Masitinib 4.5 Mg/Kg/Day, Riluzole (100 Mg)
Amyotrophic Lateral Sclerosis (Als)
Phase III
Not Yet Recruiting
Efficacy and Safety of Masitinib in Combination With SoC Versus Placebo in the Treatment of ALS Patients
Sep 11, 2025
―
Standard of Care, Masitinib (4.5)
Alzheimer Disease
Phase III
Not Yet Recruiting
Masitinib in Patients With Mild Alzheimer's Disease
Sep 29, 2022
―
Best Supportive Care, Masitinib 4.5 Mg/Kg/Day, Masitinib 6.0 Mg/Kg/Day
Mast Cell Activation Syndrome
Phase II
Unknown
Masitinib for the Treatment of Severe Mast Cell Activation Syndrome
Jul 02, 2022
―
Masitinib (4.5)
Progressive Multiple Sclerosis
Phase III
Recruiting
Masitinib in the Treatment of Patients With Primary Progressive or Non-active Secondary Progressive Multiple Sclerosis
Jun 28, 2022
―
Azacitidine, Ab8939
Acute Myeloid Leukemia Refractory, Acute Myeloid Leukemia, In Relapse, Myelodysplastic Syndrome Acute Myeloid Leukemia
Phase I/II
Recruiting
AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Jan 12, 2022
―
14C-Ab1010
Healthy Volunteers
Early Phase I
Completed
Mass Balance Recovery, Metabolite Profile and Metabolite Identification of 14C-AB1010 in Healthy Male Subjects
Dec 27, 2021
―
Masitinib Mesylate
COVID19, Sars-Cov2 Infection, Coronavirus Disease 2019
Phase II
Unknown
Masitinib in Patients With Symptomatic Mild to Moderate COVID-19
Sep 16, 2021
―
Best Supportive Care, Masitinib, Isoquercetin
Sars-Cov 2, Coronavirus Disease 2019, Covid-19
Phase II
Unknown
Masitinib Combined With Isoquercetin and Best Supportive Care in Hospitalized Patients With Moderate and Severe COVID-19
Nov 09, 2020
―
Best Supportive Care, Masitinib
Indolent Systemic Mastocytosis
Phase III
Unknown
Masitinib in Severe Indolent or Smoldering Systemic Mastocytosis Unresponsive to Optimal Symptomatic Treatment
Apr 01, 2020
―
Masitinib
Asthma
Phase III
Completed
Masitinib in the Treatment of Patients With Severe Uncontrolled Asthma and Elevated Eosinophil Levels
Dec 07, 2018
―
FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does AB Science SA (A8D) have in its pipeline
A8D is currently developing the following drugs: Masitinib 4.5 Mg/Kg/Day, Riluzole (100 Mg), Standard of Care, Masitinib (4.5), Best Supportive Care, Masitinib 4.5 Mg/Kg/Day, Masitinib 6.0 Mg/Kg/Day. These drug candidates are in various stages of clinical development as the company works toward FDA approval.