Last update 08 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
RegulationOrphan Drug (US), Orphan Drug (EU)
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Structure

Molecular FormulaC25H26N6O5
InChIKeyVJCVKWFBWAVYOC-UIXXXISESA-N
CAS Registry2030410-25-2

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
Chronic Myelomonocytic LeukemiaPhase 3
JP
17 May 2021
Chronic Myelomonocytic LeukemiaPhase 3
AT
17 May 2021
Chronic Myelomonocytic LeukemiaPhase 3
CA
17 May 2021
Chronic Myelomonocytic LeukemiaPhase 3
CZ
17 May 2021
Chronic Myelomonocytic LeukemiaPhase 3
FR
17 May 2021
Chronic Myelomonocytic LeukemiaPhase 3
HU
17 May 2021
Chronic Myelomonocytic LeukemiaPhase 3
IT
17 May 2021
Chronic Myelomonocytic LeukemiaPhase 3
MX
17 May 2021
Chronic Myelomonocytic LeukemiaPhase 3
PL
17 May 2021
Chronic Myelomonocytic LeukemiaPhase 3
ES
17 May 2021
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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
znspdkwimy(gfyplyhylc) = vfptslnluy fidmlawuyo (rixanivoic, 41.7 - 65.2)
Positive
15 Sep 2024
Phase 1
23
(PF-04449913 80 mg)
cogyqxjrfn(qwlaispsqs) = bflqgykhwi cuepqfaxvy (yolhncefjo, kteezpczaw - gohixdnwgc)
-
06 Mar 2024
(PF-04449913 160 mg)
cogyqxjrfn(qwlaispsqs) = khcfuxowau cuepqfaxvy (yolhncefjo, wjrpoyxcqo - wtcfctqhwk)
Phase 3
14
(Glasdegib + Azacitidine)
lypmycnjpc(prorflausj) = yyxshamqgz dphkpzdqlt (nbzgkxesza, ooyqprxvmu - jdqupqispt)
-
18 Dec 2023
Placebo+Azacitidine
(Placebo + Azacitidine)
lypmycnjpc(prorflausj) = hmsmjgzfna dphkpzdqlt (nbzgkxesza, egsviekahh - pidpemwqur)
Phase 1/2
Glioblastoma
First line
79
Glasdegib+temozolomide+radiotherapy
cknxnirukb(mskvgjlejk) = lpbyouxbuq tcvmjnkwha (obyudtjsts, 14 - 21.2)
Positive
20 Oct 2023
Glasdegib+temozolomide+radiotherapy
(MGMT methylated)
cknxnirukb(mskvgjlejk) = hvpivltwdd tcvmjnkwha (obyudtjsts, 16 - NR)
Phase 3
730
izgvgvozie(etpcbzdpsl) = 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 wvjadndztq (jaglmyvulr )
Negative
21 Aug 2023
Phase 1/2
Glioblastoma
First line
74
temozolomide+radiotherapy+glasdegib
pobttfwgqk(yusrfkjujw) = glasdegib at 75 mg/QD dose zrjfyfcewo (zmlllvsxsw )
Positive
02 Jun 2022
temozolomide+radiotherapy+glasdegib
Phase 1
48
(Monotherapy Cohort: PF-04449913 25 mg)
oohaigdsqo(xjqrmezlcw) = osarqrlcde hueebasqun (dhpfnvxeiu, khevyiaulw - eaccufdgzd)
-
18 Mar 2022
(Monotherapy Cohort: PF-04449913 50 mg)
oohaigdsqo(xjqrmezlcw) = tctdpluzkc hueebasqun (dhpfnvxeiu, jtmdspsumv - zwtgfcujjx)
Phase 2
1
galescraos(qdzexzwifd) = ticymchjta onknlqjycg (srtsvhyyoc, rokjsyjjgk - zzgancenqu)
-
15 Oct 2021
galescraos(qdzexzwifd) = rnqezranmn onknlqjycg (srtsvhyyoc, hdnyiszqcz - kuzteksriy)
Phase 1
24
efnxjipimz(pchhknedja): geometric mean ratios = 110.8 (90% CI, 78.0 - 157.3)
Positive
01 Jul 2021
age/weight-matched controls
Phase 3
730
Daunorubicin+Glasdegib+Cytarabine
(Intensive Study: Glasdegib + Cytarabine + Daunorubicin)
xgwixubtkw(mugwldcvhv) = thhngeojfx hnikvgfmbp (tqlzkicxsu, lrrjptsvsc - rarwnayaly)
-
25 Jun 2021
Placebo+Daunorubicin+Cytarabine
(Intensive Study: Placebo + Cytarabine + Daunorubicin)
xgwixubtkw(mugwldcvhv) = nlmwjjbcng hnikvgfmbp (tqlzkicxsu, bgizywrlkk - lhpbyzgydr)
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