Drugs / Quizartinib
Quizartinib
also known as
AC220 · AC-010220 · AC-010220 DIHYDROCHLORIDE · AC-220 DIHYDROCHLORIDE · AC010220 2HCL · AC220 (QUIZARTINIB) · AC220 2HCL · AC708 · +5 more
Small molecule targets CSF1R, FLT3, KIT, RET via inhibition
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Vanflyta | — | 2023-11-06 | europa.eu ↗ |
| Approved | US (FDA) | VANFLYTA | — | 2023-07-20 | fda.gov ↗ |
| Refused (EMA) | EU (EMA) | Vanflyta | — | 2019-12-19 | europa.eu ↗ |
Trials 43 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04459585 | Aug → Oct 2020 | — | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 116 trials | ||||||
| Phase 1 | NCT06769490 | Jul 2025 → Sep 2028 expected | acute myeloid leukemia | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT06740825 | Oct → Dec 2024 | — | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT06772246 | Oct 2024 → Jun 2025 | — | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT06740799 | Sep 2024 → Oct 2026 expected | — | Daiichi Sankyo | Recruiting | No outcome recorded |
| Phase 1 | NCT04796831 | Apr → Jun 2021 | — | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT04473664 | Sep 2020 → Jul 2021 | liver disease, severe congenital | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT04459598 | Aug → Oct 2020 | — | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT03552029 | Dec 2018 → Apr 2021 | acute myeloid leukemia | Daiichi Sankyo | Terminated | No outcome recorded |
| Phase 1 | NCT03723681 | Nov 2018 → Mar 2022 | acute myeloid leukemia | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT02834390 | Aug 2016 → Oct 2017 | acute myeloid leukemia | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT02675478 | Feb 2016 → Nov 2018 | acute myeloid leukemia | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT01468467 | Apr 2012 → Mar 2015 | acute myeloid leukemia | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT01390337 | Oct 2011 → Feb 2015 | acute myeloid leukemia | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT01411267 | Sep 2011 → Sep 2013 | childhood acute lymphoblastic leukemia, childhood acute myeloid leukemia | Therapeutic Advances in Childhood Leukemia Consortium | Completed | No outcome recorded |
| Phase 1 | NCT01049893 | Jan 2010 → Nov 2011 | cancer | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT00462761 | Jan 2007 → Mar 2009 | acute myeloid leukemia, myelodysplastic syndrome | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1/210 trials | ||||||
| Phase 1/2 | NCT04687761 | Nov 2020 → Nov 2024 | acute myeloid leukemia | PETHEMA Foundation | Completed | No outcome recorded |
| Phase 1/2 | NCT04493138 | Jul 2020 → Dec 2027 expected | chronic myelomonocytic leukemia, myelodysplastic syndrome | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04128748 | May 2020 → Dec 2027 expected | acute myeloid leukemia, myelodysplastic syndrome | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04112589 | Dec 2019 → Dec 2023 | acute myeloid leukemia | PETHEMA Foundation | Unknown | No outcome recorded |
| Phase 1/2 | NCT04047641 | Oct 2019 → Dec 2027 expected | acute biphenotypic leukemia, myelodysplastic syndrome | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03735875 | Jan 2019 → Jul 2023 | acute myeloid leukemia, FLT3 internal tandem duplication | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 1/2 | NCT03661307 | Oct 2018 → Jan 2028 expected | acute myeloid leukemia, myelodysplastic syndrome | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03793478 | Aug 2018 → May 2027 expected | acute myeloid leukemia | Daiichi Sankyo | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT01892371 | Nov 2013 → Feb 2023 | acute myeloid leukemia, FLT3 internal tandem duplication, chronic myelomonocytic leukemia, myelodysplastic syndrome | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT01236144 | Apr 2011 → Dec 2013 | acute myeloid leukemia, myelodysplastic syndrome | Cardiff University | Completed | No outcome recorded |
| Phase 29 trials | ||||||
| Phase 2 | NCT06824168 | Jul 2025 → Jun 2028 expected | acute myeloid leukemia | Daiichi Sankyo | Recruiting | No outcome recorded |
| Phase 2 | NCT06262438 | Feb 2024 → Jun 2028 expected | childhood acute myeloid leukemia | Princess Maxima Center for Pediatric Oncology | Recruiting | No outcome recorded |
| Phase 2 | NCT03989713 | Jul 2020 → Sep 2022 | acute myeloid leukemia | Prof. Dr. Richard F Schlenk | Terminated | No outcome recorded |
| Phase 2 | NCT04209725 | Jun 2020 → Apr 2021 | acute myeloid leukemia | SCRI Development Innovations, LLC | Terminated | No outcome recorded |
| Phase 2 | NCT04107727 | Sep 2019 → Oct 2024 | acute myeloid leukemia | PETHEMA Foundation | Completed | No outcome recorded |
| Phase 2 | NCT03135054 | Oct 2017 → Oct 2020 | acute myeloid leukemia, FLT3 internal tandem duplication | The University of Hong Kong | Unknown | No outcome recorded |
| Phase 2 | NCT02984995 | Dec 2016 → Mar 2018 | acute myeloid leukemia | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 2 | NCT01565668 | Apr 2012 → Mar 2015 | acute myeloid leukemia | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 2 | NCT00989261 | Nov 2009 → Sep 2012 | acute myeloid leukemia | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07425808 | Dec 2026 → Oct 2028 expected | acute myeloid leukemia | European Organisation for Research and Treatment of Cancer - EORTC | Not yet recruiting | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT07478991 | Mar 2026 → Apr 2030 expected | acute myeloid leukemia | PETHEMA Foundation | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06578247 | Nov 2024 → Jun 2030 expected | leukemia | Daiichi Sankyo | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04676243 | May 2022 → May 2025 | acute myeloid leukemia | University Hospital Heidelberg | Withdrawn | No outcome recorded |
| Phase 3 | NCT02668653 | Sep 2016 → Aug 2021 | acute myeloid leukemia | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 3 | NCT02039726 | May 2014 → Feb 2018 | acute myeloid leukemia | Daiichi Sankyo | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT03746912 | — | acute myeloid leukemia | Daiichi Sankyo | No longer available | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05735184 Background | Jul 2023 → Apr 2030 expected | acute myeloid leukemia with mutated NPM1, acute myeloid leukemia, MLL gene rearrangement, myeloid sarcoma | Kura Oncology, Inc. | Recruiting | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02272478 Comparator | Oct 2014 → Feb 2021 | acute myeloid leukemia, myelodysplastic syndrome | Cardiff University | Unknown | No outcome recorded |
Press releases naming this drug 14 releases
| Date | Issuer | Release |
|---|---|---|
| 2019-10-21 | Daiichi Sankyo | Daiichi Sankyo Receives Negative CHMP Opinion for FLT3 Inhibitor Quizartinib for Treatment of Patients with Relapsed/ Refractory FLT3-ITD AML daiichisankyo.com ↗ |
| 2019-10-10 | Daiichi Sankyo | Daiichi Sankyo Launches FLT3 Inhibitor VANFLYTA® in Japan for the Treatment of Patients with Relapsed/Refractory FLT3-ITD AML daiichisankyo.com ↗ |
| 2019-06-24 | Daiichi Sankyo | Daiichi Sankyo Provides Update on FDA Review of Quizartinib for the Treatment of Patients with Relapsed/Refractory FLT3-ITD AML daiichisankyo.com ↗ |
| 2019-06-18 | Daiichi Sankyo | Daiichi Sankyo’s VANFLYTA® Receives Approval in Japan for the Treatment of Relapsed/Refractory FLT3-ITD AML daiichisankyo.com ↗ |
| 2019-05-15 | Daiichi Sankyo | Daiichi Sankyo Announces Outcome of FDA Oncologic Drugs Advisory Committee Meeting to Review FLT3 Inhibitor Quizartinib for the Treatment of Patients with Relapsed/Refractory FLT3-ITD AML daiichisankyo.com ↗ |
| 2019-04-05 | Daiichi Sankyo | Daiichi Sankyo Provides Update on Ongoing FDA Review for Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML daiichisankyo.com ↗ |
| 2018-11-22 | Daiichi Sankyo | FDA Grants Priority Review for Daiichi Sankyo’s New Drug Application for FLT3 Inhibitor Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML daiichisankyo.com ↗ |
| 2018-11-06 | Daiichi Sankyo | EMA Validates and Grants Accelerated Assessment of Marketing Authorization Application for Daiichi Sankyo’s FLT3 Inhibitor Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML daiichisankyo.com ↗ |
| 2018-10-17 | Daiichi Sankyo | Daiichi Sankyo Submits Application in Japan for FLT3 Inhibitor Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML daiichisankyo.com ↗ |
| 2018-09-11 | Daiichi Sankyo | Daiichi Sankyo’s FLT3 Inhibitor Quizartinib Receives Orphan Drug Designation from Japanese MHLW for FLT3-Mutated AML daiichisankyo.com ↗ |
| 2018-08-01 | Daiichi Sankyo | FDA Grants Breakthrough Therapy Designation to Daiichi Sankyo’s FLT3 Inhibitor Quizartinib for Relapsed/Refractory FLT3-ITD AML daiichisankyo.com ↗ |
| 2018-06-18 | Daiichi Sankyo | Phase 3 QuANTUM-R Study Demonstrates Daiichi Sankyo’s Quizartinib Significantly Prolongs Overall Survival as Single Agent Compared to Chemotherapy in Patients with Relapsed/Refractory AML with FLT3-ITD Mutations daiichisankyo.com ↗ |
| 2018-05-08 | Daiichi Sankyo | Daiichi Sankyo Announces Single Agent Quizartinib Significantly Prolongs Overall Survival Compared with Chemotherapy in Patients with Relapsed/Refractory AML with FLT3-ITD Mutations (QuANTUM-R Study) daiichisankyo.com ↗ |
| 2016-10-12 | Daiichi Sankyo | Daiichi Sankyo Announces First Patient Enrolled in Phase 3 QuANTUM-First Trial Investigating Quizartinib in Newly-Diagnosed FLT3-ITD+ Acute Myeloid Leukemia daiichisankyo.com ↗ |
Evidence & citations 21 cited values
Every value below carries the sentence it was read from. 46 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Quizartinib | “A Phase 2, Randomized, Open-Label Study of the Safety and Efficacy of Two Doses of Quizartinib (AC220; ASP2689) in Subjects With FLT3-ITD Positive Relapsed or Refractory Acute...” NCT01565668 ↗38“Quizartinib, an FLT3 inhibitor, as monotherapy in patients with relapsed or refractory acute myeloid leukaemia: an open-label, multicentre, single-arm, phase 2 trial.” PMID 29859851 ↗ May 2018 “Safety and pharmacokinetics of quizartinib in Japanese patients with relapsed or refractory acute myeloid leukemia in a phase 1 study.” PMID 31359361 ↗ Jul 2019 “Safety and tolerability of quizartinib, a FLT3 inhibitor, in advanced solid tumors: a phase 1 dose-escalation trial.” PMID 30081867 ↗ Aug 2018 “Local SOC is "7+3" + Midostaurin (100 mg) or Quizartinib (35.4 mg)” NCT07425808 ↗ “Quizartinib: 40mg, p.o., Days: 4 - 21” NCT03989713 ↗ |
| Known as | AC-010220 | ChEMBL registry synonym — accepted as the source's own label CHEMBL576982 ↗ |
| Known as | AC-010220 DIHYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL576982 ↗ |
| Known as | AC-220 DIHYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL576982 ↗ |
| Known as | AC010220 2HCL | ChEMBL registry synonym — accepted as the source's own label CHEMBL576982 ↗ |
| Known as | AC220 | “Phase 2 Open-label, Single-arm Study of Quizartinib (AC220) Monotherapy in Japanese Patients With FLT3-ITD Positive Refractory or Relapsed Acute Myeloid Leukemia” NCT02984995 ↗7“the 2nd generation FLT3 inhibitor AC220” NCT02272478 ↗ |
| Known as | AC220 (QUIZARTINIB) | ChEMBL registry synonym — accepted as the source's own label CHEMBL576982 ↗ |
| Known as | AC220 2HCL | ChEMBL registry synonym — accepted as the source's own label CHEMBL576982 ↗ |
| Known as | AC708 | ChEMBL registry synonym — accepted as the source's own label CHEMBL576982 ↗ |
| Known as | ASP2689 | “A Phase 2, Randomized, Open-Label Study of the Safety and Efficacy of Two Doses of Quizartinib (AC220; ASP2689) in Subjects With FLT3-ITD Positive Relapsed or Refractory Acute...” NCT01565668 ↗ |
| Known as | QUIZARTINIB (AC220) | ChEMBL registry synonym — accepted as the source's own label CHEMBL576982 ↗ |
| Known as | quizartinib dihydrochloride | “Patients received quizartinib dihydrochloride (henceforth referred to as quizartinib) once daily throughout a 28-day treatment cycle.” PMID 30081867 ↗ Aug 2018 |
| Known as | Quizartinib hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL576982 ↗ |
| Known as | Vanflyta | ChEMBL registry synonym — accepted as the source's own label CHEMBL576982 ↗ |
| Action | Inhibit | “Macrophage colony stimulating factor receptor inhibitor” CHEMBL576982 ↗3“Tyrosine-protein kinase receptor RET inhibitor” CHEMBL576982 ↗ “Stem cell growth factor receptor inhibitor” CHEMBL576982 ↗ “FLT3 inhibitor” PMID 29859851 ↗ May 2018 |
| Modality | Small molecule | “The oral second-generation bis-aryl urea tyrosine kinase inhibitor quizartinib” NCT03989713 ↗ |
| Route | Oral | “Patients received quizartinib once daily as an oral solution” PMID 29859851 ↗ May 2018 |
| Target | CSF1R | “Macrophage colony stimulating factor receptor inhibitor” CHEMBL576982 ↗ |
| Target | FLT3 | “quizartinib, a FLT3 inhibitor” PMID 30081867 ↗ Aug 2018 |
| Target | KIT | “Stem cell growth factor receptor inhibitor” CHEMBL576982 ↗ |
| Target | RET | “Tyrosine-protein kinase receptor RET inhibitor” CHEMBL576982 ↗ |