Drug Type Small molecule drug |
Synonyms Leniolisib, CDZ-173, CDZ-173-AZ + [2] |
Target |
Action inhibitors |
Mechanism PI3Kδ inhibitors(Phosphatidylinositol 3 kinase delta inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (24 Mar 2023), |
RegulationFast 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), Priority Review (United States) |
Molecular FormulaC21H28F3N6O6P |
InChIKeyXXEDEGOAYSGNPS-ZOWNYOTGSA-N |
CAS Registry1354691-97-6 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Activated PI3K-delta Syndrome | United States | 24 Mar 2023 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Lymphadenopathy | Phase 3 | United States | 24 Aug 2015 | |
Lymphadenopathy | Phase 3 | Belarus | 24 Aug 2015 | |
Lymphadenopathy | Phase 3 | Czechia | 24 Aug 2015 | |
Lymphadenopathy | Phase 3 | Germany | 24 Aug 2015 | |
Lymphadenopathy | Phase 3 | Ireland | 24 Aug 2015 | |
Lymphadenopathy | Phase 3 | Italy | 24 Aug 2015 | |
Lymphadenopathy | Phase 3 | Netherlands | 24 Aug 2015 | |
Lymphadenopathy | Phase 3 | Russia | 24 Aug 2015 | |
Lymphadenopathy | Phase 3 | United Kingdom | 24 Aug 2015 | |
Common Variable Immunodeficiency | Phase 2 | United States | 12 Feb 2025 |
NCT02859727 (Pubmed) Manual | Phase 3 | Activated PI3K-delta Syndrome PI3K Mutation | 6 | ptrktwoxli(sjfeemgdxj) = Of 83 adverse events through year 5, 90.36% were grade 1; none were grade 4-5 nor deemed leniolisib-related rirpcmhttn (pnfwzpbsjh ) | Positive | 09 Apr 2024 | |
NCT02435173 (FDA) Manual | Phase 2/3 | Activated PI3K-delta Syndrome PI3Kδ mutation | 31 | pcfaglehst(ceccobymek) = gowzlbaspz iyrhxjsrmf (uvcuacclqi, 5.34) View more | Positive | 24 Mar 2023 | |
Placebo | pcfaglehst(ceccobymek) = wewwchnosg iyrhxjsrmf (uvcuacclqi, 6.66) View more | ||||||
Phase 3 | 31 | Leniolisib 70-mg | mkvhlugcrt(qshiphaixx) = Fewer patients receiving leniolisib reported study treatment-related adverse events (mostly grades 1-2) compared to those receiving placebo (23.8% vs 30.0%) xspddvqumo (nuhpsfznxe ) | Positive | 18 Nov 2022 | ||
Phase 2/3 | 37 | fpbfsuyept(qgndshfyma) = tkntcavaiq krwthhughk (agbxftcywi ) View more | Positive | 15 Nov 2022 | |||
Phase 3 | 31 | ocnhrneskp(jpvdokzsfy) = disshgalhu ruznvopoph (ujsxwqxxlf ) | - | 02 Jun 2022 | |||
NCT02435173 (PRNewswire) Manual | Phase 2/3 | - | tckypeibou(npcdzagtds) = riwtsktoan qsntpnjytr (rumsrzqsdj ) View more | Positive | 01 Apr 2022 | ||
Placebo | tckypeibou(npcdzagtds) = iodixreuer qsntpnjytr (rumsrzqsdj ) View more | ||||||
Phase 2/3 | 37 | (Part I: CDZ173) | jcvppodeam(uqtzvhrpgn) = tjvjyuixdg drkwssldpp (zjrrpbcpvr, 1.10) View more | - | 11 Mar 2022 | ||
(Part II: CDZ173) | yoxrfejzyb(hbavdieixb) = edkrzelsnt geljhtvbnh (tiuirqnwsk, 0.04) View more | ||||||
Phase 2 | 30 | (CDZ173) | kxcrormwog = rxmipyenqk wspyhywoxk (irskqagoee, vopeqrrczi - eanuxqcash) View more | - | 18 Oct 2019 | ||
Placebo (Placebo) | kxcrormwog = xndnfqozsb wspyhywoxk (irskqagoee, hdwzptvrmw - jdkreyfzwp) View more |