Clinical Trials

Numerous Phase 2 and Phase 3 clinical trials, primarily sponsored by AB Science, evaluate the therapeutic efficacy and safety of masitinib across a spectrum of oncological and autoimmune disorders, including mastocytosis, rheumatoid arthritis, multiple sclerosis, ovarian cancer, gastrointestinal stromal tumors, and advanced pancreatic cancer. Key investigations include a completed Phase 2 study in refractory multiple myeloma and a Phase 3 trial combining masitinib with gemcitabine for pancreatic cancer. Across the recorded studies, recruitment statuses range from active recruiting and completed to suspended or terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07174492 NOT_YET_RECRUITING
Amyotrophic Lateral Sclerosis (ALS)
AB Science
 2026-01-01 PHASE3
NCT07174492 NOT_YET_RECRUITING
Amyotrophic Lateral Sclerosis (ALS)
AB Science
 2026-01-01 PHASE3
NCT05441488 SUSPENDED
Progressive Multiple Sclerosis
AB Science
 2022-06-28 PHASE3
NCT05564169 NOT_YET_RECRUITING
Alzheimer Disease
AB Science
 2026-06 PHASE3
NCT05441488 SUSPENDED
Progressive Multiple Sclerosis
AB Science
 2022-06-28 PHASE3
NCT05564169 NOT_YET_RECRUITING
Alzheimer Disease
AB Science
 2026-06 PHASE3
NCT03127267 RECRUITING
Amyotrophic Lateral Sclerosis
AB Science
 2021-02-02 PHASE3
NCT03127267 RECRUITING
Amyotrophic Lateral Sclerosis
AB Science
 2021-02-02 PHASE3
NCT05449444 UNKNOWN
Mast Cell Activation Syndrome
AB Science
 2022-07-01 PHASE2
NCT05449444 UNKNOWN
Mast Cell Activation Syndrome
AB Science
 2022-07-01 PHASE2
NCT04333108 UNKNOWN
Indolent Systemic Mastocytosis
AB Science
 2020-07-01 PHASE3
NCT04333108 UNKNOWN
Indolent Systemic Mastocytosis
AB Science
 2020-07-01 PHASE3
NCT05047783 UNKNOWN
Covid19; SARS-CoV2 Infection; Coronavirus Disease 2019
AB Science
 2021-11-23 PHASE2
NCT04622865 UNKNOWN
SARS-CoV 2; COVID-19; Coronavirus Disease 2019
AB Science
 2020-06-01 PHASE2
NCT05047783 UNKNOWN
Covid19; SARS-CoV2 Infection; Coronavirus Disease 2019
AB Science
 2021-11-23 PHASE2
NCT04622865 UNKNOWN
SARS-CoV 2; COVID-19; Coronavirus Disease 2019
AB Science
 2020-06-01 PHASE2
NCT03761225 COMPLETED
Metastatic Castrate Resistant Prostate Cancer
AB Science
 2014-09 PHASE3
NCT03761225 COMPLETED
Metastatic Castrate Resistant Prostate Cancer
AB Science
 2014-09 PHASE3
NCT02490488 COMPLETED
Ovarian Cancer
AB Science
 2014-04 PHASE2; PHASE3
NCT01694277 COMPLETED
Gastrointestinal Stromal Tumors
AB Science
 2012-04 PHASE3
NCT03766295 COMPLETED
Locally Advanced or Metastatic Pancreatic Cancer
AB Science
 2014-07 PHASE3
NCT01872598 COMPLETED
Alzheimer Disease
AB Science
 2012-01 PHASE3
NCT03556956 COMPLETED
Colorectal Cancer Metastatic
AB Science
 2015-07 PHASE2; PHASE3
NCT02490488 COMPLETED
Ovarian Cancer
AB Science
 2014-04 PHASE2; PHASE3
NCT01694277 COMPLETED
Gastrointestinal Stromal Tumors
AB Science
 2012-04 PHASE3
NCT03766295 COMPLETED
Locally Advanced or Metastatic Pancreatic Cancer
AB Science
 2014-07 PHASE3
NCT01872598 COMPLETED
Alzheimer Disease
AB Science
 2012-01 PHASE3
NCT03556956 COMPLETED
Colorectal Cancer Metastatic
AB Science
 2015-07 PHASE2; PHASE3
NCT03771040 COMPLETED
Asthma
AB Science
 2016-12 PHASE3
NCT03771040 COMPLETED
Asthma
AB Science
 2016-12 PHASE3
NCT01449162 COMPLETED
Asthma
AB Science
 2011-01 PHASE3
NCT01449162 COMPLETED
Asthma
AB Science
 2011-01 PHASE3
NCT01433497 COMPLETED
Multiple Sclerosis, Secondary Progressive; Multiple Sclerosis, Primary Progressive; Multiple Sclerosis, Relapse Free
AB Science
 2011-08 PHASE3
NCT01433497 COMPLETED
Multiple Sclerosis, Secondary Progressive; Multiple Sclerosis, Primary Progressive; Multiple Sclerosis, Relapse Free
AB Science
 2011-08 PHASE3
NCT01280565 TERMINATED
Metastatic Melanoma
AB Science
 2011-01 PHASE3
NCT01280565 TERMINATED
Metastatic Melanoma
AB Science
 2011-01 PHASE3
NCT00812240 TERMINATED
Gastrointestinal Stromal Tumors
AB Science
 2009-01 PHASE3
NCT00812240 TERMINATED
Gastrointestinal Stromal Tumors
AB Science
 2009-01 PHASE3
NCT02605044 TERMINATED
Metastatic Colorectal Cancer
AB Science
 2014-01 PHASE3
NCT02605044 TERMINATED
Metastatic Colorectal Cancer
AB Science
 2014-01 PHASE3
NCT01470131 TERMINATED
Multiple Myeloma
AB Science
 2011-05 PHASE3
NCT01470131 TERMINATED
Multiple Myeloma
AB Science
 2011-05 PHASE3
NCT02588677 COMPLETED
Amyotrophic Lateral Sclerosis (ALS)
AB Science
 2013-04 PHASE2; PHASE3
NCT02588677 COMPLETED
Amyotrophic Lateral Sclerosis (ALS)
AB Science
 2013-04 PHASE2; PHASE3
NCT02009423 TERMINATED
Gastro-Intestinal Stromal Tumour
AB Science
 2015-07 PHASE3
NCT00814073 COMPLETED
Indolent Systemic Mastocytosis
AB Science
 2008-12 PHASE3
NCT02009423 TERMINATED
Gastro-Intestinal Stromal Tumour
AB Science
 2015-07 PHASE3
NCT00814073 COMPLETED
Indolent Systemic Mastocytosis
AB Science
 2008-12 PHASE3
NCT01410695 TERMINATED
Rheumatoid Arthritis (RA)
AB Science
 2011-07 PHASE2; PHASE3
NCT01410695 TERMINATED
Rheumatoid Arthritis (RA)
AB Science
 2011-07 PHASE2; PHASE3
NCT00998751 COMPLETED
Gastro-intestinal Stromal Tumours
AB Science
 2005-06 PHASE2
NCT00998751 COMPLETED
Gastro-intestinal Stromal Tumours
AB Science
 2005-06 PHASE2
NCT00789633 COMPLETED
Pancreatic Cancer
AB Science
 2008-11-25 PHASE3
NCT00789633 COMPLETED
Pancreatic Cancer
AB Science
 2008-11-25 PHASE3
NCT01506336 COMPLETED
Gastro Intestinal Stromal Tumor
AB Science
 2008-10 PHASE2
NCT01506336 COMPLETED
Gastro Intestinal Stromal Tumor
AB Science
 2008-10 PHASE2
NCT00866138 COMPLETED
Multiple Myeloma
AB Science
 2005-02 PHASE2
NCT00866138 COMPLETED
Multiple Myeloma
AB Science
 2005-02 PHASE2
NCT00913432 COMPLETED
Rheumatoid Arthritis
AB Science
 2007-03 PHASE2
NCT00913432 COMPLETED
Rheumatoid Arthritis
AB Science
 2007-03 PHASE2
NCT00976118 COMPLETED
Alzheimer's Disease
AB Science
 2006-02 PHASE2
NCT00976118 COMPLETED
Alzheimer's Disease
AB Science
 2006-02 PHASE2
NCT01266369 COMPLETED
Mastocytosis
AB Science
 2007-02 PHASE2
NCT01266369 COMPLETED
Mastocytosis
AB Science
 2007-02 PHASE2
NCT01450488 COMPLETED
Multiple Sclerosis
AB Science
 2005-06 PHASE2
NCT01450488 COMPLETED
Multiple Sclerosis
AB Science
 2005-06 PHASE2
NCT00831974 COMPLETED
Mastocytosis
AB Science
 2004-10 PHASE2
NCT00831974 COMPLETED
Mastocytosis
AB Science
 2004-10 PHASE2
NCT00831922 COMPLETED
Rheumatoid Arthritis
AB Science
 2004-09 PHASE2
NCT00831922 COMPLETED
Rheumatoid Arthritis
AB Science
 2004-09 PHASE2
NCT01045577 COMPLETED
Psoriasis
AB Science
 2005-09 PHASE2
NCT01045577 COMPLETED
Psoriasis
AB Science
 2005-09 PHASE2
NCT00866138 Completed
Multiple Myeloma
AB Science
 2005-02 Phase 2
NCT00831974 Completed
Mastocytosis
AB Science
 2004-10 Phase 2

(data from https://clinicaltrials.gov, updated on 2025-10-03)

Check the Masitinib product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Masitinib selectively binds to and inhibits receptor tyrosine kinases, including c-Kit and PDGFR, thereby blocking kinase autophosphorylation and downstream intracellular signaling pathways essential for cell growth and survival. This targeted enzymatic inhibition suppresses pathological cell proliferation and tumor progression, driving therapeutic efficacy in clinical trial conditions such as pancreatic cancer, mastocytosis, and gastrointestinal stromal tumors.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.