> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/quizartinib-6da82f4e-69c1-4bf7-87b6-9fef9cfb1094
> Record changed: 2026-10-13

# Quizartinib

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL576982)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL576982)

First approval year

2023

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL576982)

## Development status

**First approval year**

2023

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL576982)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL576982)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL576982)

**Drug name**

Quizartinib

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL576982)

**Molecular weight**

560.68

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL576982)

**Structure (SMILES)**

CC(C)(C)c1cc(NC(=O)Nc2ccc(-c3cn4c(n3)sc3cc(OCCN5CCOCC5)ccc34)cc2)no1

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL576982)

### Other names (35)

- ac 010220
- ac 220
- AC 220
- AC-010220
- Ac-220
- AC-220
- ac010220
- AC010220
- ac010220 2hcl
- AC010220.2HCL
- ac220
- AC220
- AC220 (QUIZARTINIB)
- ac220 quizartinib
- ac708
- AC708
- asp 2689
- ASP-2689
- quizartinib
- Quizartinib
- QUIZARTINIB
- QUIZARTINIB (AC220)
- quizartinib \[INN\]
- QUIZARTINIB \[MI\]
- QUIZARTINIB \[USAN\]

And 10 more, listed on the interactive page.

## Identifiers

**CAS registry numbers**

- 950769-58-1

**ChEMBL ID**

CHEMBL576982

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL576982)

**InChIKey**

CVWXJKQAOSCOAB-UHFFFAOYSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL576982)

**PubChem compound IDs**

- 24889392

**FDA ingredient codes (UNII)**

- 7LA4O6Q0D3

### ATC classification codes (2)

- L01EX11
- L01XE

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL576982)

### RxNorm IDs (RxCUI) (2)

- 2643048
- 2643049

## Regulatory information

### United States

**Applicant**

DAIICHI SANKYO INC

**Approval date**

20 Jul 2023

**Application number**

NDA216993

### European Union

**Status**

Authorised

**Status date**

6 Nov 2023

**Authorisation date**

6 Nov 2023

**Approved indications**

Vanflyta is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by Vanflyta single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia (AML) that is FLT3-ITD positive.

**Product number**

EMEA/H/C/005910

**Authorisation holder**

Daiichi Sankyo Europe GmbH

**Priority medicines scheme**

No

**Generic**

No

**Biosimilar**

No

**Generic medicines**

0

**Biosimilar medicines**

0

**Advanced therapy**

No

**Conditional approval**

No

**Additional monitoring**

Yes

**Accelerated assessment**

No

**Exceptional circumstances**

No

#### Therapeutic areas

- Leukemia, Myeloid

European medicines record

Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/vanflyta)

### Other regulatory facts

**Patents**

0

**Designations**

4

**First in class**

No

**Fast track**

Yes

**Breakthrough designation**

Yes

**Orphan designation**

No

**Priority review**

Yes

**Orphan exclusivity**

No

**Accelerated approval**

No

**Availability**

Prescription only

**Boxed warning**

Yes

## Pharmacology

### Drug classification

**Pharmacology name**

quizartinib

**Type**

Synthetic organic

**Drug name stem**

\-tinib

**Approval recorded by Guide to Pharmacology**

Yes

#### Administration routes

- Oral

### Mechanisms of action (12)

- **Action**  
Inhibition

**Action type**  
Inhibitor

**Target**  
colony stimulating factor 1 receptor

**Gene symbol**  
CSF1R

**Protein identifier**  
P07333

**Median affinity**

7.92

**Affinity units**  
pKd
- **Action**  
Inhibition

**Action type**  
Inhibitor

**Target**  
ret proto-oncogene

**Gene symbol**  
RET

**Protein identifier**  
P07949

**Median affinity**  
8

**Affinity units**  
pKd
- **Action**  
Inhibition

**Action type**  
Inhibitor

**Target**  
platelet derived growth factor receptor beta

**Gene symbol**  
PDGFRB

**Protein identifier**  
P09619

**Median affinity**

8.11

**Affinity units**  
pKd
- **Action**  
Inhibition

**Action type**  
Inhibitor

**Target**  
KIT proto-oncogene, receptor tyrosine kinase

**Gene symbol**  
KIT

**Protein identifier**  
P10721

**Median affinity**

8.32

**Affinity units**  
pKd
- **Action**  
Inhibition

**Action type**  
Inhibitor

**Target**  
platelet derived growth factor receptor alpha

**Gene symbol**  
PDGFRA

**Protein identifier**  
P16234

**Median affinity**

7.96

**Affinity units**  
pKd
- **Action**  
Inhibition

**Action type**  
Inhibitor

**Target**  
fms related receptor tyrosine kinase 3

**Gene symbol**  
FLT3

**Protein identifier**  
P36888

**Median affinity**

8.38

**Affinity units**  
pIC50

**Primary target**  
Yes
- **Mechanism**  
Macrophage colony stimulating factor receptor inhibitor

**Action type**  
Inhibitor

**Target**  
Macrophage colony-stimulating factor 1 receptor

**Protein identifier**  
P07333
- **Mechanism**  
Platelet-derived growth factor receptor inhibitor

**Action type**  
Inhibitor

**Target**  
Platelet-derived growth factor receptor

**Protein identifier**  
P09619
- **Mechanism**  
Platelet-derived growth factor receptor inhibitor

**Action type**  
Inhibitor

**Target**  
Platelet-derived growth factor receptor

**Protein identifier**  
P16234
- **Mechanism**  
Stem cell growth factor receptor inhibitor

**Action type**  
Inhibitor

**Target**  
Mast/stem cell growth factor receptor Kit

**Protein identifier**  
P10721
- **Mechanism**  
Tyrosine-protein kinase receptor FLT3 inhibitor

**Action type**  
Inhibitor

**Target**  
Receptor-type tyrosine-protein kinase FLT3

**Protein identifier**  
P36888
- **Mechanism**  
Tyrosine-protein kinase receptor RET inhibitor

**Action type**  
Inhibitor

**Target**  
Proto-oncogene tyrosine-protein kinase receptor Ret

**Protein identifier**  
P07949

### Open Targets mechanisms (5)

- **Mechanism**  
Macrophage colony stimulating factor receptor inhibitor

**Action type**  
Inhibitor

**Target**  
Macrophage colony-stimulating factor 1 receptor
- **Mechanism**  
Platelet-derived growth factor receptor inhibitor

**Action type**  
Inhibitor

**Target**  
Platelet-derived growth factor receptor
- **Mechanism**  
Stem cell growth factor receptor inhibitor

**Action type**  
Inhibitor

**Target**  
Mast/stem cell growth factor receptor Kit
- **Mechanism**  
Tyrosine-protein kinase receptor FLT3 inhibitor

**Action type**  
Inhibitor

**Target**  
Receptor-type tyrosine-protein kinase FLT3
- **Mechanism**  
Tyrosine-protein kinase receptor RET inhibitor

**Action type**  
Inhibitor

**Target**  
Proto-oncogene tyrosine-protein kinase receptor Ret

### DrugCentral mechanisms

- **Action type**  
Inhibitor

**Gene symbol**  
FLT3

**Protein identifier**  
P36888

**Organism**  
Homo sapiens

**Target development level**  
Clinical

### Investigated indications (4)

- **Condition**  
Myelodysplastic Syndromes

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000198

**Subject identifier**  
D009190
- **Condition**  
Leukemia, Myeloid, Acute

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000222

**Subject identifier**  
D015470
- **Condition**  
Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000616

**Subject identifier**  
D009369
- **Condition**  
Liver Diseases

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0001421

**Subject identifier**  
D008107

### Open Targets indications (13)

- **Condition identifier**  
EFO\_0000222

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000616
- **Condition identifier**  
EFO\_0001421

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0004355

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0004643

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0004967

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0005059

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0005070

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0006311

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0015667
- **Condition identifier**  
MONDO\_0015667

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0018874

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0018881

**Highest recorded phase**  
2

### Open Targets warnings

- **Warning**  
Black Box Warning

**Effect**  
cardiotoxicity

**Country**  
United States

### Reported adverse events (16)

- **Event**  
adrenal insufficiency

**Reports**  
3

**Reporting signal score**

13.158
- **Event**  
angiopathy

**Reports**  
3

**Reporting signal score**

16.0483
- **Event**  
arterial stenosis

**Reports**  
2

**Reporting signal score**

12.6781
- **Event**  
cardiac ventricular thrombosis

**Reports**  
2

**Reporting signal score**

12.6781
- **Event**  
cardiomyopathy

**Reports**  
3

**Reporting signal score**

12.0315
- **Event**  
coronary artery stenosis

**Reports**  
2

**Reporting signal score**

9.02592
- **Event**  
electrocardiogram qt prolonged

**Reports**  
4

**Reporting signal score**

13.4073
- **Event**  
febrile neutropenia

**Reports**  
3

**Reporting signal score**

7.79183
- **Event**  
hyperglycaemia

**Reports**  
3

**Reporting signal score**

9.93564
- **Event**  
osteonecrosis

**Reports**  
3

**Reporting signal score**

10.2018
- **Event**  
peripheral arterial occlusive disease

**Reports**  
2

**Reporting signal score**

10.095
- **Event**  
peripheral artery stenosis

**Reports**  
2

**Reporting signal score**

13.7674
- **Event**  
phlebotomy

**Reports**  
1

**Reporting signal score**

7.93939
- **Event**  
platelet count decreased

**Reports**  
3

**Reporting signal score**

6.87751
- **Event**  
systolic dysfunction

**Reports**  
2

**Reporting signal score**

12.3641
- **Event**  
vessel puncture site pain

**Reports**  
1

**Reporting signal score**

8.58119

### Trial references (20)

- NCT00989261  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00989261)
- NCT02039726  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02039726)
- NCT02668653  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02668653)
- NCT02834390  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02834390)
- NCT02984995  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02984995)
- NCT03135054  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03135054)
- NCT03552029  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03552029)
- NCT03661307  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03661307)
- NCT03723681  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03723681)
- NCT03735875  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03735875)
- NCT03793478  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03793478)
- NCT04107727  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04107727)
- NCT04112589  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04112589)
- NCT04128748  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04128748)
- NCT04209725  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04209725)
- NCT04676243  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04676243)
- NCT04687761  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04687761)
- NCT06262438  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06262438)
- NCT01049893  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01049893)
- NCT04473664  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04473664)

## Dosing

**Dose**

35.4 mg

**Route**

Oral

**How often**

Once daily

## Chemical properties

**Hydrogen bond acceptors**

9

**Hydrogen bond donors**

2

**Polar surface area**

106.16

**Calculated partition coefficient (ALogP)**

5.86

**Calculated partition coefficient (XLogP)**

5.6

**Prodrug**

No

**Chirality**

Achiral

**Inorganic**

No

**Rule-of-five violations**

2

**Rotatable bonds**

7

**Heavy atoms**

40

**Molecular formula**

C29H32N6O4S

**Monoisotopic mass**

560.22057470

**Natural product**

Yes

## Evidence counts

**Recorded assays**

5,348

**Active assays**

737

### Active assay types (3)

- Confirmatory
- Other
- Screening

## Pharmacologic actions

- Tyrosine Kinase Inhibitors  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000092004.html)
- Antineoplastic Agents  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000970.html)

## Biological measurements

### Observed measurements

#### Oral bioavailability

**Median**

52.8

**Mean**

55.375

**Minimum**

40

**Maximum**

75.9

**Unit**

%

**Assays**

4

**Standard deviation**

15.4597

**Summary method**

median

**Censored results excluded**

0

**Other units excluded**

0

**Unknown units excluded**

0

#### Measurement types

- F

## Related records

### Trials (42)

- (QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive
- A Clinical Trial to Assess the Efficacy and Safety of the Combination of a Drug Call Quizartinib With Chemotherapy (FLAG-IDA) in Patients With Acute Myeloid Leukemia That Has Not Responded to the First Treatment or That Has Returned After the First Treatment
- A Phase I Study of AC220 in Patients With Relapsed/Refractory Acute Myeloid Leukemia Regardless of FLT3 Status
- A Study of AC220 Given After Transplant in Subjects With Acute Myeloid Leukemia (AML)
- A Study of CPX-351 (Vyxeos™) With Quizartinib for the Treatment of FLT3-ITD Mutation-Positive Acute Myeloid Leukemia
- A Study of Quizartinib Pharmacokinetics in Participants With Moderate Hepatic Impairment
- A Study of the Effect of a Moderate CYP3A Inducer Efavirenz on Quizartinib Pharmacokinetics in Healthy Participants
- A Study of the Effect of Quizartinib on the Pharmacokinetics of the P-gp Substrate Dabigatran Etexilate in Healthy Participants
- A Study to Assess AC220 Given in Combination With Induction and Consolidation Therapy in Newly Diagnosed Acute Myeloid Leukemia (AML)
- A Study to Determine the Absolute Oral Bioavailability of Quizartinib Using a Radiolabeled Microtracer in Healthy Subjects
- A Study to Evaluate QTc Prolongation With Quizartinib in Healthy Subjects Under Rapid Acceleration of Heart Rate
- [A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML](https://trialight.com/data/trial/a-study-to-investigate-the-safety-and-tolerability-of-3a4970a8-b886-418f-bda5-cb9655741f9c.md)
- A Trial to Establish the Feasibility of Combining Either the Tyrosine Kinase Inhibitor AC220,CXCR4 Inhibitor Plerixafor or HSP90 Inhibitor Ganetespib With Chemotherapy in Older Patients With Acute Myeloid Leukaemia and High Risk Myelodysplastic Syndrome.
- AC220 for Children With Relapsed/Refractory ALL or AML
- Assessment of Quizartinib Pharmacokinetic in Subjects With Severe Hepatic Impairment
- Azacitidine and Quizartinib for the Treatment of Myelodysplastic Syndrome or Myelodysplastic/Myeloproliferative Neoplasm With FLT3 or CBL Mutations
- Azacytidine, Venetoclax Plus Minus Quizartinib for First Line Older/Unfit AML Patients (VENP-A-QUI)
- CHIP-AML22/Quizartinib: Quizartinib + Chemotherapy in Newly Diagnosed Pediatric FLT3-ITD+ and NPM1wt AML Patients
- Cladribine, Idarubicin, Cytarabine, and Quizartinib in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
- Clinical Trial to Assess the Safety and Tolerability of the Combination of Low-dose Cytarabine or Azacitidine Plus Venetoclax and Quizartinib in Newly Diagnosed AML Patients Aged Equal or More Than 60 Years Old

### In development for (5)

- [Acute myeloid leukemia](https://trialight.com/data/condition/acute-myeloid-leukemia-b0971a7a-c18d-544e-bd7f-b1a13b9caa30.md) Phase 3
- Childhood leukemia Phase 3
- [Liver disorder](https://trialight.com/data/condition/liver-disorder-8388d30a-2581-5015-9ddf-adc5f6a331d7.md) Phase 1
- [Myelodysplastic syndrome](https://trialight.com/data/condition/myelodysplastic-syndrome-f5df8ce5-6064-53d3-902c-f09fc4acd4bb.md) Phase 1
- Neoplasm Phase 3

### Other linked conditions (1)

- Acute myeloid leukemia by FAB classification

### Targets (6)

- [CSF1R](https://trialight.com/data/target/csf1r-c39928ca-5d68-56f1-9abd-ca1dfee5c7ff.md) Macrophage colony stimulating factor receptor inhibitor
- [FLT3](https://trialight.com/data/target/flt3-f096db07-c0a7-5257-b0ba-61832be58774.md) Tyrosine-protein kinase receptor FLT3 inhibitor
- [KIT](https://trialight.com/data/target/kit-4430e375-befc-5469-b7bf-a28dfc518a97.md) Stem cell growth factor receptor inhibitor
- [PDGFRA](https://trialight.com/data/target/pdgfra-9af831a8-8fd9-5e16-8799-a31d1bc6c91f.md) Platelet-derived growth factor receptor inhibitor
- [PDGFRB](https://trialight.com/data/target/pdgfrb-b0fcbfa5-50cf-5648-aa6d-c7487708468d.md) Platelet-derived growth factor receptor inhibitor
- [RET](https://trialight.com/data/target/ret-74a9a0b3-98e1-5324-8125-26e0d68c7b16.md) Tyrosine-protein kinase receptor RET inhibitor

---

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