Drugs / dasatinib anhydrous
dasatinib anhydrous
also known as
Dasatinib · Sprycel · BMS-354825 · XS004 · BMS-354825 HYDRATE · BMS-354825-03 · BMS-354835 · DAS · +11 more
Small molecule targets ABL1, EPHA2, ERBB4, FGFR3, FYN, HCK, KIT, LCK, LYN, PDGFRA, PDGFRB, SRC, YES1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 17 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed childhood acute lymphoblastic leukemia 1 milestone | |||||
| Filed | US (FDA) | Sprycel | childhood acute lymphoblastic leukemia | 2018-08-30 | “FDA accepted its supplemental Biologics License Application (sBLA) for Sprycel (dasatinib) in combination with chemotherapy” bms.com ↗ |
| Filed chronic myeloid leukemia 2 milestones | |||||
| Filed | US (FDA) | SPRYCEL | chronic myeloid leukemia | 2010-07-12 | “FDA has accepted for filing and review the supplemental New Drug Application (sNDA) for SPRYCEL (dasatinib)” otsuka.co.jp ↗ |
| Filed | Japan (PMDA) | SPRYCEL | chronic myeloid leukemia | — | “the supplemental New Drug Application (sNDA) for SPRYCEL for the treatment of adult patients with newly diagnosed chronic myeloid leukemia was submitted in Japan.” bms.com ↗ |
| Approved Indication not stated 8 milestones | |||||
| Label expansion | US (FDA) | PHYRAGO | — | 2025-08-01 | fda.gov ↗ |
| Filed | US (FDA) | Dasynoc | acute lymphoblastic leukemia, chronic myeloid leukemia | 2021-11-18 | “application for US market approval of its first product candidate Dasynoc (dasatinib) has been submitted, in accordance with plans, to the Food and Drug Administration (FDA)” xspraypharma.com ↗ |
| Label expansions (7) | US (FDA) | SPRYCEL | — | 2007-11-08 – 2018-12-21 | fda.gov ↗ |
| Filed | US (FDA) | Sprycel | pediatric chronic myeloid leukemia | 2017-07-10 | “FDA) accepted its supplemental New Drug Application (sNDA) to include an indication for Sprycel (dasatinib)” bms.com ↗ |
| Filed | EU (EMA) | Sprycel | pediatric chronic myeloid leukemia | 2017-05-19 | “EMA validated its grouped Type II variation/Extension of Application for Sprycel (dasatinib)” bms.com ↗ |
| Approved | EU (EMA) | Sprycel | — | 2006-11-20 | europa.eu ↗ |
| Approved | US (FDA) | SPRYCEL | — | 2006-06-28 | fda.gov ↗ |
| Rejected (CRL) | US (FDA) | Dasynoc | chronic myeloid leukemia, acute lymphoblastic leukemia | — | “we received a Complete Response Letter (CRL) from the FDA requesting more information about our application for market approval of Dasynoc.” xspraypharma.com ↗ |
Trials 287 · started per year
today
US approved 2006
EU approved 2006
2
4
11
14
35
21
31
8
16
16
10
10
11
18
9
6
3
11
9
10
8
8
8
5
1
2004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
News releases announcing trial results or a regulatory action · 65
| Date | Issuer | Release |
|---|---|---|
| 2026-09-23 | Xspray Pharma AB | Results Xspray Pharma to present CML data supporting differentiation of Dasynoc and Nilopki xspraypharma.com ↗
Dasynoc's markedly lower variability may allow a lower dose that still works for the individual patient: fewer patients exposed to the high levels linked to pleural effusion, and fewer left below the level for desired clinical effect. |
| 2026-08-19 | Xspray Pharma AB | Regulatory Xspray Pharma receives Complete Response Letter (CRL) from FDA for Dasynoc xspraypharma.com ↗
The FDA’s Complete Response Letter relates to the previously communicated observations at NerPharMa, concerning outstanding GMP (Good Manufacturing Practice) observations, as well as a request for additional commercial scale consecutive batch data following already implemented corrective actions. |
| 2026-06-01 | Novartis Pharmaceuticals | Results Scemblix® continued to show superior efficacy and favorable safety and tolerability profile at week 144 in newly diagnosed CML novartis.com ↗
The longer-term data showed a progressively larger difference in MMR rates favorable to Scemblix vs. SoC TKIs, vs. imatinib and vs. 2G TKIs 1 . |
| 2026-03-11 | Xspray Pharma AB | Regulatory Xspray Pharma: FDA accepts resubmitted application for market approval of Dasynoc® – PDUFA date August 25, 2026 xspraypharma.com ↗
The U.S. Food and Drug Administration (FDA) has accepted Xspray Pharma's resubmitted New Drug Application (NDA) for Dasynoc® for review under the 505(b)(2) procedure. |
| 2026-02-26 | Xspray Pharma AB | Regulatory Xspray Pharma re-submits its FDA application for Dasynoc xspraypharma.com ↗
Xspray Pharma AB (publ) has re-submitted its application for market approval for Dasynoc® to the U.S. Food and Drug Administration (FDA). |
| 2025-11-01 | Alembic Pharmaceuticals Ltd. | Regulatory 07th November, 2025 Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. |
| 2025-10-08 | Xspray Pharma AB | Regulatory Xspray Pharma provides update on the FDA process for Dasynoc – observations at contract manufacturer delay approval xspraypharma.com ↗
Xspray Pharma has received a CRL from the U.S. Food and Drug Administration (FDA) concerning the Company’s New Drug Application (NDA) for Dasynoc™ (dasatinib) for the treatment of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL). |
| 2025-06-27 | Xspray Pharma AB | Regulatory Xspray Pharma Passes FDA Pre-Approval Inspection – Key Regulatory Milestone Achieved for Dasynoc xspraypharma.com ↗
Xspray Pharma AB (publ) today announces that the U.S. Food and Drug Administration (FDA) has conducted a successful Pre-Approval Inspection (PAI) of the company’s manufacturing lines, located at a contract manufacturing partner. |
| 2025-05-14 | Xspray Pharma AB | Regulatory FDA sets PDUFA-date for Xspray Pharma’s re-submitted application for Dasynoc® xspraypharma.com ↗
The FDA has now set the PDUFA date to 7 October 2025, which is the FDA's deadline for communicating its decision on the company's application. |
| 2025-04-08 | Xspray Pharma AB | Regulatory Xspray Pharma re-submits its FDA application xspraypharma.com ↗
Xspray Pharma AB (publ) has re-submitted its application for market approval for Dasynoc®, the company's lead product candidate, an amorphous dasatinib for the treatment of leukemia. |
| 2025-03-05 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from USFDA for Dasatinib Tablets zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. |
| 2024-07-26 | Xspray Pharma AB | Regulatory Xspray Pharma Shares New Information on Dasynoc, a Novel CML Treatment in Development xspraypharma.com ↗
In the CRL the FDA requests additional information pertaining to the labeling comprehension and the pre-approval inspection at the third party’s manufacturing site, which was conducted 10 to 19 of June, 2024. |
| 2024-05-31 | Novartis Pharmaceuticals | Results Novartis Scemblix® Phase III data first to show superior efficacy with a favorable safety and tolerability profile vs. standard-of-care TKIs in adults with newly diagnosed CML novartis.com ↗ |
| 2024-05-24 | Xspray Pharma AB | Results Xspray to present data at ASCO highlighting frequent comedication of PPIs with TKIs in CML-patients and greater than expected negative effects on the bioavailability of crystalline dasatinib xspraypharma.com ↗
Crystalline dasatinib Cmax and AUC24 reduced by 96% and 88% respectively. |
| 2024-05-15 | Novartis Pharmaceuticals | Results Novartis highlights pioneering innovation in CML with data from Scemblix® Phase III ASC4FIRST study in newly diagnosed patients at ASCO and EHA novartis.com ↗
The primary results from ASC4FIRST, a pivotal Phase III study of Scemblix ® (asciminib) versus standard of care tyrosine kinase inhibitors (imatinib, nilotinib, dasatinib, and bosutinib) in newly diagnosed patients with Philadelphia chromosome positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) will be shared at the ASCO official Press Program and at the EHA Plenary Session. |
| 2024-02-12 | Xspray Pharma AB | Regulatory FDA Accepts Xspray Pharma’s NDA-resubmission for Dasynoc® – PDUFA Date set to 31 July xspraypharma.com ↗
The U.S. Food and Drug Administration (FDA) has accepted the resubmission of Xspray Pharma’s New Drug Application (NDA) for Dasynoc®, following a Complete Response Letter (CRL) where additional information was requested. |
| 2024-01-08 | Novartis Pharmaceuticals | Results Novartis Scemblix® shows superior major molecular response (MMR) rates vs. standard‐of‐care TKIs in Phase III trial for newly diagnosed patients with chronic myeloid leukemia novartis.com ↗ |
| 2023-10-26 | Xspray Pharma AB | Results Xspray Publication Demonstrates High Concomitant PPI and TKI Use in CML Resulting in Risk of Increased Mortality Which May be Mitigated by DASYNOC™ xspraypharma.com ↗
In healthy volunteers, neither the peak blood concentration nor the overall exposure of DASYNOC was affected by co-administration of the PPI, omeprazole; compared with DASYNOC administration alone. |
| 2023-07-11 | Xspray Pharma AB | Regulatory Xspray Pharma receives request for additional information concerning Dasynoc from FDA xspraypharma.com ↗
On July 10, Xspray Pharma received a Complete Response Letter (“CRL”) relating to its Dasynoc New Drug Application (“NDA”) for all six strengths (15 mg, 36 mg, 50 mg, 57 mg, 70 mg, and 100 mg) under review by FDA. |
| 2022-12-13 | Xspray Pharma AB | Results Xspray presents novel scientific data for XS004 in the Chronic Myeloid Leukemia (CML) session at the 2022 Meeting of the American Society of Hematology xspraypharma.com ↗
In a separate presentation, Dr Lennernäs et al shared data from a phase 1 bioavailability study demonstrating that the inter- and intrasubject variability in drug plasma concentration was reduced for XS004, relative to crystalline dasatinib. |
| 2022-11-30 | Xspray Pharma AB | Regulatory Xspray Pharma’s drug candidate XS004 granted orphan drug designation in the US for the treatment of acute lymphoblastic leukemia xspraypharma.com ↗
Xspray Pharma (Nasdaq Stockholm: Xspray) has today received a decision from the US Food and Drug Administration (FDA) granting drug candidate XS004 (dasatinib) Orphan Drug Designation (ODD) for the treatment of acute lymphoblastic leukemia (ALL). |
| 2022-11-03 | Xspray Pharma AB | Results Xspray Announces 2 Poster Presentations for XS004 in Chronic Myeloid Leukemia (CML) at the American Society of Hematology (ASH) 2022 Annual Meeting xspraypharma.com ↗
Comedication of Proton Pump Inhibitors and Dasatinib Is Common in CML but XS004, a Novel Amorphous Solid Dispersion Formulation of Dasatinib, Provides Improved Uptake and Low pH-Dependency, Minimizing Unwanted Drug-Drug Interactions |
| 2022-08-29 | Lupin Limited | Regulatory Lupin Receives Tentative Approval from U.S. FDA for Dasatinib Tablets lupin.com ↗ |
| 2022-06-01 | Alembic Pharmaceuticals Ltd. | Regulatory 101h June, 2022, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. |
| 2022-01-13 | Xspray Pharma AB | Regulatory FDA allows review of application for market approval for Xspray Pharma’s Dasynoc™ xspraypharma.com ↗
After an initial review, the FDA has now agreed to conduct a comprehensive review of Xspray Pharma’s application. |
| 2021-11-18 | Xspray Pharma AB | Regulatory Xspray Pharma submits application for market approval to FDA for its product candidate Dasynoc xspraypharma.com ↗
Xspray Pharma submits application for market approval to FDA for its product candidate Dasynoc |
| 2021-10-13 | Xspray Pharma AB | Results Xspray Pharma has obtained results from bioequivalence studies with HyNap-Dasa ANDA and decides to focus on its improved dasatinib product, Dasynoc™ xspraypharma.com ↗
The results show that the bioequivalence with the reference product Sprycel® was achieved in fed but not in fasting subjects due to the high variability of Sprycel®. |
| 2021-07-28 | Xspray Pharma AB | Results Xspray Pharma announces achievement of bioequivalence compared with reference product from bioequivalence study with HyNap-Dasa 505(b)(2) xspraypharma.com ↗
Xspray Pharma (publ) (Nasdaq Stockholm: XSPRAY) announced today that positive results have been obtained from the pivotal bioequivalence study with the company’s improved product dasatinib, known as HyNap-Dasa 505(b)(2). |
| 2021-04-08 | Xspray Pharma AB | Results Xspray Pharma announces update of its improved version of dasatinib xspraypharma.com ↗
External experienced pharmacokinetic experts have, with existing clinical data, calculated that with a 30 percent reduction in dose, the product should be bioequivalent to Sprycel®. |
| 2021-04-08 | Xspray Pharma AB | Results Xspray Pharma announces the results of two bioequivalence studies with adjusted tablet formulation of HyNap-Dasa (ANDA) xspraypharma.com ↗
In the study on non-fasting subjects, bioequivalence with Sprycel was achieved. |
| 2021-01-14 | Xspray Pharma AB | Results Xspray Pharma announces results from additional bioequivalence study and provides update regarding upcoming regulatory applications for ANDA and 505(b)(2) xspraypharma.com ↗
The results show that the study was well conducted and included a sufficient number of subjects, but that formal bioequivalence was not achieved. |
| 2020-12-30 | Xspray Pharma AB | Results Xspray Pharma reports positive results from a study with dasatinib during omeprazole treatment xspraypharma.com ↗
The results from Xspray Pharma’s clinical study show that HyNap-Dasa is not affected during omeprazol treatment which increases the gastric pH. |
| 2020-09-25 | Xspray Pharma AB | Results Xspray announces positive preliminary results from the study for its lead product candidate HyNap-Dasa xspraypharma.com ↗
The study fulfilled statistical and formal bioequivalence requirements for HyNap-Dasa compared to the reference product Sprycel. |
| 2020-08-12 | Xspray Pharma AB | Results Xspray announces preliminary results from the first study for its lead product candidate HyNap-Dasa xspraypharma.com ↗
The first study did not fulfil statistical bioequivalence requirements due to high variability in pharmacokinetic parameters for the reference product Sprycel. |
| 2019-10-31 | Xspray Pharma AB | Regulatory Xspray receives FDA clearance of IND for HyNap-Dasa xspraypharma.com ↗
Xspray Pharma (Nasdaq First North Growth Market: XSPRAY) announces that the US Food and Drug Administration (FDA) has cleared the company's IND application for the product candidate HyNap-Dasa. |
| 2019-06-14 | Novartis Pharmaceuticals | Results Novartis continues to innovate in CML with long-term treatment-free remission results following Tasigna® use and promising combination data with investigational compound asciminib (ABL001) novartis.com ↗
Separate data demonstrate promising results for asciminib (ABL001), an investigational allosteric BCR-ABL inhibitor, in combination with three different tyrosine kinase inhibitors (TKIs) in heavily pre-treated Ph+ CML-CP patients. |
| 2019-02-11 | Bristol-Myers Squibb | Regulatory European Commission Approves Bristol-Myers Squibb’s Sprycel (dasatinib) in Combination with Chemotherapy for Treatment of Pediatric Patients with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia bms.com ↗
Bristol-Myers Squibb Company (NYSE: BMY) today announced that the European Commission (EC) has approved Sprycel (dasatinib) in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). |
| 2019-01-02 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb’s Sprycel® (dasatinib) Tablets Now Approved in Combination with Chemotherapy in Certain Pediatric Patients with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia bms.com ↗ |
| 2018-12-17 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Sprycel (dasatinib) for Pediatric Patients with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia bms.com ↗ |
| 2018-10-10 | Xspray Pharma AB | Results Xspray Pharma’s HyNap-Dasa Shows Formal Bioequivalence xspraypharma.com ↗
The study results confirm bioequivalence for an optimized formulation of HyNap-Dasa and strengthen the conclusions based on preliminary data early September this year. |
| 2018-09-09 | Xspray Pharma AB | Results Xspray Pharma announces positive clinical data for its lead product candidate HyNap-Dasa xspraypharma.com ↗
The study results confirmed its primary aim to show bioequivalence of an optimized formulation of HyNap-Dasa compared to Sprycel®. |
| 2018-08-30 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Accepts Bristol-Myers Squibb’s Application for Sprycel (dasatinib) in Pediatric Patients with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia bms.com ↗ |
| 2018-07-05 | Bristol-Myers Squibb | Regulatory European Commission Approves Expanded Indication for Sprycel (dasatinib) to Include Treatment of Children with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase bms.com ↗ |
| 2017-12-09 | Bristol-Myers Squibb | Results Sprycel (dasatinib) Added to Standard Chemotherapy Demonstrates Three-Year Survival Benefit in Pediatric Patients with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia bms.com ↗
The combination demonstrated an event-free survival (EFS) rate, the study’s primary endpoint, of 65.5% (95% CI: 57.7 to 73.7), and an overall survival (OS) rate of 91.5% (95% CI: 84.2 to 95.5) at three years. |
| 2017-11-10 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Expands Approval of Sprycel® (dasatinib) to Include Treatment of Children with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase bms.com ↗ |
| 2017-07-10 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb’s Application for Sprycel (dasatinib) in Children with Philadelphia Chromosome-Positive Chronic Phase Chronic Myeloid Leukemia bms.com ↗ |
| 2017-06-05 | Bristol-Myers Squibb | Results Early, Durable Responses Seen with Sprycel (dasatinib) in First- and Second-Line Treatment of Pediatric Patients with Chronic Myeloid Leukemia in Chronic Phase (CP-CML) bms.com ↗
Target responses were sustained over time in newly diagnosed and imatinib-resistant or -intolerant pediatric patients and treatment safety profile was comparable to that in adult patients |
| 2017-05-19 | Bristol-Myers Squibb | Regulatory European Medicines Agency Validates Application for Bristol-Myers Squibb’s Sprycel (dasatinib) in Children with Chronic Myelogenous Leukemia bms.com ↗
Validation of the application confirms the submission is complete and begins the EMA’s centralized review process. |
| 2015-08-13 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory FDA Approves U.S. Product Labeling Update for Sprycel® (dasatinib) to Include Five-Year First-Line and Seven-Year Second-Line Efficacy and Safety Data in Chronic Myeloid Leukemia in Chronic Phase otsuka-us.com ↗
Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka America Pharmaceutical, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved an update to the Sprycel® (dasatinib) product labeling. |
| 2015-08-13 | Bristol-Myers Squibb | Regulatory FDA Approves U.S. Product Labeling Update for Sprycel® (dasatinib) to Include Five-Year First-Line and Seven-Year Second-Line Efficacy and Safety Data in Chronic Myeloid Leukemia in Chronic Phase bms.com ↗
Bristol-Myers Squibb Company (NYSE:BMY) and Otsuka America Pharmaceutical, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved an update to the Sprycel ® (dasatinib) product labeling. |
| 2013-12-09 | Bristol-Myers Squibb | Results Four-Year Data from Phase 3 DASISION Trial Comparing Sprycel® (dasatinib) to Imatinib in First-Line Treatment of Adults with Ph+ CP-CML Presented at Annual Meeting of the American Society of Hematology bms.com ↗
At four years, 76% of Sprycel patients vs. 63% of imatinib patients achieved a major molecular response (MMR). |
| 2013-06-20 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory FDA Approves U.S. Product Labeling Update for SPRYCEL® (dasatinib) to Include Three-Year First-Line and Five-Year Second-Line Efficacy and Safety Data in Chronic Myeloid Leukemia in Chronic Phase otsuka-us.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has approved an update to the Sprycel (dasatinib) product labeling. |
| 2013-06-20 | Bristol-Myers Squibb | Regulatory FDA Approves U.S. Product Labeling Update for Sprycel® (dasatinib) to Include Three-Year First-Line and Five-Year Second-Line Efficacy and Safety Data in Chronic Myeloid Leukemia in Chronic Phase bms.com ↗
Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka America Pharmaceutical, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved an update to the Sprycel (dasatinib) product labeling. |
| 2010-12-07 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Follow-Up Results from Study Comparing SPRYCEL (dasatinib) to Imatinib in First-Line Treatment of Adults with Ph+ CP-CML Demonstrate Improved Response Rates Consistent with 12 Month Data®*1 otsuka.co.jp ↗
Results at 18 months were consistent with 12 month data in which SPRYCEL demonstrated higher and faster rates of complete cytogenetic response (CCyR) and major molecular response (MMR) compared to imatinib. |
| 2010-12-06 | Bristol-Myers Squibb | Results Follow-Up Results from Study Comparing SPRYCEL® (dasatinib) to Imatinib in First-Line Treatment of Adults with Ph+ CP-CML Demonstrate Improved Response Rates Consistent with 12 Month Data bms.com ↗
Results at 18 months were consistent with 12 month data in which SPRYCEL demonstrated higher and faster rates of complete cytogenetic response (CCyR) and major molecular response 1 (MMR) compared to imatinib. |
| 2010-11-01 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory FDA Approves SPRYCEL (dasatinib) as Treatment for Adult Patients with Newly Diagnosed Ph+ Chronic Myeloid Leukemia in Chronic Phase® otsuka.co.jp ↗ |
| 2010-10-28 | Bristol-Myers Squibb | Regulatory FDA Approves SPRYCEL® (dasatinib) as Treatment for Adult Patients with Newly Diagnosed Ph+ Chronic Myeloid Leukemia in Chronic Phase bms.com ↗
After receiving a priority review, Bristol-Myers Squibb Company (NYSE:BMY) and Otsuka Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved SPRYCEL (dasatinib) 100 mg once daily for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. |
| 2010-07-12 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory SPRYCEL (dasatinib) Receives FDA Priority Review for the Treatment of Adult Patients with Newly Diagnosed Chronic Myeloid Leukemia (CML) in Chronic Phase® otsuka.co.jp ↗
The companies also announced today that the application has been granted a priority review designation by the FDA. |
| 2010-07-09 | Bristol-Myers Squibb | Regulatory SPRYCEL® (dasatinib) Receives FDA Priority Review for the Treatment of Adult Patients with Newly Diagnosed Chronic Myeloid Leukemia (CML) in Chronic Phase bms.com ↗
The companies also announced today that the application has been granted a priority review designation by the FDA. |
| 2010-06-09 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Four-Year Follow-Up Data for SPRYCEL (dasatinib) Demonstrate 82 Percent Overall Survival in Patients with Chronic Myeloid Leukemia Who Failed Gleevec®®* otsuka.co.jp ↗
At four years, for all patients administered SPRYCEL 100 mg once daily, overall survival was 82% (95% CI: 76%-88%) and progression-free survival was 66% (95% CI: 57%-74%). |
| 2010-06-08 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results SPRYCEL (dasatinib) Demonstrates Superior Confirmed Complete Cytogenetic Response Rates Compared to Gleevecin Study of Adult Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase®®* otsuka.co.jp ↗
Bristol-Myers Squibb Company (NYSE:BMY) and Otsuka Pharmaceutical Co., Ltd. today announced Phase III study results in which SPRYCEL (dasatinib) 100 mg once daily demonstrated a superior rate of confirmed complete cytogenetic response(CCyR) compared to Gleevec (imatinib mesylate). |
| 2010-06-07 | Bristol-Myers Squibb | Results Four-Year Follow-Up Data for SPRYCEL® (dasatinib) Demonstrate 82 Percent Overall Survival in Patients with Chronic Myeloid Leukemia Who Failed Gleevec®1 bms.com ↗
At four years, for all patients administered SPRYCEL 100 mg once daily, overall survival was 82% (95% CI: 76%-88%) and progression-free survival was 66% (95% CI: 57%-74%). |
| 2010-06-05 | Bristol-Myers Squibb | Results SPRYCEL® (dasatinib) Demonstrates Superior Confirmed Complete Cytogenetic Response Rates Compared to Gleevec®* in Study of Adult Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase bms.com ↗
Bristol-Myers Squibb Company (NYSE:BMY) and Otsuka Pharmaceutical Co., Ltd. today announced Phase III study results in which SPRYCEL (dasatinib) 100 mg once daily demonstrated a superior rate of confirmed complete cytogenetic response(CCyR) † compared to Gleevec ® (imatinib mesylate). |
| 2009-05-26 | Bristol-Myers Squibb | Regulatory FDA Grants Full Approval for SPRYCEL® (dasatinib) for the Treatment of Adults with Chronic Myeloid Leukemia Who Are Resistant or Intolerant to Prior Therapies Including Gleevec®* bms.com ↗ |
| 2009-05-14 | Bristol-Myers Squibb | Results SPRYCEL® (Dasatinib) Shows Potential as Treatment for Prostate Cancer bms.com ↗
Bristol-Myers Squibb Company (NYSE: BMY) today announced interim results from two Phase II studies of SPRYCEL® (dasatinib) which demonstrate that the medicine may have potential as a treatment for a certain type of advanced prostate cancer. |
All press releases naming this drug 82 releases
Evidence & citations 27 cited values
Every value below carries the sentence it was read from. 350 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | dasatinib anhydrous | “estimate the safety and tolerability of dasatinib anhydrous (dasatinib) in the setting of COVID-19 infection.” NCT04830735 ↗ |
| Known as | BMS-354825 | “Study of BMS-354825 (Dasatinib) in Patients With Chronic Myeloid Leukemia Who Are Either Resistant or Intolerant to Imatinib” NCT00101660 ↗6“Long-Term Safety and Efficacy of Dasatinib (BMS-354825) in Subjects Who Experienced Clinical Benefit on Protocol CA 180-002” NCT00345826 ↗ “Phase I Study of Dasatinib (BMS-354825) and Imatinib in Subjects With Chronic Myeloid Leukemia in Chronic Phase” NCT00324077 ↗ “Dasatinib = BMS-354825, Sprycel” NCT00652574 ↗ “Drug: Dasatinib (BMS-354825)” NCT00255346 ↗ “Dasatinib (BMS-354825)” NCT00364286 ↗ “Dasatinib (BMS-354825)” NCT00388427 ↗ |
| Known as | BMS-354825 HYDRATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1421 ↗ |
| Known as | BMS-354825-03 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1421 ↗ |
| Known as | BMS-354835 | “Dasatinib (BMS-354835) Versus Imatinib Mesylate in Subjects With Chronic Myeloid Leukemia” NCT00103844 ↗ |
| Known as | DAS | “Dasatinib (DAS) and interferon-α have antileukemic and immunostimulatory effects and induce deep responses in chronic myeloid leukemia (CML).” PMID 27133821 ↗ May 2016 |
| Known as | Dasatinib | “Per patient, the inhibitory potency of sunitinib, dasatinib, erlotinib, sorafenib, everolimus, and lapatinib was determined in tumor lysates from fresh biopsies using a...” PMID 30018133 ↗ Jul 2018344“Doses are halved/reduced per protocol: Flumatinib 400/200 mg QD, Imatinib 200 mg QD, Nilotinib 300 mg QD, Dasatinib 50 mg QD, or Olverembatinib 20 mg QD, based on pre-entry therapy.” NCT07839988 ↗ “Low dose tyrosine kinase inhibitor (lowTKI) (dasatinib 50 mg daily or imatinib 300 mg daily or nilotinib 300 mg daily) at investigators discretion” NCT05143840 ↗ “Imatinib was given at a dose of 400mg/d or 600mg/d, dasatinib at a dose of 100mg/d or 140mg/d, and nilotinib at a dose of 400mg twice daily.” NCT01883219 ↗ “subjects with molecular typing of ABL1/ABL2/PDGFRB fusion were to receive chemotherapy combined with dasatinib 100mg orally once a day” NCT07203352 ↗ “subjects will take 140 mg of dasatinib along with 58 mg to 174 mg (based on body weight) bio-quercetin and 44.5 mg bio-fisetin” NCT04994561 ↗ “a drug called Asciminib (having different way of action), used either by itself or with another drug called Dasatinib” NCT07538401 ↗ “Imatinib was initiated at a dose of 200mg/d, dasatinib at a dose of 50mg/d, and ponatinib at a dose of 30mg/d.” NCT03624530 ↗ “The BCR-ABL TKIs that will be used include imatinib, dasatinib, nilotinib or bosutinib.” NCT03610971 ↗ “Dasatinib is a potent BCR-ABL inhibitor with proven efficacy in adults” PMID 23715577 ↗ May 2013 “Hydroxychloroquine, Metformin, Sirolimus, Dasatinib” NCT05036226 ↗ |
| Known as | Dasatinib accord | ChEMBL registry synonym — accepted as the source's own label CHEMBL1421 ↗ |
| Known as | Dasatinib accord healthcare | ChEMBL registry synonym — accepted as the source's own label CHEMBL1421 ↗ |
| Known as | Dasatinib accordpharma | ChEMBL registry synonym — accepted as the source's own label CHEMBL1421 ↗ |
| Known as | Dasatinib hydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1421 ↗ |
| Known as | Dasatinib monohydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1421 ↗ |
| Known as | Dasatinib/BMS-354825 | “Dasatinib/BMS-354825” NCT01392703 ↗ |
| Known as | NSC #732517 | “A Phase II Study of Dasatinib (NSC #732517) in Patients With Previously Treated Malignant Mesothelioma” NCT00509041 ↗ |
| Known as | NSC-759877 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1421 ↗ |
| Known as | Sprycel | “Comparative Bioavailability of XS004 (Dasatinib) Formulation G and SPRYCEL® (Dasatinib) in Healthy, Adult Subjects Under Fasting Conditions” NCT05439408 ↗12“SPRYCEL® (dasatinib) 100 mg Film-Coated Tablets in combination with Omeprazole Delayed-Release Capsules USP, 40 mg” NCT06145217 ↗ “Dasatinib (D) is given as (1) 100mg capsule daily for 2 consecutive days (Sprycel®, Bristol Myers Squibb).” NCT04685590 ↗ “Subjects will be evaluated for the efficacy and safety of dasatinib (Sprycel).” NCT01802450 ↗ “A Phase II Study of Dasatinib (Sprycel®) (NSC #732517) as Primary Therapy” NCT01256398 ↗ “Dasatinib (SPRYCEL®) vs. Dasatinib Plus Smoothened Antagonist (BMS-833923)” NCT01357655 ↗ “Sprycel® (dasatinib): 20 mg and 50 mg tablets.” NCT02233049 ↗ “It is sold under the name of Sprycel.” NCT00817531 ↗ “Dasatinib = BMS-354825, Sprycel” NCT00652574 ↗ “Dasatinib(Sprycel) arm” NCT06257394 ↗ “dasatinib (SPRYCEL®)” NCT02890784 ↗ |
| Known as | Sprycel (Dasatinib) | “Sprycel (Dasatinib)” NCT00597038 ↗ |
| Known as | Vysentri | ChEMBL registry synonym — accepted as the source's own label CHEMBL1421 ↗ |
| Known as | XS004 | “Comparative Bioavailability of XS004 (Dasatinib) Formulation G and SPRYCEL® (Dasatinib) in Healthy, Adult Subjects Under Fasting Conditions” NCT05439408 ↗1“XS004 (Dasatinib) Tablets” NCT05433896 ↗ |
| Known as | 依尼舒 | “自诱导化疗第8天开始口服达沙替尼（商品名依尼舒，正大天晴药业集团股份有限公司产品）100 mg/d，持续应用至整体治疗结束。” PMID 33858040 ↗ Feb 2021 |
| Action | Inhibit | “Platelet-derived growth factor receptor beta inhibitor” CHEMBL1421 ↗1“dasatinib, a BCR-ABL inhibitor” PMID 16775234 ↗ Jun 2006 |
| Modality | Small molecule | “Although second generation TKIs like dasatinib proved more efficient in achieving molecular remission compared to first generation TKI imatinib” PMID 30120281 ↗ Aug 2018 |
| Route | Oral | “dasatinib PO” NCT00036738 ↗ |
| Target | EPHA2 | “activation or overexpression of ≥ 2 putative dasatinib targets in GBM (ie, SRC, c-KIT, EPHA2, and PDGFR).” PMID 25758746 ↗ Mar 2015 |
| Target | KIT | “activation or overexpression of ≥ 2 putative dasatinib targets in GBM (ie, SRC, c-KIT, EPHA2, and PDGFR).” PMID 25758746 ↗ Mar 2015 |
| Target | PDGFRB | “Platelet-derived growth factor receptor beta inhibitor” CHEMBL1421 ↗ |
| Target | SRC | “activation or overexpression of ≥ 2 putative dasatinib targets in GBM (ie, SRC, c-KIT, EPHA2, and PDGFR).” PMID 25758746 ↗ Mar 2015 |