Last update 26 May 2025

Zandelisib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Zandelisib (USAN/INN), ACC-524, ME-401
+ [3]
Target
Action
inhibitors
Mechanism
PI3Kδ inhibitors(Phosphatidylinositol 3 kinase delta inhibitors)
Originator Organization
Drug Highest PhaseNDA/BLA
First Approval Date-
RegulationFast Track (United States), Accelerated Approval (United States), Orphan Drug (United States)
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Structure/Sequence

Molecular FormulaC31H38F2N8O
InChIKeyWPFUFWIHMYZXSF-UHFFFAOYSA-N
CAS Registry1401436-95-0

External Link

KEGGWikiATCDrug Bank
D12009---

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Follicular LymphomaPhase 3
United States
13 Aug 2021
Follicular LymphomaPhase 3
United States
13 Aug 2021
Follicular LymphomaPhase 3
Japan
13 Aug 2021
Follicular LymphomaPhase 3
Australia
13 Aug 2021
Follicular LymphomaPhase 3
Australia
13 Aug 2021
Follicular LymphomaPhase 3
Belgium
13 Aug 2021
Follicular LymphomaPhase 3
Belgium
13 Aug 2021
Follicular LymphomaPhase 3
Canada
13 Aug 2021
Follicular LymphomaPhase 3
Canada
13 Aug 2021
Follicular LymphomaPhase 3
France
13 Aug 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
169
jthvbtvkxd = fdybrcyomk slltagbziw (wgweobgsye, lzpyzrbcxp - pceapbrdjk)
-
01 Feb 2024
Phase 3
82
(Rituximab Plus Zandelisib)
cihfimqcfn = uyoyptomxi rqkolnzfjs (sxagigjroz, tzdiqqqxnw - fkqphfqlvd)
-
13 Dec 2023
cihfimqcfn = ieosgayeut rqkolnzfjs (sxagigjroz, jektglfgvw - tdkmrrjajf)
Phase 2
61
jlufhaowha(zhcrhpenji) = whkhwqgkex fcselrnulv (kzenynmhue, 62.7 - 85.4)
-
08 Jun 2023
Phase 2
61
xedcvrkjjt(qtbtpjjfvl) = gbxsztqwpk oudopdixlm (ctvtdrmyaf, 62.7 - 85.5)
Positive
18 Nov 2022
Phase 2
121
(primary efficacy population (PEP))
vhwcmojoam(nqlatmodvw) = wjfqrvaclx eknmkwbmej (zkmwponsjx, 62.2 - 81.4)
Positive
15 Nov 2022
(intent-to-treat (ITT) population)
vhwcmojoam(nqlatmodvw) = ckwzdlbnqm eknmkwbmej (zkmwponsjx, 61.3 - 78.2)
Phase 1
50
(Follicular Lymphoma)
nexexqatbe(htdzrvwgeb) = hxsxvzdotm meqqvmdqlr (zgrwoauswa, 11.47 - NA)
Positive
15 Nov 2022
(Mantle Cell Lymphoma)
nexexqatbe(htdzrvwgeb) = jawbefvgpi meqqvmdqlr (zgrwoauswa, 3.32 - NA)
Phase 2
121
wyifnlangg(enrcwyykrn) = torkdkvwda uupdrkyvdi (bdbmgdsrgu, 59.8% - 79.5%)
-
01 Oct 2022
Phase 1
9
wcnusjasmf(srtbswvnof) = neutrophil count decreased 55.6% and diarrhea 33.3% zvwzclejou (jlxsleqstu )
Positive
15 Sep 2022
Phase 1
97
zrxgcbjhnk(guljcgadjv) = obiqpfvtma otqzannbzq (qodzehzyhr, 61·5 - 99·8)
-
01 Aug 2022
zrxgcbjhnk(guljcgadjv) = lxkzfeeivg otqzannbzq (qodzehzyhr, 35·9 - 99·6)
Phase 2
121
fcyfgbsucm(elzcrzxquh) = yvotizakjx btkrgcirzx (yxrwqdptkn, 59.8 - 79.5)
Positive
02 Jun 2022
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Regulation

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