Drugs / Fostamatinib
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed primary thrombocytopenia 4 milestones | |||||
| Filed | Japan (PMDA) | — | primary thrombocytopenia | 2022-04-27 | “an NDA was submitted to Japan's Pharmaceuticals and Medical Devices Agency for fostamatinib in chronic ITP.” rigel.com ↗ “慢性特発性血小板減少性紫斑病（以下、慢性ITP）を適応症として、日本国内における製造販売承認申請を行いました” kissei.co.jp ↗ |
| Filed | EU (EMA) | — | primary thrombocytopenia | 2018-10-04 | “the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for fostamatinib in adult chronic immune thrombocytopenia.” rigel.com ↗ “On October 4, 2018, the EMA validated the marketing authorization application for fostamatinib in adult chronic ITP, which was submitted by Rigel.” rigel.com ↗ |
| Filed | US (FDA) | TAVALISSE | primary thrombocytopenia | 2017-06-19 | “FDA has filed its New Drug Application (NDA) for the use of TAVALISSE™ (fostamatinib disodium) in patients with chronic or persistent immune thrombocytopenia (ITP)” rigel.com ↗ |
| Filed | US (FDA) | — | primary thrombocytopenia | 2017-04-17 | “has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for fostamatinib in patients with chronic and persistent immune thrombocytopenia (ITP)” rigel.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Tavlesse | — | 2020-01-09 | europa.eu ↗ |
| Approved | US (FDA) | TAVALISSE | — | 2018-04-17 | fda.gov ↗ |
Trials 55
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 119 trials | ||||||
| Phase 1 | NCT06948097 | Oct 2026 → Jul 2028 expected | — | National Heart, Lung, and Blood Institute (NHLBI) | 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 | 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 | 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 | NCT01276262 | Mar → Nov 2011 | — | 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 · 3 met primary · 1 missed | ||||||
| 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 Stop: Enrollment |
| 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 Stop: Enrollment |
| 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 Stop: Enrollment |
| Phase 2 | NCT01640054 | Jul 2012 → Jul 2013 | rheumatoid arthritis | AstraZeneca | Terminated | No outcome recorded |
| Phase 2 | NCT01563978 | Apr 2012 → Jan 2013 | rheumatoid arthritis | AstraZeneca | Completed | Met primary |
| Phase 2 | NCT01569074 | Apr 2012 → Jul 2013 | rheumatoid arthritis | AstraZeneca | Terminated | Missed primary |
| 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 | Met primary |
| Phase 2 | NCT01264770 | Jan 2011 → Oct 2012 | rheumatoid arthritis | AstraZeneca | Terminated | Mixed |
| 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 Stop: Business |
| 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 | Met primary |
| 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 · 1 missed | ||||||
| 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 | Missed primary |
| Phase 310 trials · 3 met primary · 2 missed | ||||||
| Phase 3 | NCT04132050 | Dec 2019 → Dec 2021 | thrombocytopenic purpura | Kissei Pharmaceutical Co., Ltd. | Completed | Met primary |
| 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 | Missed primary |
| Phase 3 | NCT02076412 | Jan 2015 → Aug 2016 | autoimmune thrombocytopenic purpura | Rigel Pharmaceuticals | Completed | Missed primary |
| 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 | Met primary |
| 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 | Met primary |
| Phase 3 | NCT01197521 | Sep 2010 → Nov 2012 | rheumatoid arthritis | AstraZeneca | Completed | Mixed |
| 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 |
| Comparator or background therapy6 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 1/2 | NCT04581954 Comparator | Oct 2020 → Nov 2022 | COVID-19, pneumonia | Imperial College London | Completed | No outcome recorded |
| 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 3 | NCT04629703 Comparator | Mar 2021 → Sep 2022 | COVID-19, severe acute respiratory syndrome, viral pneumonia | Rigel Pharmaceuticals | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 40
| Date | Issuer | Release |
|---|---|---|
| 2025-01-21 | Kissei Pharmaceutical Co., Ltd. | Regulatory 脾臓チロシンキナーゼ阻害剤「ホスタマチニブ」の韓国における販売承認取得のお知らせ kissei.co.jp ↗
キッセイ薬品工業株式会社（本社：長野県松本市、代表取締役会長兼最高経営責任者：神澤陸雄、以下「当社」）は、脾臓チロシンキナーゼ阻害剤「ホスタマチニブ」（一般名、以下「本剤」）について、技術導出先であるJWファーマシューティカル社（JW Pharmaceutical CORPORATION、本社：韓国、CEO：YS Shin、以下「JWファーマ社」）が、2025年1月20日付で韓国食品医薬品安全処（MFDS）より、慢性特発性血小板減少性紫斑病（以下「慢性ITP」）の適応で販売承認を取得したことをお知らせいたします。 |
| 2024-11-05 | Rigel Pharmaceuticals | Results Rigel Announces Six Poster Presentations at the 66th American Society of Hematology Annual Meeting and Exposition rigel.com ↗
demonstrated that the combination led to a clinically meaningful response in a majority of patients with ITP. |
| 2022-12-23 | Kissei Pharmaceutical Co., Ltd. | Regulatory 経口血小板破壊抑制薬「タバリス®錠100mg、同150mg」の国内における製造販売承認取得のお知らせ kissei.co.jp ↗
本日、経口血小板破壊抑制薬「タバリス®錠100mg、同150mg」（一般名：ホスタマチニブナトリウム水和物、開発番号：R788、以下「本剤」）について、慢性特発性血小板減少性紫斑病（以下、慢性ITP）を適応症として、厚生労働省より製造販売承認を取得しましたので、お知らせします。 |
| 2022-12-19 | Kissei Pharmaceutical Co., Ltd. | Results 脾臓チロシンキナーゼ阻害剤「ホスタマチニブ」の国内第Ⅲ相臨床試験結果が「British Journal of Haematology」に掲載 kissei.co.jp ↗
二重盲検期において、本剤またはプラセボを24週間経口投与し、本剤の有効性と安全性を検討した結果、主要評価項目であるStable platelet responseの達成割合 ※2 は、プラセボ投与群に比較して本剤投与群で有意に高い結果が示されました（本剤投与群 36%、プラセボ投与群 0%、p=0.030）。 |
| 2022-11-01 | Rigel Pharmaceuticals | Results Rigel Announces Top-line Results from FOCUS Phase 3 Clinical Trial of Fostamatinib in High Risk Hospitalized COVID-19 Patients rigel.com ↗
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), today announced top-line efficacy and safety results from the FOCUS Phase 3 clinical trial of fostamatinib in hospitalized COVID-19 patients without respiratory failure who have certain high-risk prognostic factors. |
| 2022-06-08 | Rigel Pharmaceuticals | Results Rigel Announces Top-line Results from FORWARD Phase 3 Clinical Trial of Fostamatinib in Patients with Warm Autoimmune Hemolytic Anemia rigel.com ↗
The trial did not demonstrate statistical significance in the primary efficacy endpoint of durable hemoglobin response in the overall study population. |
| 2022-04-27 | Kissei Pharmaceutical Co., Ltd. | Regulatory チロシンキナーゼ阻害剤「ホスタマチニブ」の国内製造販売承認申請のお知らせ kissei.co.jp ↗
このたび、チロシンキナーゼ阻害剤「ホスタマチニブ」（一般名、開発番号：R788）について、慢性特発性血小板減少性紫斑病（以下、慢性ITP）を適応症として、日本国内における製造販売承認申請を行いましたので、お知らせいたします。 |
| 2022-03-08 | Rigel Pharmaceuticals | Results Rigel Announces Publication of Data from Phase 2 Clinical Study of Fostamatinib for the Treatment of Warm Antibody Autoimmune Hemolytic Anemia in the American Journal of Hematology rigel.com ↗
The results observed in our Phase 2 study in warm autoimmune hemolytic anemia reinforce the potential of fostamatinib to help patients with this rare, serious blood disorder for whom no disease-targeted therapies are currently approved |
| 2021-12-21 | Rigel Pharmaceuticals | Results Fostamatinib Meets Primary Endpoint in Phase 3 Trial in Japan for Treatment of Chronic Immune Thrombocytopenia rigel.com ↗
The Phase 3 clinical study (n=34) showed that patients receiving fostamatinib (R788) achieved a stable platelet response significantly higher than patients receiving a placebo control. |
| 2021-12-21 | Kissei Pharmaceutical Co., Ltd. | Results チロシンキナーゼ阻害剤「ホスタマチニブ」の 慢性特発性血小板減少性紫斑病を対象とした国内第Ⅲ相臨床試験の 第Ⅰ期解析結果について ―主要評価項目を達成― kissei.co.jp ↗
今般、第Ⅰ期を対象とする解析を行い、主要評価項目である「Stable platelet response の達成割合」は、ホスタマチニブ群ではプラセボ群と比べ統計学的に有意に高い結果が得られました。 |
| 2021-09-01 | Rigel Pharmaceuticals | Results Data from NIH/NHLBI-Sponsored Phase 2 Trial of Fostamatinib in Hospitalized COVID-19 Patients Published in Clinical Infectious Diseases rigel.com ↗
Patients treated with fostamatinib not only had less severe adverse events, but were observed to have improved clinical outcomes compared to those receiving placebo and standard of care. |
| 2021-08-13 | Rigel Pharmaceuticals | Regulatory Rigel Pharmaceuticals Provides Update on COVID-19 Program rigel.com ↗
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that clinical data submitted in late-May from a 59-patient NIH/NHLBI-sponsored Phase 2 trial of fostamatinib to treat hospitalized patients suffering from COVID-19 are insufficient for an emergency use authorization (EUA) at this time. |
| 2021-07-14 | Rigel Pharmaceuticals | Results New TAVALISSE® Data Analyses To Be Presented at International Society on Thrombosis and Haemostasis (ISTH) 2021 Congress rigel.com ↗ |
| 2021-04-13 | Rigel Pharmaceuticals | Results Positive Topline Data Shows Fostamatinib Meets Primary Endpoint of Safety in Phase 2 Clinical Trial in Hospitalized Patients with COVID-19 rigel.com ↗
The trial, being conducted in collaboration with the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), and Inova Health System, met its primary endpoint of safety. |
| 2020-12-04 | Rigel Pharmaceuticals | Results Rigel Announces Two Posters Highlighting TAVALISSE at the 62nd ASH Annual Meeting & Exposition rigel.com ↗
No new safety signals nor cumulative toxicity were observed with up to 62 months (5.2 years) of continuous treatment in ITP patients and up to 81 months (6.8 years) of continuous treatment in RA patients. |
| 2020-11-23 | Rigel Pharmaceuticals | Regulatory Rigel and Medison Announce Health Canada Approval of TAVALISSE®, an Oral Medication for the Treatment of Adults with Chronic Immune Thrombocytopenia rigel.com ↗
Health Canada has approved the new drug submission (NDS) for TAVALISSE ® (fostamatinib disodium hexahydrate) |
| 2020-07-27 | Rigel Pharmaceuticals | Results Rigel Announces Post-hoc Data Analysis of TAVALISSE® in Adult Patients with Immune Thrombocytopenia Published in the British Journal of Haematology rigel.com ↗
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), today announced that a paper presenting a post-hoc data analysis of TAVALISSE ® (fostamatinib disodium hexahydrate) tablets, as well as accompanying commentary have been published in the British Journal of Haematology. |
| 2020-06-11 | Rigel Pharmaceuticals | Results Rigel to Present Poster Highlighting TAVALISSE at the Virtual Edition of the 25th European Hematology Association (EHA) Annual Congress rigel.com ↗
In this previously presented post-hoc analysis, 32 patients received TAVALISSE as a second-line therapy, and 78% (25/32) achieved ≥1 platelet count of ≥50,000/µL (without rescue therapy). |
| 2019-11-15 | Rigel Pharmaceuticals | Regulatory Rigel Receives Positive CHMP Opinion for Fostamatinib Disodium Hexahydrate for Adult Patients with Chronic Immune Thrombocytopenia (ITP) in Europe rigel.com ↗
The positive opinion will now be reviewed by the EC, which will issue a decision on the approval of fostamatinib in Europe within approximately 70 days. |
| 2019-11-07 | Rigel Pharmaceuticals | Results Rigel Announces Upcoming Data Presentations at the 61st ASH Annual Meeting & Exposition rigel.com ↗
In this analysis, 32 patients received fostamatinib as a second-line therapy, and 78% (25/32) achieved ≥1 platelet count of ≥50,000/µL (without rescue therapy). |
| 2019-10-18 | Rigel Pharmaceuticals | Regulatory Rigel Receives Positive Trend Vote from CHMP for Fostamatinib Disodium Hexahydrate for Adult Patients with Chronic Immune Thrombocytopenia (ITP) in Europe rigel.com ↗
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive trend vote on the Marketing Authorization Application (MAA) for fostamatinib disodium hexahydrate (fostamatinib). |
| 2018-10-11 | Rigel Pharmaceuticals | Regulatory Rigel Receives EMA Validation of the Marketing Authorization Application for Fostamatinib Disodium Hexahydrate in Chronic Immune Thrombocytopenia (ITP) in Adult Patients rigel.com ↗
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for fostamatinib in adult chronic immune thrombocytopenia. |
| 2018-06-12 | Rigel Pharmaceuticals | Results Rigel To Present Phase 2 Results for Fostamatinib in Autoimmune Hemolytic Anemia at EHA rigel.com ↗
A total of 9 of 17 (53%) evaluable patients achieved a response to fostamatinib treatment, one a late responder in the Stage 1 extension study. |
| 2018-04-30 | Rigel Pharmaceuticals | Results TAVALISSE™ (fostamatinib disodium hexahydrate) Phase 3 Data Published in the American Journal of Hematology Describes Pivotal Data and Overall Response Rate Versus Placebo rigel.com ↗
Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today announced that the American Journal of Hematology has published positive results from the Fostamatinib in Thrombocytopenia (FIT) Phase 3 clinical program of TAVALISSE™ (fostamatinib disodium hexahydrate) for the treatment of adults with chronic immune thrombocytopenia (ITP). |
| 2018-04-17 | Rigel Pharmaceuticals | Regulatory Rigel Announces FDA Approval of TAVALISSE™ (fostamatinib disodium hexahydrate) for Chronic Immune Thrombocytopenia (ITP) in Adult Patients rigel.com ↗
Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today announced that the U.S. Food and Drug Administration (FDA) approved TAVALISSE™ (fostamatinib disodium hexahydrate) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. |
| 2018-04-03 | Rigel Pharmaceuticals | Results Rigel Announces Topline Data from Proof-of-Concept Phase 2 Study of Fostamatinib in IgA Nephropathy rigel.com ↗
Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL), today announced topline data from its proof-of-concept Phase 2 study of fostamatinib in patients with IgA nephropathy (IgAN), an orphan autoimmune disease of the kidneys. |
| 2018-01-04 | Rigel Pharmaceuticals | Results Rigel to Provide Business Review and Updated Phase 2 Results for Fostamatinib in AIHA at the 36th Annual J.P. Morgan Healthcare Conference rigel.com ↗
Additionally, we have now shown in preliminary results that 47% of the patients treated with fostamatinib in our autoimmune hemolytic anemia study had a clinical response as measured by a defined increase in hemoglobin. |
| 2017-10-03 | Rigel Pharmaceuticals | Results Fostamatinib Meets Pre-Specified Primary Endpoint in Stage 1 of Autoimmune Hemolytic Anemia (AIHA) Phase 2 Study rigel.com ↗
On a top-line, preliminary basis, the Phase 2 study has achieved the pre-specified primary efficacy endpoint for Stage 1. |
| 2017-06-19 | Rigel Pharmaceuticals | Regulatory FDA Accepts Rigel's New Drug Application for TAVALISSE™ (fostamatinib disodium) for the Treatment of Chronic ITP rigel.com ↗ |
| 2017-04-27 | Rigel Pharmaceuticals | Regulatory Rigel Announces Tavalisse™ as Proprietary Name for Fostamatinib in the United States rigel.com ↗
Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted the proprietary name Tavalisse™ for the company's investigational product candidate, fostamatinib disodium, an oral spleen tyrosine kinase (SYK) inhibitor. |
| 2017-04-17 | Rigel Pharmaceuticals | Regulatory Rigel Submits New Drug Application to FDA for Fostamatinib in Chronic ITP rigel.com ↗
Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for fostamatinib in patients with chronic and persistent immune thrombocytopenia (ITP). |
| 2017-01-30 | Rigel Pharmaceuticals | Results Fostamatinib Study Results Continue to Trend Positive rigel.com ↗
Of those, 22% (9/41, p=0.0078) achieved a prospectively defined stable platelet response, which Rigel believes further validates fostamatinib as a potential new treatment option for some patients with this serious disease. |
| 2016-10-20 | Rigel Pharmaceuticals | Results Rigel Announces Results from the Second FIT Phase 3 Study and the Long-Term Open-Label Extension Study for Fostamatinib in ITP rigel.com ↗
In the FIT 2 (Study 048) Phase 3 study, the fostamatinib response rate was 18%, consistent with the recently reported FIT 1 (Study 047) Phase 3 study. |
| 2016-08-30 | Rigel Pharmaceuticals | Results Rigel's Fostamatinib Meets Primary Endpoint in Phase 3 Study in Chronic ITP rigel.com ↗
The study (n=76) showed that 18% of patients receiving fostamatinib achieved a stable platelet response compared to none receiving a placebo control (p=0.0261). |
| 2015-09-08 | Rigel Pharmaceuticals | Regulatory Rigel Granted Orphan Drug Designation for Fostamatinib in ITP rigel.com ↗
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to Fostamatinib, Rigel's oral spleen tyrosine kinase (SYK) inhibitor which is currently in Phase 3 clinical studies in patients with chronic immune thrombocytopenic purpura (ITP). |
| 2013-06-04 | AstraZeneca | Results AstraZeneca announces top-line results from Phase III OSKIRA Trials of FOSTAMATINIB and decision not to proceed with regulatory filings astrazeneca.com ↗
AstraZeneca today announced top-line results from OSKIRA-2 and OSKIRA-3, the remaining pivotal Phase III clinical trials investigating fostamatinib, the first oral spleen tyrosine kinase (SYK) inhibitor in development as an oral treatment for rheumatoid arthritis (RA). |
| 2013-04-05 | Rigel Pharmaceuticals | Results AstraZeneca Announces Top-Line Results From OSKIRA-1 Phase 3 Study of Fostamatinib in Rheumatoid Arthritis rigel.com ↗
Fostamatinib did not demonstrate a statistically significant difference in mTSS compared to placebo at 24 weeks for either dose (p=0.252 and p=0.170, respectively). |
| 2013-04-05 | AstraZeneca | Results AstraZeneca announces top-line results from OSKIRA-1 Phase III study of fostamatinib in rheumatoid arthritis astrazeneca.com ↗
Friday, 5 April 2013 AstraZeneca today announced top-line results of OSKIRA-1, a Phase III study to assess the efficacy and safety of fostamatinib, the first oral spleen tyrosine kinase (SYK) inhibitor in development for rheumatoid arthritis (RA). |
| 2012-12-13 | Rigel Pharmaceuticals | Results AstraZeneca Announces Top-Line Results of OSKIRA-4 Phase IIb Study of Fostamatinib as a Monotherapy for Rheumatoid Arthritis rigel.com ↗
The OSKIRA-4 study did not meet its second primary objective as all fostamatinib monotherapy doses were inferior to adalimumab monotherapy at week 24 based on DAS28. |
| 2012-12-13 | AstraZeneca | Results AstraZeneca announces top-line results of OSKIRA-4 Phase IIb study of fostamatinib as a monotherapy for rheumatoid arthritis astrazeneca.com ↗
The OSKIRA-4 study did not meet its second primary objective as all fostamatinib monotherapy doses were inferior to adalimumab monotherapy at week 24 based on DAS28. |
All press releases naming this drug 75 releases
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 NCT01608542 ↗ |
| 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)” NCT00752999 ↗ “Fostamatinib Disodium / R935788” NCT00706342 ↗ “Fostamatinib disodium (R935788)” NCT00665626 ↗ “Fostamatinib disodium (R935788)” NCT00665925 ↗ |
| Known as | R788 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00326339 ↗ |
| Known as | R935788 | “R935788 (fostamatanib disodium) is a kinase inhibitor” NCT00923481 ↗3“Fostamatinib Disodium / R935788” NCT00706342 ↗ “Fostamatinib Disodium (R935788)” NCT00752999 ↗ “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 |