Masitinib

also known as AB1010 · Kinavet · Masican · Masitinib mesilate · Masitinib Mesylate · Masitinib methanesulfonate · Masivet · Masiviera

Small molecule targets FGFR3, FYN, KIT, LYN via inhibition

Developed for: gastrointestinal stromal tumor · Alzheimer disease · amyotrophic lateral sclerosis · asthma · rheumatoid arthritis · colorectal cancer · COVID-19 · indolent systemic mastocytosis
+11 more
· mastocytosis · multiple sclerosis · plasma cell myeloma · castration-resistant prostate carcinoma · malignant pancreatic neoplasm · mast cell activation syndrome · metastatic melanoma · ovarian cancer · primary progressive multiple sclerosis · secondary progressive multiple sclerosis · psoriasis
Investigated by: AB Science

Regulatory milestones approvals, filings & regulatory actions · 8 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed amyotrophic lateral sclerosis 28 4 milestones
Refused (EMA)	EU (EMA)	—	amyotrophic lateral sclerosis 28	2024-06-28	“the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted, in line with the trend vote, a negative opinion on the application...” ab-science.com ↗ “EMA negative opinion on the marketing authorisation application for masitinib in amyotrophic lateral sclerosis” ab-science.com ↗
Filed	EU (EMA)	Alsitek	amyotrophic lateral sclerosis 28	2022-08-24	“filed an application for conditional Marketing Authorization to the European Medicines Agency (EMA) for Alsitek (masitinib) in the treatment of amyotrophic lateral sclerosis (ALS).” ab-science.com ↗
Filed	Other	—	amyotrophic lateral sclerosis 28	2022-05-26	“Health Canada has issued a screening acceptance letter for the application of masitinib in the treatment of amyotrophic lateral sclerosis (ALS)” ab-science.com ↗ “Filing of a marketing authorization application for masitinib in the treatment of amyotrophic lateral sclerosis (ALS) in Canada” ab-science.com ↗
Rejected	Other	—	amyotrophic lateral sclerosis 28	—	“Health Canada issued a Notice of Deficiency-Withdrawal (NOD/w) regarding the New Drug Submission (NDS) for masitinib in the treatment of ALS” ab-science.com ↗ “Health Canada had issued a Notice of Deficiency-Withdrawal (NOD/w) regarding the submission file for masitinib in the treatment of ALS” ab-science.com ↗
Rejected Indication not stated 4 milestones
Refused (EMA)	EU (EMA)	Masitinib AB Science	—	2024-12-19	europa.eu ↗
Refused (EMA)	EU (EMA)	Alsitek	—	2018-07-26	europa.eu ↗
Refused (EMA)	EU (EMA)	Masipro	—	2017-12-18	europa.eu ↗
Refused (EMA)	EU (EMA)	Masican	—	2014-07-04	europa.eu ↗

Trials 37

today NCT05564169 · Ph 3 NCT07174492 · Ph 3 NCT05449444 · Ph 2 NCT05441488 · Ph 3 NCT05047783 · Ph 2 NCT03127267 · Ph 3 NCT04333108 · Ph 3 NCT04622865 · Ph 2 NCT05200169 · Ph 0 NCT03771040 · Ph 3 NCT02009423 · Ph 3 NCT03556956 · Ph 2/3 NCT03761225 · Ph 3 NCT03766295 · Ph 3 NCT02490488 · Ph 2/3 NCT02605044 · Ph 3 NCT02588677 · Ph 2/3 NCT01694277 · Ph 3 NCT01872598 · Ph 3 NCT01433497 · Ph 3 NCT01410695 · Ph 2/3 NCT01470131 · Ph 3 NCT01280565 · Ph 3 NCT01449162 · Ph 3 NCT00812240 · Ph 3 NCT00814073 · Ph 3 NCT00789633 · Ph 3 NCT01506336 · Ph 2 NCT00913432 · Ph 2 NCT01266369 · Ph 2 NCT00976118 · Ph 2 NCT00842270 · Ph 2 NCT01450488 · Ph 2 NCT00998751 · Ph 2 NCT00866138 · Ph 2 NCT00831974 · Ph 2 NCT00831922 · Ph 2

20042005200620072008200920102011201220132014201520162017201820192020202120222023202420252026202720282029

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 01 trial
Phase 0	NCT05200169	Jul → Sep 2017	—	AB Science	Completed	No outcome recorded
Phase 213 trials · 2 met primary · 1 missed
Phase 2	NCT05449444	Jul 2022 → Dec 2024	mast cell activation syndrome	AB Science	Unknown	No outcome recorded
Phase 2	NCT05047783	Nov 2021 → Dec 2023	COVID-19	AB Science	Unknown	No outcome recorded
Phase 2	NCT04622865	Jun 2020 → Dec 2023	COVID-19	AB Science	Unknown	No outcome recorded
Phase 2	NCT01506336	Oct 2008 → Sep 2011	gastrointestinal stromal tumor	AB Science	Completed	No outcome recorded
Phase 2	NCT00913432	Mar 2007 → Jun 2009	rheumatoid arthritis	AB Science	Completed	No outcome recorded
Phase 2	NCT01266369	Feb → Nov 2007	mastocytosis	AB Science	Completed	No outcome recorded
Phase 2	NCT00976118	Feb 2006 → Jul 2008	Alzheimer disease	AB Science	Completed	Met primary
Phase 2	NCT00842270	Jan 2006 → Jul 2007	asthma	AB Science	Completed	No outcome recorded
Phase 2	NCT01450488	Jun 2005 → Jul 2007	multiple sclerosis	AB Science	Completed	Missed primary
Phase 2	NCT00998751	Jun 2005 → Jun 2013	gastrointestinal stromal tumor	AB Science	Completed	No outcome recorded
Phase 2	NCT00866138	Feb 2005 → Jan 2011	plasma cell myeloma	AB Science	Completed	No outcome recorded
Phase 2	NCT00831974	Oct 2004 → Feb 2007	mastocytosis	AB Science	Completed	Met primary
Phase 2	NCT00831922	Sep 2004 → Oct 2006	rheumatoid arthritis	AB Science	Completed	No outcome recorded

Phase 2/34 trials
Phase 2/3	NCT03556956	Jul 2015 → Dec 2020	colorectal cancer	AB Science	Completed	No outcome recorded
Phase 2/3	NCT02490488	Apr 2014 → Dec 2020	ovarian cancer	AB Science	Completed	No outcome recorded
Phase 2/3	NCT02588677	Apr 2013 → Dec 2016	amyotrophic lateral sclerosis	AB Science	Completed	No outcome recorded
Phase 2/3	NCT01410695	Jul 2011 → Oct 2015	rheumatoid arthritis	AB Science	Terminated	No outcome recorded Stop: Business
Phase 319 trials · 5 met primary · 1 missed
Phase 3	NCT05564169	Jun 2026 → Dec 2028 expected	Alzheimer disease	AB Science	Not yet recruiting	No outcome recorded
Phase 3	NCT07174492	Jan 2026 → Dec 2028 expected	amyotrophic lateral sclerosis	AB Science	Not yet recruiting	No outcome recorded
Phase 3	NCT05441488	Jun 2022 → Dec 2028	multiple sclerosis	AB Science	Suspended	No outcome recorded
Phase 3	NCT03127267	Feb 2021 → Dec 2027 expected	amyotrophic lateral sclerosis	AB Science	Recruiting	No outcome recorded
Phase 3	NCT04333108	Jul 2020 → Dec 2024	indolent systemic mastocytosis	AB Science	Unknown	No outcome recorded
Phase 3	NCT03771040	Dec 2016 → Sep 2020	asthma	AB Science	Completed	No outcome recorded
Phase 3	NCT02009423	Jul → Nov 2015	gastrointestinal stromal tumor	AB Science	Terminated	No outcome recorded Stop: Business
Phase 3	NCT03761225	Sep 2014 → Dec 2020	castration-resistant prostate carcinoma	AB Science	Completed	Met primary
Phase 3	NCT03766295	Jul 2014 → Dec 2020	—	AB Science	Completed	Met primary
Phase 3	NCT02605044	Jan 2014 → Dec 2017	colorectal cancer	AB Science	Terminated	No outcome recorded Stop: Business
Phase 3	NCT01694277	Apr 2012 → Dec 2020	gastrointestinal stromal tumor	AB Science	Completed	No outcome recorded
Phase 3	NCT01872598	Jan 2012 → Dec 2020	Alzheimer disease	AB Science	Completed	No outcome recorded
Phase 3	NCT01433497	Aug 2011 → Sep 2019	primary progressive multiple sclerosis, secondary progressive multiple sclerosis	AB Science	Completed	Met primary
Phase 3	NCT01470131	May 2011 → Jan 2017	plasma cell myeloma	AB Science	Terminated	No outcome recorded Stop: Business
Phase 3	NCT01280565	Jan 2011 → Aug 2019	metastatic melanoma	AB Science	Terminated	No outcome recorded Stop: Business
Phase 3	NCT01449162	Jan 2011 → Nov 2019	asthma	AB Science	Completed	Met primary
Phase 3	NCT00812240	Jan 2009 → Jul 2018	gastrointestinal stromal tumor	AB Science	Terminated	No outcome recorded Stop: Business
Phase 3	NCT00814073	Dec 2008 → Nov 2015	indolent systemic mastocytosis	AB Science	Completed	Met primary
Phase 3	NCT00789633	Nov 2008 → Dec 2011	malignant pancreatic neoplasm	AB Science	Completed	Missed primary

Comparator or background therapy1 trial
Phase 2	NCT01045577 Comparator	Sep 2005 → Jan 2006	psoriasis	AB Science	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 84

Date	Issuer	Release
2026-06-09	AB Science	Results AB Science is invited to present at the 2026 ENCALS annual meeting the survival data from masitinib clinical program in ALS ab-science.com ↗ The analysis of patients receiving masitinib at 4.5 mg/kg/day revealed a five-year survival rate of 42.3% from symptom onset, significantly exceeding the published registry benchmarks.
2026-04-20	AB Science	Results New publication on medrxiv demonstrating substantial survival benefits and preserved quality of life with masitinib in ALS patients ab-science.com ↗ Masitinib treatment associated with a 5-year survival rate from disease onset of 42.3%, representing a 2-fold improvement over historical benchmarks
2026-02-24	AB Science	Results AB Science announces the identification of a plasma biomarker that indicates the activity of masitinib in treating ALS ab-science.com ↗
2026-02-09	AB Science	Regulatory FDA granted the status of Minor Use in Major Species (MUMS) for Masivet® ab-science.com ↗ AB Science SA (Euronext - FR0010557264 - AB) announced that the Food and Drug Administration (FDA) granted the status of Minor Use in Major Species (MUMS) for Masivet® in the treatment of canine mast cell tumors.
2025-12-11	AB Science	Results AB Science announces new publication on Medrxiv highlighting clinical benefit with masitinib in Amyotrophic Lateral Sclerosis patients prior any complete loss of function ab-science.com ↗ Median progression-free survival (PFS) extended by 9 months (p=0.0057)
2025-07-24	AB Science	Regulatory AB Science has received approval from several European countries to initiate the confirmatory phase 3 study of masitinib in ALS ab-science.com ↗
2025-07-04	AB Science	Regulatory Masitinib receives FDA and EMA authorization for confirmatory phase 3 trial in metastatic castrate-resistant prostate cancer, with biomarker-driven patient selection targeting population most likely to benefit ab-science.com ↗ The authorization of our confirmatory Phase 3 study by both the FDA and EMA represents a critical milestone for masitinib in metastatic castrate-resistant prostate cancer.
2025-05-15	AB Science	Results AB Science reports a new publication in the scientific journal PLOS One ab-science.com ↗ A NEW PUBLICATION IN THE SCIENTIFIC JOURNAL PLOS ONE, SHOWS THAT MASITINIB CAN LOWER SERUM NEUROFILAMENT LIGHT CHAIN, AN IMPORTANT BIOMARKER FOR NEURODEGENERATIVE DISORDERS, INCLUDING MULTIPLE SCLEROSIS, AMYOTROPHIC LATERAL SCLEROSIS AND ALZHEIMER'S DISEASE
2025-05-05	AB Science	Results AB Science will present new data from masitinib clinical program in ALS in two presentations at the 2025 ENCALS Annual Meeting ab-science.com ↗ MASITINIB REDUCES SERUM NEUROFILAMENT LIGHT CHAIN (NFL) LEVELS, SUGGESTING THAT IT HAS DISEASE-MODIFYING POTENTIAL
2025-01-29	AB Science	Results Summary of the webcast held on January 28, 2025 ab-science.com ↗ Long term follow-up shows 53% of patients surviving more than 5 years, with a +36 months benefit over ENCALS prediction
2024-10-17	AB Science	Regulatory AB Science provides an update on the application for conditional marketing authorisation of masitinib in ALS ab-science.com ↗ AB Science SA (Euronext - FR0010557264 - AB) today announces that the European Medicines Agency (EMA) confirmed a negative opinion for the conditional marketing authorization of ma sitinib in the treatment of amyotrophic lateral sclerosis (ALS), following a vote adopted during the Com mittee for Medicinal Products for Human Use (CHMP) meeting on 14-17 October 2024 .
2024-07-08	AB Science	Results Positive results of the Phase 2 study evaluating masitinib in Covid-19 ab-science.com ↗ The study showed an odds ratio of 2.4 in favor of the treatment arm after 15 days of treatment, superior to the odds ratio of 2.2 initially hypothesized, with p=0.038 simulated with 200 patients and p=0.072 detected with 95 patients recruited.
2024-06-28	AB Science	Regulatory AB Science provides an update on the application for conditional marketing authorisation of masitinib in ALS ab-science.com ↗ AB Science SA (Euronext - FR0010557264 - AB) today announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted, in line with the trend vote, a negative opinion on the application for conditional marketing authorization of masitinib in the treatment of amyotrophic lateral sclerosis (ALS).
2024-05-31	AB Science	Regulatory Summary of the live webcast held on May 30, 2024, giving an update on the application for conditional marketing authorization of masitinib in ALS ab-science.com ↗
2024-05-30	AB Science	Results AB Science webcast of May 30, 2024 ab-science.com ↗ Impact analysis showed no impact of these deviations, favouring masitinib or modifying study outcome
2024-05-29	AB Science	Regulatory AB Science provides an update on the application for conditional marketing authorisation of masitinib in ALS ab-science.com ↗ adopted a trending toward a n egative opinion on the application for conditional marketing authorisation of masi tinib in the treatment of amyotrophic lateral sclerosis (ALS)
2024-04-03	AB Science	Regulatory AB Science announces that Health Canada has granted eligibility for reconsideration request for masitinib in ALS ab-science.com ↗ AB Science SA (Euronext - FR0010557264 - AB) today announces that Health Canada has granted eligibility for reconsideration request for masitinib in amyotrophic lateral sclerosis (ALS).
2024-03-13	AB Science	Results New research shows that masitinib limits neuronal damage in a model of neuroimmune-driven neurodegenerative disease ab-science.com ↗ AB Science SA (Euronext - FR0010557264 - AB) today announced the publication of new preclinical results for masitinib in neurodegenerative diseases (NDD) .
2024-02-26	AB Science	Regulatory AB Science announces that Health Canada has issued a Notice of Deficiency-Withdrawal (NOD/w) for masitinib in ALS ab-science.com ↗ AB Science SA (Euronext - FR0010557264 - AB) today announces that Health Canada has issued a Notice of Deficiency-Withdrawal (NOD/w) regarding its New Drug Submission (NDS) for masitin ib in the treatment of amyotrophic lateral sclerosis (ALS).
2024-01-26	AB Science	Regulatory AB Science announces an update in the marketing authorization application of masitinib in amyotrophic lateral sclerosis at the European Medicines Agency ab-science.com ↗ This week, before the date planned date of the Oral Explanation, the CHMP has proposed that AB Science addresses these objections in writing instead of the Oral Explanation.
2023-05-09	AB Science	Regulatory AB Science announces that Health Canada has resumed its review of the New Drug Submission for masitinib in amyotrophic lateral sclerosis, following issuance of a screening acceptance letter ab-science.com ↗ This letter is an important step in the procedure and effectively marks the restart date of the application’s review by Health Canada.
2023-04-27	AB Science	Results Summary of the presentation on masitinib in ALS delivered at 2023 AAN Annual Meeting ab-science.com ↗
2023-04-27	AB Science	Results Presentation on masitinib in ALS delivered at 2023 AAN Annual Meeting ab-science.com ↗ Masitinib Shows Prolonged Survival in Amyotrophic Lateral Sclerosis (ALS) Patients with Mild or Moderate Disease Severity at Baseline
2023-04-12	AB Science	Results Results of masitinib in ALS selected for a scientific platform presentation at the AAN 2023, including long-term survival analysis and a new analysis of patient population with no complete loss of function at baseline ab-science.com ↗
2023-04-04	AB Science	Regulatory AB Science announces that it has submitted its response to the day 120 questions in the EMA regulatory review of masitinib in amyotrophic lateral sclerosis and clarifies the new timeline for responding to Health Canada ab-science.com ↗ As part of the ongoing EMA procedure, AB Science has submitted its responses to the Day 120 assessment of the procedure.
2023-02-28	AB Science	Results Publication of the masitinib pivotal phase 3 clinical trial in Alzheimer’s Disease in the journal Alzheimer’s Research & Therapy ab-science.com ↗ AB Science SA (Euronext - FR0010557264 - AB) today announced publication of results from its positive pivotal phase 3 trial (AB09004) of masitinib in mild- to-moderate Alzheimer’s disease (AD) in the renowned international peer-reviewed journal Alzheimer's Research & Therapy [1].
2022-12-29	AB Science	Regulatory AB Science has received approval from the U.S. Food and Drug Administration (FDA) to initiate the confirmatory Phase 3 study with masitinib in the treatment of progressive multiple sclerosis ab-science.com ↗
2022-12-27	AB Science	Regulatory Masitinib receives orphan drug status for the treatment of amyotrophic lateral sclerosis in Switzerland ab-science.com ↗
2022-12-13	AB Science	Regulatory AB Science receives Notice of Deficiency (NOD) from Health Canada for masitinib in the treatment of amyotrophic lateral sclerosis (ALS) ab-science.com ↗ AB Science SA (Euronext - FR0010557264 - AB) today announced that it has received a Notice of Deficiency (“NOD”) for its masitinib New Drug Submission in the treatment of amyotrophic lateral sclerosis.
2022-11-21	AB Science	Regulatory AB Science receives U.S. Food and Drug Administration (FDA) authorization to initiate confirmatory Phase 3 clinical study with masitinib in the treatment of Alzheimer’s Disease ab-science.com ↗ AB Science SA (Euronext - FR0010557264 - AB) today announced that it has received an Investigational New Drug (IND) approval letter from the FDA to initiate Phase III study (AB21004 ) in patients with mild to moderate Alzheimer's disease (AD).
2022-10-10	AB Science	Regulatory AB Science receives first agencies authorizations to initiate confirmatory Phase 3 clinical study with masitinib in the treatment of Alzheimer’s disease ab-science.com ↗ AB SCIENCE RECEIVES FIRST AGENCIES AUTHORIZATIONS TO INITIATE CONFIRMATORY PHASE 3 CLINICAL STUDY WITH MASITINIB IN THE TREATMENT OF ALZHEIMER’S DISEASE
2022-09-14	AB Science	Results Positive recommendation of the Data and Safety Monitoring Board to continue the Phase 2 study evaluating the antiviral activity of masitinib in Covid-19 ab-science.com ↗
2022-08-24	AB Science	Regulatory AB Science announces that it has filed an application for conditional Marketing Authorization to EMA for masitinib in the treatment of ALS ab-science.com ↗ AB Science SA (Euronext - FR0010557264 - AB) today announced that it has filed an application for conditional Marketing Authorization to the European Medicines Agency (EMA) for Alsitek (masitinib) in the treatment of amyotrophic lateral sclerosis (ALS).
2022-06-07	AB Science	Results Publication of results from the positive study of masitinib in severe asthma uncontrolled by oral corticosteroids in Journal of Asthma and Allergy ab-science.com ↗ Results from this phase 3 study showed that corticosteroid-dependent severe asthma patients treated with masitinib at 6.0 mg/kg/d had a lower risk of severe asthma exacerbations compared with those in a placebo- control group that did not receive masitinib.
2022-05-26	AB Science	Regulatory AB Science announces that Health Canada has started the review of New Drug Submission for masitinib in the treatment of ALS ab-science.com ↗ This letter is an important step in the procedure and marks the starting date of the review of the application.
2022-02-28	AB Science	Regulatory Webcast Presentation – Masitinib filing in the treatment of ALS in Canada and update on AB Science clinical program in all indications ab-science.com ↗
2022-02-22	AB Science	Results Publication of the masitinib positive pivotal phase 3 trial in progressive forms of multiple sclerosis in the journal Neurology® Neuroimmunology & Neuroinflammation ab-science.com ↗ More specifically, results showed that masitinib at 4.5 mg/kg/d can benefit patients by slowing EDSS-based di sability worsening, including a statistically significant reduction in the risk of requiring a wheelchair, which is a clinically meaningful outcome for patients .
2022-02-21	AB Science	Regulatory Health Canada has granted authorization to file a New Drug Submission for masitinib in the treatment of ALS under the Notice of Compliance with Conditions (NOC/c) policy ab-science.com ↗ AB Science SA (Euronext - FR0010557264 - AB) today announces that Health Canada has granted authorization to file a New Drug Submission for masitinib in the treatment of amyotrophic lateral sclerosis (ALS) under the Notice of Compliance with Conditions (NOC/c) policy.
2022-02-02	AB Science	Regulatory AB Science granted authorization to initiate confirmatory Phase III trial of masitinib in progressive forms of multiple sclerosis by the Swedish Medical Products Agency ab-science.com ↗ AB Science SA (Euronext - FR0010557264 - AB) today announces that it has been authorized by the Swedish Medical Products Agency, to initiate a Phase III study (AB20009) evaluating masitinib in patients with Primary Progressive Multiple Sclerosis (PPMS) or non-active Secondary Progressive Multiple Sclerosis (nSPMS).
2022-01-19	AB Science	Regulatory AB Science granted authorization to initiate Phase II study in patients with severe mast cell activation syndrome by the French Health Authority (ANSM) ab-science.com ↗ AB SCIENCE HAS BEEN GRANTED AUTHORIZATION TO INITIATE PHASE II STUDY IN PATIENTS WITH SEVERE MAST CELL ACTIVATION SYNDROME BY THE FRENCH HEALTH AUTHORITY (ANSM)
2022-01-03	AB Science	Regulatory AB Science granted authorization to initiate confirmatory Phase III trial of masitinib in progressive forms of multiple sclerosis by the French Health Authority (ANSM) ab-science.com ↗ AB SCIENCE HAS BEEN GRANTED AUTHORIZATION TO INITIATE CONFIRMATORY PHASE III TRIAL OF MASITINIB IN PROGRESSIVE FORMS OF MULTIPLE SCLEROSIS BY THE FRENCH HEALTH AUTHORITY (ANSM)
2021-11-18	AB Science	Regulatory AB Science received authorization from the FDA to resume patient enrollment in the confirmatory Phase 3 study of masitinib (AB19001) in patients with ALS ab-science.com ↗
2021-10-04	AB Science	Regulatory AB Science receives FDA authorization to start clinical development program of masitinib in mast cell activation syndrome (MCAS) ab-science.com ↗
2021-09-28	AB Science	Regulatory AB Science receives regulatory authorization to commence a second Phase 2 Covid-19 study ab-science.com ↗ AB Science SA (Euronext - FR0010557264 - AB) today announced that a new clinical trial with masitinib in patients with symptomatic mild and moderate COVID- 19 has been approved by the Regulatory Authorities of Russia and South Africa .
2021-09-20	AB Science	Results Abstract on the long-term survival of masitinib in ALS has been selected for a platform presentation at the Annual Meeting of the Spanish Society of Neurology ab-science.com ↗
2021-09-16	AB Science	Regulatory Authorization to resume patient enrollment in the phase 2 masitinib study of COVID-19 ab-science.com ↗ AB Science SA (Euronext - FR0010557264 - AB) announced today that it has received authorization from the Russian Health Ministry (MoH) to resume patient enrollment in the phase 2 masitinib study of COVID-19 (AB20001).
2021-09-14	AB Science	Regulatory New authorizations to resume patient enrollment in Phase 3 studies of masitinib ab-science.com ↗ AB SCIENCE ANNOUNCES THAT IT HAS RECEIVED NEW AUTHORIZATIONS TO RESUME PATIENT ENROLLMENT IN ITS PHASE 3 STUDIES OF MASITINIB, CONFIRMING A GLOBAL RESUMPTION OF THESE STUDIES
2021-09-13	AB Science	Results Results from masitinib study AB12003 in prostate cancer have been presented at the 2021 American Urological Association ab-science.com ↗ Results from study AB12003 indicate that the combination of masitinib plus docetaxel may provide a new first-line treatment option for mCRPC patients with low metastatic involvement.
2021-09-02	AB Science	Results Latest clinical data on long-term survival analyses in ALS will be presented at the 2021 symposium on ALS/MND ab-science.com ↗ Long-term follow-up of masitinib study AB10015 shows prolonged survival in patients that start treatment prior to severe impairment of functionality.
2021-08-25	AB Science	Regulatory Second authorization to resume patient enrollment, in the Phase 3 study of masitinib in mastocytosis ab-science.com ↗ AB Science SA (Euronext - FR0010557264 - AB) announced today that it has received authorization from the French National Agency (ANSM) to resume patient enrollment in the confirmatory Phase 3 study of masitinib (AB15003) in mastocytosis.
2021-08-23	AB Science	Regulatory First authorization to resume patient enrollment in the Phase 3 study of masitinib in ALS ab-science.com ↗ AB Science SA (Euronext - FR0010557264 - AB) today announced that it has received the fi rst authorization to resume patient enrollment in the confirmatory Phase 3 study of masitinib (AB19001) in amyotrophic lateral sclerosis (ALS).
2021-08-19	AB Science	Results Publication of a pathogenic mechanism triggered by mast cells in the ALS spinal cord that can be targeted by masitinib ab-science.com ↗
2021-07-29	AB Science	Results Results from Phase 3 AB09004 study on Alzheimer’s disease have been presented at the annual Alzheimer’s Association International Conference (AAIC) ab-science.com ↗ Masitinib administered at 4.5 mg/kg/day, significantly slowed cognitive deter ioration relative to placebo and also showed reduced loss of functional ability in activ ities of daily living .
2021-07-20	AB Science	Results Publication in the world-renowned journal Science confirms potential of masitinib as a treatment of Covid-19 with anti-viral activity against SARS-CoV-2 and all tested variants of concern ab-science.com ↗
2021-07-19	AB Science	Results Publication of new survival data showing that masitinib extended survival in ALS by 25 months relative to placebo ab-science.com ↗ LONG-TERM FOLLOW-UP OF 75 MONTHS SHOWED THAT MASITINIB EXTENDED SURVIVAL IN AMYOTROPHIC LATERAL SCLEROSIS BY 25 MONTHS RELATIVE TO PLACEBO, PROVIDED THAT TREATMENT STARTS EARLY IN DISEASE COURSE.
2021-07-12	AB Science	Regulatory Validation of the Risk Management Plan by the French National Agency (ANSM) in order to restart patient enrollment in France ab-science.com ↗ AB SCIENCE ANNOUNCES THE VALIDATION OF ITS RISK MANAGEMENT PLAN BY THE FRENCH NATIONAL AGENCY (ANSM) IN ORDER TO RESTART PATIENT ENROLLMENT IN FRANCE
2021-06-10	AB Science	Results Results from masitinib study AB12005 in pancreatic cancer have been presented at the 2021 ASCO Annual Meeting ab-science.com ↗ RESULTS FROM MASITINIB STUDY AB12005 IN PANCREATIC CANCER PRESENTED AT THE ASCO ANNUAL MEETING WITH THE FULL ABSTRACT PUBLISHED IN THE JOURNAL OF CLINICAL ONCOLOGY
2021-06-01	AB Science	Regulatory AB Science announces a voluntary hold in the clinical studies of masitinib ab-science.com ↗ AB SCIENCE ANNOUNCES A VOLUNTARY HOLD IN THE CLINICAL STUDIES OF MASITINIB WORLDWIDE
2021-05-26	AB Science	Results Results from Phase 3 study evaluating masitinib in prostate cancer ab-science.com ↗ AB Science SA (Euronext – FR0010557264 – AB) communicate d the results from phase 3 study evaluating masitinib in prostate cancer during the webcast that was held on May 25, 2021.
2021-04-29	AB Science	Results Masitinib Phase 2B/3 study in prostate cancer met its primary endpoint ab-science.com ↗ AB Science SA (Euronext - FR0010557264 - AB) today announced that its masitinib Phase 2B/ 3 study (AB12003) in metastatic castrate-resistant prostate cancer (mCRPC) eligible to chemotherapy met its predefined primary endpoint.
2021-02-23	AB Science	Results A new independent publication confirms the role of masitinib as a potential therapy in pancreatic cancer ab-science.com ↗ The density of mast cells positive for tryptase (MCDPT) and area of mast cells positive for tryptase (MCAPT) are tissue biomarkers that could be predictive of response to masitinib (anti‐c‐Kit therapy).
2021-01-25	AB Science	Results A new independent publication confirms that masitinib has anti-viral activity against the SARS-CoV-2 virus in vitro ab-science.com ↗ AB Science SA (NYSE Euronext - FR0010557264 - AB) today announced the publication o f preclinical study results with masitinib in COVID-19.
2020-12-18	AB Science	Results Results from phase 2B/3 study evaluating masitinib in Alzheimer’s disease ab-science.com ↗ AB Science SA (NYSE Euronext – FR0010557264 – AB) today communicates the results from phase 2B/3 study evaluating masitinib in Alzheimer’s disease, together with details on the m ode of action of masitinib in Alzheimer’s disease.
2020-12-17	AB Science	Results Masitinib in Alzheimer’s Disease Webcast Presentation ab-science.com ↗ Positive effect detected on Daily activity
2020-12-17	AB Science	Results Corrective press release regarding adverse events information from study AB09004 ab-science.com ↗ AB Science SA (Euronext - FR0010557264 - AB) today announced that the press release issued on December 16, 2020 regarding the results from study AB09004, which evaluated masitinib in the treatment of Alzheimer disease, contained a material error in the adverse events information reported.
2020-12-16	AB Science	Results Positive Phase 2/3 study AB09004 with masitinib in Alzheimer’s Disease ab-science.com ↗ AB Science SA (Euronext - FR0010557264 - AB) today announced that the Phase 2B/3 study (AB09 004 - NCT01872598) evaluating oral masitinib in patients with mild and moderate Alzheimer’s di sease met its predefined primary endpoint.
2020-12-16	AB Science	Results Live webcast on Thursday December 17, 2020 on masitinib’s results in Alzheimer’s Disease ab-science.com ↗ On December 16 th, AB Science announced that its Phase 2B/3 trial with oral masitinib met its predefined primary endpoint.
2020-12-04	AB Science	Results Positive confirmatory Phase 3 study AB12005 with masitinib in first line pancreatic cancer with pain ab-science.com ↗ In the population with unresectable locally advanced tumors with pain, the masitinib treatment-arm showed a significant improvement in overall survival (OS) relative to the control arm.
2020-10-20	AB Science	Results Positive top-line Phase 3 results for oral masitinib in severe asthma ab-science.com ↗ 20/10/2020 – AB Science announces positive top-line Phase 3 results for oral masitinib in severe asthma
2020-09-14	AB Science	Results AB Science Presents Phase 2B/3 Study Results in Progressive Multiple Sclerosis at the World’s Largest Multiple Sclerosis Research Conference ab-science.com ↗ 14/09/2020 – AB Science presents Phase 2B/3 study results in Progressive Multiple Sclerosis at the world’s largest Multiple Sclerosis research conference
2020-09-02	AB Science	Results New independent research reveals that masitinib has direct anti-viral activity against the SARS-CoV-2 virus in vitro ab-science.com ↗ New independent research reveals that masitinib has direct anti-viral activity against the SARS-CoV-2 virus in-vitro and is a promising candidate for treating COVID-19
2020-07-08	AB Science	Results New results published in Journal of Alzheimer’s Disease support masitinib’s potential mode of action in Alzheimer’s Disease ab-science.com ↗ AB Science announces that new results published in the peer-reviewed Journal of Alzheimer’s Disease support masitinib’s potential mode of action in Alzheimer’s Disease
2020-05-06	AB Science	Regulatory Authorization by ANSM to initiate Phase 2 study evaluating masitinib in combination with isoquercetin for the treatment of COVID-19 ab-science.com ↗ 06/05/2020 – AB Science granted authorization by ANSM to initiate Phase 2 study evaluating masitinib in combination with isoquercetin for the treatment of COVID-19
2020-03-31	AB Science	Regulatory FDA clears masitinib IND in Amyotrophic Lateral Sclerosis, allowing U.S. patient enrollment to commence in Phase 3 study ab-science.com ↗ AB Science SA (NYSE Euronext - FR0010557264 - AB) today announces that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) ap plication, allowing the Company to initiate its masitinib Phase 3 study (AB19001) in amyotrophic lateral sclerosis (ALS).
2020-02-20	AB Science	Results Positive top-line Phase 2B/3 results for masitinib in progressive forms of MS ab-science.com ↗ AB Science announces positive top-line Phase 2B/3 results for oral masitinib in progressive forms of multiple sclerosis
2020-01-08	AB Science	Regulatory FDA green-lights U.S. patient enrollment in masitinib phase 3 study in metastatic castrate-resistant prostate cancer ab-science.com ↗ FDA green-lights U.S. patient enrollment in masitinib phase 3 study following IND clearance in metastatic castrate-resistant prostate cancer eligible to chemotherapy
2019-12-23	AB Science	Results Publication of new results in in the peer-reviewed journal Glia that further support masitinib’s potential mode of action in ALS ab-science.com ↗ 23/12/2019 – AB Science announces publication of new results in the peer-reviewed journal Glia that further support masitinib’s potential mode of action in ALS
2019-11-07	AB Science	Results Positive top-line Phase 3 results for masitinib in severe asthma ab-science.com ↗ 07/11/2019 – AB Science announces positive top-line phase 3 results for oral masitinib in severe asthma
2019-10-24	AB Science	Regulatory Authorization to initiate phase 3 confirmatory study in mastocytosis ab-science.com ↗ AB Science granted authorization to initiate phase 3 confirmatory study of masitinib in indolent systemic mastocytosis
2019-08-02	AB Science	Results Results of masitinib study in metastatic melanoma ab-science.com ↗ 02/08/2019 – AB Science reports the analysis for its phase 3 trial evaluating masitinib in patients with non-resectable or metastatic stage 3 or stage 4 melanoma.
2019-07-08	AB Science	Results Publication of the positive phase 2/3 clinical trial with masitinib in ALS in the journal ALSFD ab-science.com ↗ AB Science announces the publication of the positive phase 2/3 clinical trial with masitinib in ALS in the journal Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration.
2019-06-26	AB Science	Results Results of interim analysis for masitinib in Alzheimer’s Disease ab-science.com ↗ 26/06/2019 – AB Science reports the outcome from the interim analysis of study AB09004 in Alzheimer’s Disease
2019-06-12	AB Science	Results Positive IDMC recommendation following interim analysis in pancreatic cancer ab-science.com ↗ 12/06/2019 – AB Science announces the positive recommendation of IDMC following the interim analysis of AB12005 study in the first-line treatment of pancreatic cancer
2019-05-28	AB Science	Regulatory Lifting of the ANSM clinical hold ab-science.com ↗ 28/05/2019 – AB Science announces the lifting of the ANSM clinical hold.

All press releases naming this drug 126 releases

Date	Issuer	Release
Show all 126 releases opens the full record — a long page

Evidence & citations 14 cited values

Every value below carries the sentence it was read from. 41 sources stand behind the page.

Field	Value	Cited text
Known as	Masitinib	“There was no control group and no blinding as the objective was to assess the mass balance of masitinib after a single oral intake.” NCT05200169 ↗ 35 NCT01045577 ↗ NCT01872598 ↗ NCT03771040 ↗ NCT01470131 ↗ NCT01506336 ↗ NCT00831922 ↗ NCT00913432 ↗ NCT00812240 ↗ NCT01433497 ↗ NCT00998751 ↗ Show 25 more sources
Known as	AB1010	“This study evaluates the safety and efficacy of masitinib (AB1010), a potent and selective protein tyrosine kinase inhibitor of c-KIT, in the monotherapy treatment of...” PMID 19549290 ↗ Jun 2009 7 “The objective of this study is to compare the safety and efficacy of masitinib (AB1010) to placebo in patients with mastocytosis with handicap.” NCT00814073 ↗ “masitinib (AB1010) 3 or 6 mg/kg/day” NCT00976118 ↗ “masitinib (AB1010) 6 mg/kg/day” NCT00831974 ↗ “masitinib (AB1010)” NCT00866138 ↗ “Masitinib (AB1010)” NCT02605044 ↗ “Masitinib (AB1010)” NCT01045577 ↗ NCT00842270 ↗
Known as	Kinavet	ChEMBL registry synonym — accepted as the source's own label CHEMBL1908391 ↗
Known as	Masican	ChEMBL registry synonym — accepted as the source's own label CHEMBL1908391 ↗
Known as	Masitinib mesilate	ChEMBL registry synonym — accepted as the source's own label CHEMBL1908391 ↗
Known as	Masitinib Mesylate	ClinicalTrials.gov intervention name — accepted as the source's own label NCT05047783 ↗
Known as	Masitinib methanesulfonate	ChEMBL registry synonym — accepted as the source's own label CHEMBL1908391 ↗
Known as	Masivet	ChEMBL registry synonym — accepted as the source's own label CHEMBL1908391 ↗
Known as	Masiviera	ChEMBL registry synonym — accepted as the source's own label CHEMBL1908391 ↗
Action	Inhibit	“Masitinib is a TK inhibitor, selectively and effectively inhibiting c-Kit (mast cell growth factor receptor), PDGF receptor, FGF receptor and to a lower extent the FAK kinases.” NCT00789633 ↗ 1 “Fibroblast growth factor receptor 3 inhibitor” CHEMBL1908391 ↗
Modality	Small molecule	“Masitinib, a selective oral tyrosine kinase inhibitor” PMID 21504563 ↗ Apr 2011
Route	Oral	“Masitinib at 9 mg/kg/day given orally twice daily” NCT00789633 ↗
Target	FGFR3	“Fibroblast growth factor receptor 3 inhibitor” CHEMBL1908391 ↗
Target	KIT	“Masitinib is a selective tyrosine kinase inhibitor with potent activity against wild-type c-Kit” NCT00812240 ↗