 | 2027-04-09 | DP | U-2343, U-2573 |
| 10239867 | 2027-04-09 | DS, DP | U-2512, U-2569 |
| 11639347 | 2027-04-09 | DS, DP | U-2569 |
| 8410274 | 2026-12-28 | DP | |
| 8754224 | 2026-12-28 | DS, DP | |
| 9670163 | 2026-12-28 | DP | U-2246 |
| 9931334 | 2026-12-28 | DP | U-2275, U-2575 |
| 8354427 | 2026-07-06 | U-3021 | |
| 8629162 | 2025-06-24 | U-2247 | |
HCPCS
No data
Clinical
Clinical Trials
107 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 | 11 | 13 | 39 | 2 | 42 | 105 |
| Fibrosis | D005355 | — | — | 4 | 13 | 39 | 2 | 35 | 91 |
| Medication adherence | D055118 | EFO_0006344 | — | — | — | — | 1 | 2 | 3 |
| Drug interactions | D004347 | — | — | — | — | — | 1 | — | 1 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | — | — | — | 1 | — | 1 |
| Gastrointestinal diseases | D005767 | — | — | — | — | — | 1 | — | 1 |
| Digestive system diseases | D004066 | HP_0011024 | K92.9 | — | — | — | 1 | — | 1 |
| Bronchiectasis | D001987 | HP_0002110 | J47 | — | — | — | 1 | — | 1 |
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Paranasal sinus diseases | D010254 | — | — | — | — | — | — | 2 | 2 |
| Lung diseases | D008171 | HP_0002088 | J98.4 | — | — | — | — | 2 | 2 |
| Respiratory signs and symptoms | D012818 | — | — | — | — | — | — | 1 | 1 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 1 | 1 |
| Pneumonia | D011014 | EFO_0003106 | — | — | — | — | — | 1 | 1 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | — | 1 | 1 |
| Communicable diseases | D003141 | — | — | — | — | — | — | 1 | 1 |
| Bacterial infections | D001424 | — | A49 | — | — | — | — | 1 | 1 |
| Symptom flare up | D000067251 | — | — | — | — | — | — | 1 | 1 |
| Hereditary congenital and neonatal diseases and abnormalities | D009358 | — | — | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Tezacaftor |
| INN | tezacaftor |
| 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 class | cystic 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-ID | 1152311-62-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3544914 |
| ChEBI ID | — |
| PubChem CID | 46199646 |
| DrugBank | DB11712 |
| UNII ID | 8RW88Y506K (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
No data
Financial
Revenue by drug
$
€
£
â‚£
Symdeko – 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 1,891 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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15,898 adverse events reported
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