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 · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 8 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 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 1/21 trial | ||||||
| Phase 1/2 | NCT04006847 Background | Sep 2020 → May 2021 | chronic myeloid leukemia | Milton S. Hershey Medical Center | Terminated | No outcome recorded |
| Phase 23 trials | ||||||
| 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 | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT04971226 Comparator | Oct 2021 → Nov 2023 overdue | chronic myeloid leukemia | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03106779 Comparator | Oct 2017 → May 2020 | chronic myeloid leukemia | Novartis Pharmaceuticals | Completed | No outcome recorded |
Press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-12-08 | Novartis Pharmaceuticals | Novartis investigational STAMP inhibitor asciminib (ABL001) shows superior MMR rate to Bosulif®* in chronic myeloid leukemia trial novartis.com ↗ |
| 2018-02-23 | Pfizer | Pfizer Receives Positive CHMP Opinion for Two Hematology Medicines, MYLOTARG™ and BOSULIF® pfizer.com ↗ |
| 2017-12-19 | Pfizer | U.S. FDA Approves Pfizer’s BOSULIF® (bosutinib) for the Treatment of Patients with Newly-Diagnosed Ph+ Chronic Myelogenous Leukemia (CML) pfizer.com ↗ |
| 2017-08-29 | Pfizer | 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 ↗ |
| 2016-12-05 | Pfizer | 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 ↗ |
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 | “compare the efficacy and safety of olverembatinib (investigational arm) versus bosutinib (control arm)” NCT06423911 ↗55“SKI-606 (Bosutinib) will be taken by mouth with water and food as continuous once-daily dosing.” NCT00811070 ↗ “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 ↗ “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 Lyn inhibitor” CHEMBL288441 ↗ “Tyrosine-protein kinase HCK inhibitor” CHEMBL288441 ↗ “Tyrosine-protein kinase ABL 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 |