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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Commercial
Therapeutic Areas
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 Pharmaceuticals | N-217660 RX | 2023-04-26 | 2 products, RLD, RS |
| TRIKAFTA (COPACKAGED) | Vertex Pharmaceuticals | N-212273 RX | 2019-10-21 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| trikafta | New Drug Application | 2025-02-12 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| cystic fibrosis | EFO_0000390 | D003550 | E84 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR / IVACAFTOR, TRIKAFTA (COPACKAGED), VERTEX PHARMS INC | |||
| 2030-04-26 | ODE-433 | ||
| 2028-06-08 | ODE-357 | ||
| 2027-12-21 | ODE-323 | ||
| 2026-10-21 | ODE-275 | ||
| 2026-04-26 | NP | ||
| 2024-10-21 | NCE | ||
| 2024-06-08 | NPP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Elexacaftor, Ivacaftor, Tezacaftor / Ivacaftor, Trikafta (Copackaged), Vertex Pharms Inc | |||
| 10793547 | 2037-12-08 | DS, DP | U-2645, U-3028, U-3144, U-3588 |
| 11179367 | 2037-12-08 | DP | U-3253, U-3597 |
| 11453655 | 2037-12-08 | DS, DP | |
| 11517564 | 2037-12-08 | DP | U-3498, U-3586 |
| 10758534 | 2035-10-06 | DS, DP | U-2645, U-3028, U-3144, U-3589 |
| 11426407 | 2035-10-06 | DS, DP | U-3425, U-3595 |
| 9012496 | 2033-07-15 | U-2649, U-3154 | |
| 8883206 | 2033-02-27 | DP | |
| 10272046 | 2033-02-27 | DP | U-3599 |
| 11147770 | 2033-02-27 | DP | U-3598 |
| 11752106 | 2033-02-27 | DP | U-3696 |
| 10081621 | 2031-03-25 | DP | U-2652, U-3032, U-3157, U-3600 |
| 11578062 | 2031-03-25 | DP | U-3544, U-3584 |
| 10646481 | 2029-08-13 | DP | |
| 11564916 | 2029-08-13 | U-3525, U-3585 | |
| 8415387 | 2027-11-12 | U-2645, U-3028, U-3144, U-3589 | |
| 8324242 | 2027-08-05 | U-2645, U-3028, U-3144, U-3589 | |
| 7776905 | 2027-06-03 | DS, DP | |
| 7495103 | 2027-05-20 | DS, DP | |
| 7645789 | 2027-05-01 | DS, DP | |
| 8598181 | 2027-05-01 | U-2645, U-3028, U-3144, U-3589 | |
| 8623905 | 2027-05-01 | DS, DP | |
| 9974781 | 2027-04-09 | DP | U-2645, U-3028, U-3144, U-3589 |
| 10022352 | 2027-04-09 | DP | U-2651, U-3156, U-3596 |
| 10239867 | 2027-04-09 | DS, DP | U-2653, U-3033, U-3158, U-3590 |
| 11639347 | 2027-04-09 | DS, DP | U-3583, U-3587 |
| 8410274 | 2026-12-28 | DP | |
| 8754224 | 2026-12-28 | DS, DP | |
| 9670163 | 2026-12-28 | DP | U-2650, U-3031, U-3155, U-3591 |
| 9931334 | 2026-12-28 | DP | U-2650, U-3031, U-3155, U-3591 |
| 8354427 | 2026-07-06 | U-2646, U-3029, U-3145, U-3593 | |
| 8629162 | 2025-06-24 | U-2648, U-3030, U-3146, U-3592 | |
HCPCS
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Clinical
Clinical Trials
61 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 | 1 | 3 | 23 | 2 | 31 | 59 |
| Fibrosis | D005355 | — | — | 1 | 1 | 19 | 1 | 24 | 45 |
| Medication adherence | D055118 | EFO_0006344 | — | — | — | — | 1 | 1 | 2 |
| Drug interactions | D004347 | — | — | — | — | — | 1 | — | 1 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | — | — | 1 | — | 1 |
| Gastrointestinal diseases | D005767 | — | — | — | — | — | 1 | — | 1 |
| Digestive system diseases | D004066 | EFO_0000405 | K92.9 | — | — | — | 1 | — | 1 |
| Bronchiectasis | D001987 | — | J47 | — | — | — | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Paranasal sinus diseases | D010254 | — | — | — | — | — | — | 2 | 2 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | — | — | — | 2 | 2 |
| Pseudomonas infections | D011552 | EFO_0001076 | A41.52 | — | — | — | — | 1 | 1 |
| Respiratory signs and symptoms | D012818 | — | — | — | — | — | — | 1 | 1 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 1 | 1 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | — | — | 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 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Elexacaftor |
| INN | elexacaftor |
| Description | Elexacaftor is a medication that acts as cystic fibrosis transmembrane conductance regulator (CFTR) corrector.
|
| Classification | Small molecule |
| Drug class | cystic 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-ID | 2216712-66-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4298128 |
| ChEBI ID | — |
| PubChem CID | 134587348 |
| DrugBank | DB15444 |
| UNII ID | RRN67GMB0V (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
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Trikafta – Vertex Pharmaceuticals
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Tabular view
Estimated US medical usage
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Trikafta
Adverse Events
Top Adverse Reactions
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13,896 adverse events reported
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