Eltrombopag Olamine Clinical Trials

Size	Price	Qty
5mg	USD 147
1g	USD 3,990

Clinical Trials

Numerous clinical trials across all development phases evaluate the therapeutic efficacy and safety of eltrombopag olamine across several hematological indications, including primary immune thrombocytopenia, myelodysplastic syndrome, acute myeloid leukemia, and lymphoma-associated cytopenias. Conducted by both academic institutions and industry sponsors, these studies encompass completed, actively recruiting, terminated, and not yet recruiting protocols.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07189910	NOT_YET_RECRUITING	Primary Immune Thrombocytopenia (ITP)	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	2025-12-01	PHASE4
NCT05961410	RECRUITING	Lymphoma; Peripheral Blood Stem Cell Transplantation	National Taiwan University Hospital	2023-08-15	PHASE2
NCT01927731	COMPLETED	Bone Marrow Transplantation Recipient; Cord Blood Transplant Recipient; Hematopoietic Cell Transplantation Recipient	M.D. Anderson Cancer Center	2013-10-14	PHASE2
NCT06768619	COMPLETED	Thrombocytopenia	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	2023-03-20
NCT01428635	COMPLETED	Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Primary Myelofibrosis; Thrombocytopenia	M.D. Anderson Cancer Center	2012-01-13	PHASE2; PHASE3
NCT01772420	COMPLETED	Adult Myelodysplastic Syndrome; Anemia; Chronic Myelomonocytic Leukemia	Albert Einstein College of Medicine	2012-10	PHASE2
NCT06768632	COMPLETED	Thrombocytopenia	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	2020-01-02
NCT02071901	COMPLETED	Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome; Adult Acute Basophilic Leukemia; Adult Acute Eosinophilic Leukemia; Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia in Remission; Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Secondary Acute Myeloid Leukemia	Case Comprehensive Cancer Center	2014-08-14	PHASE2
NCT01610180	COMPLETED	Purpura, Thrombocytopenic, Idiopathic; Autoimmune Thrombocytopenic Purpura; Autoimmune Thrombocytopenia; Chronic Lymphocytic Leukemia; Non Hodgkin's Lymphoma	Fondazione Progetto Ematologia	2012-06	PHASE2
NCT00351468	COMPLETED	Purpura, Thrombocytopaenic, Idiopathic	Novartis Pharmaceuticals	2006-06	PHASE3
NCT01147809	COMPLETED	Thrombocytopaenia	GlaxoSmithKline	2010-06	PHASE2
NCT01550185	TERMINATED	Adult Acute Basophilic Leukemia; Adult Acute Eosinophilic Leukemia; Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Recurrent Adult Acute Myeloid Leukemia	Roswell Park Cancer Institute	2012-05	PHASE1
NCT01098487	COMPLETED	Purpura, Thrombocytopaenic, Idiopathic	GlaxoSmithKline	2010-05	PHASE4
NCT00903422	COMPLETED	Myelodysplastic Syndrome	GlaxoSmithKline	2009-05-14	PHASE1
NCT01550185	Terminated	Adult Acute Basophilic Leukemia\|Adult Acute Eosinophilic Leukemia\|Adult Acute Megakaryoblastic Leukemia (M7)\|Adult Acute Minimally Differentiated Myeloid Leukemia (M0)\|Adult Acute Monoblastic Leukemia (M5a)\|Adult Acute Monocytic Leukemia (M5b)\|Adult Acute Myeloblastic Leukemia With Maturation (M2)\|Adult Acute Myeloblastic Leukemia Without Maturation (M1)\|Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities\|Adult Acute Myeloid Leukemia With Del(5q)\|Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)\|Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)\|Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)\|Adult Acute Myelomonocytic Leukemia (M4)\|Adult Erythroleukemia (M6a)\|Adult Pure Erythroid Leukemia (M6b)\|Recurrent Adult Acute Myeloid Leukemia	Roswell Park Cancer Institute\|GlaxoSmithKline	2012-05	Phase 1
NCT01416311	Completed	Purpura Thrombocytopaenic Idiopathic	Novartis Pharmaceuticals\|Novartis	2010-12-21	--
NCT00424177	COMPLETED	Purpura, Thrombocytopaenic, Idiopathic	GlaxoSmithKline	2007-03	PHASE2
NCT00370331	COMPLETED	Purpura, Thrombocytopaenic, Idiopathic	GlaxoSmithKline	2006-11	PHASE3

(data from https://clinicaltrials.gov, updated on 2025-09-24)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Eltrombopag olamine functions as a selective nonpeptide agonist of the thrombopoietin receptor (TpoR/c-mpl), binding to the receptor to initiate downstream activation of the JAK-STAT signaling pathway. This signaling cascade drives the proliferation and differentiation of megakaryocytes to elevate systemic platelet levels, establishing its clinical utility in treating primary immune thrombocytopenia, myelodysplastic syndromes, and leukemia-associated cytopenias.

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>).