Drugs / Bosutinib
Bosutinib
also known as
SKI-606 · Bosulif · Bosutinib (as monohydrate) · Bosutinib hydrate · BOSUTINIB MONOHYDRATE · Bosutinib(Bosulif, SKI-606, Pfizer) · PF-05208763 · SK-606 · +1 more
Small molecule targets ABL1, BCR, HCK, LYN, SRC via inhibition
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed chronic myeloid leukemia 2 milestones | |||||
| Filed | EU (EMA) | BOSULIF | chronic myeloid leukemia | 2017-08-29 | “the European Medicines Agency (EMA) has validated for review a Type II Variation application for use of BOSULIF in the same patient population” pfizer.com ↗ |
| Filed | US (FDA) | BOSULIF | chronic myeloid leukemia | 2017-08-29 | “a supplemental New Drug Application (sNDA) for BOSULIF® (bosutinib) has been accepted for filing” pfizer.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (4) | US (FDA) | BOSULIF | — | 2017-04-13 – 2023-09-26 | fda.gov ↗ |
| Approved | EU (EMA) | Bosulif | — | 2013-03-27 | europa.eu ↗ |
| Approved | US (FDA) | BOSULIF | — | 2012-09-04 | fda.gov ↗ |
Trials 55
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 125 trials | ||||||
| Phase 1 | NCT04655391 | Jun 2022 → Dec 2023 | acute myeloid leukemia | City of Hope Medical Center | Withdrawn | No outcome recorded |
| Phase 1 | NCT05032690 | Jan → Jun 2022 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03023319 | Dec 2019 → May 2022 | cervical cancer, mesothelioma, non-small cell lung carcinoma, ovarian cancer +4 | Nagla Abdel Karim | Completed | No outcome recorded |
| Phase 1 | NCT03854903 | Apr 2019 → Nov 2023 | hormone receptor-positive breast cancer | Georgetown University | Completed | No outcome recorded |
| Phase 1 | NCT02782403 | Mar 2017 → Nov 2019 | Philadelphia-positive myelogenous leukemia, blast phase chronic myelogenous leukemia, BCR-ABL1 positive, leukemia, myeloid, accelerated-phase | M.D. Anderson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02921477 | Sep 2016 → Dec 2023 | cognitive impairment with or without cerebellar ataxia, dementia | Neurological Associates of West Los Angeles | Unknown | No outcome recorded |
| Phase 1 | NCT02192294 | Aug → Oct 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02058277 | May → Jun 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02102633 | May → Jun 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01233882 | Dec 2010 → Jun 2012 | acute kidney injury, end stage renal failure | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01025570 | May 2010 → May 2012 | pancreatic adenocarcinoma | University of California, San Francisco | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT01080365 | Feb → Mar 2010 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00952913 | Aug → Oct 2009 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00934674 | Jul → Aug 2009 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00914121 | Jun → Aug 2009 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00757341 | Dec 2008 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00759837 | Oct 2008 → May 2009 | breast cancer, chronic myeloid leukemia | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00721474 | Sep 2008 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00725426 | Jul → Aug 2008 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00777530 | Apr → Aug 2008 | breast cancer, leukemia | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00499538 | Jul → Sep 2007 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00434486 | Mar 2007 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00406406 | Nov 2006 → Aug 2007 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01001936 | Feb 2006 → Dec 2008 | neoplasm | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00195260 | Oct 2004 → Nov 2007 | neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 1/25 trials | ||||||
| Phase 1/2 | NCT04793399 | Feb → Sep 2021 | chronic myeloid leukemia | Fundacion Espanola para la Curacion de la Leucemia Mieloide Cronica | Terminated | No outcome recorded |
| Phase 1/2 | NCT04258943 | Jul 2020 → Jul 2028 expected | Philadelphia-positive myelogenous leukemia, blast phase chronic myelogenous leukemia, BCR-ABL1 positive, leukemia, myeloid, accelerated-phase | Children's Oncology Group | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04744532 | Mar 2019 → Mar 2024 | amyotrophic lateral sclerosis | Kyoto University | Unknown | No outcome recorded |
| Phase 1/2 | NCT02311998 | Apr 2015 → Mar 2022 | B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2), Philadelphia-positive myelogenous leukemia, blast phase chronic myelogenous leukemia, BCR-ABL1 positive | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT00959946 | Sep 2009 → Mar 2011 | breast cancer, cholangiocarcinoma, colorectal cancer, glioblastoma +1 | Pfizer | Terminated | No outcome recorded |
| Phase 218 trials · 2 met primary | ||||||
| Phase 2 | NCT04578847 | Jan 2020 → Jan 2025 | Philadelphia-positive myelogenous leukemia, chronic myeloid leukemia | National Research Center for Hematology, Russia | Unknown | No outcome recorded |
| Phase 2 | NCT03610971 | Nov 2019 → Sep 2025 overdue | chronic myeloid leukemia | H. Lee Moffitt Cancer Center and Research Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03831776 | Mar 2019 → Dec 2024 | chronic myeloid leukemia | St. Olavs Hospital | Completed | No outcome recorded |
| Phase 2 | NCT03297606 | Mar 2018 → Dec 2026 expected | non-Hodgkin lymphoma, plasma cell myeloma | Canadian Cancer Trials Group | Recruiting | No outcome recorded |
| Phase 2 | NCT03128411 | May 2017 → Mar 2019 | chronic myeloid leukemia | Pfizer | Completed | Met primary |
| Phase 2 | NCT02810990 | Nov 2016 → Apr 2020 | chronic myeloid leukemia | GIMEMA Foundation | Completed | No outcome recorded |
| Phase 2 | NCT02906696 | Oct 2016 → Aug 2019 | chronic myeloid leukemia | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT03205267 | Mar 2016 → Oct 2019 | chronic myeloid leukemia | University of Bonn | Unknown | No outcome recorded |
| Phase 2 | NCT02638467 | Nov 2015 → Nov 2018 | Philadelphia-positive myelogenous leukemia | University of Milano Bicocca | Completed | No outcome recorded |
| Phase 2 | NCT02445742 | May 2015 → Dec 2018 | chronic myeloid leukemia | PETHEMA Foundation | Completed | No outcome recorded |
| Phase 2 | NCT02269267 | Dec 2014 → Apr 2021 | chronic myeloid leukemia | Medical College of Wisconsin | Completed | No outcome recorded |
| Phase 2 | NCT01331291 | Apr 2011 → Dec 2014 | glioblastoma | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT01233869 | Dec 2010 → Jul 2014 | autosomal dominant polycystic kidney disease | Pfizer | Completed | Met primary |
| Phase 2 | NCT00880009 | Jul 2009 → May 2010 | breast cancer | Pfizer | Terminated | No outcome recorded |
| Phase 2 | NCT00793546 | Feb 2009 → Jun 2010 | female breast carcinoma | Pfizer | Terminated | No outcome recorded |
| Phase 2 | NCT00811070 | Dec 2007 → Mar 2013 | chronic myeloid leukemia | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00319254 | May 2006 → Feb 2009 | breast cancer, metastatic malignant neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00261846 | Jan 2006 → Sep 2009 | chronic myeloid leukemia | Pfizer | Completed | No outcome recorded |
| Phase 33 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT06423911 | Feb 2024 → Jun 2027 expected | chronic myeloid leukemia | Ascentage Pharma Group Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT02130557 | Jul 2014 → Aug 2016 | chronic myeloid leukemia | Pfizer | Completed | Met primary |
| Phase 3 | NCT00574873 | Feb 2008 → Aug 2010 | chronic myeloid leukemia | Pfizer | Completed | Missed primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT04877522 | Aug 2022 → Aug 2030 expected | chronic myeloid leukemia | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 4 | NCT02228382 | Nov 2014 → Oct 2020 | Philadelphia-positive myelogenous leukemia | Pfizer | Terminated | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT02551718 | Sep 2015 → Jun 2020 | acute leukemia of ambiguous lineage, acute lymphoblastic leukemia | University of Washington | Completed | No outcome recorded |
| — | NCT01903733 | Aug 2013 → Jun 2020 | chronic myeloid leukemia | Pfizer | Completed | No outcome recorded |
| Comparator or background therapy8 trials | ||||||
| Phase 1 | NCT04916769 Comparator | Aug 2021 → Jan 2022 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03747679 Background | Nov 2018 → Jan 2019 | chronic myeloid leukemia | Pfizer | Completed | No outcome recorded |
| Phase 1/2 | NCT04006847 Background | Sep 2020 → May 2021 | chronic myeloid leukemia | Milton S. Hershey Medical Center | Terminated | No outcome recorded |
| Phase 2 | NCT04626024 Background | Dec 2020 → Nov 2028 expected | chronic myeloid leukemia | Baylor College of Medicine | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03888222 Comparator | Apr 2019 → Aug 2021 | Lewy body dementia | Georgetown University | Completed | No outcome recorded |
| Phase 2 | NCT03654768 Comparator | Oct 2018 → Jul 2024 overdue | chronic myeloid leukemia | SWOG Cancer Research Network | Active not recruiting | Missed primary |
| Phase 3 | NCT04971226 Comparator | Oct 2021 → Nov 2023 overdue | chronic myeloid leukemia | Novartis Pharmaceuticals | Active not recruiting | Met primary |
| Phase 3 | NCT03106779 Comparator | Oct 2017 → May 2020 | chronic myeloid leukemia | Novartis Pharmaceuticals | Completed | Met primary |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 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 . |
| 2026-01-01 | Alembic Pharmaceuticals Ltd. | Regulatory 12th January, 2026 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 supplemental Abbreviated New Drug Application (sANDA) Bosutinib Tablets, 400 mg. |
| 2025-05-01 | Alembic Pharmaceuticals Ltd. | Regulatory 30th May, 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) Bosutinib Tablets, 100 mg and 500 mg. |
| 2024-07-01 | Alembic Pharmaceuticals Ltd. | Regulatory 1st July, 2024, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced t hat it has received tentative approval for Bosutinib Tablets, 100 mg and 500 mg. |
| 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 ↗ |
| 2024-05-15 | 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. |
| 2024-01-08 | 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 ↗ |
| 2023-05-11 | Novartis Pharmaceuticals | Results Novartis to feature new PNH and CML scientific data from broad hematology portfolio at European Hematology Association Annual Meeting novartis.com ↗
Head-to-head data from Phase III ASCEMBL trial reaffirm Scemblix superiority over Bosulif* in patients with chronic myeloid leukemia (CML) in chronic phase, previously treated with two or more tyrosine kinase inhibitors |
| 2022-06-07 | Novartis Pharmaceuticals | Results Novartis Scemblix®, with novel mechanism of action, shows superior, long-term efficacy and consistent tolerability in 96-week follow-up of chronic myeloid leukemia trial novartis.com ↗
In this analysis, the proportion of patients in the Scemblix ® (asciminib) arm (n=157) who achieved a major molecular response (MMR) at 96 weeks was more than double that in the Bosulif ® (bosutinib) arm (n=76) (37.6% vs. 15.8% [ P =.001]), substantially increasing from previous analyses 1,2 . |
| 2021-12-11 | Novartis Pharmaceuticals | Results Novartis Scemblix® demonstrates sustained response rate in 48-week follow-up in patients with chronic myeloid leukemia novartis.com ↗
The proportion of patients treated with Scemblix who experienced adverse reactions leading to discontinuation was more than three times lower than those in the Bosulif arm (7.1% vs. 25%) 1 . |
| 2020-12-08 | Novartis Pharmaceuticals | Results Novartis investigational STAMP inhibitor asciminib (ABL001) shows superior MMR rate to Bosulif®* in chronic myeloid leukemia trial novartis.com ↗
At 24 weeks, asciminib nearly doubled the major molecular response (MMR) rate compared to Bosulif ® (bosutinib)* , in patients resistant to , or intolerant of , at least two prior tyrosine kinase inhibitor ( TKI ) therapies |
| 2020-08-26 | Novartis Pharmaceuticals | Results Novartis investigational novel STAMP inhibitor asciminib (ABL001) meets primary endpoint of Phase III chronic myeloid leukemia study novartis.com ↗
At primary analysis, ASCEMBL met its primary endpoint of significant superiority in major molecular response rate at 24 weeks for asciminib (ABL001) vs. bosutinib in patients previously treated with two or more tyrosine-kinase inhibitors (TKIs) 1 |
| 2018-02-23 | Pfizer | Regulatory Pfizer Receives Positive CHMP Opinion for Two Hematology Medicines, MYLOTARG™ and BOSULIF® pfizer.com ↗
BOSULIF® (bosutinib) has been granted a positive opinion for the treatment of adults with newly diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML). |
| 2017-12-19 | Pfizer | Regulatory U.S. FDA Approves Pfizer’s BOSULIF® (bosutinib) for the Treatment of Patients with Newly-Diagnosed Ph+ Chronic Myelogenous Leukemia (CML) pfizer.com ↗
The sNDA was reviewed and approved under the FDA’s Priority Review and accelerated approval programs based on molecular and cytogenetic response rates. |
| 2017-08-29 | Pfizer | Regulatory U.S. FDA and European Medicines Agency Accept Regulatory Submissions for BOSULIF® (bosutinib) for the Treatment of Patients with Newly Diagnosed Ph+ Chronic Myeloid Leukemia pfizer.com ↗
Pfizer Inc. (NYSE:PFE) and Avillion LLP today announced that a supplemental New Drug Application (sNDA) for BOSULIF® (bosutinib) has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA). |
| 2016-12-05 | Pfizer | Results Pfizer and Avillion Announce Positive Top-Line Results for Phase 3 BFORE Study of BOSULIF for First-Line Treatment of Philadelphia Chromosome Positive Chronic Myeloid Leukemia pfizer.com ↗
The study met its primary endpoint of major molecular response (MMR) at 12 months. |
All press releases naming this drug 17 releases
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 67 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Bosutinib | “SKI-606 (Bosutinib) will be taken by mouth with water and food as continuous once-daily dosing.” NCT00811070 ↗55“SKI-606 (Bosutinib) 400mg once daily, for as long as tolerated or until disease progression.” NCT00319254 ↗ “The BCR-ABL TKIs that will be used include imatinib, dasatinib, nilotinib or bosutinib.” NCT03610971 ↗ “oral SKI-606 (bosutinib) administered on a daily schedule” NCT00195260 ↗ “Bortezomib Bosutinib Busulfan” NCT02551718 ↗ “Drug: Bosutinib” NCT06423911 ↗ “Bosutinib” NCT00934674 ↗ “Bosutinib” NCT04006847 ↗ |
| Known as | Bosulif | “Bosutinib (Bosulif®) is an orally bioavailable, potent, multi-targeted, dual Src-Abl tyrosine kinase inhibitor (TKI) that has been approved for the treatment of adult patients...” NCT02130557 ↗ |
| Known as | Bosutinib (as monohydrate) | ChEMBL registry synonym — accepted as the source's own label CHEMBL288441 ↗ |
| Known as | Bosutinib hydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL288441 ↗ |
| Known as | BOSUTINIB MONOHYDRATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL288441 ↗ |
| Known as | Bosutinib(Bosulif, SKI-606, Pfizer) | “Bosutinib(Bosulif®, SKI-606, Pfizer)” NCT03888222 ↗ |
| Known as | PF-05208763 | “A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Of The Safety, Clinical Activity And Pharmacokinetics Of Bosutinib (PF-05208763) Versus Placebo In...” NCT01233869 ↗ |
| Known as | SK-606 | ChEMBL registry synonym — accepted as the source's own label CHEMBL288441 ↗ |
| Known as | SKI-606 | “Bosutinib (SKI-606) is an orally bioavailable, competitive tyrosine kinase inhibitor that selectively targets both Src and Abl tyrosine kinases.” PMID 22884766 ↗ Aug 2012 |
| Known as | SKI-606 MONOHYDRATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL288441 ↗ |
| Action | Inhibit | “Bosutinib is an orally active, competitive inhibitor of Src/Abl tyrosine kinases.” PMID 24919837 ↗ Jun 20143“Tyrosine-protein kinase ABL inhibitor” CHEMBL288441 ↗ “Tyrosine-protein kinase Lyn inhibitor” CHEMBL288441 ↗ “Tyrosine-protein kinase HCK inhibitor” CHEMBL288441 ↗ |
| Modality | Small molecule | “Bosutinib is an orally active, dual Src/Abl tyrosine kinase inhibitor for treatment of chronic myeloid leukemia (CML) following resistance/intolerance to prior therapy.” PMID 24711212 ↗ Apr 2014 |
| Route | Oral | “Part 2, 500 mg oral, continuous, daily dosing.” NCT00261846 ↗ |
| Target | ABL1 | “Tyrosine-protein kinase ABL inhibitor” CHEMBL288441 ↗ |
| Target | HCK | “Tyrosine-protein kinase HCK inhibitor” CHEMBL288441 ↗ |
| Target | LYN | “Tyrosine-protein kinase Lyn inhibitor” CHEMBL288441 ↗ |
| Target | SRC | “Bosutinib is an orally active, competitive inhibitor of Src/Abl tyrosine kinases.” PMID 24919837 ↗ Jun 2014 |