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Systemic Mastocytosis

2
Pipeline Programs
2
Companies
37
Clinical Trials
1 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
1
0
1
0
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
1100%
+ 1 programs with unclassified modality

Competitive Landscape

2 companies ranked by most advanced pipeline stage

AB Science
AB ScienceFrance - Paris
1 program
1
masitinibPhase 3Small Molecule5 trials
Active Trials
NCT05564169Not Yet Recruiting600Est. Dec 2029
NCT07174492Not Yet Recruiting412Est. Dec 2029
NCT05449444Unknown72Est. Dec 2024
+2 more trials
Sandoz
SandozAustria - Kundl
1 program
1
RAD001Phase 21 trial
Active Trials
NCT00449748Completed10Est. Oct 2009

Trial Timeline

Clinical trial activity over time

2021
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2024
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2026
2027
2028
2029
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Showing 15 of 37 trials with date data

Clinical Trials (37)

Total enrollment: 9,018 patients across 37 trials

Masitinib in Patients With Mild Alzheimer's Disease

Start: Jun 2026Est. completion: Dec 2029600 patients
Phase 3Not Yet Recruiting

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

Start: Jan 2026Est. completion: Dec 2029412 patients
Phase 3Not Yet Recruiting

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

Start: Jun 2022Est. completion: Dec 2028800 patients
Phase 3Active Not Recruiting

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

Start: Feb 2021Est. completion: Dec 2027495 patients
Phase 3Recruiting

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

Start: Jul 2020Est. completion: Jun 2025140 patients
Phase 3Unknown

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

Start: Dec 2016Est. completion: Sep 2020347 patients
Phase 3Completed

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

Start: Jul 2015Est. completion: Nov 20157 patients
Phase 3Terminated

Masitinib Plus Docetaxel in Metastatic Castration-resistant Prostate Cancer

Start: Sep 2014Est. completion: Dec 2020714 patients
Phase 3Completed

Masitinib Plus Gemcitabine in Pancreatic Cancer

Start: Jul 2014Est. completion: Dec 2020377 patients
Phase 3Completed

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

Start: Jan 2014Est. completion: Dec 2017123 patients
Phase 3Terminated

Masitinib in Patients With Gastrointestinal Stromal Tumour After Progression With Imatinib

Start: Apr 2012Est. completion: Dec 2020258 patients
Phase 3Completed

Masitinib in Patients With Mild to Moderate Alzheimer's Disease

Start: Jan 2012Est. completion: Dec 2020721 patients
Phase 3Completed

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

Start: Aug 2011Est. completion: Feb 2020656 patients
Phase 3Completed

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

Start: May 2011Est. completion: Feb 2017147 patients
Phase 3Terminated

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

Start: Jan 2011Est. completion: Nov 2019420 patients
Phase 3Completed

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

Start: Jan 2011Est. completion: Aug 2019134 patients
Phase 3Terminated

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

Start: Jan 2009Est. completion: Jul 2018335 patients
Phase 3Terminated

Masitinib in Severe Indolent or Smoldering Systemic Mastocytosis

Start: Dec 2008Est. completion: Nov 2015135 patients
Phase 3Completed

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

Start: Nov 2008Est. completion: Aug 2012353 patients
Phase 3Completed

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

Start: Jul 2015Est. completion: Dec 2020219 patients
Phase 2/3Completed

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

Start: Apr 2014Est. completion: Dec 2020248 patients
Phase 2/3Completed

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

Start: Apr 2013Est. completion: Mar 2018394 patients
Phase 2/3Completed

Masitinib in Refractory Active Rheumatoid Arthritis

Start: Jul 2011Est. completion: Oct 2015324 patients
Phase 2/3Terminated

Masitinib for the Treatment of Severe Mast Cell Activation Syndrome

Start: Jul 2022Est. completion: Dec 202472 patients
Phase 2Unknown

Masitinib in Patients With Symptomatic Mild to Moderate COVID-19

Start: Nov 2021Est. completion: Dec 202378 patients
Phase 2Unknown

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

Start: Jun 2020Est. completion: Dec 2023200 patients
Phase 2Unknown

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

Start: Oct 2008Est. completion: Apr 201244 patients
Phase 2Completed

Everolimus (RAD001) as Therapy for Patients With Systemic Mastocytosis

Start: Apr 2007Est. completion: Oct 200910 patients
Phase 2Completed

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

Start: Mar 2007Est. completion: Sep 201020 patients
Phase 2Completed

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

Start: Feb 2007Est. completion: May 201021 patients
Phase 2Completed

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

Start: Feb 2006Est. completion: Feb 200934 patients
Phase 2Completed

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

Start: Sep 2005Est. completion: Feb 200825 patients
Phase 2Completed

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

Start: Jun 2005Est. completion: Jan 201035 patients
Phase 2Completed

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

Start: Jun 2005Est. completion: Jun 201330 patients
Phase 2Completed

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

Start: Feb 2005Est. completion: Jan 201124 patients
Phase 2Completed

Efficacy of AB1010 in Patients With Systemic Indolent Mastocytosis

Start: Oct 200423 patients
Phase 2Completed

Efficacy of Oral AB1010 in Adult Patients With Active Rheumatoid Arthritis

Start: Sep 200443 patients
Phase 2Completed

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

1 late-stage (Phase 3) programs, potential near-term approvals
1 actively recruiting trials targeting 9,018 patients
2 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.