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Tucatinib

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Synopsis

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Chemistry

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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 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 Formula	C₂₆H₂₄N₈O₂
Molecular Weight	480.5 g/mol
XLogP3	4
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	8
Rotatable Bond Count	6
Exact Mass	480.20222204 g/mol
Monoisotopic Mass	480.20222204 g/mol
Topological Polar Surface Area	111 Å²
Heavy Atom Count	36
Formal Charge	0
Complexity	796
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

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.

API SUPPLIERS

01

Dr. Reddy's Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI India 2024

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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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02

MSN Laboratories

India

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euroPLX 86 Munich

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03

Teva Pharmaceutical Industries

Israel

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04

Natco Pharma

India

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05

Beijing Sjar Technology Developmen...

China

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06

Beijing Mesochem Technology

China

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euroPLX 86 Munich

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07

Shanghai Hope Chem

China

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euroPLX 86 Munich

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Drugs in Development

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U.S.A

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DMF submissions from China jump 42% as India continues to top list in Q1 2024

Generic drugs play a crucial role in providing access to life-saving drugs at affordable prices. To that end, drugmakers submit Drug Master Files (DMFs) or their ‘recipes for making generics’ to the US Food and Drug Administration (FDA) for review. Of these, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs.PharmaCompass has been reviewing Type II submissions for several years now. We have noticed that these filings have been increasing in recent years. There has been a 33.5 percent increase in Type II DMF submissions since Q1 2018 (when 176 Type II DMFs had been submitted). However, at 235, the first quarter (Q1) of 2024 saw only a 1.3 percent increase in DMF submissions over Q1 2023. In Q1 2023, DMF submissions had increased by 21.5 percent (over Q1 2022).Of the 235 Type II submissions received by the FDA in Q1 of this year, only 35 (or around 15 percent) had their review completed under the Generic Drug User Fee Act (GDUFA). The total number of reviews completed by the US federal agency so far this year is 129.In all, FDA received 353 Type II, III, IV, and V DMF submissions, compared to 291 in Q1 2023, an increase of 21.3 percent.View FDA DMF Filings in Q1 2024 (Power BI Dashboard, Free Excel Available)DMF submissions from India dip 1.8%; China witnesses 42% rise in filings As has been the trend, India (dubbed as the pharmacy of the world) and China filed the maximum DMF submissions, with 107 and 101 submissions respectively. However, DMFs filed by Indian companies saw a marginal dip of 1.8 percent in Q1 2024 — in Q1 2023, Indian companies had filed 109 Type II DMFs. Meanwhile, DMF filings by Chinese drugmakers increased 42.2 percent in Q1 2024, up from 71 in Q1 2023.India’s MSN Laboratories was the clear leader with 15 DMF submissions to the FDA, while China’s Sichuan Elixir Pharmaceutical came a distant second with nine submissions. Indian drugmakers Aurobindo Pharma and Global Calcium (with seven submissions each) were tied at third position. There were two players at the fifth spot — India’s Dr. Reddy’s Laboratories and China’s Zhejiang Jingsheng Pharmaceutical — as both these drugmakers registered six submissions each.View FDA DMF Filings in Q1 2024 (Power BI Dashboard, Free Excel Available) Diabetes, cancer drugs emerge as hot molecules in Q1 2024Approved in June 2020, triheptanoin is the first and only FDA-approved treatment for children and adults with long-chain fatty acid oxidation disorders (LC-FAOD). At five, triheptanoin saw the maximum DMF filings. Four of those applications have already been positively reviewed.Anti-diabetic drug sitagliptin phosphate monohydrate saw four DMF filings. Empagliflozin, the API found in Boehringer Ingelheim and Eli Lilly’s diabetes drug Jardiance, drew three DMF filings in Q1 2024.In the US, Jazz Pharmaceuticals’ Zepzelca (lurbinectedin) is indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC). Three DMF applications were submitted for lurbinectedin. Similarly, ruxolitinib phosphate, used for the treatment of patients with intermediate or high-risk myelofibrosis, also received three DMF applications.Semaglutide — the glucagon-like peptide-1 receptor agonist that catapulted Novo Nordisk to the position of the most valuable public company in Europe — received three DMF filings. Semaglutide’s arch rival, tirzepatide, also drew three DMF filings.AstraZeneca’s Brilinta (ticagrelor) plus aspirin is currently approved in over 115 countries for the prevention of stroke, heart attack, and other events in adults with acute coronary syndrome (ACS). Ticagrelor received three DMF submissions. Vonoprazan fumarate, a first-in-class potassium-competitive acid blocker to treat acid-related diseases, also received three DMF submissions.View FDA DMF Filings in Q1 2024 (Power BI Dashboard, Free Excel Available) Eighteen DMFs filed for first time in Q1 2024 During the first quarter of this year, 14 drugs saw first time filing of DMFs. Together, these 14 drugs attracted 18 DMF filings with tirzepatide topping the list with three submissions from Chinese companies.The 14 drugs that saw first time filing were clascoterone, capmatinib hydrochloride, niraparib tosylate monohydrate, vibegron, cabozantinib sulfate, ruxolitinib hemifumarate, ripretinib, ruxolitinib, ruxolitinib mesylate, tucatinib hemiethanolate, tecovirimat, tirzepatide, tolvaptan povidone, and azilsartan.View FDA DMF Filings in Q1 2024 (Power BI Dashboard, Free Excel Available) Our viewUntil 2020, DMF submissions by Indian companies used to be double those of Chinese and American firms put together. In 2022, DMF filings from India began to dip, while submissions by Chinese companies began to rise. In the first half of 2023, there was a 46.5 percent rise in DMF submissions from China. The gap between DMF filings by India and China has narrowed down considerably this year. The reasons behind this phenomenon may be multiple. But it definitely implies that America will find it increasingly difficult to reduce its reliance on China.