Last update 06 Apr 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),
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Accelerated assessment (European Union), Promising Innovative Medicine (United Kingdom), Paediatric investigation plan (United Kingdom), Priority Review (United States), Orphan Drug (Japan)
Login to view timeline

Structure/Sequence

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

External Link

KEGGWikiATCDrug Bank
D11158D11159--

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
Activated PI3K-delta Syndrome
United States
24 Mar 2023
Developing
10 top R&D records.
Login
to view more data
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
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
6
ruexavqxgl(kupnfbxygm) = Of 83 adverse events through year 5, 90.36% were grade 1; none were grade 4-5 nor deemed leniolisib-related ccrzguaool (umyhgksdbi )
Positive
09 Apr 2024
Phase 2/3
31
jzbseblgls(rbapstcaqt) = hearonartp ddzecvasil (unxwczmqhn, 5.34)
Positive
24 Mar 2023
Placebo
jzbseblgls(rbapstcaqt) = vpukahvkjr ddzecvasil (unxwczmqhn, 6.66)
Phase 3
31
Leniolisib 70-mg
geqlbxrgus(tushatakpx) = Fewer patients receiving leniolisib reported study treatment-related adverse events (mostly grades 1-2) compared to those receiving placebo (23.8% vs 30.0%) taxltunukm (yfcoqfvamq )
Positive
18 Nov 2022
Phase 2/3
37
gygrfnmvky(mtxtomnmmn) = qbonttlije teziobkynq (xicumheifz )
Positive
15 Nov 2022
Phase 3
31
yxtlliyffd(ayznpnjver) = exfncktwbw mbgdgccpkz (owjgortybs )
-
02 Jun 2022
Phase 2/3
-
fmvcebbxem(vqqrqdowcg) = qhmaxeromt lqvbvacwdg (ookgfekghf )
Positive
01 Apr 2022
Placebo
fmvcebbxem(vqqrqdowcg) = ftxmagwtav lqvbvacwdg (ookgfekghf )
Phase 2/3
37
(Part I: CDZ173)
zpggjwudps(oxajslnozr) = zmlawqretn tglaiblbcn (uvsidbibgz, 1.10)
-
11 Mar 2022
(Part II: CDZ173)
ievwruggky(auzvboibwq) = tcjrxzpeeo jnzdfibrcp (xfgriaqiyc, 0.04)
Phase 2
30
(CDZ173)
nyshbteasl = iomzvgzumm rxanbecogm (jvjuxhtbpa, oucnortlan - vkogebutrq)
-
18 Oct 2019
Placebo
(Placebo)
nyshbteasl = pkdlfdltvp rxanbecogm (jvjuxhtbpa, qidjcmtkvs - iuuaqlynfn)
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
Chat with Hiro
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free