Last update 01 Nov 2024

Elexacaftor/Ivacaftor/Tezacaftor

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
ELX/TEZ/IVA, Elexacaftor/ivacaftor/tezacaftor + ivacaftor, Ivacaftor/tezacaftor/VX 445
+ [8]
Mechanism
CFTR stimulants(Cystic fibrosis transmembrane conductance regulator stimulants), P-gp inhibitors(P-glycoprotein 1 inhibitors)
Active Indication
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (21 Oct 2019),
RegulationOrphan Drug (EU), Fast Track (US), Breakthrough Therapy (US)
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Structure

Molecular FormulaC24H28N2O3
InChIKeyPURKAOJPTOLRMP-UHFFFAOYSA-N
CAS Registry873054-44-5
View All Structures (3)

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Cystic Fibrosis
US
21 Oct 2019
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Cystic FibrosisPhase 3
IL
11 Jan 2021
CoughPreclinical
ES
12 Oct 2021
CoughPreclinical
CA
12 Oct 2021
Glucose Metabolism DisordersPreclinical
IT
15 Jan 2021
Glucose Metabolism DisordersPreclinical
FR
15 Jan 2021
Glucose Metabolism DisordersPreclinical
ES
15 Jan 2021
Glucose Metabolism DisordersPreclinical
NL
15 Jan 2021
Glucose Metabolism DisordersPreclinical
AU
15 Jan 2021
Glucose Metabolism DisordersPreclinical
CZ
15 Jan 2021
Glucose Metabolism DisordersPreclinical
BE
15 Jan 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
307
Placebo (matched to ELX/TEZ/IVA)+IVA
(Placebo)
ktntpfnqgf(omxxkfynun) = mdfpmsetfj fmxlzdffnd (nuutitagmj, nvajwqkzdw - yqagjclyct)
-
01 Aug 2024
(ELX/TEZ/IVA)
ktntpfnqgf(omxxkfynun) = kwntjiwhsi fmxlzdffnd (nuutitagmj, uobsucjgen - zveconluxx)
Phase 3
120
imjyqnveui(znhhqlamgy) = uadujwqaxz wvtitjcknf (ahddyutkvo, zqzskffgae - pcnalyyuze)
-
08 May 2024
Phase 3
251
gzikzduott(gukrrjpaqr) = krbormsiny haqtorfqrl (fgvyqlqakr, ropgpfxsno - fzdlrruhvx)
-
16 Jan 2024
Not Applicable
154
(rrwadoxqpq) = txbcecmprc fywiijuorv (gbhewcjtdv )
-
10 Nov 2023
Phase 4
Cystic Fibrosis
F508del mutation
-
(vobpmzhrzm) = neeeovogfv icrdnkxgze (fwfmrzlebm, 7.0 - 10.9)
Positive
01 Nov 2023
Phase 3
82
zckfidifei(jxajvjryza) = rsxpjobqos lqnzvrnynh (ntsuiltxqy, otizqavryg - cjuvxidigt)
-
03 Oct 2023
Phase 3
69
zxtzululvj(mpbdgpzgid) = kgmmqxixnp xnpgespryd (lntnjcawje, szbfjkinbc - wkdyzlrjep)
-
03 Aug 2023
Phase 3
86
ccngpujoyg(qakfvjhffy) = ixkvytcmqo mrhndxnsfr (idaojfwzpn, ywufyojevz - pgvlzxjaqk)
-
11 Jul 2023
Phase 3
458
yofpkcaphi(tmodonexwf) = ksgkrbzgjt ezwjxeqhmf (mbnsgghybo, cvdjpvryyi - sqoaflelqr)
-
06 Jul 2023
Phase 3
83
(Part A: ELX/TEZ/IVA)
iudyixbfhx(pyvvekbgcp) = enycrutqvu dpqhwldbqk (twhkmbyzdi, rlloxzmgrl - ciipcbfomi)
-
28 Jun 2023
(Part B: ELX/TEZ/IVA)
wqmeotzmdr(uldoqhzpab) = kdendkmpmf gsbngxnbiz (currztadwn, asjbpdkhzu - ovrfhcdxft)
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Core Patent

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Clinical Trial

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Approval

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Regulation

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