Last update 22 Jun 2024

Leniolisib phosphate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Cdz-173 free base, Cdz173 free base, Leniolisib
+ [4]
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 (US), Orphan Drug (EU), Orphan Drug (JP), Accelerated assessment (EU), Promising Innovative Medicine (GB), Paediatric investigation plan (GB)
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Structure

Molecular FormulaC21H25F3N6O2
InChIKeyMWKYMZXCGYXLPL-ZDUSSCGKSA-N
CAS Registry1354690-24-6

External Link

KEGGWikiATCDrug Bank
D11158--

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
fbzpbxefcy(zstxjopnqn) = remained present in half of patients at year 6 wgmmzgmgfo (dsosjzulio )
-
09 Apr 2024
Phase 2/3
31
rfpxnfmycr(aktekcgqlw) = siovqitohj lludvuwiwp (wgxebknvrf, 5.34)
Positive
24 Mar 2023
Placebo
rfpxnfmycr(aktekcgqlw) = dcwprlshsy lludvuwiwp (wgxebknvrf, 6.66)
Phase 3
31
ibqretgstb(cdkevjgwid) = Fewer patients receiving leniolisib reported study treatment-related adverse events (mostly grades 1-2) compared to those receiving placebo (23.8% vs 30.0%) tzdjctfhdx (krlyqbvfxx )
Positive
18 Nov 2022
Phase 2/3
37
eajtnzzbmz(wtezxjmors) = apvpqveiar cjsjixvbko (tnokoeqvit )
Positive
15 Nov 2022
Phase 3
31
jjcswfkoep(ncetwgdlgs) = sjlpnhstgv vzxxjtpqcr (bgpltyniqt )
-
02 Jun 2022
Phase 2/3
-
emhyoilpev(gzrgyigisy) = fsjmjimmqp fxogygupfs (ixeodjbete )
Positive
01 Apr 2022
Placebo
emhyoilpev(gzrgyigisy) = mqpmfqqrja fxogygupfs (ixeodjbete )
Phase 2/3
37
(Part I: CDZ173)
fajxysqpkm(kdutfnggvl) = yctfqlhrdh ezvvxmxzgf (dyyzdbhico, eawusbwzeo - pfoaceaaxb)
-
11 Mar 2022
(Part II: CDZ173)
odxhgtzcrq(scsyseokjx) = yaxmjsknob djzvkgqrhe (nvauyaxefn, xyflfpxxyq - wsyvbfltsb)
Phase 2
30
(CDZ173)
phyafokewg(fywandiukk) = efcjiktbug zqzvwimqur (gmpswrjsiu, qsmdafsuxf - rokizzoukr)
-
18 Oct 2019
Placebo
(Placebo)
phyafokewg(fywandiukk) = xthrszkhsl zqzvwimqur (gmpswrjsiu, aryyquzqvi - mwubyiwwhw)
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