DAURISMO

Peak

glasdegib

NDAORALTABLETPriority Review
Approved
Nov 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
10

Mechanism of Action

Smoothened Receptor Antagonists

Pharmacologic Class:

Hedgehog Pathway Inhibitor

Indications (1)

Clinical Trials (5)

NCT04842604Phase 3Completed

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

Started May 2021
14 enrolled
Acute Myeloid LeukemiaMyelodysplastic SyndromeChronic Myelomonocytic Leukemia
NCT04093505Phase 3Terminated

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

Started Apr 2021
28 enrolled
Acute Myeloid Leukemia
NCT04231851Phase 2Active Not Recruiting

CPX-351 and Glasdegib for Newly Diagnosed Acute Myelogenous Leukemia With MDS Related Changes or Therapy-related Acute Myeloid Leukemia

Started Feb 2020
30 enrolled
Acute Myelogenous Leukemia (AML) Due to TherapyAcute Myeloid Leukemia With Myelodysplasia-Related Changes
NCT04051996Phase 2Terminated

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

Started Dec 2019
1 enrolled
ACUTE MYELOID LEUKEMIA
NCT03416179Phase 3Completed

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

Started Apr 2018
730 enrolled
Leukemia, Myeloid, Acute

Loss of Exclusivity

LOE Date
Apr 13, 2036
123 months away
Patent Expiry
Apr 13, 2036

Patent Records (5)

Patent #ExpiryTypeUse Code
8431597
Jun 29, 2028
Product
8148401
Apr 14, 2029
SubstanceProduct
10414748
Apr 13, 2036
SubstanceProduct
11168066
Apr 13, 2036
U-3254
11891372
Apr 13, 2036
U-3254