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Chemistry

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Also known as: 950769-58-1, Ac220, Quizartinib (ac220), Ac-220, Ac 220, Quizartinib hcl
Molecular Formula
C29H32N6O4S
Molecular Weight
560.7  g/mol
InChI Key
CVWXJKQAOSCOAB-UHFFFAOYSA-N
FDA UNII
7LA4O6Q0D3

Quizartinib
Quizartinib is an orally available small molecule with potential antineoplastic activity. Quizartinib selectively inhibits class III receptor tyrosine kinases, including FMS-related tyrosine kinase 3 (FLT3/STK1), colony-stimulating factor 1 receptor (CSF1R/FMS), stem cell factor receptor (SCFR/KIT), and platelet derived growth factor receptors (PDGFRs), resulting in inhibition of ligand-independent leukemic cell proliferation and apoptosis. Mutations in FLT3, resulting in constitutive activation, are the most frequent genetic alterations in acute myeloid leukemia (AML) and occur in approximately one-third of AML cases.
1 2D Structure

Quizartinib

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
1-(5-tert-butyl-1,2-oxazol-3-yl)-3-[4-[6-(2-morpholin-4-ylethoxy)imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl]urea
2.1.2 InChI
InChI=1S/C29H32N6O4S/c1-29(2,3)25-17-26(33-39-25)32-27(36)30-20-6-4-19(5-7-20)22-18-35-23-9-8-21(16-24(23)40-28(35)31-22)38-15-12-34-10-13-37-14-11-34/h4-9,16-18H,10-15H2,1-3H3,(H2,30,32,33,36)
2.1.3 InChI Key
CVWXJKQAOSCOAB-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC(C)(C)C1=CC(=NO1)NC(=O)NC2=CC=C(C=C2)C3=CN4C5=C(C=C(C=C5)OCCN6CCOCC6)SC4=N3
2.2 Other Identifiers
2.2.1 UNII
7LA4O6Q0D3
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Ac220 Compound

2.3.2 Depositor-Supplied Synonyms

1. 950769-58-1

2. Ac220

3. Quizartinib (ac220)

4. Ac-220

5. Ac 220

6. Quizartinib Hcl

7. Ac010220

8. Quizartinib Freebase

9. Ac 010220

10. Asp-2689

11. 1-(5-(tert-butyl)isoxazol-3-yl)-3-(4-(7-(2-morpholinoethoxy)benzo[d]imidazo[2,1-b]thiazol-2-yl)phenyl)urea

12. 7la4o6q0d3

13. Chembl576982

14. N-(5-tert-butylisoxazol-3-yl)-n'-{4-[7-(2-morpholin-4-ylethoxy)imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea

15. Chebi:90217

16. 950769-58-1 (free Base)

17. Ac-010220

18. 1132827-21-4 (hcl)

19. 1-(5-tert-butyl-1,2-oxazol-3-yl)-3-(4-{7-[2-(morpholin-4-yl)ethoxy]imidazo[2,1-b][1,3]benzothiazol-2-yl}phenyl)urea

20. 1-(5-tert-butyl-1,2-oxazol-3-yl)-3-[4-[6-(2-morpholin-4-ylethoxy)imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl]urea

21. N-(5-tert-butyl-isoxazol-3-yl)-n'-{4-[7-(2-morpholin-4-yl-ethoxy)imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea Dihydrochloride

22. Chembl2386811

23. 1-(5-(tert-butyl)isoxazol-3-yl)-3-(4-(7-(2-morpholinoethoxy)-benzo[d]imidazo[2,1-b]thiazol-2-yl)phenyl)urea

24. N-(5-(1,1-dimethylethyl)isoxazol-3-yl)-n'-(4-(7-(2-(morpholin-4-yl)ethoxy)imidazo(2,1- B)benzothiazol-2-yl)phenyl)urea

25. N-(5-(1,1-dimethylethyl)isoxazol-3-yl)-n'-(4-(7-(2-(morpholin-4-yl)ethoxy)imidazo(2,1-b)benzothiazol-2-yl)phenyl)urea

26. Urea, N-(5-(1,1-dimethylethyl)-3-isoxazolyl)-n'-(4-(7-(2-(4-morpholinyl)ethoxy) Imidazo(2,1-b)benzothiazol-2-yl)phenyl)-

27. Ac220 Compound

28. Ac220,quizartinib

29. Quizartinib [usan]

30. Quizartinib [usan:inn]

31. Quizartinibum

32. Unii-7la4o6q0d3

33. 1-(5-tert-butyl-1,2-oxazol-3-yl)-3-(4-(7-(2-(morpholin-4-yl)ethoxy)imidazo(2,1-b)(1,3)benzothiazol-2-yl)phenyl)urea

34. N-(5-tert-butylisoxazol-3-yl)-n'-(4-(7-(2-(morpholin-4-yl)ethoxy)imidazo(2,1-b)(1,3)benzothiazol-2-yl)phenyl)urea

35. N-(5-tert-butylisoxazol-3-yl)-n'-[4-[7-[2-(morpholin-4-yl)ethoxy]imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl]urea

36. Quizartinib, 95%

37. Quizartinib, Ac220

38. Quizartinib, Free Base

39. Ac220 - Quizartinib

40. Quizartinib [mi]

41. Quizartinib; Plx3397

42. Quizartinib [inn]

43. Quizartinib (usan/inn)

44. Quizartinib, Ac010220

45. Schembl72923

46. Quizartinib [who-dd]

47. Mls006011240

48. Gtpl5658

49. Dtxsid70241746

50. Bcpp000443

51. Hms3244k09

52. Hms3244k10

53. Hms3244l09

54. Hms3265g09

55. Hms3265g10

56. Hms3265h09

57. Hms3265h10

58. Hms3654j20

59. Hms3743g21

60. Bcp02224

61. Bdbm50300690

62. Mfcd18074524

63. Nsc756647

64. Nsc799659

65. Nsc800857

66. S1526

67. Zinc43204002

68. Akos015891557

69. Bcp9000223

70. Ccg-264906

71. Cs-0211

72. Db12874

73. Nsc-756647

74. Nsc-799659

75. Nsc-800857

76. Sb16610

77. Ncgc00242493-01

78. Ncgc00242493-02

79. Ncgc00242493-07

80. As-16178

81. Hy-13001

82. Smr004703000

83. Ft-0687630

84. Sw218131-2

85. D09955

86. J-524214

87. Q7272714

88. Brd-k93918653-001-01-4

89. 3-(5-tert-butyl-1,2-oxazol-3-yl)-1-(4-{10-[2-(morpholin-4-yl)ethoxy]-7-thia-2,5-diazatricyclo[6.4.0.0^{2,6}]dodeca-1(12),3,5,8,10-pentaen-4-yl}phenyl)urea

90. N-(5-tert-butyl-isoxazol-3-yl)-n''-{4-[7-(2-morpholin-4-yl-ethoxy)imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea

91. N-(5-tert-butyl-isoxazol-3-yl)-n'-(4-(7-(2-(morpholin-4-ylethoxy)imidazo(2,1-b) (1,3)benzothiazol-2-yl)phenyl)urea

92. N-(5-tert-butyl-isoxazol-3-yl)-n'-{4-[7-(2-morpholin-4-yl-ethoxy)imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea

93. N-[5-(1,1-dimethylethyl)-3-isoxazolyl]-n'-[4-[7-[2-(4-morpholinyl)ethoxy]imidazo[2,1-b]benzothiazol-2-yl]phenyl]urea

2.4 Create Date
2008-09-08
3 Chemical and Physical Properties
Molecular Weight 560.7 g/mol
Molecular Formula C29H32N6O4S
XLogP35.6
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count8
Rotatable Bond Count8
Exact Mass560.22057470 g/mol
Monoisotopic Mass560.22057470 g/mol
Topological Polar Surface Area134 Ų
Heavy Atom Count40
Formal Charge0
Complexity849
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Treatment of acute myeloid leukaemia.


Treatment of acute myeloid leukaemia


5 Pharmacology and Biochemistry
5.1 Pharmacology

In preclinical studies, Quizartinib demonstrated dose-dependent activity and favorable drug-like profiles in bioavailability, pharmacokinetics, cytochrome P450 (CYP) liability, and absorption, distribution, metabolism, excretion (ADME).


5.2 ATC Code

L01XE


L - Antineoplastic and immunomodulating agents

L01 - Antineoplastic agents

L01E - Protein kinase inhibitors

L01EX - Other protein kinase inhibitors

L01EX11 - Quizartinib


5.3 Mechanism of Action

Quizartinib potently inhibits FLT3, a kinase that is mutated in approximately one-third of acute myeloid leukemia cases, and patients with FLT3 mutations are less responsive to traditional therapies.


FDF Dossiers

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Cancer Research
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Cancer Research
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QUIZARTINIB DIHYDROCHLORIDE

Brand Name : VANFLYTA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 17.7MG BASE

Packaging :

Approval Date : 2023-07-20

Application Number : 216993

Regulatory Info : RX

Registration Country : USA

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Immuno-Oncology 360
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Immuno-Oncology 360
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QUIZARTINIB DIHYDROCHLORIDE

Brand Name : VANFLYTA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 26.5MG BASE

Packaging :

Approval Date : 2023-07-20

Application Number : 216993

Regulatory Info : RX

Registration Country : USA

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FDA Orange Book

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Immuno-Oncology 360
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Immuno-Oncology 360
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QUIZARTINIB DIHYDROCHLORIDE

Brand Name : VANFLYTA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 17.7MG BASE

Approval Date : 2023-07-20

Application Number : 216993

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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Immuno-Oncology 360
Not Confirmed
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Immuno-Oncology 360
Not Confirmed

QUIZARTINIB DIHYDROCHLORIDE

Brand Name : VANFLYTA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 26.5MG BASE

Approval Date : 2023-07-20

Application Number : 216993

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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FDA approvals rise 49% in 2023; CRISPR’s gene editing therapy sees light of day
In 2022, when the US Food and Drug Administration (FDA) was reeling under the impact of the pandemic, new drug approvals by the agency dropped by 26 percent. But last year, FDA’s new drug approvals rebounded by an impressive 49 percent, with the Center for Drug Evaluation and Research (CDER) approving 55 new drugs in 2023. Of them, 36 percent were considered first-in-class, while small molecules made up for 62 percent of the total drugs approved (i.e. 34). FDA’s Center for Biologics Evaluation and Research (CBER) okayed 19 biologics in 2023 compared to eight in the previous year.The first half of 2023 saw the debut of vaccines for the all-too-common respiratory syncytial virus (RSV). Among the other notable approvals in H1 was Biogen and Eisai’s Alzheimer’s drug Leqembi (lecanemab). Out of the total 55 drug approvals, 29 came in H2 2023. This includes Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy that relies on the Nobel Prize-winning CRISPR gene-editing technology. Casgevy has been approved as a treatment for sickle-cell disease (SCD) and β-thalassemia.While FDA witnessed a sharp rise in approvals in 2023, many other drug regulators didn’t. The European Medicines Agency (EMA) granted marketing authorization to 32 novel drugs in 2023, a fall from 33 in 2022. Similarly, Health Canada’s approvals in 2023 decreased to 38, compared to 45 in the previous year.As usual, oncology topped the list of drug approvals by therapeutic area, at 39 (as opposed to 35 in 2022). Rare diseases was the second most popular therapeutic area for drug approvals. With drugmakers clearly paying heed to the unmet needs of patients suffering from rare diseases, this therapeutic area sprinted from a 9 percent share and the fourth position among new approvals in 2022 to an impressive 34 percent share in 2023. A quarter of the new drug approvals were in infectious diseases, followed by immunology (19 percent) and neurology (7 percent).View New Drug Approvals in 2023 with Estimated Sales (Free Excel Available) Casgevy, postpartum depression drug Zurzuvae emerge as potential blockbustersGene therapy Casgevy, postpartum depression (PPD) med Zurzuvae, blood cancer med Elrexfio and ulcerative colitis drug Velsipity were some of the prominent approvals of 2023.Britain’s Medicines and Healthcare products Regulatory Agency was the first to okay Casgevy in November as a cure for SCD and β-thalassemia. Soon, the FDA approved it for SCD. In January this year, the American agency also approved it for transfusion-dependent β-thalassemia (TDT). Analysts estimate Casgevy to generate US$ 2.6 billion in peak sales, says Nature. Biogen and Sage’s PPD therapy Zurzuvae became the first and only FDA-approved pill for the condition that can be life-threatening for both the mother and the child. Global sales of Zurzuvae are forecast to hit US$ 1.28 billion by 2028.In August, Pfizer’s Elrexfio (elranatamab) became the first “off-the-shelf” (ready-to-use) therapy in the US for multiple myeloma. The drug provides an option for patients with hard to treat or relapsed blood cancer and is estimated to bring in US$ 861 million in peak sales by 2028, says Nature.Pfizer also bagged another significant approval in October — its drug Velsipity (etrasimod) was greenlit by the FDA to treat adults with ulcerative colitis, an inflammatory bowel disease. Peak revenue for Velsipity is expected to come in at US$ 825 million, as per Evaluate.View New Drug Approvals in 2023 with Estimated Sales (Free Excel Available) Astra’s Truqap, GSK’s Ojjaara among top cancer therapies given FDA nod in H2In November, FDA approved AstraZeneca’s Truqap (capivasertib) in combination with the Anglo-Swedish drugmaker’s Faslodex (fulvestrant) for treating adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations. Evaluate Pharma forecasts peak Truqap sales to come in at about US$ 690 million.In September, FDA approved GSK’s Ojjaara (momelotinib) as the first and only treatment for myelofibrosis with anemia. Nearly all myelofibrosis patients are estimated to develop anemia over the course of the disease. Ojjaara is taken orally once a day.Other notable oncology treatments okayed by FDA in H2 2023 include Daiichi’s Vanflyta (quizartinib) in July to treat an aggressive blood cancer known as acute myeloid leukemia (AML). In August, FDA approved Janssen’s bispecific antibody Talvey (talquetamab-tgvs) for difficult-to-treat blood cancer. The agency approved two cancer therapies in November — BMS’ Augtyro (repotrectinib) for ROS1-positive non-small cell lung cancer (NSCLC) and Takeda’s targeted oral therapy Fruzaqla (fruquintinib) for adult patients with metastatic colorectal cancer (mCRC).View New Drug Approvals in 2023 with Estimated Sales (Free Excel Available) Rare disease drugs Santhera-Catalyst’s Agamree, Novo’s Rivfloza bag approval in H2In October, FDA approved Santhera Pharmaceuticals and Catalyst Pharma’s Agamree (vamorolone), an oral suspension treatment for Duchenne muscular dystrophy (DMD) in patients two years of age and older. This makes it the first drug fully approved in both the US and Europe for the muscle degeneration disorder. Agamree acts in a manner similar to other steroids, which are the standard of care for the inherited rare disease. However, it causes fewer side effects.FDA also okayed Novo Nordisk’s once-a-month injection Rivfloza (nedosiran) in October to treat a rare genetic condition — primary hyperoxaluria type 1 (PH1) — that causes recurring kidney stones.In November, the agency approved Takeda’s Adzynma (ADAMTS13, recombinant-krhn) as the first treatment for both adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP), a rare genetic blood disorder. Other noteworthy FDA approvals in H2 2023 for rare blood diseases include Novartis’ Fabhalta and bluebird bio's Lyfgenia. Fabhalta is the first oral monotherapy for the treatment of adults with paroxysmal nocturnal hemoglobinuria, a rare disease that causes symptoms such as hemolytic anemia, hemoglobinuria (excretion of hemoglobin in the urine), fatigue, shortness of breath etc. Lyfgenia is the first cell-based gene therapy for the treatment of SCD in patients 12 years and older. Similarly, another rare disease drug — Regeneron’s Veopoz —  bagged FDA approval in August last. Veopoz treats CHAPLE disease, an ultra-rare disease in which patients have severe gastrointestinal problems.View New Drug Approvals in 2023 with Estimated Sales (Free Excel Available) Our viewAfter a lull in 2022, new drug approvals have finally gathered momentum. The good news is that this year, several pathbreaking drugs are coming up for approval, such as Madrigal Pharmaceuticals’ resmetirom (the first treatment for NASH with liver fibrosis), Merck’s sotatercept (a treatment for pulmonary arterial hypertension), Lilly’s donanemab for Alzheimer’s disease and Karuna Therapeutics’ drug to treat schizophrenia. Let’s hope 2024 turns out to be an even bigger year for new drug approvals.

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Looking for 950769-58-1 / Quizartinib API manufacturers, exporters & distributors?

Quizartinib manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Quizartinib API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Quizartinib manufacturer or Quizartinib supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Quizartinib manufacturer or Quizartinib supplier.

PharmaCompass also assists you with knowing the Quizartinib API Price utilized in the formulation of products. Quizartinib API Price is not always fixed or binding as the Quizartinib Price is obtained through a variety of data sources. The Quizartinib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Quizartinib

Synonyms

950769-58-1, Ac220, Quizartinib (ac220), Ac-220, Ac 220, Quizartinib hcl

Cas Number

950769-58-1

Unique Ingredient Identifier (UNII)

7LA4O6Q0D3

About Quizartinib

Quizartinib is an orally available small molecule with potential antineoplastic activity. Quizartinib selectively inhibits class III receptor tyrosine kinases, including FMS-related tyrosine kinase 3 (FLT3/STK1), colony-stimulating factor 1 receptor (CSF1R/FMS), stem cell factor receptor (SCFR/KIT), and platelet derived growth factor receptors (PDGFRs), resulting in inhibition of ligand-independent leukemic cell proliferation and apoptosis. Mutations in FLT3, resulting in constitutive activation, are the most frequent genetic alterations in acute myeloid leukemia (AML) and occur in approximately one-third of AML cases.

Quizartinib Manufacturers

A Quizartinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Quizartinib, including repackagers and relabelers. The FDA regulates Quizartinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Quizartinib API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Quizartinib Suppliers

A Quizartinib supplier is an individual or a company that provides Quizartinib active pharmaceutical ingredient (API) or Quizartinib finished formulations upon request. The Quizartinib suppliers may include Quizartinib API manufacturers, exporters, distributors and traders.

Quizartinib GMP

Quizartinib Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Quizartinib GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Quizartinib GMP manufacturer or Quizartinib GMP API supplier for your needs.

Quizartinib CoA

A Quizartinib CoA (Certificate of Analysis) is a formal document that attests to Quizartinib's compliance with Quizartinib specifications and serves as a tool for batch-level quality control.

Quizartinib CoA mostly includes findings from lab analyses of a specific batch. For each Quizartinib CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Quizartinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Quizartinib EP), Quizartinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Quizartinib USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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