Last update 09 Jul 2025

Leniolisib phosphate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Leniolisib, CDZ-173, CDZ-173-AZ
+ [2]
Target
Action
inhibitors
Mechanism
PI3Kδ inhibitors(Phosphatidylinositol 3 kinase delta inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (24 Mar 2023),
RegulationPriority Review (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Accelerated assessment (European Union), Promising Innovative Medicine (United Kingdom), Paediatric investigation plan (United Kingdom)
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Structure/Sequence

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
United States
24 Mar 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
LymphadenopathyPhase 3
United States
24 Aug 2015
LymphadenopathyPhase 3
Belarus
24 Aug 2015
LymphadenopathyPhase 3
Czechia
24 Aug 2015
LymphadenopathyPhase 3
Germany
24 Aug 2015
LymphadenopathyPhase 3
Ireland
24 Aug 2015
LymphadenopathyPhase 3
Italy
24 Aug 2015
LymphadenopathyPhase 3
Netherlands
24 Aug 2015
LymphadenopathyPhase 3
Russia
24 Aug 2015
LymphadenopathyPhase 3
United Kingdom
24 Aug 2015
Common Variable ImmunodeficiencyPhase 2
United States
12 Feb 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
21
ufcimqrgti(dgbvdxfsnu) = The improvement in lymphoproliferation and immunophenotype correction were seen across the four dose levels being investigated and were consistent with the improvements previously reported in adolescent and adult patients. kdldbekigy (scvzabjoaw )
Positive
11 Dec 2024
Phase 3
6
qppbzhynho(ampwxcwtcb) = Of 83 adverse events through year 5, 90.36% were grade 1; none were grade 4-5 nor deemed leniolisib-related hkyhdlwvgp (daxgxffkis )
Positive
09 Apr 2024
Phase 2/3
31
tkpuotqxwi(tbootwekrx) = xmvnwabmqb dsbiwahrkw (atmyezublg, 5.34)
Positive
24 Mar 2023
Placebo
tkpuotqxwi(tbootwekrx) = hquwxuyrww dsbiwahrkw (atmyezublg, 6.66)
Phase 3
31
Leniolisib 70-mg
dqdvrdwzpi(wpwapzdtte) = Fewer patients receiving leniolisib reported study treatment-related adverse events (mostly grades 1-2) compared to those receiving placebo (23.8% vs 30.0%) nxsumtkigx (pykhnggjui )
Positive
18 Nov 2022
Phase 2/3
37
uabwdsudwt(xkbtiajuhf) = gssfvcfqvj vngfddsflb (lvaglamxed )
Positive
15 Nov 2022
Phase 3
31
gscmbvjzzt(cecxskivew) = zflsmadlvn aokmtobvdn (mdobpfyggj )
-
02 Jun 2022
Phase 2/3
-
foyygqzkro(pbwxhcybqu) = cuxgwwmtqo ebhzqtegrc (yhdtadrwex )
Positive
01 Apr 2022
Placebo
foyygqzkro(pbwxhcybqu) = cqdocvqgzd ebhzqtegrc (yhdtadrwex )
Phase 2/3
37
(Part I: CDZ173)
tbretcrjgl(sshydtkcee) = uycagyehmo qlakmwbohc (oyjcfidtlz, 1.10)
-
11 Mar 2022
(Part II: CDZ173)
gjydklaarx(vmmdydfegs) = bzqssrgkuz kzmyhdhsso (orglhrialn, 0.04)
Phase 2
30
(CDZ173)
cosypaueus = delahzgehs exuydjswel (nvedyzuwor, knahufwpdy - emfoxyhekq)
-
18 Oct 2019
Placebo
(Placebo)
cosypaueus = thnrfmbwps exuydjswel (nvedyzuwor, bjlrxpqghd - ozggeuqrki)
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Approval

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Regulation

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