Lanraplenib (GS-SYK) Clinical Trials

Size	Price	Qty
5mg	USD 169
25mg	USD 507

Clinical Trials

Multiple clinical trials sponsored by organizations including Gilead Sciences and Kronos Bio have evaluated lanraplenib across Phase I and Phase II studies. These investigations explored conditions such as relapsed or refractory acute myeloid leukemia, Sjögren's syndrome, cutaneous lupus erythematosus, lupus membranous nephropathy, and general inflammatory disease. While several autoimmune trials completed recruitment, early-phase oncology evaluations were terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05028751	TERMINATED	Acute Myeloid Leukemia; Relapsed Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia	Kronos Bio	2022-08-05	PHASE1; PHASE2
NCT05028751	Terminated	Acute Myeloid Leukemia\|Relapsed Acute Myeloid Leukemia\|Refractory Acute Myeloid Leukemia	Kronos Bio	2022-08-05	Phase 1\|Phase 2
NCT03285711	COMPLETED	Lupus Membranous Nephropathy	Gilead Sciences	2017-10-06	PHASE2
NCT03134222	COMPLETED	Cutaneous Lupus Erythematosus	Gilead Sciences	2017-05-24	PHASE2
NCT03100942	COMPLETED	Sjogren's Syndrome	Gilead Sciences	2017-05-01	PHASE2
NCT02959138	COMPLETED	Inflammatory Disease	Gilead Sciences	2016-11-21	PHASE1
NCT02959138	Completed	Inflammatory Disease	Gilead Sciences	2016-11-21	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-08-07)

Check the Lanraplenib (GS-SYK) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lanraplenib selectively binds to and inhibits spleen tyrosine kinase with an IC50 of 9.5 nM, effectively blocking downstream intracellular activation cascades including glycoprotein VI receptor-mediated signaling in platelets. This enzymatic inhibition suppresses immunocyte activation and malignant blast survival, providing a mechanistically targeted approach relevant to clinical trial investigations in acute myeloid leukemia, Sjogren's syndrome, and cutaneous lupus erythematosus.

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>).