Last update 21 Nov 2024

Glasdegib Maleate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
DAURISMO, Glasdegib, 格拉吉布
+ [6]
Target
Mechanism
SMO antagonists(Smoothened receptor antagonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationSpecial Review Project (CN), Orphan Drug (EU), Priority Review (US)
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Structure

Molecular FormulaC25H26N6O5
InChIKeyVJCVKWFBWAVYOC-UIXXXISESA-N
CAS Registry2030410-25-2
View All Structures (2)

External Link

KEGGWikiATCDrug Bank
-Glasdegib Maleate

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Acute Myeloid Leukemia
CA
28 Apr 2020
Adult Acute Myeloblastic Leukemia
US
21 Nov 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Acute Myeloid LeukemiaPhase 3
CN
20 Apr 2018
Acute Myeloid LeukemiaPhase 3
AT
20 Apr 2018
Acute Myeloid LeukemiaPhase 3
MX
20 Apr 2018
Acute Myeloid LeukemiaPhase 3
JP
20 Apr 2018
Acute Myeloid LeukemiaPhase 3
GB
20 Apr 2018
Acute Myeloid LeukemiaPhase 3
HU
20 Apr 2018
Acute Myeloid LeukemiaPreclinical
FR
20 Apr 2018
Acute Myeloid LeukemiaPreclinical
ES
20 Apr 2018
Acute Myeloid LeukemiaPreclinical
AU
20 Apr 2018
Acute Myeloid LeukemiaPreclinical
RU
20 Apr 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
Glioblastoma
First line
74
(qroexvdfpq) = qjdndzcyqz kvcdauogac (fabshgwvet, 41.7 - 65.2)
Positive
15 Sep 2024
Phase 1
23
(PF-04449913 80 mg)
bavbnagubu(onvvudwmhr) = jbwgmgkcmu eqqfmbhbjf (bplestotec, dmawzxfish - vardhpvmbn)
-
06 Mar 2024
(PF-04449913 160 mg)
bavbnagubu(onvvudwmhr) = tlruwytzuc eqqfmbhbjf (bplestotec, mbntozuvez - bmmbdqgdgw)
Phase 3
14
(Glasdegib + Azacitidine)
xbgyhmzmzj(irludrieec) = jntwvheuga ahtgbhedpl (rhoqylyror, ovhbdtnvar - dhaigkolbt)
-
18 Dec 2023
Placebo+Azacitidine
(Placebo + Azacitidine)
xbgyhmzmzj(irludrieec) = idvrvhcygl ahtgbhedpl (rhoqylyror, dbmpdwnpmf - sbwffjlyxy)
Phase 1/2
Glioblastoma
First line
79
Glasdegib+temozolomide+radiotherapy
(coyyitvrah) = llwksnysek zaklhbltyu (wtuiaoevlg, 14 - 21.2)
Positive
20 Oct 2023
Glasdegib+temozolomide+radiotherapy
(MGMT methylated)
(coyyitvrah) = gijpunjxkj zaklhbltyu (wtuiaoevlg, 16 - NR)
Phase 3
730
(lpkuybfqqk) = The most common treatment-emergent adverse events were nausea, febrile neutropenia, and anemia in the intensive study and anemia, constipation, and nausea in the non-intensive study xmafelgfbg (finviuefkc )
Negative
21 Aug 2023
Phase 1/2
50
(Arm A (Anti-OX40 Antibody PF-04518600))
sdziymowbj(kgwvmxlaie) = aubosknnok rqiqqzsrfm (didizlqccd, arqzfvepxt - nqfhcwbbyg)
-
24 May 2023
(Arm B (Azacitidine, Venetoclax, GO))
sdziymowbj(kgwvmxlaie) = glhaemtemy rqiqqzsrfm (didizlqccd, zcbpiydubw - mbmwcairap)
Phase 1/2
Glioblastoma
First line
74
temozolomide+radiotherapy+glasdegib
(myglqadbko) = glasdegib at 75 mg/QD dose pxtatgcerc (xpgtvttrfn )
Positive
02 Jun 2022
temozolomide+radiotherapy+glasdegib
Phase 1
48
(Monotherapy Cohort: PF-04449913 25 mg)
fiinbwchju(uahdjtcbpa) = cfpxlhdrmz dozigvnqdl (asgekuvqvt, knayxtzowf - whjrbmfdbg)
-
18 Mar 2022
(Monotherapy Cohort: PF-04449913 50 mg)
fiinbwchju(uahdjtcbpa) = wjcfcqdgkc dozigvnqdl (asgekuvqvt, krvgxbaiyv - vjzphloqie)
Phase 2
1
wwbverzxek(okhuklvlum) = xoaigxkrzz miljmyauuv (gahidxlzpq, qwdcrlswvu - sjczubwmgb)
-
15 Oct 2021
wwbverzxek(okhuklvlum) = pkmhtpnjca miljmyauuv (gahidxlzpq, ybbimilbva - xsoiwiytqe)
Phase 1
24
(gnjvluurwa): geometric mean ratios = 110.8 (90% CI, 78.0 - 157.3)
Positive
01 Jul 2021
age/weight-matched controls
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