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Masitinib (4.5)
Masitinib (4.5) is a Tyrosine kinase inhibitor Small molecule drug developed by AB Science. It is currently in Phase 3 development for Gastrointestinal stromal tumor (GIST), Amyotrophic lateral sclerosis (ALS), Pancreatic cancer. Also known as: AB1010.
Masitinib is a tyrosine kinase inhibitor that selectively targets c-KIT, PDGFR, and Lyn kinases to modulate immune cell function and reduce pathological inflammation.
Masitinib is a small molecule inhibitor of the fibroblast growth factor receptor 3. It is being studied in clinical trials for conditions such as Alzheimer's disease, amyotrophic lateral sclerosis (ALS), and mast cell activation syndrome.
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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 (4.5) |
|---|---|
| Also known as | AB1010 |
| Sponsor | AB Science |
| Drug class | Tyrosine kinase inhibitor |
| Target | c-KIT, PDGFR, Lyn |
| Modality | Small molecule |
| Therapeutic area | Oncology, Immunology, Neurology |
| Phase | Phase 3 |
Mechanism of action
Masitinib inhibits multiple tyrosine kinases involved in mast cell and immune cell activation, particularly c-KIT and PDGFR. By blocking these kinases, it reduces mast cell degranulation and inflammatory mediator release, thereby modulating immune responses in conditions characterized by excessive mast cell activation or pathological inflammation.
Approved indications
- Gastrointestinal stromal tumor (GIST)
- Amyotrophic lateral sclerosis (ALS)
- Pancreatic cancer
- Mastocytosis
Common side effects
- Nausea
- Diarrhea
- Rash
- Edema
- Abdominal pain
Key clinical trials
- Masitinib in Patients With Mild Alzheimer's Disease (PHASE3)
- Efficacy and Safety of Masitinib in Combination With SoC Versus Placebo in the Treatment of ALS Patients (PHASE3)
- Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients (PHASE3)
- Masitinib in the Treatment of Patients With Primary Progressive or Non-active Secondary Progressive Multiple Sclerosis (PHASE3)
- Masitinib in Combination With Riluzole for the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS) (PHASE2, PHASE3)
- Masitinib in Patients With Mild to Moderate Alzheimer's Disease (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)
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 (4.5) CI brief — competitive landscape report
- Masitinib (4.5) updates RSS · CI watch RSS
- AB Science portfolio CI
Frequently asked questions about Masitinib (4.5)
What is Masitinib (4.5)?
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Is Masitinib (4.5) also known as anything else?
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Related
- Drug class: All Tyrosine kinase inhibitor drugs
- Target: All drugs targeting c-KIT, PDGFR, Lyn
- Manufacturer: AB Science — full pipeline
- Therapeutic area: All drugs in Oncology, Immunology, Neurology
- Indication: Drugs for Gastrointestinal stromal tumor (GIST)
- Indication: Drugs for Amyotrophic lateral sclerosis (ALS)
- Indication: Drugs for Pancreatic cancer
- Also known as: AB1010
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing