Treats newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia…. Sold as Sprycel, Phyrago. Every FDA application for this active ingredient: 3 branded and 10 generic.
As of Nov 14, 2026, FDA lists 13 applications for Dasatinib (sold as Sprycel, Phyrago), first approved Jun 28, 2006, with 10 new uses approved and 0 published complete response letters.
| A Randomized Study of ELVN-001 Versus Investigator-Selected TKI, in CP-CML Previously Treated With One or More TKIsChronic Myeloid Leukemia (CML), Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive · Enliven Therapeutics | Phase 3 | Not yet recruiting | Oct 29, 2026 |
| A Study of HS-10382 Versus Investigator-selected TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CPChronic Myeloid Leukemia · Jiangsu Hansoh Pharmaceutical Co., Ltd. | Phase 3 | Not yet recruiting | Oct 21, 2026 |
| De-escalation Strategy of Tyrosine Kinase Inhibitors Before Treatment Discontinuation in Patients With Chronic Myeloid LeukemiaChronic Myeloid Leukemia in Chronic Phase · Nanfang Hospital, Southern Medical University | Phase 4 | Not yet recruiting | Sep 24, 2026 |
| Asciminib Frontline Risk AdaptedChronic Myeloid Leukemia (CML) · Prof. Dr. med. Andreas Hochhaus | Phase 2 | Not yet recruiting | Sep 4, 2026 |
| A Study on the Tolerability, Safety and Effectiveness of Asciminib in Patients With Philadelphia Chromosome-positive Chronic Myeloid Leukemia in the Chronic Phase in GermanyLeukemia, Chronic Myeloid · Novartis Pharmaceuticals | — | Recruiting | Apr 24, 2026 |
| ASCiminib, With or Without Dasatinib Combination, as a 2nd-Line Therapy to ADVANCE the Treatment for Chronic Myelogenous Leukemia in Chronic Phase (ASC2ADVANCE)Chronic Myeloid Leukemia (CML) in · University Health Network, Toronto | Phase 2 | Not yet recruiting | Apr 20, 2026 |
| Asciminib & Standard-of-Care Integration in Maintenance Therapy for POST Allogeneic Stem Cell Transplant (Allo-HSCT) of Patient With Ph+ B-ALL or Blastic Transformed CMLPh+ Acute Lymphoblastic Leukemia (Ph+ALL), Blastic Transformation of Chronic Myeloid Leukemia · The University of Hong Kong | Phase 2 | Not yet recruiting | Mar 25, 2026 |
| Dasatinib for HIV-1 Reservoir ReductionHIV Infections · National Institute of Allergy and Infectious Diseases (NIAID) | Phase 1 | Recruiting | Jan 15, 2026 |
| Jun 28, 2006 | SprycelNDA 21986 · New molecular entity | Bristol Myers Squibb | 23 | Marketed |
| Jun 28, 2006 | SprycelNDA 22072 · TYPE 6 | Bristol Myers Squibb | 2 | Marketed |
| Jun 10, 2016 | DasatinibANDA 202103 | Apotex | 9 | Marketed |
| Nov 23, 2021 | DasatinibANDA 203180 | Apotex | 3 | Marketed |
| Dec 5, 2023 | PhyragoNDA 216099 · New formulation or manufacturer | Handa Therap | 4 | Marketed |
| Mar 3, 2025 | DasatinibANDA 213383 | Dr Reddys | 1 | Marketed |
| Mar 3, 2025 | DasatinibANDA 217217 | Biocon Pharma | 0 | Marketed |
| Mar 3, 2025 | DasatinibANDA 218719 | Zydus Pharms | 0 | Marketed |
| Apr 22, 2025 | DasatinibANDA 216547 | Eugia Pharma | 0 | Marketed |
| Aug 25, 2025 | DasatinibANDA 214350 | Lupin | 0 | Marketed |
| Aug 27, 2025 | DasatinibANDA 211094 | Teva Pharms USA | 0 | Marketed |
| Nov 6, 2025 | DasatinibANDA 216261 | Alembic | 0 | Marketed |
| Sep 11, 2026 | DasatinibANDA 219579 | Msn | 0 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA