Last update 06 Dec 2024

Valganciclovir Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Cymeval, Valganciclovir, Valganciclovir hydrochloride (JAN/USP)
+ [21]
Mechanism
DNA-directed DNA polymerase inhibitors
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (29 Mar 2001),
RegulationOrphan Drug (KR)
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Structure

Molecular FormulaC14H23ClN6O5
InChIKeyZORWARFPXPVJLW-MTFPJWTKSA-N
CAS Registry175865-59-5

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Virus Diseases
CN
13 Dec 2005
Acquired Immunodeficiency Syndrome
JP
05 Nov 2004
Cytomegalovirus Infections
AU
17 Jun 2002
Cytomegalovirus Retinitis
US
29 Mar 2001
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Peripheral Stem Cell TransplantationPhase 3
US
01 Nov 2001
HIV InfectionsPhase 3
CA
01 Jan 1997
Hearing Loss, SensorineuralPhase 2
US
31 Aug 2018
Chronic Lymphocytic LeukemiaPhase 2
US
01 Sep 2003
Human herpesvirus 8 infectionPhase 2
US
01 Dec 2002
Cystic FibrosisPhase 1
US
01 Dec 2004
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
137
euhfydnfqu(hrkyfggfds) = kbbetrdirq fkeidnoixb (bepsjfsxva )
Positive
01 Jun 2024
Valganciclovir
euhfydnfqu(hrkyfggfds) = lfennpirhh fkeidnoixb (bepsjfsxva )
Phase 3
-
Valganciclovir (dose-adjusted for renal clearance)
qqqjonqyer(bfatreyygq) = fbcgzcyyuz ipumhyyiyp (cmxlzdstqc )
Negative
30 Nov 2023
Not Applicable
33
(sfonevyxcp) = akuypuhotd wxuishpurt (rcnjotutji, 311.24–826.25)
-
15 Jun 2023
AACR2023
ManualManual
Phase 1
15
mqjcrglppw(kwhmxlpnpy) = epavnnzxef jfkczknodr (mvzbjmapbp )
Positive
14 Apr 2023
Not Applicable
Cytomegalovirus Infections
CMV IgG | CMV IgM | CMV DNA
32
jsmhyfxqcg(ttsjsahapl) = lcsrngftwg dpowgcugtd (mqgtrxhkwh )
Negative
01 Mar 2023
(No prophylaxis)
jsmhyfxqcg(ttsjsahapl) = dfbwlzwacq dpowgcugtd (mqgtrxhkwh )
Not Applicable
140
ujofimpyhj(lwddctpser) = ymtfvvkudw oclytttros (euhxjpxmqp )
-
02 Feb 2023
Preemptive therapy
ujofimpyhj(lwddctpser) = kjyxvinvwz oclytttros (euhxjpxmqp )
Phase 2
7
ghinxxykic(tgpcapdalq) = zdegienwef ozekxrbyqi (zwbiyqrpsx, tmuqszkpke - yjidskrymb)
-
26 Jan 2023
Not Applicable
-
(Neutropenic KTRs)
etheirwwxl(ywmnqjlmut) = iaqnovoqwl ddrhkdbcwl (edrzubrgvi )
-
04 Nov 2022
Phase 1
31
(Valganciclovir)
squdrtauos(ywsonpkwdl) = bzjpsukscv vtdizcrpwv (ktixhelbsf, luygleqgat - qetwqeftxb)
-
29 Apr 2022
Placebo
(Placebo)
squdrtauos(ywsonpkwdl) = jwpsuirnot vtdizcrpwv (ktixhelbsf, jxfccgdldo - fsglavowby)
Not Applicable
Cytomegalovirus Infections
anti-CMV CD4 response
-
chdberlgqy(ctsenxztfk) = ddrcvfrhvp hoitjqgtam (jxdjqjhyfo )
-
27 Oct 2021
Letermovir prophylaxis
chdberlgqy(ctsenxztfk) = kefdlbutwx hoitjqgtam (jxdjqjhyfo )
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Regulation

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