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Drugs in Development
Lead Product(s) : Tolebrutinib
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Sanofi MS Drug Tolebrutinib Misses Goal in Relapsing Disease Trials
Details : SAR442168 (tolebrutinib) is an investigational brain-penetrant and bioactive BTK inhibitor. Tolebrutinib is being evaluated for relapsing forms of MS, nrSPMS and PPMS.
Brand Name : SAR442168
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 02, 2024
Lead Product(s) : Tolebrutinib
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
New Data for Tolebrutinib, Sanofi’s Investigational Brain-Penetrant BTK Inhibitor, Showed Signif...
Details : SAR442168 (tolebrutinib) is an investigational brain-penetrant and bioactive BTK inhibitor that achieves CSF concentrations predicted to modulate B lymphocytes and microglial cells. Tolebrutinib is being evaluated for relapsing forms of MS, nrSPMS and PP...
Brand Name : SAR442168
Molecule Type : Small molecule
Upfront Cash : Not Applicable
February 23, 2023
Lead Product(s) : Tolebrutinib
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Tolebrutinib Clinical Trial Program Update
Details : SAR442168 (tolebrutinib) is an investigational brain-penetrant and bioactive Bruton’s tyrosine kinase (BTK) inhibitor that achieves CSF concentrations sufficient to modulate B lymphocytes and microglial cells.
Brand Name : SAR442168
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 08, 2022
Lead Product(s) : Tolebrutinib
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Patient Enrollment of Phase III Tolebrutinib Trials Paused in the U.S.
Details : SAR442168 (tolebrutinib) is an investigational brain-penetrant and bioactive Bruton’s tyrosine kinase (BTK) inhibitor that achieves CSF concentrations needed for targeting B lymphocytes and microglial cells.
Brand Name : SAR442168
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 30, 2022
Lead Product(s) : Tolebrutinib
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
New Preclinical Tolebrutinib Data Demonstrated Superior Brain Penetration and Potency
Details : Preclinical findings showed that tolebrutinib, among the investigational BTK inhibitors tested, had the best combination of brain penetration and potency that reinforces its potential to impact neuroinflammation.
Brand Name : SAR442168
Molecule Type : Small molecule
Upfront Cash : Not Applicable
February 24, 2022
Lead Product(s) : Tolebrutinib
Therapeutic Area : Immunology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Tolebrutinib is an investigational brain-penetrant Bruton’s tyrosine kinase inhibitor that achieves CSF concentrations needed for targeting B lymphocytes and microglial cells, modulating neuroinflammation.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 13, 2021
Lead Product(s) : Tolebrutinib
Therapeutic Area : Immunology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Sanofi
Deal Size : $3,680.0 million
Deal Type : Acquisition
Sanofi to acquire Principia Biopharma
Details : The acquisition expands and accelerates development of Sanofi's BTK inhibitors consisting ‘168, rilzabrutinib and PRN473 Topical, across multiple indications.
Brand Name : SAR442168
Molecule Type : Small molecule
Upfront Cash : $3,680
August 17, 2020
Lead Product(s) : Tolebrutinib
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Sanofi
Deal Size : Not Applicable
Deal Type : Not Applicable
Principia Announces First Patient Enrolled in Sanofi’s Phase 3 Trial of SAR442168 in Relapsing M...
Details : First patient has been enrolled in Sanofi’s Phase 3 clinical trial of SAR442168 in patients with relapsing M.S. SAR442168, discovered by Principia, is a BTK inhibitor that crosses the blood-brain barrier and modulates immune cell function in both the p...
Brand Name : SAR442168
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 23, 2020
Lead Product(s) : Tolebrutinib
Therapeutic Area : Neurology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Study’s primary endpoint was met, demonstrating that the BTK inhibitor significantly reduced disease activity associated with multiple sclerosis (MS) as measured by magnetic resonance imaging.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 17, 2020
Lead Product(s) : Tolebrutinib
Therapeutic Area : Neurology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Sanofi brain-penetrant BTK inhibitor meets primary endpoint
Details : Sanofi’s BTK inhibitor will be first disease-modifying therapy to address sources of multiple sclerosis damage in the brain.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
February 06, 2020
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ABOUT THIS PAGE
A Tolebrutinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tolebrutinib, including repackagers and relabelers. The FDA regulates Tolebrutinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tolebrutinib 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 Tolebrutinib supplier is an individual or a company that provides Tolebrutinib active pharmaceutical ingredient (API) or Tolebrutinib finished formulations upon request. The Tolebrutinib suppliers may include Tolebrutinib API manufacturers, exporters, distributors and traders.
Tolebrutinib 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 Tolebrutinib 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 Tolebrutinib GMP manufacturer or Tolebrutinib GMP API supplier for your needs.
A Tolebrutinib CoA (Certificate of Analysis) is a formal document that attests to Tolebrutinib's compliance with Tolebrutinib specifications and serves as a tool for batch-level quality control.
Tolebrutinib CoA mostly includes findings from lab analyses of a specific batch. For each Tolebrutinib 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.
Tolebrutinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Tolebrutinib EP), Tolebrutinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tolebrutinib USP).
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