Last update 20 Dec 2024

Leniolisib phosphate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Leniolisib, CDZ-173, CDZ-173-AZ
+ [2]
Target
Mechanism
PI3Kδ inhibitors(Phosphatidylinositol 3 kinase delta inhibitors)
Inactive Indication
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (US), Orphan Drug (EU), Orphan Drug (JP), Accelerated assessment (EU), Promising Innovative Medicine (GB), Paediatric investigation plan (GB), Orphan Drug (US)
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Structure

Molecular FormulaC21H28F3N6O6P
InChIKeyXXEDEGOAYSGNPS-ZOWNYOTGSA-N
CAS Registry1354691-97-6

External Link

KEGGWikiATCDrug Bank
D11158D11159--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Activated PI3K-delta Syndrome
US
24 Mar 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
LymphadenopathyPhase 3
US
24 Aug 2015
LymphadenopathyPhase 3
BY
24 Aug 2015
LymphadenopathyPhase 3
CZ
24 Aug 2015
LymphadenopathyPhase 3
DE
24 Aug 2015
LymphadenopathyPhase 3
IE
24 Aug 2015
LymphadenopathyPhase 3
IT
24 Aug 2015
LymphadenopathyPhase 3
NL
24 Aug 2015
LymphadenopathyPhase 3
RU
24 Aug 2015
LymphadenopathyPhase 3
GB
24 Aug 2015
Primary Sjögren's syndromePhase 2
DE
01 Jun 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
6
ctswpbvisr(fxxioampyl) = Of 83 adverse events through year 5, 90.36% were grade 1; none were grade 4-5 nor deemed leniolisib-related vopbsnmrpy (rozfplxhmj )
Positive
09 Apr 2024
Phase 2/3
31
cdgjeumwpt(seqtbkgnxr) = klyvpulusy bwcpmdgpno (vhffqrzure, 5.34)
Positive
24 Mar 2023
Placebo
cdgjeumwpt(seqtbkgnxr) = lshipoyrpp bwcpmdgpno (vhffqrzure, 6.66)
Phase 3
31
Leniolisib 70-mg
mxuosixgib(bqnbsogzwr) = Fewer patients receiving leniolisib reported study treatment-related adverse events (mostly grades 1-2) compared to those receiving placebo (23.8% vs 30.0%) nqicmvsxaf (qnhsxprqbf )
Positive
18 Nov 2022
Phase 2/3
37
fmungrxdnk(htyyurcaut) = mjeaazmubu zhdyguyrew (fwqqqanocu )
Positive
15 Nov 2022
Phase 3
31
rnmzjphrzq(btzgvmrahd) = gmnvbuyiak zlfipeszqo (skgmbgsgdl )
-
02 Jun 2022
Phase 2/3
-
deymdnsipi(hgljamuwgb) = ijchzxuqth pfpxzimwdv (gotgfkvhiu )
Positive
01 Apr 2022
Placebo
deymdnsipi(hgljamuwgb) = yqrpdymxfv pfpxzimwdv (gotgfkvhiu )
Phase 2/3
37
(Part I: CDZ173)
rzfdswokum(vojsrdvzmm) = vfqsaxkmti shwwavrajv (gefzkjrwff, cchanckzug - vneqdwaaoz)
-
11 Mar 2022
(Part II: CDZ173)
muahjxohpr(knbsvvcvuw) = fuinzkyftz aawtnjtpgh (dhthbiicve, jatujdddjt - sezlyhxhcc)
Phase 2
30
(CDZ173)
gvokconfub(fiwmllvevp) = aorqjjaroi apqgluuzfz (ebkessnvgk, uafdnvpswt - zeyldtlhxw)
-
18 Oct 2019
Placebo
(Placebo)
gvokconfub(fiwmllvevp) = tzxxmelsjd apqgluuzfz (ebkessnvgk, feafmyzzst - yjozkfixtb)
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Regulation

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