quizartinib
Trade name: VANFLYTA
Small moleculeapprovedOrphan Drug FDAFast Track FDA
Approved
Jul 20, 2023
Quizartinib, sold under the brand name Vanflyta, is an anti-cancer medication used for the treatment of acute myeloid leukemia. — Wikipedia
Clinical trial activity
41 trials · 20 clinical orgs · 1 marketing orgs
Phase 1
26
Phase 2
22
Phase 3
5
Phase 4
0
Earliest trial started Jan 1, 2007 (NCT00462761)
Timeline
2000s
- Jan 1, 2007
Daiichi Sankyo — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2009
Daiichi Sankyo — Earliest Phase 2 Sponsor(trial)
- Mar 18, 2009
Orphan Drug Designation
2010s
- Jan 1, 2014
Daiichi Sankyo — Earliest Phase 3 Sponsor(trial)
2020s
- Jul 20, 2023
Daiichi Sankyo — Earliest FDA Approval
- Jul 20, 2023
Daiichi Sankyo — Marketing Organization
- Jul 20, 2023
Daiichi Sankyo — NDA Secondary Org
- Jul 20, 2023
Daiichi Sankyo — NDA Organization
Indications
Approved for
Studied for
- Biomarkers · Phase 1/Phase 2
- Bone Marrow Cells · Phase 2
- Drug Interactions · Early Phase 1
- Drugs, Investigational · Early Phase 1
- Healthy Volunteers · Phase 1
- Leukemia · Phase 3
- Leukemia, Myeloid, Acute · Phase 3
- Leukemia, Myelomonocytic, Chronic · Phase 1/Phase 2
- Liver Diseases · Phase 1
- Mutation · Phase 1/Phase 2
- Myelodysplastic Syndromes · Phase 3
- Myeloproliferative Disorders · Phase 1/Phase 2
- Neoplasms · Phase 1
- Pharmacokinetics · Early Phase 1
- Precursor Cell Lymphoblastic Leukemia-Lymphoma · Phase 1
Mechanism of action
Platelet-derived growth factor receptor inhibitor
FLT3 inhibitor
CSF1R inhibitor
- Stem cell growth factor receptorINHIBITOR
KIT inhibitor
- Tyrosine-protein kinase receptor RETINHIBITOR
RET inhibitor
Approval history
- approvedPriority reviewFast trackJul 20, 2023
Chemistry & pharmacology
Loading structure…
SMILES
CC(C)(C)c1cc(NC(=O)Nc2ccc(-c3cn4c(n3)sc3cc(OCCN5CCOCC5)ccc34)cc2)no1- Mol. weight
- 560.68 g/mol
- Lipinski Ro5
- 2 violation(s)
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Black box warning
Sources
- ChEMBLCHEMBL576982 ↗
- WikipediaQuizartinib ↗
- ChEMBLCHEMBL2105709 ↗
Also known as
- ac010220
- ac010220
- ac010220.2hcl
- ac010220.2hcl
- ac220
- ac220
- ac220
- ac-220
- ac-220
- ac220 compound
- asp-2689
- asp-2689
- quizartinib
- quizartinib
- quizartinib
- quizartinib
- quizartinib
- quizartinib dihydrochloride
- quizartinib dihydrochloride
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06769490 | Phase 1 | Jun 30, 2025 | University of Texas at Houston |
| NCT06824168 | Phase 2 | May 21, 2025 | Daiichi Sankyo |
| NCT06578247 | Phase 3 | Oct 30, 2024 | Daiichi Sankyo |
| NCT06740825 | Phase 1 | Oct 29, 2024 | Daiichi Sankyo |
| NCT06772246 | Phase 1 | Oct 24, 2024 | Daiichi Sankyo |
| NCT06740799 | Phase 1 | Sep 30, 2024 | Daiichi Sankyo |
| NCT06262438 | Phase 2 | Feb 6, 2024 | Daiichi Sankyo, Princess Maxima Center for Pediatric Oncology |
| NCT04676243 | Phase 3 | Nov 15, 2021 | Daiichi Sankyo, University of Heidelberg |
| NCT04796831 | Phase 1 | Apr 15, 2021 | Daiichi Sankyo |
| NCT04687761 | Phase 1/Phase 2 (Phase 2) | Nov 4, 2020 | Hospital San Pedro de Alcantara, PETHEMA Foundation, University of Valencia |
| NCT04473664 | Phase 1 | Sep 29, 2020 | Daiichi Sankyo |
| NCT04459585 | Early Phase 1 (Phase 1) | Sep 17, 2020 | Daiichi Sankyo |
| NCT04459598 | Early Phase 1 (Phase 1) | Sep 8, 2020 | Daiichi Sankyo |
| NCT04493138 | Phase 1/Phase 2 (Phase 2) | Jul 21, 2020 | National Cancer Institute (NCI), University of Texas at Houston |
| NCT04128748 | Phase 1/Phase 2 (Phase 2) | Feb 28, 2020 | National Cancer Institute (NCI), University of Texas at Houston |
| NCT04209725 | Phase 2 | Jan 31, 2020 | Colorado Blood Cancer Institute, SCRI Development Innovations |
| NCT04112589 | Phase 1/Phase 2 (Phase 2) | Oct 31, 2019 | Daiichi Sankyo, PETHEMA Foundation, Syntax for Science, University of Valencia |
| NCT04107727 | Phase 2 | Sep 5, 2019 | Daiichi Sankyo, Dynamic Science S.L., PETHEMA Foundation, University of Valencia |
| NCT04047641 | Phase 2 | Aug 10, 2019 | National Cancer Institute (NCI), University of Texas at Houston |
| NCT03989713 | Phase 2 | Jul 31, 2019 | University of Heidelberg |
Showing 20 of 41 trials
Page 1 / 3
Organizations
Research & Development (20)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Daiichi Sankyo | For profit | 28 | 24 | 4 | 2007 |
| Ambit Biosciences | For profit | 8 | 0 | 2 | 2007 |
| University of Texas at Houston | Academic/Hospital | 8 | 7 | 3 | 2013 |
| National Cancer Institute (NCI) | Government | 7 | 0 | 1 | 2013 |
| PETHEMA Foundation | Academic/Hospital | 3 | 3 | 1 | 2019 |
| University of Valencia | Academic/Hospital | 3 | 0 | 1 | 2019 |
| Cardiff University | Academic/Hospital | 2 | 2 | 2 | 2011 |
| University of Heidelberg | Academic/Hospital | 2 | 2 | 2 | 2019 |
| University of Nottingham | Academic/Hospital | 2 | 0 | 2 | 2011 |
| Cancer Research UK | Academic/Hospital | 1 | 0 | 1 | 2014 |
| Celgene | For profit | 1 | 0 | 1 | 2013 |
| Colorado Blood Cancer Institute | Academic/Hospital | 1 | 0 | 1 | 2020 |
| Dynamic Science S.L. | For profit | 1 | 0 | 1 | 2019 |
| Emory University | Academic/Hospital | 1 | 0 | 1 | 2011 |
| Hospital San Pedro de Alcantara | Academic/Hospital | 1 | 0 | 1 | 2020 |
| Innovative Therapies For Children with Cancer Consortium | Academic/Hospital | 1 | 0 | 1 | 2018 |
| Princess Maxima Center for Pediatric Oncology | Academic/Hospital | 1 | 1 | 1 | 2024 |
| SCRI Development Innovations | For profit | 1 | 1 | 1 | 2020 |
| Syntax for Science | For profit | 1 | 0 | 1 | 2019 |
| University of Southern California | Academic/Hospital | 1 | 1 | 1 | 2011 |
20 organizations
Page 1 / 1
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Daiichi Sankyo | For profit | MKTG | Jul 20, 2023 |
| Daiichi Sankyo | For profit | NDA2 | Jul 20, 2023 |
| Daiichi Sankyo | For profit | NDA | Jul 20, 2023 |