[{"company":"AB Science","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"AB Science announces positive top-line Phase 2B\/3 results for oral masitinib in progressive forms of multiple sclerosis","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"February 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"AB Science"},{"company":"MedDay Pharmaceuticals","sponsor":"Not Applicable ","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"MedDay Reports Top-Line Data from Phase III Trial \u201cSPI2\u201d","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"March 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"MedDay Pharmaceuticals"},{"company":"AB Science","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"AB Science announces that FDA clears masitinib IND in Amyotrophic Lateral Sclerosis (ALS)","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"March 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"AB Science"},{"company":"Pharnext","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pharnext Provides Regulatory and Clinical Update on PXT3003 Phase III Study for the Treatment of Charcot-Marie-Tooth Type 1A","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Pharnext"},{"company":"Sanofi","sponsor":"Sanofi","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Principia Announces First Patient Enrolled in Sanofi\u2019s Phase 3 Trial of SAR442168 in Relapsing Multiple Sclerosis","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Sanofi"},{"company":"AB Science","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"AB Science Publish New Results in Journal of Alzheimer's Disease Support Masitinib\u2019s Potential Mode of Action in AD","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"AB Science"},{"company":"AB Science","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"AB Science Presents Phase 2B\/3 Study Results in Progressive Multiple Sclerosis at the World's Largest Multiple Sclerosis Research Conference","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"AB Science"},{"company":"AB Science","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"AB Science Abstract Results from its Phase 3 AB09004 Study on Alzheimer Disease Selected","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"July 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"AB Science"},{"company":"AB Science","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Results from Masitinib Study AB09004 in Mild to Moderate Alzheimer\u2019s Disease Presented at\n AAIC","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"July 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"AB Science"},{"company":"AB Science","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"AB Science Receives U.S. Food and Drug Administration (FDA) Authorization to Resume Patient Enrolment in The Phase 3 Study of Masitinib in Amyotrophic Lateral Sclerosis (ALS)","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"November 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"AB Science"},{"company":"AB Science","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"AB Science Granted Authorization to Initiate Confirmatory Phase III Trial of Masitinib in Progressive Forms of Multiple Sclerosis by the French Health Authority (ANSM)","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"January 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"AB Science"},{"company":"AB Science","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"AB Science to Present on its Amyotrophic Lateral Sclerosis (ALS) Development Program at the 2022 ALS Drug Development Summit","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"February 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"AB Science"},{"company":"AB Science","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"AB Science Will Host a Live Webcast on February 28, 2022 to Provide Details on the Masitinib Filing in the Treatment Als in Canada and to Provide an Update on Its Clinical Program in All Indications","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"February 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"AB Science"},{"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Preclinical Tolebrutinib Data Demonstrated Superior Brain Penetration and Potency","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Sanofi"},{"company":"AB Science","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"AB Science Announces that Health Canada Has Started the Review of New Drug Submission for Masitinib in The Treatment of ALS","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"AB Science"},{"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Patient Enrollment of Phase III Tolebrutinib Trials Paused in the U.S.","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Sanofi"},{"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Tolebrutinib Clinical Trial Program Update","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Sanofi"},{"company":"AB Science","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ab Science Announces that It Has Filed an Application for Conditional Marketing Authorization to EMA for Masitinib in the Treatment of ALS","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"August 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"AB Science"}]
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.
Lead Product(s):
Tolebrutinib
Therapeutic Area: Neurology
Product Name: SAR442168
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
August 08, 2022
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.
Lead Product(s):
Tolebrutinib
Therapeutic Area: Neurology
Product Name: SAR442168
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
June 30, 2022
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.
Lead Product(s):
Tolebrutinib
Therapeutic Area: Neurology
Product Name: SAR442168
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
February 24, 2022
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 periphery and in the CNS.
Lead Product(s):
Tolebrutinib
Therapeutic Area: Neurology
Product Name: SAR442168
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Sanofi
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
June 23, 2020
Details:
Long-term follow-up survival data showing a significant benefit in favor of Alsitek (masitinib) in moderate ALS patients (between group difference in median OS of +25 months, hazard ratio 0.56 (95%CI [0.32;0.96])).
Lead Product(s):
Masitinib Mesylate,Riluzole
Therapeutic Area: Neurology
Product Name: Alsitek
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
August 24, 2022
Details:
The authorization was made based on a pre-submission package sent by AB Science including efficacy data of study AB10015, long-term survival data (75 months average follow-up from diagnosis) of study AB10015, and safety data.
Lead Product(s):
Masitinib Mesylate
Therapeutic Area: Neurology
Product Name: AB1010
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
May 26, 2022
Details:
AB1010 (masitinib), a selective tyrosine kinase inhibitor, modulates the activity of mast cells and macrophages in patients for the treatment of ALS, and is currently developed in three therapeutic areas: neurology, inflammatory diseases and oncology.
Lead Product(s):
Masitinib Mesylate,Riluzole
Therapeutic Area: Neurology
Product Name: AB1010
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
February 24, 2022
Details:
Study AB10015 previously showed that masitinib (4.5 mg/kg/day) as an add-on to standard riluzole, significantly slowed functional decline at week 48 relative to those treated with riluzole alone.
Lead Product(s):
Masitinib Mesylate,Riluzole
Therapeutic Area: Neurology
Product Name: AB1010
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
February 07, 2022
Details:
Company initiated Phase III study on the basis of results from Phase 2B/3 study of AB1010 (Masitinib) which showed significant reduction in the risk of first disability progression by 42% and the risk of confirmed disability progression by 37%.
Lead Product(s):
Masitinib Mesylate
Therapeutic Area: Neurology
Product Name: AB1010
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
January 03, 2022
Details:
Masitinib is a orally administered tyrosine kinase inhibitor that targets mast cells and macrophages, important cells for immunity, through inhibiting a limited number of kinases.
Lead Product(s):
Masitinib Mesylate,Riluzole
Therapeutic Area: Neurology
Product Name: AB1010
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
November 18, 2021
Market Place
News Type
Pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme. 
Contact Supplier
