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Kalydeco(ivacaftor)
Kaftrio, Kalydeco, Orkambi, Symdeko, Symkevi, Trikafta (ivacaftor) is a small molecule pharmaceutical. Ivacaftor was first approved as Kalydeco on 2012-01-31. 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
Top 200 Pharmaceuticals by Retail Sales
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
respiratory tract diseasesD012140
hereditary congenital and neonatal diseases and abnormalitiesD009358
Trade Name
FDA
EMA
Kalydeco
Combinations
Orkambi, Symdeko, 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 PharmaceuticalsN-212273 RX2019-10-21
2 products, RLD, RS
TRIKAFTA (COPACKAGED)Vertex PharmaceuticalsN-217660 RX2023-04-26
2 products, RLD, RS
Ivacaftor
Tradename
Company
Number
Date
Products
KALYDECOVertex PharmaceuticalsN-203188 RX2012-01-31
1 products, RLD, RS
KALYDECOVertex PharmaceuticalsN-207925 RX2015-03-17
5 products, RLD, RS
Ivacaftor
+
Ivacaftor
+
tezacaftor
Tradename
Company
Number
Date
Products
SYMDEKO (COPACKAGED)Vertex PharmaceuticalsN-210491 RX2018-02-12
2 products, RLD, RS
Ivacaftor
+
Lumacaftor
Tradename
Company
Number
Date
Products
ORKAMBIVertex PharmaceuticalsN-206038 RX2015-07-02
2 products, RLD, RS
ORKAMBIVertex PharmaceuticalsN-211358 RX2018-08-07
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
kalydecoNew Drug Application2020-12-21
orkambiNew Drug Application2020-05-11
symdekoNew Drug Application2021-08-03
trikaftaNew Drug Application2021-10-11
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
cystic fibrosisEFO_0000390D003550E84
Agency Specific
FDA
EMA
Expiration
Code
IVACAFTOR / LUMACAFTOR, ORKAMBI, VERTEX PHARMS INC
2029-09-02ODE-408
2025-09-02NPP, NS
2025-08-07ODE-195
2023-09-28ODE-123
ELEXACAFTOR, IVACAFTOR, TEZACAFTOR / IVACAFTOR, TRIKAFTA (COPACKAGED), VERTEX PHARMS INC
2028-06-08ODE-357
2027-12-21ODE-323
2026-10-21ODE-275
2026-04-26NP
2024-10-21NCE
2024-06-08NPP
2023-02-12NCE
IVACAFTOR, KALYDECO, VERTEX PHARMS
2027-12-21ODE-338
2025-08-15ODE-199
2024-07-31ODE-189
2024-05-17ODE-190
IVACAFTOR, KALYDECO, VERTEX PHARMS INC
2027-12-21ODE-338
2026-04-29ODE-236
2025-08-15ODE-199
2024-07-31ODE-189
2024-05-17ODE-190
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
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-2248, U-2649, U-3154
88832062033-02-27DP
102720462033-02-27DPU-2531, U-2967, U-3599, U-3605
111477702033-02-27DPU-3339, U-3598, U-3604
100816212031-03-25DPU-2420, U-2571, U-2652, U-3024, U-3025, U-3032, U-3157, U-3600
115780622031-03-25DPU-3544, U-3545, U-3584
106464812029-08-13DP
115649162029-08-13U-3525, U-3526, U-3527, U-3528, U-3529, U-3530, U-3585, U-3603
84153872027-11-12U-2246, U-2645, U-3028, U-3144, U-3589
83242422027-08-05U-1311, U-1906, U-1911, U-2246, U-2374, U-2527, U-2645, U-2963, U-3028, U-3144, U-3424, U-3589, U-3609
77769052027-06-03DS, DP
74951032027-05-20DS, DP
76457892027-05-01DS, DP
85981812027-05-01U-2246, U-2645, U-3028, U-3144, U-3589
86239052027-05-01DS, DP
99747812027-04-09DPU-2318, U-2574, U-2645, U-3028, U-3144, U-3589
100223522027-04-09DPU-2343, U-2573, U-2651, U-3156, U-3596
102398672027-04-09DS, DPU-2512, U-2569, U-2653, U-3033, U-3158, U-3590
116393472027-04-09DS, DPU-2569, U-3583, U-3587
84102742026-12-28DP
87542242026-12-28DS, DP
96701632026-12-28DPU-1311, U-1911, U-2246, U-2376, U-2530, U-2650, U-2966, U-3031, U-3155, U-3429, U-3591, U-3606
99313342026-12-28DPU-2275, U-2276, U-2376, U-2575, U-2650, U-3031, U-3155, U-3429, U-3591
83544272026-07-06U-1311, U-1905, U-2528, U-2646, U-2964, U-3021, U-3029, U-3145, U-3593, U-3608
86291622025-06-24U-2234, U-2247, U-2529, U-2648, U-2965, U-3030, U-3146, U-3592, U-3607
Ivacaftor / Ivacaftor, Tezacaftor, Symdeko (Copackaged), Vertex Pharms Inc
102068772035-04-14DPU-2498, U-2570, U-3026, U-3027
100585462033-07-15U-2399, U-2572, U-3022, U-3023
Ivacaftor / Lumacaftor, Orkambi, Vertex Pharms Inc
89936002030-12-11DP
85075342030-09-20DS, DP
87163382030-09-20DPU-1718, U-1910, U-2396, U-3426
91926062029-09-29DPU-1912, U-2397, U-3428
88467182029-07-02U-1717, U-1908, U-2375, U-3427
86531032028-12-04DP
91505522028-12-04U-1908, U-2375, U-3427
100765132028-12-04DPU-2411
105973842028-12-04DS, DPU-2777, U-2778, U-3430
110520752028-12-04DPU-3181
79730382026-11-08U-1973, U-2374, U-3424
87419332026-11-08U-1717, U-1909, U-2374, U-3424
92169692026-11-08DP
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
— R07AX02: Ivacaftor
— R07AX30: Ivacaftor and lumacaftor
— R07AX31: Ivacaftor and tezacaftor
— R07AX32: Ivacaftor, tezacaftor and elexacaftor
HCPCS
No data
Clinical
Clinical Trials
93 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cystic fibrosisD003550EFO_0000390E8412152452581
Chronic bronchitisD029481J42—1—1—2
Drug interactionsD004347———1—1
Gastrointestinal diseasesD005767———1—1
Medication adherenceD055118EFO_0006344———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Lung diseasesD008171EFO_0003818J98.4——1—12
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.912———3
Long qt syndromeD008133HP_0001657I45.81—1———1
Ciliary motility disordersD002925EFO_0003900—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—3————3
Hepatic insufficiencyD0485501————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Glucose intoleranceD018149HP_0000833R73.03————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameIVACAFTOR
INNivacaftor
Description
Ivacaftor is an aromatic amide obtained by formal condensation of the carboxy group of 4-oxo-1,4-dihydroquinoline-3-carboxylic acid with the amino group of 5-amino-2,4-di-tert-butylphenol. Used for the treatment of cystic fibrosis. It has a role as a CFTR potentiator and an orphan drug. It is a quinolone, a member of phenols, an aromatic amide and a monocarboxylic acid amide.
Classification
Small molecule
Drug classcystic fibrosis transmembrane regulator (CFTR) protein modulators
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CC(C)(C)c1cc(C(C)(C)C)c(NC(=O)c2c[nH]c3ccccc3c2=O)cc1O
Identifiers
PDB—
CAS-ID873054-44-5
RxCUI1243041
ChEMBL IDCHEMBL2010601
ChEBI ID66901
PubChem CID16220172
DrugBankDB08820
UNII ID1Y740ILL1Z (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
VCV002502286CFTR, 3808G>T, Asp1270Tyrdrug response2021-03-241A
VCV000196277CFTR, 220C>T, Arg74Trpdrug response2021-03-241A
VCV000053714CFTR, 330C>A, Asp110Gludrug response2021-03-241A
VCV000053688CFTR, 3222T>A, Phe1074Leudrug response2021-03-241A
VCV000053685CFTR, 3208C>T, Arg1070Trpdrug response2021-03-241A
VCV000053671CFTR, 3179A>C, Lys1060Thrdrug response2021-03-241A
VCV000053601CFTR, 2930C>T, Ser977Phedrug response2021-03-241A
VCV000053365CFTR, 1736A>G, Asp579Glydrug response2021-03-241A
VCV000035867CFTR, 3454G>C, Asp1152Hisdrug response2021-03-241A
VCV000035866CFTR, 3209G>A, Arg1070Glndrug response2021-03-241A
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Financial
Trikafta - Vertex Pharmaceuticals
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Kalydeco - Vertex Pharmaceuticals
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Orkambi - Vertex Pharmaceuticals
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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 3,349 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,602 adverse events reported
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