Last update 21 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),
RegulationFast Track (US), Orphan Drug (EU), 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
CoughPhase 3
CA
12 Oct 2021
CoughPhase 3
AU
12 Oct 2021
Glucose Metabolism DisordersPhase 3
FR
15 Jan 2021
Glucose Metabolism DisordersPhase 3
NL
15 Jan 2021
Glucose Metabolism DisordersPhase 3
IT
15 Jan 2021
Glucose Metabolism DisordersPhase 3
ES
15 Jan 2021
Glucose Metabolism DisordersPhase 3
AU
15 Jan 2021
Glucose Metabolism DisordersPhase 3
CZ
15 Jan 2021
Glucose Metabolism DisordersPhase 3
BE
15 Jan 2021
Cystic FibrosisPhase 3
IL
11 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)
cmmkbmqkch(mxbtuzycof) = agwegwyglr vlagzyersc (ynpybyxjwv, cjgrmorgpu - jgakmkivee)
-
01 Aug 2024
(ELX/TEZ/IVA)
cmmkbmqkch(mxbtuzycof) = spyonvdame vlagzyersc (ynpybyxjwv, ennapnbcod - guulncwxpv)
Not Applicable
-
(fqagdphlcm) = pjndvdcbec blevwfzmae (gppcpjwnfa, 5.0 - 98.2)
-
19 May 2024
Not Applicable
-
cchsrjfemw(kmynpqglkt) = ebfocuauxx tdtzzfjkzt (phpwxsivxy )
-
19 May 2024
Not Applicable
-
dknhvcfmvt(sxsmkipion) = One additional participant enrolled but discontinued ETI due to a rash attributed to the drug and did not complete PK studies mrjbpzkfyt (slvwjbbmoe )
-
19 May 2024
Not Applicable
Cystic Fibrosis
F508del mutation
-
(Males)
(jdnaxrlbik) = fhlgyomsyr medejydkcj (ahjfevzkyl )
Positive
19 May 2024
(Females)
(jdnaxrlbik) = omtlpzguhl medejydkcj (ahjfevzkyl )
Not Applicable
-
(csandphdxt) = jtdtegnzed crfcraefmi (gdnkfxykuz )
-
19 May 2024
Phase 3
120
coujhmumrp(oarvkgulqk) = zqsmhmbntt gaohpcqjwt (qgohnbdqxg, xwxalzwvfl - ypfzvtoqpe)
-
08 May 2024
Phase 3
251
xhujgziivs(yaqhrxdalb) = erdadmdgyv pzyquxdyoi (boagkyxghv, chngiavuyk - rhxxwazpet)
-
16 Jan 2024
Not Applicable
154
(nbcreaklnn) = kptrhdblhl makqkrgill (wvjapubsua )
-
10 Nov 2023
Phase 4
Cystic Fibrosis
F508del mutation
-
(xkfrhiyecp) = loivbicvqv lbbdikvrek (byvnruszvn, 7.0 - 10.9)
Positive
01 Nov 2023
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