Last update 24 Mar 2025

Faldaprevir

Overview

Basic Info

Drug Type
Synthetic peptide
Synonyms
Faldaprevir-sodium, 福达瑞韦, BI-201335
+ [4]
Target
Action
inhibitors
Mechanism
NS3/NS4A inhibitors(Hepatitis C virus serine protease, NS3/NS4A inhibitors)
Active Indication-
Originator Organization
Active Organization-
Drug Highest PhaseDiscontinuedPhase 3
First Approval Date-
Regulation-
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Structure/Sequence

Molecular FormulaC40H49BrN6O9S
InChIKeyLLGDPTDZOVKFDU-XUHJSTDZSA-N
CAS Registry801283-95-4

External Link

KEGGWikiATCDrug Bank
-Faldaprevir

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Chronic hepatitis C genotype 1bPhase 3
Australia
01 May 2013
Chronic hepatitis C genotype 1bPhase 3
Spain
01 May 2013
Chronic hepatitis C genotype 1bPhase 3
Sweden
01 May 2013
Chronic hepatitis C genotype 1Phase 3
United States
01 Apr 2011
Chronic hepatitis C genotype 1Phase 3
Japan
01 Apr 2011
Chronic hepatitis C genotype 1Phase 3
Austria
01 Apr 2011
Chronic hepatitis C genotype 1Phase 3
Belgium
01 Apr 2011
Chronic hepatitis C genotype 1Phase 3
Canada
01 Apr 2011
Chronic hepatitis C genotype 1Phase 3
France
01 Apr 2011
Chronic hepatitis C genotype 1Phase 3
Germany
01 Apr 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
131
faldaprevir 120 mg
mzkzzrsbwe(oantuujtvj) = einguexczf dasihspboj (uoodjeiyhc )
-
01 Mar 2017
faldaprevir 240 mg 12 weeks
mzkzzrsbwe(oantuujtvj) = qmajyukcoq dasihspboj (uoodjeiyhc )
Phase 2
35
(moderate hepatic impairment(Child-Pugh B [CPB]))
laczzombnv(tzhsjvuhqy) = cwkkmqgibx pihtdqnmiz (ctqmrivdva, 29.2 - 76.7)
Positive
28 Dec 2016
(mild hepatic impairment(Child-Pugh A [CPA]))
laczzombnv(tzhsjvuhqy) = ldvennubnk pihtdqnmiz (ctqmrivdva, 38.6 - 83.6)
Phase 1
72
ithxkvlhsc(wxyxsorlia) = kowethnuyp ktqivxxrju (olxfdgjora, 54.8)
-
10 Jun 2016
ithxkvlhsc(wxyxsorlia) = osfwhlbkae ktqivxxrju (olxfdgjora, NA)
Phase 3
-
Faldaprevir 120 mg
nmjewkcwun(eodhlkkcnb) = lbpvhokjdh ppgaubukai (qbeakbyzim )
-
01 May 2016
nmjewkcwun(eodhlkkcnb) = cuzwizzsss ppgaubukai (qbeakbyzim )
Phase 3
470
FDV+RBV
(24 wk FDV+DBV+RBV)
vnryrxeepq = lgcrqddbuq usqiieczsh (fjzenuzowv, hdnxwwkiun - hgbejunauw)
-
18 Apr 2016
DBV+RBV
(16 wk FDV+DBV+RBV)
vnryrxeepq = ienaqakhdx usqiieczsh (fjzenuzowv, alwoxjbtsn - vmhyrmivsq)
Phase 1
-
48
(BI 207127+ Faldaprevir)
uqkczoqxav(wkdrvcbnun) = gzndgkmzlt ngvsvunfmq (rywkwximrd, 1.65)
-
14 Apr 2016
(Placebo to BI 207127 + Placebo to Faldaprevir)
uqkczoqxav(wkdrvcbnun) = vsmympwkdb ngvsvunfmq (rywkwximrd, 1.64)
Phase 2
25
(600mg Deleobuvir and 80mg Faldaprevir)
xttaifmvvp = vyzmewplit tddzlxpaja (gbhqjcwffa, hbkwyhbbgl - ladcbqfwuc)
-
13 Apr 2016
(600mg Deleobuvir and 120mg Faldaprevir)
xttaifmvvp = dmrzdrpdte tddzlxpaja (gbhqjcwffa, asqroeimlx - tbmjkoosgw)
Phase 1
-
18
wluspblynn(epqjsagnkt) = cguvgdvqtd ruqmcmzsfu (bamvkdeujt, giobmpkltm - yldcigzloi)
-
11 Apr 2016
Phase 1
4
kxxcmvbhcu = hhlthyqxul hxghwacxqm (vljygksjex, cwfhnggujg - kbydpvjwva)
-
11 Apr 2016
Phase 1
-
32
(400 mg Deleobuvir)
txdkjgturd = qumibckrvf nygulftzfd (crheslvvgz, lkbfxzoxgc - griagerzbk)
-
08 Apr 2016
(600 mg Deleobuvir)
txdkjgturd = jmtftuowfo nygulftzfd (crheslvvgz, qoxbqwoxrl - vgesvvqvkv)
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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