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Masitinib (6.0)
Masitinib (6.0) is a Tyrosine kinase inhibitor Small molecule drug developed by AB Science. It is currently in Phase 3 development for Amyotrophic lateral sclerosis (ALS), Pancreatic cancer, Mastocytosis. Also known as: AB1010.
Masitinib is a tyrosine kinase inhibitor that selectively targets c-Kit, PDGF receptor, and Lyn kinase to modulate immune cell activation and reduce inflammatory responses.
Masitinib is a medication being studied for the treatment of Mast Cell Activation Syndrome, Covid-19, SARS-CoV-2 Infection, Coronavirus Disease 2019, and Indolent Systemic Mastocytosis. It is administered at a dose of 4.5 mg/kg/day in clinical trials, and is being developed by AB Science.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Masitinib (6.0) |
|---|---|
| Also known as | AB1010 |
| Sponsor | AB Science |
| Drug class | Tyrosine kinase inhibitor |
| Target | c-Kit, PDGF receptor, Lyn kinase |
| Modality | Small molecule |
| Therapeutic area | Neurology, Immunology, Oncology |
| Phase | Phase 3 |
Mechanism of action
Masitinib inhibits multiple tyrosine kinases involved in mast cell and immune cell signaling, particularly c-Kit and PDGF receptors. By blocking these pathways, it reduces mast cell degranulation and inflammatory mediator release, thereby modulating immune responses in inflammatory and neurodegenerative conditions. This mechanism allows it to address both the immune component and neuroinflammation in diseases like amyotrophic lateral sclerosis and other inflammatory disorders.
Approved indications
- Amyotrophic lateral sclerosis (ALS)
- Pancreatic cancer
- Mastocytosis
- Severe asthma
Common side effects
- Gastrointestinal disorders (nausea, diarrhea, abdominal pain)
- Rash
- Edema
- Elevated liver enzymes
- Headache
Key clinical trials
- Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients (PHASE3)
- Masitinib in Severe Indolent or Smoldering Systemic Mastocytosis Unresponsive to Optimal Symptomatic Treatment (PHASE3)
- Masitinib in Patients With Symptomatic Mild to Moderate COVID-19 (PHASE2)
- Masitinib for the Treatment of Severe Mast Cell Activation Syndrome (PHASE2)
- Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST) (PHASE3)
- Masitinib in the Treatment of Patients With Severe Uncontrolled Asthma and Elevated Eosinophil Levels (PHASE3)
- Masitinib in Refractory Active Rheumatoid Arthritis (PHASE2, PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Masitinib (6.0) CI brief — competitive landscape report
- Masitinib (6.0) updates RSS · CI watch RSS
- AB Science portfolio CI
Frequently asked questions about Masitinib (6.0)
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Related
- Drug class: All Tyrosine kinase inhibitor drugs
- Target: All drugs targeting c-Kit, PDGF receptor, Lyn kinase
- Manufacturer: AB Science — full pipeline
- Therapeutic area: All drugs in Neurology, Immunology, Oncology
- Indication: Drugs for Amyotrophic lateral sclerosis (ALS)
- Indication: Drugs for Pancreatic cancer
- Indication: Drugs for Mastocytosis
- Also known as: AB1010
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing