Daurismo

(Glasdegib)

Phase 3Small molecule

Pfizer

Daurismo is one of 67 small molecule programs targeting Acute Myeloid Leukemia. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Acute Myeloid LeukemiaTerminated

Advanced Soft-Tissue SarcomaActive, not recruiting

Acute Myeloid LeukemiaPhase 3

Terminated

Advanced Soft-Tissue SarcomaPhase 3

Active, not recruiting

Competition

Competitive Landscape

255 competitors in Acute Myeloid Leukemia

#DrugCompanyPhaseTrials

Idamycin

Pfizer

Phase 3

59 2

Novantrone

Pfizer

Phase 3

34 3

Xospata

Astellas

Phase 3

24 4

Cerubidine

EEastern Cooperative Oncology Group

Phase 3

42 5

Vepesid

AAvyxa

Phase 3

52 6

Mylotarg

WWyeth-Lederle Vaccines

Phase 3

38 7

Neupogen

EEastern Cooperative Oncology Group

Phase 3

31 8

Cerubidine

HHikma Pharmaceuticals LLC

Phase 3

30 9

Nexavar

Cellcept

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 2Active, not recruiting

Acute Myeloid Leukemia

NCT04231851

Clinical

Trials by Indication[1]

Acute Myeloid Leukemia7 trials

Geriatric Assessment & Genetic Profiling to Personalize Therapy in Older Adults With Acute Myeloid Leukemia

Completed·UUniversity of Nebraska·Phase 2·NCT03226418·75 enrolled

GLAD-AML - Glasdegib (Pf-04449913) With Two Standard Decitabine Regimens for Older Patients With Poor-risk Acute Myeloid Leukemia

Terminated·YYale University·Phase 2·NCT04051996·1 enrolled

Acute Myeloid Leukemia Real World Treatment Patterns

Withdrawn· Pfizer logo

Pfizer··NCT04230564

Show 4 more trials

OX40, Venetoclax, Avelumab, Glasdegib, Gemtuzumab Ozogamicin, and Azacitidine in Relapsed or Refractory Acute Myeloid Leukemia

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT03390296·50 enrolled

Gemtuzumab Ozogamicin in Induction and Glasdegib in Postremission Therapy in Patients With AML (Acute Myeloid Leukemia)

Terminated·UUniversity Hospital Heidelberg·Phase 3·NCT04093505·28 enrolled

A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia

Completed· Pfizer logo

Pfizer·Phase 3·NCT03416179·730 enrolled

Phase II Study of the Combination of CPX-351 and Glasdegib in Previously Untreated Patients With Acute Myelogenous Leukemia With MDS Related Changes or Therapy-related Acute Myeloid Leukemia

Active, not recruiting·UUniversity of California, Irvine·Phase 2·NCT04231851·30 enrolled

Chronic Graft Versus Host Disease2 trials

Glasdegib in Refractory Patients With Sclerotic Chronic Graft-Versus-Host Disease

Unknown status·GGrupo Espanol de trasplantes hematopoyeticos y terapia celular·Phase 1/2·NCT03415867·21 enrolled

Glasdegib for Chronic Graft-Versus-Host Disease

Terminated·FFred Hutchinson Cancer Center·Phase 1/2·NCT04111497·15 enrolled

Phase 21 trial

A Study Of Glasdegib In Healthy Volunteers To Establish The Bioequivalence Of The Phase 2 Formulation To The ICH Formulation

Completed· Pfizer logo

Pfizer·Phase 1·NCT03130556·24 enrolled

Myelofibrosis1 trial

Single-Agent Glasdegib In Patients With Myelofibrosis Previously Treated With Ruxolitinib

Terminated· Pfizer logo

Pfizer·Phase 2·NCT02226172·21 enrolled

Hepatic Impairment1 trial

A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Glasdegib

Completed· Pfizer logo

Pfizer·Phase 1·NCT03627754·24 enrolled

6 more indications

Tics1 trial

Understanding The Effect Of A Strong CYP3A4 Inducer On Glasdegib Pharmacokinetics

Completed· Pfizer logo

Pfizer·Phase 1·NCT02430545·12 enrolled

Advanced Soft-tissue Sarcoma1 trial

Molecular Profiling of Advanced Soft-tissue Sarcomas

Active, not recruiting·IInstitut National de la Santé Et de la Recherche Médicale, France·Phase 3·NCT03784014·603 enrolled

Untreated AML1 trial

Continuation Study of B1371019(NCT03416179) and B1371012(NCT02367456) Evaluating Azacitidine With Or Without Glasdegib In Patients With Previously Untreated AML, MDS or CMML

Completed· Pfizer logo

Pfizer·Phase 3·NCT04842604·14 enrolled

Renal Impairment1 trial

Glasdegib Renal Impairment Study

Completed· Pfizer logo

Pfizer·Phase 1·NCT03596567·18 enrolled

Cardiac Repolarization1 trial

A Phase 1 Study To Evaluate The Effect Of Glasdegib On The Cardiac Repolarization In Healthy Subjects

Completed· Pfizer logo

Pfizer·Phase 1·NCT03162900·36 enrolled

Unspecified1 trial

Glasdegib Absolute Bioavailability Study

Completed· Pfizer logo

Pfizer·Phase 1·NCT03270878·12 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 21, 2018

DAURISMO

NDA NDA210656

Sources

References

[1]
ClinicalTrials.gov — 18 trial records for Glasdegib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Glasdegib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Glasdegib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA210656). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Daurismo. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Pfizer

Patent Landscape[5]

Patent Cliff

Jun 29, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8431597Jun 29, 2028

8148401Apr 14, 2029

11168066Apr 13, 2036

11891372Apr 13, 2036

10414748Apr 13, 2036

Daurismo

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Trials by Indication[1]

Acute Myeloid Leukemia7 trials

Chronic Graft Versus Host Disease2 trials

Phase 21 trial

Myelofibrosis1 trial

Hepatic Impairment1 trial

Tics1 trial

Advanced Soft-tissue Sarcoma1 trial

Untreated AML1 trial

Renal Impairment1 trial

Cardiac Repolarization1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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