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Chemistry

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Also known as: 1206101-20-3, Glpg0634, 1206161-97-8, Glpg-0634, N-(5-(4-((1,1-dioxidothiomorpholino)methyl)phenyl)-[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide, Filgotinib (glpg0634)
Molecular Formula
C21H23N5O3S
Molecular Weight
425.5  g/mol
InChI Key
RIJLVEAXPNLDTC-UHFFFAOYSA-N
FDA UNII
3XVL385Q0M

Filgotinib
Filgotinib is an orally bioavailable inhibitor of the tyrosine kinase Janus kinase 1 (JAK1), with potential anti-inflammatory and immunomodulating activities. Upon oral administration, filgotinib specifically targets, binds to, and inhibits the phosphorylation of JAK1, which interferes with JAK/STAT (signal transducer and activator of transcription)-dependent signaling. As JAK1 mediates signaling of many pro-inflammatory cytokines, JAK1 inhibition prevents cytokine signaling and activity in many inflammatory and immune-mediated processes and leads to a decrease in inflammation and activation of certain immune cells. JAK1 plays a key role in the signaling and activity of many cytokines and growth factors and is often dysregulated in a variety of autoimmune and inflammatory diseases, as well as some malignancies.
1 2D Structure

Filgotinib

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
N-[5-[4-[(1,1-dioxo-1,4-thiazinan-4-yl)methyl]phenyl]-[1,2,4]triazolo[1,5-a]pyridin-2-yl]cyclopropanecarboxamide
2.1.2 InChI
InChI=1S/C21H23N5O3S/c27-20(17-8-9-17)23-21-22-19-3-1-2-18(26(19)24-21)16-6-4-15(5-7-16)14-25-10-12-30(28,29)13-11-25/h1-7,17H,8-14H2,(H,23,24,27)
2.1.3 InChI Key
RIJLVEAXPNLDTC-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C1CC1C(=O)NC2=NN3C(=N2)C=CC=C3C4=CC=C(C=C4)CN5CCS(=O)(=O)CC5
2.2 Other Identifiers
2.2.1 UNII
3XVL385Q0M
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

1. 1206101-20-3

2. Glpg0634

3. 1206161-97-8

4. Glpg-0634

5. N-(5-(4-((1,1-dioxidothiomorpholino)methyl)phenyl)-[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide

6. Filgotinib (glpg0634)

7. Filgotinib(glpg0634)

8. Gs-6034 Free Base

9. 3xvl385q0m

10. Gplg0634

11. N-[5-[4-[(1,1-dioxo-1,4-thiazinan-4-yl)methyl]phenyl]-[1,2,4]triazolo[1,5-a]pyridin-2-yl]cyclopropanecarboxamide

12. G146034

13. G-146034

14. N-[5-[4-[(1,1-dioxido-4-thiomorpholinyl)methyl]phenyl][1,2,4]triazolo[1,5-a]pyridin-2-yl]cyclopropanecarboxamide

15. Jyseleca

16. Filgotinib [inn]

17. N-(5-(4-((1,1-dioxidothiomorpholino)methyl)phenyl)-[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide.

18. Filgotinib [usan:inn]

19. Unii-3xvl385q0m

20. Glpg 0634

21. N-(5-{4-[(1,1-dioxidothiomorpholin-4-yl)methyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide

22. Glpg0634-analogue

23. Filgotinib (usan/inn)

24. Filgotinib [usan]

25. Filgotinib; Gplg0634

26. Filgotinib [who-dd]

27. Schembl253559

28. Filgotinib Pound Glpg0643)

29. Gtpl7913

30. Chembl3301607

31. Amy3802

32. Dtxsid80152935

33. Ex-a741

34. Bdbm103727

35. Hms3653p15

36. Hms3673e07

37. Bcp08496

38. Mfcd20527867

39. Nsc800100

40. S7605

41. Zinc96174616

42. Akos025291103

43. Ccg-268951

44. Db14845

45. Nsc-800100

46. Sb16799

47. Ncgc00345855-01

48. Ncgc00345855-07

49. As-16295

50. Bf159062

51. Da-33603

52. Da-33604

53. Hy-18300

54. Ft-0700114

55. Ft-0761510

56. Sw220020-1

57. A14232

58. D10871

59. P12798

60. Us8563545, 1

61. A892158

62. J-690063

63. Syn1158;glpg 0634; Glpg-0634; Filgotinib

64. Q19904163

65. Cyclopropanecarboxamide, N-(5-(4-((1,1-dioxido-4-thiomorpholinyl)methyl)phenyl)(1,2,4)triazolo(1,5-a)pyridin-2-yl)-

66. Glpg0634;n-[5-[4-[(1,1-dioxido-4-thiomorpholinyl)methyl]phenyl][1,2,4]triazolo[1,5-a]pyridin-2-yl]cyclopropanecarboxamide

67. N-(5-(4-((1,1-oxo-.lambda.6-thiomorpholin-4-yl)methyl)phenyl((1,2,4)triazolo(1,5-a)pyridin-2-yl)cyclopropanecarboxamide

2.4 Create Date
2011-01-10
3 Chemical and Physical Properties
Molecular Weight 425.5 g/mol
Molecular Formula C21H23N5O3S
XLogP31.4
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count6
Rotatable Bond Count5
Exact Mass425.15216079 g/mol
Monoisotopic Mass425.15216079 g/mol
Topological Polar Surface Area105 Ų
Heavy Atom Count30
Formal Charge0
Complexity715
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

Filgotinib is indicated for the treatment of active moderate to severe rheumatoid arthritis alone or in combination with methotrexate. Filgotinib is currently reserved for patients who are unable to tolerate or who have not responded adequately to one or more disease-modifying anti-rheumatic drugs (DMARDS). Filgotinib is also indicated for treatment of moderately to severely active ulcerative colitis in adult patients who had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent.


Treatment of chronic idiopathic arthritis (including rheumatoid arthritis , ankylosing spondylarthritis , psoriatic arthritis , and juvenile idiopathic arthritis )


Rheumatoid arthritis

Jyseleca is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Jyseleca may be used as monotherapy or in combination with methotrexate (MTX).

Ulcerative colitis

Jyseleca is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent.


Treatment of Crohn's disease, Treatment of ulcerative colitis


5 Pharmacology and Biochemistry
5.1 Pharmacology

In addition to targeted Janus kinase (JAK) 1 inhibition, filgotinib targets pro-inflammatory cytokine signalling by inhibiting IL-6 induced STAT1 phosphorylation. Serum C-reactive protein levels are also reduced in response to filgotinib administration.


5.2 ATC Code

L04AA


L - Antineoplastic and immunomodulating agents

L04 - Immunosuppressants

L04A - Immunosuppressants

L04AA - Selective immunosuppressants

L04AA45 - Filgotinib


5.3 Absorption, Distribution and Excretion

Absorption

Filgotinib is rapidly absorbed after oral administration. Median peak plasma concentrations occurred 2-3 hours post-dose for filgotinib and 5 hours post-dose for GS-829845. Steady-state concentrations can be observed in 2-3 days for filgotinib and in 4 days for GS-829845. Food does not appear to have a significant effect on the absorption of filgotinib; therefore, the medication can be administered without regard to food. After repeated oral dosing of filgotinib 200 mg, the reported Cmax and AUC values of filgotinib were 2.15 ug/mL and 6.77 ugxh/mL, respectively. For GS-829845 (the major metabolite) the reported Cmax was 4.43 ug/mL and the reported AUC was 83.2 ugxh/mL.


Route of Elimination

Of the total administered dose of filgotinib, approximately 87% undergoes renal elimination while 15% undergoes faecal elimination.


5.4 Metabolism/Metabolites

Carboxylesterase enzymes are involved in the metabolism of filgotinib. The carboxylesterase 2 (CES2) isoform is chiefly responsible for metabolizing filgotinib to its major metabolite, GS-829845. Although carboxylesterase 1 (CES1) plays a less prominent role in the biotransformation of filgotinib, in vitro studies have demonstrated that CES1 will partially compensate in the event of CES2 saturation. GS-829845 is thus far the only major circulating metabolite to have been identified.


5.5 Biological Half-Life

The half-life of filgotinib is estimated to be 7 hours, while the half-life of its active metabolite GS-829845 is estimated to be 19 hours.


5.6 Mechanism of Action

There are four Janus kinase (JAK) enzymes including JAK1, JAK2, JAK3, and tyrosine kinase 2. JAK1 mediates inflammatory cytokine signaling, while JAK2 and JAK3 are important components of hematologic and immune functions. Filgotinib selectively inhibits JAK1 and is for example nearly 30-fold more selective for JAK1 compared to JAK2. The Janus kinase (JAK)-signal transducer and activator of transcription (STAT) pathway is implicated in several inflammatory pathologies and has been found to be continuously active in patients who have RA. Sustained activation of this pathway contributes to aberrant processes which lead to disease progression including elevated levels of matrix metalloproteinases (MMPs) and reduced cell apoptosis in RA affected synovial tissues. Filgotinib acts on the JAK-STAT pathway by selectively inhibiting JAK1 phosphorylation and preventing STAT activation, which ultimately results in reduced proinflammatory cytokine signaling.


API SUPPLIERS

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Metrochem API Private Limited

India

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Shanghai Hope Chem

China

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

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Beijing Sjar Technology Developmen...

China

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Filgotinib

About the Company :

Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product ...

Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
Metrochem

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Filgotinib

About the Company : Beijing Sjar Technology Development Co., Ltd. founded in 2014, it is a high-tech enterprise which specialized in the research and development of active pharmaceutical ingredients a...

Beijing Sjar Technology Development Co., Ltd. founded in 2014, it is a high-tech enterprise which specialized in the research and development of active pharmaceutical ingredients and their intermediates, electronic chemical materials and intermediates, large-scale production, sales and services, and provide customized synthetic services according to customer requirements. Sjar-Tech locates in Beijing Economic and Technological Development Zone, has its own R&D and development laboratory. Sjar-Tech has set up a R&D team with rich experience and strong technical strength, most of the practitioners have more than ten years' experience.
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Filgotinib

About the Company : Hope Chem is dedicated to manufacturing, marketing, and CMO service of Active Pharmaceutical Ingredients (APIs), Intermediates, and Specialty Chemicals since the year 2010. Current...

Hope Chem is dedicated to manufacturing, marketing, and CMO service of Active Pharmaceutical Ingredients (APIs), Intermediates, and Specialty Chemicals since the year 2010. Currently, they have exclusive partnerships with multiple, state-of-the-art and GMP-compliant manufacturers in China and abroad to service our esteemed partners for competitive, long-term & stable supplies. The main products are APIs and intermediates of antiviral drug substances and anti-inflammatory, analgesic, and non-steroidal pharmaceuticals.
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ABOUT THIS PAGE

Filgotinib Manufacturers

A Filgotinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Filgotinib, including repackagers and relabelers. The FDA regulates Filgotinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Filgotinib 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 Filgotinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Filgotinib Suppliers

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

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

Filgotinib KDMF

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

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

After submitting a Filgotinib 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 Filgotinib API can apply through the Korea Drug Master File (KDMF).

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

Filgotinib 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 Filgotinib as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Filgotinib 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 Filgotinib 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 Filgotinib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Filgotinib NDC to their finished compounded human drug products, they may choose to do so.

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

Filgotinib GMP

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

Filgotinib CoA

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

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

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