Lusutrombopag Clinical Trials

Size	Price	Qty
5mg	USD 227
25mg	USD 689

Clinical Trials

Multiple clinical trials spanning Phase 1 through Phase 4 evaluate lusutrombopag, funded by commercial pharmaceutical sponsors such as Shionogi alongside academic medical centers. These studies target conditions including chronic liver disease with thrombocytopenia, immune thrombocytopenia, aplastic anemia, hematologic disorders following allogeneic stem cell transplantation, and healthy volunteers. Recruitment statuses across these investigations encompass completed, active recruiting, terminated, and unknown states.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07483385	RECRUITING	Patients With Hematologic Disorders After Allogeneic Hematopoietic Stem Cell Transplantation; Hematologic Disorders	The General Hospital of Western Theater Command	2026-01-13
NCT06673498	RECRUITING	Thrombocytopenia	Anhui Provincial Hospital	2024-11-10	PHASE2
NCT06426043	UNKNOWN	Aplastic Anemia	Peking Union Medical College Hospital	2024-06	PHASE4
NCT06287567	COMPLETED	Idiopathic Thrombocytopenic Purpura; Immune Thrombocytopenia	Institute of Hematology & Blood Diseases Hospital, China	2024-04-17	PHASE2
NCT02389621	COMPLETED	Chronic Liver Disease; Thrombocytopenia	Shionogi	2015-06-15	PHASE3
NCT02389621	Completed	Chronic Liver Disease\|Thrombocytopenia	Shionogi\|Shionogi Inc.	2015-06-15	Phase 3
NCT01129024	TERMINATED	Immune Thrombocytopenia	Shionogi	2010-04-29	PHASE2
NCT01054443	TERMINATED	Immune Thrombocytopenia (ITP)	Shionogi	2010-03-18	PHASE2
NCT01054443	Terminated	Immune Thrombocytopenia (ITP)	Shionogi\|Shionogi Inc.	2010-03-18	Phase 2
NCT03897413	Completed	Healthy Volunteer	Shionogi\|Shionogi Inc.	2009-11-06	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-03-25)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lusutrombopag selectively binds to the transmembrane domain of the human thrombopoietin receptor on megakaryocytes, activating downstream signal transduction pathways that drive megakaryocyte proliferation and differentiation. This stimulation elevates endogenous platelet production, thereby mitigating bleeding complications in patients presenting with chronic liver disease-associated thrombocytopenia or immune thrombocytopenia.

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>).