Synopsis
Synopsis
0
API Suppliers
0
USDMF
0
CEP/COS
0
JDMF
0
EU WC
0
KDMF
0
NDC API
0
VMF
0
Listed Suppliers
0
API
0
FDF
0
FDF Dossiers
0
FDA Orange Book
0
Europe
0
Canada
0
Australia
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
0
EDQM
0
USP
0
JP
0
Others
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Weekly News Recap #Phispers
US Medicaid
NA
Annual Reports
NA
Finished Drug Prices
NA
1. Lou064
2. N-(3-(6-amino-5-(2-(methyl(prop-2-enoyl)amino)ethoxy)pyrimidin-4-yl)-5-fluoro-2-methylphenyl)-4-cyclopropyl-2-fluorobenzamide
1. 1787294-07-8
2. Remibrutinib [inn]
3. Lou064
4. Remibrutinib [usan]
5. I7mvz8hdnu
6. Remibrutinib (lou064)
7. Nvp-lou064-nxa
8. Lou064-nxa
9. N-(3-(6-amino-5-(2-(n-methylacrylamido)ethoxy)pyrimidin-4-yl)-5-fluoro-2-methylphenyl)-4-cyclopropyl-2-fluorobenzamide
10. N-[3-[6-amino-5-[2-[methyl(1-oxo-2-propen-1-yl)amino]ethoxy]-4-pyrimidinyl]-5-fluoro-2-methylphenyl]-4-cyclopropyl-2-fluorobenzamide
11. N-[3-[6-amino-5-[2-[methyl(prop-2-enoyl)amino]ethoxy]pyrimidin-4-yl]-5-fluoro-2-methylphenyl]-4-cyclopropyl-2-fluorobenzamide
12. Benzamide, N-(3-(6-amino-5-(2-(methyl(1-oxo-2-propen-1-yl)amino)ethoxy)-4-pyrimidinyl)-5-fluoro-2-methylphenyl)-4-cyclopropyl-2-fluoro-
13. Unii-i7mvz8hdnu
14. Chembl4483575
15. Schembl16754888
16. Gtpl10457
17. Lou-064
18. Ex-a3421
19. S9660
20. Who 11062
21. Example 6 [wo2015079417a1]
22. Compound 25 [pmid: 32083858]
23. Ac-36985
24. Hy-128757
25. Cs-0103905
26. Us9512084, 6
27. A930622
28. Lou-064;n-(3-(6-amino-5-(2-(n-methylacrylamido)ethoxy)pyrimidin-4-yl)-5-fluoro-2-methylphenyl)-4-cyclopropyl-2-fluorobenzamide
| Molecular Weight | 507.5 g/mol |
|---|---|
| Molecular Formula | C27H27F2N5O3 |
| XLogP3 | 3.9 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 8 |
| Rotatable Bond Count | 9 |
| Exact Mass | 507.20819606 g/mol |
| Monoisotopic Mass | 507.20819606 g/mol |
| Topological Polar Surface Area | 110 Ų |
| Heavy Atom Count | 37 |
| Formal Charge | 0 |
| Complexity | 815 |
| 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 |
Protein Kinase Inhibitors
Agents that inhibit PROTEIN KINASES. (See all compounds classified as Protein Kinase Inhibitors.)
Drugs in Development
Details:
LOU064 (remibrutinib) is a highly selective, oral Bruton’s tyrosine kinase (BTK) inhibitor, being investigated in a late stage study for spontaneous urticaria.
Lead Product(s): Remibrutinib
Therapeutic Area: Immunology Brand Name: LOU064
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 30, 2024
Lead Product(s) : Remibrutinib
Therapeutic Area : Immunology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Novartis Confirms Long-term Safety of Remibrutinib in Chronic Spontaneous Urticaria
Details : LOU064 (remibrutinib) is a highly selective, oral Bruton’s tyrosine kinase (BTK) inhibitor, being investigated in a late stage study for spontaneous urticaria.
Brand Name : LOU064
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 30, 2024
Details:
LOU064 (remibrutinib) is a highly selective, oral Bruton’s tyrosine kinase (BTK) inhibitor that blocks the BTK cascade and prevents the release of histamine that causes itch, hives/welts and swelling, which is investigated for spontaneous urticaria.
Lead Product(s): Remibrutinib
Therapeutic Area: Immunology Brand Name: LOU064
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 2023
Lead Product(s) : Remibrutinib
Therapeutic Area : Immunology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : LOU064 (remibrutinib) is a highly selective, oral Bruton’s tyrosine kinase (BTK) inhibitor that blocks the BTK cascade and prevents the release of histamine that causes itch, hives/welts and swelling, which is investigated for spontaneous urticaria.
Brand Name : LOU064
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 09, 2023
Details:
LOU064 (remibrutinib) is a highly selective, oral Bruton’s tyrosine kinase (BTK) inhibitor that blocks the BTK cascade and prevents the release of histamine that causes itch, hives/welts and swelling.
Lead Product(s): Remibrutinib
Therapeutic Area: Immunology Brand Name: LOU064
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 09, 2023
Lead Product(s) : Remibrutinib
Therapeutic Area : Immunology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : LOU064 (remibrutinib) is a highly selective, oral Bruton’s tyrosine kinase (BTK) inhibitor that blocks the BTK cascade and prevents the release of histamine that causes itch, hives/welts and swelling.
Brand Name : LOU064
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 09, 2023
Details:
Remibrutinib is a highly selective, potent oral BTK inhibitor discovered within Novartis and being developed in a number of clinical and early settings. The primary endpoint was achieved with remibrutinib showing a significant dose-response compared to placebo.
Lead Product(s): Remibrutinib
Therapeutic Area: Immunology Brand Name: LOU064
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 30, 2021
Lead Product(s) : Remibrutinib
Therapeutic Area : Immunology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Remibrutinib is a highly selective, potent oral BTK inhibitor discovered within Novartis and being developed in a number of clinical and early settings. The primary endpoint was achieved with remibrutinib showing a significant dose-response compared to p...
Brand Name : LOU064
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 30, 2021
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
STOCK RECAP #PipelineProspector
NEWS #PharmaBuzz
ABOUT THIS PAGE
A Remibrutinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Remibrutinib, including repackagers and relabelers. The FDA regulates Remibrutinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Remibrutinib API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Remibrutinib supplier is an individual or a company that provides Remibrutinib active pharmaceutical ingredient (API) or Remibrutinib finished formulations upon request. The Remibrutinib suppliers may include Remibrutinib API manufacturers, exporters, distributors and traders.
Remibrutinib 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 Remibrutinib 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 Remibrutinib GMP manufacturer or Remibrutinib GMP API supplier for your needs.
A Remibrutinib CoA (Certificate of Analysis) is a formal document that attests to Remibrutinib's compliance with Remibrutinib specifications and serves as a tool for batch-level quality control.
Remibrutinib CoA mostly includes findings from lab analyses of a specific batch. For each Remibrutinib 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.
Remibrutinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Remibrutinib EP), Remibrutinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Remibrutinib USP).
LOOKING FOR A SUPPLIER?
