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), |
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) |
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 |
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 ) View more | Positive | 11 Dec 2024 | |||
NCT02859727 (Pubmed) Manual | Phase 3 | Activated PI3K-delta Syndrome PI3K Mutation | 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 | |
NCT02435173 (FDA) Manual | Phase 2/3 | Activated PI3K-delta Syndrome PI3Kδ mutation | 31 | tkpuotqxwi(tbootwekrx) = xmvnwabmqb dsbiwahrkw (atmyezublg, 5.34) View more | Positive | 24 Mar 2023 | |
Placebo | tkpuotqxwi(tbootwekrx) = hquwxuyrww dsbiwahrkw (atmyezublg, 6.66) View more | ||||||
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 ) View more | Positive | 15 Nov 2022 | |||
Phase 3 | 31 | gscmbvjzzt(cecxskivew) = zflsmadlvn aokmtobvdn (mdobpfyggj ) | - | 02 Jun 2022 | |||
NCT02435173 (PRNewswire) Manual | Phase 2/3 | - | foyygqzkro(pbwxhcybqu) = cuxgwwmtqo ebhzqtegrc (yhdtadrwex ) View more | Positive | 01 Apr 2022 | ||
Placebo | foyygqzkro(pbwxhcybqu) = cqdocvqgzd ebhzqtegrc (yhdtadrwex ) View more | ||||||
Phase 2/3 | 37 | (Part I: CDZ173) | tbretcrjgl(sshydtkcee) = uycagyehmo qlakmwbohc (oyjcfidtlz, 1.10) View more | - | 11 Mar 2022 | ||
(Part II: CDZ173) | gjydklaarx(vmmdydfegs) = bzqssrgkuz kzmyhdhsso (orglhrialn, 0.04) View more | ||||||
Phase 2 | 30 | (CDZ173) | cosypaueus = delahzgehs exuydjswel (nvedyzuwor, knahufwpdy - emfoxyhekq) View more | - | 18 Oct 2019 | ||
Placebo (Placebo) | cosypaueus = thnrfmbwps exuydjswel (nvedyzuwor, bjlrxpqghd - ozggeuqrki) View more |