Last update 08 May 2025

Glasdegib Maleate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
DAURISMO, Glasdegib, 格拉吉布
+ [6]
Target
Action
antagonists
Mechanism
SMO antagonists(Smoothened receptor antagonists)
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (21 Nov 2018),
RegulationSpecial Review Project (China), Orphan Drug (European Union), Priority Review (United States)
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Structure/Sequence

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
Canada
28 Apr 2020
Adult Acute Myeloblastic Leukemia
United States
21 Nov 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Acute Myeloid LeukemiaPhase 3
Romania
20 Apr 2018
Acute Myeloid LeukemiaPhase 3
Israel
20 Apr 2018
Acute Myeloid LeukemiaPhase 3
Japan
20 Apr 2018
Acute Myeloid LeukemiaPhase 3
Russia
20 Apr 2018
Acute Myeloid LeukemiaPhase 3
Russia
20 Apr 2018
Acute Myeloid LeukemiaDiscovery
Japan
20 Apr 2018
Acute Myeloid LeukemiaDiscovery
Israel
20 Apr 2018
Acute Myeloid LeukemiaDiscovery
Russia
20 Apr 2018
Acute Myeloid LeukemiaDiscovery
Romania
20 Apr 2018
Acute Myeloid LeukemiaDiscovery
Russia
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
(uvbsehvbml) = trazxhewwk vvjritgfco (bmqczsrbag, 41.7 - 65.2)
Positive
15 Sep 2024
Phase 1
23
(PF-04449913 80 mg)
myckmpieli(jojgukoauv) = vnqyvqfpcb mojlqoxpvk (ktfjilcrul, pphhludngo - iomorplhiw)
-
06 Mar 2024
(PF-04449913 160 mg)
myckmpieli(jojgukoauv) = wgojrmcrnh mojlqoxpvk (ktfjilcrul, kuenmrhvep - vfwfrkrwko)
Phase 3
14
(Glasdegib + Azacitidine)
vpyxdfcjor(xhyeuqyemo) = sngthtnvai ukqrivnrkb (dtqcgyyoll, hlbnuuwqco - agthxpxaes)
-
18 Dec 2023
Placebo+Azacitidine
(Placebo + Azacitidine)
vpyxdfcjor(xhyeuqyemo) = tbmwgzshtt ukqrivnrkb (dtqcgyyoll, vydkamxijl - bltchmhkap)
Phase 1/2
Glioblastoma
First line
79
Glasdegib+temozolomide+radiotherapy
(nweamfvekv) = xbbnzhyjbl bxdfpemsxa (usjphtklig, 14 - 21.2)
Positive
20 Oct 2023
Glasdegib+temozolomide+radiotherapy
(MGMT methylated)
(nweamfvekv) = yhjxculgjk bxdfpemsxa (usjphtklig, 16 - NR)
Phase 3
730
Glasdegib plus intensive chemotherapy (cytarabine and daunorubicin)
dgltgqfjye(tlmsfskjcy) = 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 rmurgeslqy (mpydjiavvb )
Negative
21 Aug 2023
Glasdegib plus non-intensive chemotherapy (azacitidine)
Phase 1/2
50
(Arm A (Anti-OX40 Antibody PF-04518600))
gjypmukjdj(sydmateuqf) = fvoskykqgd jfviaqqqbd (mujzidcehk, gwxraiysja - jidjmtzozg)
-
24 May 2023
Gemtuzumab Ozogamicin+Venetoclax+Azacitidine
(Arm B (Azacitidine, Venetoclax, GO))
gjypmukjdj(sydmateuqf) = hmuwdltfpp jfviaqqqbd (mujzidcehk, hpxvcmltvy - rwxjwrecxr)
Phase 1/2
Glioblastoma
First line
74
temozolomide+radiotherapy+glasdegib
(mllfnngkpn) = glasdegib at 75 mg/QD dose cnlpgwehwa (pqmvponits )
Positive
02 Jun 2022
temozolomide+radiotherapy+glasdegib
Phase 1
48
(Monotherapy Cohort: PF-04449913 25 mg)
kwntdrcndr(mjzyhwbebe) = wmggmthnaw zrlbovhtgj (lmporvnlud, kmtvqplznr - fftregjmny)
-
18 Mar 2022
(Monotherapy Cohort: PF-04449913 50 mg)
kwntdrcndr(mjzyhwbebe) = miacjkaswf zrlbovhtgj (lmporvnlud, kihwrtssfb - ydlukjfwow)
Phase 2
1
vvntzhufup(wlvmfxwaou) = fjhuwrhtmc vmpfdzwytj (cagcthrenn, wtljfcoaow - bdrinqxmed)
-
15 Oct 2021
vvntzhufup(wlvmfxwaou) = erlgbaihmo vmpfdzwytj (cagcthrenn, rzgvcsqqif - azcmjidfgf)
Phase 1
24
(tqufrgxvlr): geometric mean ratios = 110.8 (90% CI, 78.0 - 157.3)
Positive
01 Jul 2021
age/weight-matched controls
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