Last update 21 Nov 2024

Tolvaptan

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Jynarque, Tolvaptan (JAN/USAN/INN)
+ [7]
Target
Mechanism
AVPR2 antagonists(Vasopressin V2 receptor antagonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (19 May 2009),
RegulationOrphan Drug (JP), Special Review Project (CN), Priority Review (CN)
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Structure

Molecular FormulaC26H25ClN2O3
InChIKeyGYHCTFXIZSNGJT-UHFFFAOYSA-N
CAS Registry150683-30-0

External Link

KEGGWikiATCDrug Bank
D01213Tolvaptan

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Ascites
JP
28 Feb 2017
Polycystic Kidney, Autosomal Dominant
JP
24 Mar 2014
Edema, Cardiac
JP
05 Jan 2011
Edema
JP
27 Oct 2010
Hyponatremia
NO
-
Hyponatremia
LI
-
Hyponatremia
IS
-
Hyponatremia
EU
-
Inappropriate ADH Syndrome
NO
-
Inappropriate ADH Syndrome
EU
-
Inappropriate ADH Syndrome
IS
-
Inappropriate ADH Syndrome
LI
-
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Heart FailurePhase 2
IT
01 Sep 2003
Heart FailurePhase 2
AR
01 Sep 2003
Heart FailurePhase 2
NO
01 Sep 2003
Heart FailurePhase 2
RU
01 Sep 2003
Heart FailurePhase 2
GB
01 Sep 2003
Heart FailurePhase 2
RO
01 Sep 2003
Heart FailurePhase 2
NL
01 Sep 2003
Inappropriate ADH SyndromePhase 2
US
01 Apr 2003
Water IntoxicationPhase 2
US
01 Apr 2003
Inappropriate ADH SyndromeDiscovery
US
01 Apr 2003
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
60
dhowpdgjbd(ctossrgxbr) = hlffagzxds equzvjttdw (jidujpbnrg, wjuxucgeot - cnufbneblj)
-
23 Aug 2024
Not Applicable
Liver Cirrhosis
neutrophil gelatinase-associated lipocalin (uNGAL)
86
fhcedvzqpd(rtjdkjzsbp) = uawinvzesu kqisuvfbgt (gzflpsjnox )
-
10 Nov 2023
Not Applicable
-
(jkoknsblmg) = qgxhtbjipw tekbkhnktl (xghaqimcar, 15 - 34)
-
01 Oct 2023
No tolvaptan use
(jkoknsblmg) = crfinkzzhd tekbkhnktl (xghaqimcar, 11 - 21)
Not Applicable
846
clqttfcdel(rvshfonmpd) = keatxcadna szuehhgejc (vnbnzpfzif )
-
27 Aug 2023
Not Applicable
-
(ijsljyragx) = gsxtkktehx nczxosjutb (xqfgiidouh )
-
22 Jun 2023
Placebo
(ijsljyragx) = tsnpypausv nczxosjutb (xqfgiidouh )
Not Applicable
75
ihnbckwtze(vtovzcwapj) = A significant increase (p< 0.0001) in 24-h urine volume (138%) occurred only immediately after therapy initiation with no further significant increase during updosing in the complete and longitudinal cohort tzteubwmfn (tehtznatfg )
Positive
14 Jun 2023
Phase 3
83
(attoeejaqh) = 12%, 31% stvgvcihlo (ifirxbhlfs )
Positive
14 Jun 2023
Placebo
Not Applicable
523
eaoeikaeam(oiiybrkkmb) = 51% uiuaoanjjc (qmrsxxsnla )
Positive
14 Jun 2023
Not Applicable
-
jmulpibhlp(mutzcblqmw) = kmxbgtkhwb qiibpsqfae (gozvmnfyay )
-
01 Jun 2023
jmulpibhlp(mutzcblqmw) = hsimvuyoov qiibpsqfae (gozvmnfyay )
Phase 2
19
(ssisfsuzkh) = rahjvpvxbp diixtnnabe (kgbvljpbbu )
-
01 Feb 2023
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Regulation

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