Drugs / Fostamatinib
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Tavlesse | — | 2020-01-09 | europa.eu ↗ |
| Approved | US (FDA) | TAVALISSE | — | 2018-04-17 | fda.gov ↗ |
Trials 55 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 119 trials | ||||||
| Phase 1 | NCT06948097 | Jul 2026 → Jul 2028 expected | — | National Heart, Lung, and Blood Institute (NHLBI) | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06233110 | Oct 2025 → Jan 2029 expected | chronic graft versus host disease | Stefanie Sarantopoulos, MD, PhD. | Recruiting | No outcome recorded |
| Phase 1 | NCT05904093 | Dec 2024 → May 2027 expected | beta thalassemia, sickle cell disease | National Heart, Lung, and Blood Institute (NHLBI) | Recruiting | No outcome recorded |
| Phase 1 | NCT06639724 | Dec 2024 → Dec 2027 expected | pancreatic ductal adenocarcinoma | University of California, San Diego | Recruiting | No outcome recorded |
| Phase 1 | NCT05030675 | Aug 2021 → Aug 2024 | chronic myelomonocytic leukemia, myelodysplastic syndrome | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT03246074 | Apr 2018 → Aug 2022 | ovarian cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 1 | NCT02611063 | Jan 2016 → Feb 2021 | hematopoietic and lymphoid cell neoplasm | Stefanie Sarantopoulos, MD, PhD. | Completed | No outcome recorded |
| Phase 1 | NCT01608542 | Jun → Aug 2012 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01598571 | May → Aug 2012 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01387308 | Aug → Oct 2011 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01355354 | Jun → Sep 2011 | rheumatoid arthritis | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01336218 | Apr → Jul 2011 | rheumatoid arthritis | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01276262 | Mar → Nov 2011 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01311622 | Mar → May 2011 | rheumatoid arthritis | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01309854 | Mar → May 2011 | rheumatoid arthritis | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01245790 | Nov 2010 → Jun 2011 | impaired renal function disease, rheumatoid arthritis | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01222455 | Oct 2010 → Jun 2011 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01208155 | Sep → Nov 2010 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01167868 | Jul 2010 → May 2011 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT03991780 | May 2019 → Apr 2023 overdue | transplant rejection | Imperial College London | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT00446095 | Apr 2007 → Apr 2010 | lymphoma | Rigel Pharmaceuticals | Completed | No outcome recorded |
| Phase 221 trials | ||||||
| Phase 2 | NCT06564207 | Aug 2026 → May 2027 expected | adult acute respiratory distress syndrome | Inova Health Care Services | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05509582 | Nov 2025 | autoimmune hemolytic anemia, chronic graft versus host disease, thrombocytopenia due to immune destruction | National Heart, Lung, and Blood Institute (NHLBI) | Withdrawn | No outcome recorded |
| Phase 2 | NCT05502783 | Mar → Jun 2023 | autoimmune hemolytic anemia, chronic graft versus host disease, thrombocytopenia due to immune destruction | National Heart, Lung, and Blood Institute (NHLBI) | Terminated | No outcome recorded |
| Phase 2 | NCT05040698 | Oct 2021 → Jan 2023 | hidradenitis suppurativa | Holdsworth House Medical Practice | Completed | No outcome recorded |
| Phase 2 | NCT04543279 | May 2021 → Jul 2022 | myelofibrosis, thrombocytopenia | Washington University School of Medicine | Terminated | No outcome recorded |
| Phase 2 | NCT02612558 | Jul 2016 → Dec 2019 | autoimmune hemolytic anemia, warm type | Rigel Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02433236 | Sep 2015 | IgA glomerulonephritis | Rigel Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 2 | NCT01640054 | Jul 2012 → Jul 2013 | rheumatoid arthritis | AstraZeneca | Terminated | No outcome recorded |
| Phase 2 | NCT01569074 | Apr 2012 → Jul 2013 | rheumatoid arthritis | AstraZeneca | Terminated | No outcome recorded |
| Phase 2 | NCT01563978 | Apr 2012 → Jan 2013 | rheumatoid arthritis | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT01499303 | Dec 2011 → Oct 2013 | diffuse large B-cell lymphoma | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT02092961 | Feb 2011 → Jul 2013 | rheumatoid arthritis | AstraZeneca | Terminated | No outcome recorded |
| Phase 2 | NCT01264770 | Jan 2011 → Oct 2012 | rheumatoid arthritis | AstraZeneca | Terminated | No outcome recorded |
| Phase 2 | NCT00923481 | Apr 2009 | colorectal cancer, head and neck neoplasm, non-small cell lung carcinoma, pheochromocytoma +1 | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT00798096 | Mar 2009 → Apr 2010 | T-cell non-Hodgkin lymphoma | Rigel Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00752999 | Nov 2008 → Nov 2009 | systemic lupus erythematosus | Rigel Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 2 | NCT00805467 | Aug 2008 → Aug 2013 | rheumatoid arthritis | AstraZeneca | Terminated | No outcome recorded |
| Phase 2 | NCT00665626 | May 2008 → Jun 2009 | rheumatoid arthritis | Rigel Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00665925 | May 2008 → Jun 2009 | rheumatoid arthritis | Rigel Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00706342 | Jan 2007 → Apr 2010 | autoimmune thrombocytopenic purpura | Rigel Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00326339 | Aug 2006 → Oct 2007 | rheumatoid arthritis | Rigel Pharmaceuticals | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT05593770 | Oct 2022 → Dec 2023 | COVID-19 | NEAT ID Foundation | Terminated | No outcome recorded |
| Phase 2/3 | NCT04924660 | Jul 2021 → Oct 2023 | COVID-19 | Sean Collins | Completed | No outcome recorded |
| Phase 310 trials | ||||||
| Phase 3 | NCT04132050 | Dec 2019 → Dec 2021 | thrombocytopenic purpura | Kissei Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT04138927 | Oct 2019 → Apr 2024 overdue | autoimmune hemolytic anemia, warm type | Rigel Pharmaceuticals | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT03764618 | Apr 2019 → Apr 2022 | autoimmune hemolytic anemia, warm type | Rigel Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02076412 | Jan 2015 → Aug 2016 | autoimmune thrombocytopenic purpura | Rigel Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02077192 | Oct 2014 → Jun 2020 | autoimmune thrombocytopenic purpura | Rigel Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02076399 | Jul 2014 → Apr 2016 | autoimmune thrombocytopenic purpura | Rigel Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01242514 | Jan 2011 → Jan 2015 | rheumatoid arthritis | AstraZeneca | Terminated | No outcome recorded |
| Phase 3 | NCT01197534 | Sep 2010 → Mar 2013 | rheumatoid arthritis | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT01197521 | Sep 2010 → Nov 2012 | rheumatoid arthritis | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT01197755 | Sep 2010 → Feb 2013 | rheumatoid arthritis | AstraZeneca | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT03363334 | — | autoimmune thrombocytopenic purpura | Rigel Pharmaceuticals | No longer available | No outcome recorded |
Also used as a comparator or background therapy in 6 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT01725230 Background | Nov 2012 → Jan 2013 | rheumatoid arthritis | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01682408 Comparator | Sep → Dec 2012 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04581954 Comparator | Oct 2020 → Nov 2022 | COVID-19, pneumonia | Imperial College London | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT04579393 Comparator | Oct 2020 → Mar 2021 | COVID-19 | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 2 | NCT02112838 Comparator | Oct 2014 → Mar 2018 | IgA glomerulonephritis | Rigel Pharmaceuticals | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT04629703 Comparator | Mar 2021 → Sep 2022 | COVID-19, severe acute respiratory syndrome, viral pneumonia | Rigel Pharmaceuticals | Completed | No outcome recorded |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 64 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fostamatinib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04581954 ↗56 |
| Known as | FOS | “To determine the safety and efficacy of ruxolitinib (RUX) and fostamatinib (FOS) compared with standard of care (SOC) in patients requiring hospital admission for the treatment...” PMID 41644167 ↗ Feb 2026 |
| Known as | FosD | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01167868 ↗ |
| Known as | Fostamatinib disodium | “(OSKIRA-1): A Phase III, Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid...” NCT01197521 ↗9“A Study to Assess the Safety, Tolerability, and Blood and Urine Drug Levels of Fostamatinib Disodium (FosD) in Healthy Japanese and White Subjects” NCT01167868 ↗ “Inhibition of Syk with fostamatinib disodium has significant clinical activity in non-Hodgkin lymphoma and chronic lymphocytic leukemia.” PMID 19965662 ↗ Nov 2009 “Fostamatinib Disodium tablet 100 mg or 150 mg PO bid (morning and evening) over the course of 24 weeks.” NCT02076412 ↗ “Drug: Fostamatinib Disodium (R935788)” NCT00805467 ↗ “Fostamatinib disodium (R935788)” NCT00665925 ↗ “Fostamatinib disodium (R935788)” NCT00665626 ↗ “Fostamatinib Disodium / R935788” NCT00706342 ↗ “Fostamatinib Disodium (R935788)” NCT00752999 ↗ |
| Known as | R788 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04132050 ↗ |
| Known as | R935788 | “R935788 (fostamatanib disodium) is a kinase inhibitor” NCT00923481 ↗3“Fostamatinib Disodium (R935788)” NCT00752999 ↗ “Fostamatinib Disodium / R935788” NCT00706342 ↗ “Fostamatinib disodium (R935788)” NCT00665626 ↗ |
| Action | Inhibit | “Spleen Tyrosine Kinase (Syk) Inhibitor” NCT00665626 ↗ |
| Modality | Small molecule | “a small molecule inhibitor of Syk” PMID 29669391 ↗ Jul 2018 |
| Route | Oral | “R788 50 mg PO bid” NCT00326339 ↗ |
| Target | SYK | “a small molecule inhibitor of Syk” PMID 29669391 ↗ Jul 2018 |