Fostamatinib disodium hexahydrate Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 387

Clinical Trials

Multiple clinical trials evaluate fostamatinib across several hematologic and autoimmune conditions, including primary and chronic immune thrombocytopenia, immune-mediated anemias, chronic graft-versus-host disease, myelofibrosis, post-transplant cytopenias, and sickle cell disease. Ranging from Phase 1 and Phase 2 studies to observational evaluations, these trials are sponsored by academic institutions, government entities like the National Heart, Lung, and Blood Institute, and industry partners such as Rigel Pharmaceuticals. Across the portfolio, recruitment statuses vary, encompassing active enrollment by invitation, completed studies, non-recruiting protocols, and terminated trials.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05904093	Not yet recruiting	Sickle Cell Disease\|Hb-SS Disease\|Hemoglobin S\|Disease Sickle Cell Anemia\|Sickle Cell Disorders\|Hemoglobin Beta Thalassemia Disease	National Heart Lung and Blood Institute (NHLBI)\|National Institutes of Health Clinical Center (CC)	2024-05-15	Phase 1
NCT05509582	Enrolling by invitation	Immune Mediated Anemia\|Immune Mediated Thrombocytopenia\|Chronic GVHD	National Heart Lung and Blood Institute (NHLBI)\|National Institutes of Health Clinical Center (CC)	2024-05-15	Phase 2
NCT06071520	Completed	Primary Immune Thrombocytopenia	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla	2023-03-01	--
NCT05613296	Not yet recruiting	ITP - Immune Thrombocytopenia\|Chronic ITP\|Refractory ITP	Gruppo Italiano Malattie EMatologiche dell''Adulto	2023-02	--
NCT04543279	Terminated	Myelofibrosis\|Thrombocytopenia	Washington University School of Medicine\|Rigel Pharmaceuticals	2021-05-03	Phase 2
NCT04904276	Terminated	ITP\|Immune Thrombocytopenia	Rigel Pharmaceuticals	2021-05-18	--

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Fostamatinib disodium hexahydrate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fostamatinib disodium hexahydrate acts as a prodrug that is converted into its active metabolite R406, which potently inhibits spleen tyrosine kinase (Syk) with an IC50 of 41 nM in cell-free assays and suppresses downstream Fc receptor and B-cell receptor signal transduction. By blocking Syk-dependent intracellular signaling, the compound reduces immune-mediated cellular activation and destruction, providing therapeutic relevance in clinical trial indications such as immune thrombocytopenia and sickle cell disease.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).