masitinib

Phase 3Small molecule

masitinib is a small molecule that works as a Platelet-Derived Growth Factor Receptor Inhibitor; Stem Cell Growth Factor Receptor Inhibitor; Fibroblast Growth Factor Receptor 3 Inhibitor.[2] It is being investigated across 2 indications, with its most advanced program in Phase 3.[1]

masitinib is one of 54 small molecule programs targeting Secondary Progressive Multiple Sclerosis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Secondary Progressive Multiple SclerosisActive, not recruiting

Alzheimer's DiseaseNot yet recruiting

Secondary Progressive Multiple SclerosisPhase 3

Active, not recruiting

Alzheimer's DiseasePhase 3

Not yet recruiting

Competition

Competitive Landscape

59 competitors in Alzheimer's Disease

#DrugCompanyPhaseTrials

Aricept

Eisai

Approved

31 2

Leqembi

Eisai

Phase 3

7 3

Nuplazid

AACADIA Pharmaceuticals Inc.

Ozempic

3 5

Qalsody

Biogen

Phase 3

1 6

Namenda

AbbVie

Phase 2

2 7

Leukine

Sanofi

Phase 2

1 8

Niacor

AbbVie

Phase 2

1 9

Briviact

UCB

Phase 2

1 10

Sprycel

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Phase 2

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Phase 3Recruiting

Efficacy and Safety

NCT03127267

Q4 2028

Phase 3Active, not recruiting

Secondary Progressive Multiple Sclerosis

NCT05441488

Q4 2029

Phase 3Not yet recruiting

Alzheimer's Disease

NCT05564169

Phase 3Not yet recruiting

Efficacy and Safety

NCT07174492

Clinical

Trials by Indication[1]

Rheumatoid Arthritis3 trials

Masitinib in Refractory Active Rheumatoid Arthritis

Terminated·AAB Science·Phase 2/3·NCT01410695·324 enrolled

Efficacy of Oral AB1010 in Adult Patients With Active Rheumatoid Arthritis

Completed·AAB Science·Phase 2·NCT00831922·43 enrolled

Masitinib in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis

Completed·AAB Science·Phase 2·NCT00913432·20 enrolled

Secondary Progressive Multiple Sclerosis2 trials

Masitinib in Primary Progressive Multiple Sclerosis or Relapse-free Secondary Progressive Multiple Sclerosis

Completed·AAB Science·Phase 2·NCT01450488·35 enrolled

Masitinib in the Treatment of Patients With Primary Progressive or Non-active Secondary Progressive Multiple Sclerosis

Active, not recruiting·AAB Science·Phase 3·NCT05441488·800 enrolled

Mastocytosis2 trials

Masitinib in Patients With Mastocytosis With Handicap and Bearing the D816V Mutation

Completed·AAB Science·Phase 2·NCT01266369·21 enrolled

Efficacy of AB1010 in Patients With Systemic Indolent Mastocytosis

Completed·AAB Science·Phase 2·NCT00831974·23 enrolled

Mild to Moderate Alzheimer's Disease2 trials

Masitinib in Patients With Mild to Moderate Alzheimer's Disease

Completed·AAB Science·Phase 3·NCT01872598·721 enrolled

Activity of Masitinib (AB1010) in Mild to Moderate Alzheimer's Disease

Completed·AAB Science·Phase 2·NCT00976118·34 enrolled

Asthma2 trials

Masitinib in the Treatment of Patients With Severe Uncontrolled Asthma and Elevated Eosinophil Levels

Completed·AAB Science·Phase 3·NCT03771040·347 enrolled

Masitinib in Treatment of Patients With Severe Persistent Asthma Treated With Oral Corticosteroids

Completed·AAB Science·Phase 3·NCT01449162·420 enrolled

18 more indications

Efficacy and Safety2 trials

Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients

Recruiting·AAB Science·Phase 3·NCT03127267·495 enrolled

Efficacy and Safety of Masitinib in Combination With SoC Versus Placebo in the Treatment of ALS Patients

Not yet recruiting·AAB Science·Phase 3·NCT07174492·412 enrolled

Multiple Myeloma2 trials

Masitinib in Relapse or Refractory Multiple Myeloma With t(4/14) Translocation Expressing or Not FGFR3

Completed·AAB Science·Phase 2·NCT00866138·24 enrolled

A Phase 3 Study to Evaluate Efficacy and Safety of Masitinib in Patients With Relapse or Refractory Multiple Myeloma

Terminated·AAB Science·Phase 3·NCT01470131·147 enrolled

Metastatic Colorectal Cancer2 trials

Masitinib in Combination With FOLFIRI for Second-line Treatment of Patients With Metastatic Colorectal Cancer

Terminated·AAB Science·Phase 3·NCT02605044·123 enrolled

Masitinib in Combination With FOLFIRI in Third or Fourth Line of Treatment of Patients With Metastatic Colorectal Cancer

Completed·AAB Science·Phase 2/3·NCT03556956·219 enrolled

Treatment2 trials

Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)

Terminated·AAB Science·Phase 3·NCT00812240·335 enrolled

Masitinib for the Treatment of Severe Mast Cell Activation Syndrome

Unknown status·AAB Science·Phase 2·NCT05449444·72 enrolled

Pancreatic Cancer2 trials

Masitinib in Combination With Gemcitabine for Treatment of Patients With Advanced/Metastatic Pancreatic Cancer

Completed·AAB Science·Phase 3·NCT00789633·353 enrolled

Masitinib Plus Gemcitabine in Pancreatic Cancer

Completed·AAB Science·Phase 3·NCT03766295·377 enrolled

COVID-192 trials

Masitinib Combined With Isoquercetin and Best Supportive Care in Hospitalized Patients With Moderate and Severe COVID-19

Unknown status·AAB Science·Phase 2·NCT04622865·200 enrolled

Masitinib in Patients With Symptomatic Mild to Moderate COVID-19

Unknown status·AAB Science·Phase 2·NCT05047783·78 enrolled

Systemic Mastocytosis2 trials

Masitinib in Severe Indolent or Smoldering Systemic Mastocytosis Unresponsive to Optimal Symptomatic Treatment

Unknown status·AAB Science·Phase 3·NCT04333108·140 enrolled

Masitinib in Severe Indolent or Smoldering Systemic Mastocytosis

Completed·AAB Science·Phase 3·NCT00814073·135 enrolled

Ovarian Cancer1 trial

Masitinib in Combination With Gemcitabine in Advanced/Metastatic Epithelial Ovarian Cancer Patients

Completed·AAB Science·Phase 2/3·NCT02490488·248 enrolled

Gastrointestinal Stromal Tumour1 trial

Masitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib

Completed·AAB Science·Phase 3·NCT01694277·258 enrolled

Amyotrophic Lateral Sclerosis1 trial

Masitinib in Combination With Riluzole for the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS)

Completed·AAB Science·Phase 2/3·NCT02588677·394 enrolled

Alzheimer's Disease1 trial

Masitinib in Patients With Mild Alzheimer's Disease

Not yet recruiting·AAB Science·Phase 3·NCT05564169·600 enrolled

Locally Advanced1 trial

Masitinib in Locally Advanced/Metastatic Gastro-intestinal Stromal Tumour (GIST)

Completed·AAB Science·Phase 2·NCT00998751·30 enrolled

Multiple Sclerosis1 trial

Efficacy and Safety of Masitinib in the Treatment of Progressive Multiple Sclerosis

Completed·AAB Science·Phase 3·NCT01433497·656 enrolled

Tumour1 trial

Masitinib in Patients With Gastro-Intestinal Stromal Tumour Resistant to Imatinib

Completed·AAB Science·Phase 2·NCT01506336·44 enrolled

Prostate Cancer1 trial

Masitinib Plus Docetaxel in Metastatic Castration-resistant Prostate Cancer

Completed·AAB Science·Phase 3·NCT03761225·714 enrolled

Psoriasis1 trial

A Double-blind, Placebo-controlled, Randomized, Parallel-group Study to Evaluate the Activity of Oral AB1010 in Adults Patients With Moderate to Severe Chronic Plaque Psoriasis

Completed·AAB Science·Phase 2·NCT01045577·25 enrolled

Melanoma1 trial

Masitinib in Non-Resectable or Metastatic Stage 3/4 Melanoma Carrying a Mutation in the Juxta Membrane Domain of c-Kit

Terminated·AAB Science·Phase 3·NCT01280565·134 enrolled

Recurrence1 trial

Masitinib in Patients With Localized, Primary GIST After Complete Surgery and With High Risk of Recurrence

Terminated·AAB Science·Phase 3·NCT02009423·7 enrolled

Sources

References

[1]
ClinicalTrials.gov — 36 trial records for masitinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — masitinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for masitinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — AB Science company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Platelet-Derived Growth Factor Receptor Inhibitor; Stem Cell Growth Factor Receptor Inhibitor; Fibroblast Growth Factor Receptor 3 Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: AAB Science

masitinib

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Q4 2028

Q4 2029

Trials by Indication[1]

Rheumatoid Arthritis3 trials

Secondary Progressive Multiple Sclerosis2 trials

Mastocytosis2 trials

Mild to Moderate Alzheimer's Disease2 trials

Asthma2 trials

Efficacy and Safety2 trials

Multiple Myeloma2 trials

Metastatic Colorectal Cancer2 trials

Treatment2 trials

Pancreatic Cancer2 trials

COVID-192 trials

Systemic Mastocytosis2 trials

Ovarian Cancer1 trial

Gastrointestinal Stromal Tumour1 trial

Amyotrophic Lateral Sclerosis1 trial

Alzheimer's Disease1 trial

Locally Advanced1 trial

Multiple Sclerosis1 trial

Tumour1 trial

Prostate Cancer1 trial

Psoriasis1 trial

Melanoma1 trial

Recurrence1 trial

References

Drug Info

Quick Facts

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