drug · small molecule
DASATINIB
Marketedupdated 3mo agoby Xspray Pharma AB🔗 ChEMBL
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 4Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for acute lymphoblastic leukemia and chronic myelogenous leukemia and 7 investigational indications.
targets
Bcr/Abl fusion protein
all catalysts(2)
Trials studying DASATINIB
- phase2Frontline Asciminib Combination in Chronic Phase CML
- phase4Asciminib Roll-over Study
- phase1Venetoclax, Dasatinib, Prednisone, Rituximab and Blinatumomab for the Treatment of Newly Diagnosed or Relapsed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia
- phase2Blinatumomab and Tyrosine Kinase Inhibitor Therapy in People With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
- phase3A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP
- phase2Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR)
- phase1A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Hematologic Malignancies
- phase2Asciminib & Standard-of-Care Integration in Maintenance Therapy for POST Allogeneic Stem Cell Transplant (Allo-HSCT) of Patient With Ph+ B-ALL or Blastic Transformed CML
Patent cliff
source: FDA Orange Bookfirst barrier falls
Sep 28, 2026
39 days
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (48)
- Jan 22, 2041method-of-use (U-3772)US 11202778
- Jan 22, 2041method-of-use (U-3772)US 11202778
- Jan 22, 2041method-of-use (U-3772)US 11202778
- Jan 22, 2041method-of-use (U-3772)US 11202778
- Jan 22, 2041method-of-use (U-3772)US 11202778
- Jan 22, 2041method-of-use (U-3772)US 11202778
- Jan 22, 2041formulationUS 11298356
- Jan 22, 2041formulationUS 11298356
- Jan 22, 2041formulationUS 11298356
- Jan 22, 2041formulationUS 11298356
- Jan 22, 2041formulationUS 11298356
- Jan 22, 2041formulationUS 11298356
- Jan 22, 2041method-of-use (U-3767)US 11324745
- Jan 22, 2041method-of-use (U-3767)US 11324745
- Jan 22, 2041method-of-use (U-3767)US 11324745
- Jan 22, 2041method-of-use (U-3767)US 11324745
- Jan 22, 2041method-of-use (U-3767)US 11324745
- Jan 22, 2041method-of-use (U-3769)US 11324745
- Jan 22, 2041method-of-use (U-3772)US 12433891
- Jan 22, 2041method-of-use (U-3772)US 12433891
- Jan 22, 2041method-of-use (U-3772)US 12433891
- Jan 22, 2041method-of-use (U-3772)US 12433891
- Jan 22, 2041method-of-use (U-3772)US 12433891
- Jan 22, 2041method-of-use (U-3772)US 12433891
- Jan 22, 2041formulationUS 12465606
- Jan 22, 2041formulationUS 12465606
- Jan 22, 2041formulationUS 12465606
- Jan 22, 2041formulationUS 12465606
- Jan 22, 2041formulationUS 12465606
- Jan 22, 2041formulationUS 12465606
- Jan 22, 2041method-of-use (U-3772)US 12544376
- Jan 22, 2041method-of-use (U-3772)US 12544376
- Jan 22, 2041method-of-use (U-3772)US 12544376
- Jan 22, 2041method-of-use (U-3772)US 12544376
- Jan 22, 2041method-of-use (U-3772)US 12544376
- Jan 22, 2041method-of-use (U-3772)US 12544376
- Sep 28, 2026patentUS 7491725*PED39d
- Sep 28, 2026patentUS 7491725*PED39d
- Sep 28, 2026patentUS 7491725*PED39d
- Sep 28, 2026patentUS 7491725*PED39d
- Sep 28, 2026patentUS 7491725*PED39d
- Sep 28, 2026patentUS 7491725*PED39d
- Mar 28, 2026compositionUS 7491725
- Mar 28, 2026compositionUS 7491725
- Mar 28, 2026compositionUS 7491725
- Mar 28, 2026compositionUS 7491725
- Mar 28, 2026compositionUS 7491725
- Mar 28, 2026compositionUS 7491725
FDA exclusivities (18)
- Dec 5, 2026M-307Method (3y)107d
- Dec 5, 2026M-307Method (3y)107d
- Dec 5, 2026M-307Method (3y)107d
- Dec 5, 2026M-307Method (3y)107d
- Dec 5, 2026M-307Method (3y)107d
- Dec 5, 2026M-307Method (3y)107d
- Jun 21, 2026PEDPediatric (6mo bonus)
- Jun 21, 2026PEDPediatric (6mo bonus)
- Jun 21, 2026PEDPediatric (6mo bonus)
- Jun 21, 2026PEDPediatric (6mo bonus)
- Jun 21, 2026PEDPediatric (6mo bonus)
- Jun 21, 2026PEDPediatric (6mo bonus)
- Dec 21, 2025ODE-225Orphan Drug (7y)
- Dec 21, 2025ODE-225Orphan Drug (7y)
- Dec 21, 2025ODE-225Orphan Drug (7y)
- Dec 21, 2025ODE-225Orphan Drug (7y)
- Dec 21, 2025ODE-225Orphan Drug (7y)
- Dec 21, 2025ODE-225Orphan Drug (7y)
News(1)
- Dr Mauro on the Significance of Alternative TKI Formulations in CMLMichael Mauro, MD, details the FDA approval of the small-molecule formulation of dasatinib and other alternate TKI formulations in chronic myeloid leukemia.onclive · 3mo ago
Data sources
last refreshed 1h ago
Found something off?
comments(0)
5-min edit window · permanent after that