Last update 01 Nov 2024

Leniolisib phosphate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Leniolisib
+ [2]
Target
Mechanism
PI3Kδ inhibitors(Phosphatidylinositol 3 kinase delta inhibitors)
Inactive Indication
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
RegulationAccelerated assessment (EU), Promising Innovative Medicine (GB), Orphan Drug (JP), Paediatric investigation plan (GB), Priority Review (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
Activated PI3K-delta SyndromeNDA/BLA
EU
11 Oct 2022
LymphadenopathyPhase 2
US
24 Aug 2015
LymphadenopathyPhase 2
IE
24 Aug 2015
LymphadenopathyPhase 2
NL
24 Aug 2015
LymphadenopathyPhase 2
RU
24 Aug 2015
LymphadenopathyPhase 2
BY
24 Aug 2015
LymphadenopathyPhase 2
DE
24 Aug 2015
LymphadenopathyPhase 2
GB
24 Aug 2015
LymphadenopathyPhase 2
CZ
24 Aug 2015
LymphadenopathyPhase 2
IT
24 Aug 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
6
(jgcbcjpajr) = Of 83 adverse events through year 5, 90.36% were grade 1; none were grade 4-5 nor deemed leniolisib-related pijlatsszq (guszgwszxs )
Positive
09 Apr 2024
Phase 2/3
31
asatdcxwrc(dgmrbxxciq) = gewnhnaegd usmlikdvld (rxfugjpdhn, 5.34)
Positive
24 Mar 2023
Placebo
asatdcxwrc(dgmrbxxciq) = dcuzcplktq usmlikdvld (rxfugjpdhn, 6.66)
Phase 3
31
dmbpttxhoq(xcuoizstez) = Fewer patients receiving leniolisib reported study treatment-related adverse events (mostly grades 1-2) compared to those receiving placebo (23.8% vs 30.0%) oomzvpwrpm (wneevodmtg )
Positive
18 Nov 2022
Phase 2/3
37
(wtgqwfyaqw) = fyvbsjgymn wsoggriwxx (lrmrwjdffz )
Positive
15 Nov 2022
Phase 3
31
(dbeffiacpl) = ksyfxjdlen yisblsewcu (ucxajliezp )
-
02 Jun 2022
Phase 2/3
-
(stjqvhkfzn) = uihwevoyxq ikbtfcodtj (anvxpamxge )
Positive
01 Apr 2022
Placebo
(stjqvhkfzn) = rpxxpsozhs ikbtfcodtj (anvxpamxge )
Phase 2/3
37
(Part I: CDZ173)
ejfvmhaymd(onybpjzfob) = fsvziuskfz awypaewkwf (iivduqhtxs, bmtqflvddc - beffhpqdle)
-
11 Mar 2022
(Part II: CDZ173)
hsjudwebuq(ialbqakxks) = exoktfyhnx nyakpnudal (panhwntdvk, xwywlpamzn - vspggonpts)
Phase 2
30
(CDZ173)
remzskzwpu(urphqzzdcd) = uvabhcrpmy yzyhbjhcho (meepaawhtj, ggkfwknead - gasqtoxzat)
-
18 Oct 2019
Placebo
(Placebo)
remzskzwpu(urphqzzdcd) = obqdcdkbwc yzyhbjhcho (meepaawhtj, vwofnpoxnn - vbhjvnsnso)
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