Fostamatinib
- Generic Name
- Fostamatinib
- Brand Names
- Tavalisse, Tavlesse
- Drug Type
- Small Molecule
- Chemical Formula
- C23H26FN6O9P
- CAS Number
- 901119-35-5
- Unique Ingredient Identifier
- SQ8A3S5101
- Background
Fostamatinib has been investigated for the treatment and basic science of Rheumatoid Arthritis and Immune Thrombocytopenic Purpura (ITP). It was approved on April 17, 2018, under the trade name Tavalisse for use in ITP . Fostamatinib has also been granted orphan drug status by the FDA .
Recently, fostamatinib has been identified as a potential therapeutic for controlling acute respiratory distress syndrome (ARDS) in patients with severe COVID-19 through its ability to modulate the SYK kinase.
- Indication
用于治疗对既往治疗反应不足的慢性免疫性血小板减少症（ITP）成年患者的血小板减少症。
- Associated Conditions
- Chronic immune thrombocytopenia
Rigel Pharmaceuticals Reports Strong Growth with TAVALISSE and REZLIDHIA in 2024, Expands Global Reach
• Rigel Pharmaceuticals achieved significant revenue growth in 2024, with TAVALISSE sales increasing 12% to $104.8 million and REZLIDHIA sales growing 118% to $23.0 million.
• The company secured key regulatory approvals for TAVALISSE in South Korea and Mexico, while establishing a new partnership with Dr. Reddy's Laboratories for REZLIDHIA commercialization across multiple territories.
• Rigel's R289 program for lower-risk MDS received FDA Fast Track designation, with promising Phase 1b data presented at ASH 2024 showing good tolerability and preliminary efficacy.
Rigel's Fostamatinib Enrolls First Patient in Phase I Sickle Cell Disease Trial
• Rigel Pharmaceuticals has announced the enrollment of the first patient in a Phase I clinical trial of fostamatinib for sickle cell disease (SCD).
• The Phase I trial, sponsored by the NIH/NHLBI, will assess the safety and tolerability of fostamatinib in approximately 20 SCD patients.
• Fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor, may reduce complications related to red blood cell sickling and thrombo-inflammation.
• The study will explore fostamatinib's impact on red blood cell membrane integrity, sickling kinetics, and platelet and neutrophil activation in SCD.
NIH Launches Study of Fostamatinib for Sickle Cell Disease Treatment
The National Institutes of Health is investigating Rigel Pharmaceuticals' fostamatinib as a potential treatment for sickle cell disease (SCD). The drug, which is already approved for chronic immune thrombocytopenia, shows promise in addressing SCD's thromboinflammatory complications through SYK inhibition and could potentially improve red blood cell stability without increasing bleeding risks.
TAVALISSE® (Fostamatinib) Approved in Mexico for Chronic ITP Treatment
• Knight Therapeutics' Mexican affiliate receives regulatory approval for TAVALISSE® (fostamatinib) from COFEPRIS to treat thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP).
• Fostamatinib, an orally administered spleen tyrosine kinase (SYK) inhibitor, offers a new therapeutic alternative for patients who have had an insufficient response to previous ITP treatments.
• The approval marks a significant step in expanding treatment options for ITP patients in Latin America, with the launch of TAVALISSE® in Mexico expected in the first half of 2026.
Thrombocytopenia Treatment Market Shows Promising Growth with Novel Therapies and Clinical Trials
• The thrombocytopenia market is experiencing significant growth, driven by the introduction of novel therapies and ongoing clinical trials.
• Key players like Sanofi, Takeda, and Amgen are actively involved in developing and marketing treatments for various types of thrombocytopenia.
• Emerging therapies such as Rilzabrutinib and Nipocalimab show promise in addressing unmet needs in immune and alloimmune thrombocytopenia.
• Clinical trials are exploring new treatments for chemotherapy-induced thrombocytopenia and myelofibrosis-related thrombocytopenia.
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.
© Copyright 2025. All Rights Reserved by MedPath