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Also known as: Irbinitinib, 937263-43-9, Ont-380, Tukysa, 6-diamine, N6-(4,4-dimethyl-4,5-dihydrooxazol-2-yl)-n4-(3-methyl-4-((1,2,4)triazolo(1,5-a)pyridin-7-yloxy)phenyl)quinazoline-4,6-diamine
Molecular Formula
C26H24N8O2
Molecular Weight
480.5  g/mol
InChI Key
SDEAXTCZPQIFQM-UHFFFAOYSA-N
FDA UNII
234248D0HH

Tucatinib
Tucatinib is an orally bioavailable inhibitor of the human epidermal growth factor receptor tyrosine kinase ErbB-2 (also called HER2) with potential antineoplastic activity. Tucatinib selectively binds to and inhibits the phosphorylation of ErbB-2, which may prevent the activation of ErbB-2 signal transduction pathways, resulting in growth inhibition and death of ErbB-2-expressing tumor cells. ErbB-2 is overexpressed in a variety of cancers and plays an important role in cellular proliferation and differentiation.
Tucatinib is a Kinase Inhibitor. The mechanism of action of tucatinib is as a Tyrosine Kinase Inhibitor, and Cytochrome P450 3A Inhibitor, and P-Glycoprotein Inhibitor, and Cytochrome P450 2C8 Inhibitor.
1 2D Structure

Tucatinib

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
6-N-(4,4-dimethyl-5H-1,3-oxazol-2-yl)-4-N-[3-methyl-4-([1,2,4]triazolo[1,5-a]pyridin-7-yloxy)phenyl]quinazoline-4,6-diamine
2.1.2 InChI
InChI=1S/C26H24N8O2/c1-16-10-17(5-7-22(16)36-19-8-9-34-23(12-19)28-15-30-34)31-24-20-11-18(4-6-21(20)27-14-29-24)32-25-33-26(2,3)13-35-25/h4-12,14-15H,13H2,1-3H3,(H,32,33)(H,27,29,31)
2.1.3 InChI Key
SDEAXTCZPQIFQM-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC1=C(C=CC(=C1)NC2=NC=NC3=C2C=C(C=C3)NC4=NC(CO4)(C)C)OC5=CC6=NC=NN6C=C5
2.2 Other Identifiers
2.2.1 UNII
234248D0HH
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Irbinitinib

2. N6-(4,4-dimethyl-4,5-dihydrooxazol-2-yl)-n4-(3-methyl-4-((1,2,4)triazolo(1,5-a)pyridin-7-yloxy)phenyl)quinazoline-4,6-diamine

3. N6-(4,5-dihydro-4,4-dmethyl-2-oxazolyl)-n4-(3-methyl-4-((1,2,4)triazolo(1,5-a)pyridin-7-yloxy)phenyl)-4,6-quinazolinediamine

4. Ont-380

5. Tukysa

2.3.2 Depositor-Supplied Synonyms

1. Irbinitinib

2. 937263-43-9

3. Ont-380

4. Tukysa

5. 6-diamine

6. N6-(4,4-dimethyl-4,5-dihydrooxazol-2-yl)-n4-(3-methyl-4-((1,2,4)triazolo(1,5-a)pyridin-7-yloxy)phenyl)quinazoline-4,6-diamine

7. 234248d0hh

8. Irbinitinib; Arry-380; Ont-380

9. 4,6-quinazolinediamine, N6-(4,5-dihydro-4,4-dimethyl-2-oxazolyl)-n4-(3-methyl-4-((1,2,4)triazolo(1,5-a)pyridin-7-yloxy)phenyl)-

10. N4-(4-([1,2,4]triazolo[1,5-a]pyridin-7-yloxy)-3-methylphenyl)-n6-(4,4-dimethyl-4,5-dihydrooxazol-2-yl)quinazoline-4,6-diamine

11. N6-(4,5-dihydro-4,4-dimethyl-2-oxazolyl)-n4-[3-methyl-4-([1,2,4]triazolo[1,5-a]pyridin-7-yloxy)phenyl]-4,6-quinazolinediamine

12. Tucatinib [inn]

13. 6-n-(4,4-dimethyl-5h-1,3-oxazol-2-yl)-4-n-[3-methyl-4-([1,2,4]triazolo[1,5-a]pyridin-7-yloxy)phenyl]quinazoline-4,6-diamine

14. Unii-234248d0hh

15. Ont 380

16. Tukysa (tn)

17. Ont-380;tucatinib

18. Tucatinib [mi]

19. Tucatinib (usan/inn)

20. Tucatinib [usan:inn]

21. Tucatinib [usan]

22. Irbinitinib(arry-380)

23. Irbinitinib; Arry-380

24. Tucatinib [who-dd]

25. Gtpl9922

26. Schembl1193050

27. Tucatinib [orange Book]

28. Chembl3989868

29. Bdbm471617

30. Dtxsid601027958

31. Bcp15983

32. Ex-a1031

33. Mfcd22380467

34. Nsc764581

35. Nsc799335

36. S8362

37. Zinc68250462

38. Arry-380 (ont-380)

39. Akos026750449

40. Ccg-264747

41. Cs-3906

42. Db11652

43. Nsc-764581

44. Nsc-799335

45. Sb17126

46. Us10822334, Compound Ont380

47. Ncgc00482879-02

48. Ac-33037

49. As-56109

50. Bt177688

51. Hy-16069

52. Example 11 [wo2007059257a2]

53. Db-130430

54. A16413

55. D11141

56. A857335

57. Q25100690

58. 4,6-quinazolinediamine,n6-(4,5-dihydro-4,4-dimethyl-2-oxazolyl)-n4-[3-methyl-4-([1,2,4]triazolo[1,5-a]pyridin-7-yloxy)phenyl]-

59. N6-(4,5-dihydro-4,4-dimethyl-2-oxazolyl)-n4-[3-methyl-4-([1,2,4]triazolo[1,5-a]pyridin-7-yloxy)phenyl]-4,6-quinazolinediamine;

60. N6-(4,5-dihydro-4,4-dmethyl-2-oxazolyl)-n4-(3-methyl-4-((1,2,4)triazolo(1,5-a)pyridin-7-yloxy)phenyl)-4,6-quinazolinediamine

2.4 Create Date
2011-04-25
3 Chemical and Physical Properties
Molecular Weight 480.5 g/mol
Molecular Formula C26H24N8O2
XLogP34
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count8
Rotatable Bond Count6
Exact Mass480.20222204 g/mol
Monoisotopic Mass480.20222204 g/mol
Topological Polar Surface Area111 Ų
Heavy Atom Count36
Formal Charge0
Complexity796
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

Tucatinib is indicated with trastuzumab and capecitabine for treatment of adults diagnosed with advanced unresectable or metastatic HER2-positive breast cancer. This includes patients with brain metastases and those who have received one or more prior anti-HER2-based regimens in the metastatic setting.


Tukysa is indicated in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2positive locally advanced or metastatic breast cancer who have received at least 2 prior antiHER2 treatment regimens.


5 Pharmacology and Biochemistry
5.1 Pharmacology

By inhibiting tyrosine kinase, tucatinib exerts anti-tumor activity, reducing the size of HER-2 positive breast cancer tumors. In clinical trials, the regimen of tucatinib and [trastuzumab] showed enhanced activity both in vitro and in vivo when compared to either drug administered by itself.


5.2 MeSH Pharmacological Classification

Antineoplastic Agents

Substances that inhibit or prevent the proliferation of NEOPLASMS. (See all compounds classified as Antineoplastic Agents.)


Protein Kinase Inhibitors

Agents that inhibit PROTEIN KINASES. (See all compounds classified as Protein Kinase Inhibitors.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
TUCATINIB
5.3.2 FDA UNII
234248D0HH
5.3.3 Pharmacological Classes
Cytochrome P450 3A Inhibitors [MoA]; Kinase Inhibitor [EPC]; P-Glycoprotein Inhibitors [MoA]; Tyrosine Kinase Inhibitors [MoA]; Cytochrome P450 2C8 Inhibitors [MoA]
5.4 ATC Code

L01


L - Antineoplastic and immunomodulating agents

L01 - Antineoplastic agents

L01E - Protein kinase inhibitors

L01EH - Human epidermal growth factor receptor 2 (her2) tyrosine kinase inhibitors

L01EH03 - Tucatinib


5.5 Absorption, Distribution and Excretion

Absorption

The Tmax for tucatinib ranges from 1 to 4 hours. One pharmacokinetic study revealed a Cmax of 1120 ng/mL after a dose of 350 mg twice daily with a Tmax ranging from 1 to 3 hours. The AUCtau was reported to be about 7120 hoursng/mL.


Route of Elimination

In a study of radiolabled tucatinib, about 86% of the total dose was excreted in the feces and 4.1% was found in the urine. About 16% of the tucatinib dose recovered in the feces was identified as unchanged tucatinib.


Volume of Distribution

The volume of distribution of tucatinib is about 1670 L. This drug penetrates the blood-brain barrier.


Clearance

The apparent clearance is 148 L/h.


5.6 Metabolism/Metabolites

Tucatinib is metabolized by CYP2C8 with some contributions from CYP3A.


5.7 Biological Half-Life

A pharmacokinetic study revealed a half-life of approximately 5.38 hours. Prescribing information mentions a geometric mean half-life of about 8.21 hours.


5.8 Mechanism of Action

Mutations in the HER-2 gene are observed in some types of breast carcinoma. Tucatinib inhibits the tyrosine kinase enzyme of the HER-2 gene. Mutations of tyrosine kinase in the HER-2 gene lead to cascade effects of increased cell signaling and proliferation, resulting in malignancy. Results of in vitro studies show that tucatinib inhibits the phosphorylation of both HER-2 and HER-3, leading to downstream changes in MAPK and AKT signaling and cell proliferation. Anti-tumor activity occured in the cells that expressed HER-2. In vivo, tucatinib has been shown to inhibit HER-2 expressing tumors, likely by the same mechanism.


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Tucatinib hemiethanolate

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Company :

Tucatinib

Drug Cost (USD) : 91,179,471

Year : 2022

Prescribers : 906

Prescriptions : 4812

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Company :

Tucatinib

Drug Cost (USD) : 81,591,015

Year : 2021

Prescribers : 941

Prescriptions : 4657

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Brand Name : Tukysa

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Tucatinib

Dosage Form : Tablet, film-coated

Dosage Strength : 50 mg

Price Per Pack (Euro) : 1,902.74

Published in :

Country : Norway

RX/OTC/DISCN :

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Brand Name : Tukysa

Tucatinib

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Brand Name : Tukysa

U.S.A
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Tucatinib

Main Therapeutic Indication : Oncology

Currency : USD

2023 Revenue in Millions : 17

2022 Revenue in Millions : 0

Growth (%) : Acquired from Seagen

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TUCATINIB

US Patent Number : 11666572

Drug Substance Claim :

Drug Product Claim :

Application Number : 213411

Patent Use Code : U-3783

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2038-04-27

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TUCATINIB

US Patent Number : 8648087

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 213411

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-04-12

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TUCATINIB

US Patent Number : 12048698

Drug Substance Claim :

Drug Product Claim :

Application Number : 213411

Patent Use Code : U-3783

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2038-04-27

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TUCATINIB

US Patent Number : 8648087

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 213411

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Patent Use Description :

Patent Expiration Date : 2031-04-12

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TUCATINIB

US Patent Number : 12048698

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Application Number : 213411

Patent Use Code : U-3783

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2038-04-27

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TUCATINIB

US Patent Number : 9457093

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 213411

Patent Use Code : U-2788

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2032-10-12

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TUCATINIB

US Patent Number : 9693989

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 213411

Patent Use Code : U-2788

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Patent Use Description :

Patent Expiration Date : 2027-05-09

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TUCATINIB

US Patent Number : 11504370

Drug Substance Claim :

Drug Product Claim :

Application Number : 213411

Patent Use Code : U-2788

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2033-03-25

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TUCATINIB

US Patent Number : 11207324

Drug Substance Claim :

Drug Product Claim :

Application Number : 213411

Patent Use Code : U-3783

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2038-04-27

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TUCATINIB

US Patent Number : 11666572

Drug Substance Claim :

Drug Product Claim :

Application Number : 213411

Patent Use Code : U-3783

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2038-04-27

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Exclusivity Code : ODE-309

Exclusivity Expiration Date : 2027-04-17

Application Number : 213411

Product Number : 1

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Exclusivity Code : NCE

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Application Number : 213411

Product Number : 1

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Exclusivity Code : I-906

Exclusivity Expiration Date : 2026-01-19

Application Number : 213411

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Exclusivity Code : ODE-422

Exclusivity Expiration Date : 2030-01-19

Application Number : 213411

Product Number : 1

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Product Number : 2

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ABOUT THIS PAGE

Looking for 937263-43-9 / Tucatinib API manufacturers, exporters & distributors?

Tucatinib manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Tucatinib 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 Tucatinib manufacturer or Tucatinib supplier for your needs.

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

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

API | Excipient name

Tucatinib

Synonyms

Irbinitinib, 937263-43-9, Ont-380, Tukysa, 6-diamine, N6-(4,4-dimethyl-4,5-dihydrooxazol-2-yl)-n4-(3-methyl-4-((1,2,4)triazolo(1,5-a)pyridin-7-yloxy)phenyl)quinazoline-4,6-diamine

Cas Number

937263-43-9

Unique Ingredient Identifier (UNII)

234248D0HH

About Tucatinib

Tucatinib is an orally bioavailable inhibitor of the human epidermal growth factor receptor tyrosine kinase ErbB-2 (also called HER2) with potential antineoplastic activity. Tucatinib selectively binds to and inhibits the phosphorylation of ErbB-2, which may prevent the activation of ErbB-2 signal transduction pathways, resulting in growth inhibition and death of ErbB-2-expressing tumor cells. ErbB-2 is overexpressed in a variety of cancers and plays an important role in cellular proliferation and differentiation.

Tucatinib Manufacturers

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

click here to find a list of Tucatinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Tucatinib Suppliers

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

click here to find a list of Tucatinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Tucatinib USDMF

A Tucatinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Tucatinib active pharmaceutical ingredient (API) in detail. Different forms of Tucatinib DMFs exist exist since differing nations have different regulations, such as Tucatinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Tucatinib DMF submitted to regulatory agencies in the US is known as a USDMF. Tucatinib USDMF includes data on Tucatinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tucatinib USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Tucatinib suppliers with USDMF on PharmaCompass.

Tucatinib KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Tucatinib Drug Master File in Korea (Tucatinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tucatinib. The MFDS reviews the Tucatinib KDMF as part of the drug registration process and uses the information provided in the Tucatinib KDMF to evaluate the safety and efficacy of the drug.

After submitting a Tucatinib KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Tucatinib API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Tucatinib suppliers with KDMF on PharmaCompass.

Tucatinib NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Tucatinib as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Tucatinib API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Tucatinib as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Tucatinib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tucatinib NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Tucatinib suppliers with NDC on PharmaCompass.

Tucatinib GMP

Tucatinib 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 Tucatinib 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 Tucatinib GMP manufacturer or Tucatinib GMP API supplier for your needs.

Tucatinib CoA

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

Tucatinib CoA mostly includes findings from lab analyses of a specific batch. For each Tucatinib 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.

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