Drugs / Masitinib
Masitinib
also known as
AB1010 · Kinavet · Masican · Masitinib mesilate · Masitinib Mesylate · Masitinib methanesulfonate · Masivet · Masiviera
Small molecule targets FGFR3, FYN, KIT, LYN via inhibition
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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 · a red edge is where a trial was stopped
| 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 | ||||||
| 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 | No outcome recorded |
| Phase 2 | NCT00842270 | Jan 2006 → Jul 2007 | asthma | AB Science | Completed | No outcome recorded |
| Phase 2 | NCT00998751 | Jun 2005 → Jun 2013 | gastrointestinal stromal tumor | AB Science | Completed | No outcome recorded |
| Phase 2 | NCT01450488 | Jun 2005 → Jul 2007 | multiple sclerosis | 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 | No outcome recorded |
| 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 |
| Phase 319 trials | ||||||
| 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 |
| Phase 3 | NCT03761225 | Sep 2014 → Dec 2020 | castration-resistant prostate carcinoma | AB Science | Completed | No outcome recorded |
| Phase 3 | NCT03766295 | Jul 2014 → Dec 2020 | — | AB Science | Completed | No outcome recorded |
| Phase 3 | NCT02605044 | Jan 2014 → Dec 2017 | colorectal cancer | AB Science | Terminated | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT01470131 | May 2011 → Jan 2017 | plasma cell myeloma | AB Science | Terminated | No outcome recorded |
| Phase 3 | NCT01280565 | Jan 2011 → Aug 2019 | metastatic melanoma | AB Science | Terminated | No outcome recorded |
| Phase 3 | NCT01449162 | Jan 2011 → Nov 2019 | asthma | AB Science | Completed | No outcome recorded |
| Phase 3 | NCT00812240 | Jan 2009 → Jul 2018 | gastrointestinal stromal tumor | AB Science | Terminated | No outcome recorded |
| Phase 3 | NCT00814073 | Dec 2008 → Nov 2015 | indolent systemic mastocytosis | AB Science | Completed | No outcome recorded |
| Phase 3 | NCT00789633 | Nov 2008 → Dec 2011 | malignant pancreatic neoplasm | AB Science | Completed | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT01045577 Comparator | Sep 2005 → Jan 2006 | psoriasis | AB Science | Completed | No outcome recorded |
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 |
| 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 20097“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)” NCT01045577 ↗ “Masitinib (AB1010)” NCT02605044 ↗ “masitinib (AB1010)” NCT00866138 ↗ |
| 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 ↗ |