Obatoclax Mesylate (GX15-070) Clinical Trials

Size	Price	Qty
5mg	USD 170
50mg	USD 870

Clinical Trials

Numerous clinical trials, spanning Phase 1 through Phase 3, have evaluated obatoclax mesylate for hematological malignancies—including chronic lymphocytic leukemia, myelofibrosis, lymphoma subtypes, and systemic mastocytosis—as well as solid tumors like metastatic melanoma. Sponsored by both pharmaceutical entities and academic or government institutions, these studies exhibit varying completion statuses, with several successfully finished investigations alongside others that were ultimately terminated or withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01563601	WITHDRAWN	Extensive-stage Small Cell Lung Cancer	Cephalon	2012-08	PHASE3
NCT00612612	TERMINATED	B-cell Chronic Lymphocytic Leukemia; Leukemia; Prolymphocytic Leukemia; Refractory Chronic Lymphocytic Leukemia; Stage I Chronic Lymphocytic Leukemia; Stage II Chronic Lymphocytic Leukemia; Stage III Chronic Lymphocytic Leukemia; Stage IV Chronic Lymphocytic Leukemia	National Cancer Institute (NCI)	2008-01	PHASE1
NCT00933985	TERMINATED	Acute Leukemias of Ambiguous Lineage; Acute Undifferentiated Leukemia; Angioimmunoblastic T-cell Lymphoma; Blastic Phase Chronic Myelogenous Leukemia; Childhood Burkitt Lymphoma; Childhood Chronic Myelogenous Leukemia; Childhood Diffuse Large Cell Lymphoma; Childhood Immunoblastic Large Cell Lymphoma; Childhood Nasal Type Extranodal NK/T-cell Lymphoma; Cutaneous B-cell Non-Hodgkin Lymphoma; Hepatosplenic T-cell Lymphoma; Intraocular Lymphoma; Noncutaneous Extranodal Lymphoma; Peripheral T-cell Lymphoma; Recurrent Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Acute Myeloid Leukemia; Recurrent Childhood Anaplastic Large Cell Lymphoma; Recurrent Childhood Grade III Lymphomatoid Granulomatosis; Recurrent Childhood Large Cell Lymphoma; Recurrent Childhood Lymphoblastic Lymphoma; Recurrent Childhood Small Noncleaved Cell Lymphoma; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome; Recurrent/Refractory Childhood Hodgkin Lymphoma; Refractory Chronic Lymphocytic Leukemia; Refractory Hairy Cell Leukemia; Relapsing Chronic Myelogenous Leukemia; Small Intestine Lymphoma; Unspecified Childhood Solid Tumor, Protocol Specific	National Cancer Institute (NCI)	2009-06	PHASE1
NCT01238146	WITHDRAWN	Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Nodal Marginal Zone B-cell Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Marginal Zone Lymphoma; Splenic Marginal Zone Lymphoma	National Cancer Institute (NCI)	2010-10	PHASE1; PHASE2
NCT00682981	COMPLETED	Extensive-stage Small Cell Lung Cancer	Gemin X	2008-05	PHASE1; PHASE2
NCT00538187	TERMINATED	Adult Non-Hodgkin Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Small Lymphocytic Lymphoma	National Cancer Institute (NCI)	2007-12	PHASE1
NCT00719901	TERMINATED	Refractory Multiple Myeloma; Stage I Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma	National Cancer Institute (NCI)	2008-07	PHASE1; PHASE2
NCT00918931	TERMINATED	Leukemia; Systemic Mastocytosis	M.D. Anderson Cancer Center	2009-06	PHASE2
NCT00521144	COMPLETED	Recurrent Small Cell Lung Cancer; Unspecified Adult Solid Tumor, Protocol Specific	National Cancer Institute (NCI)	2007-08	PHASE1; PHASE2
NCT00684918	COMPLETED	AML	Gemin X	2008-04	PHASE2
NCT00407303	COMPLETED	Mantle-Cell Lymphoma	Gemin X	2006-10	PHASE1; PHASE2
NCT00413114	COMPLETED	Myelodysplastic Syndromes	Gemin X	2006-12	PHASE2
NCT00427856	COMPLETED	Lymphoma, Follicular	Gemin X	2007-03	PHASE2
NCT00405951	COMPLETED	Lung Cancer	Gemin X	2006-10	PHASE1; PHASE2
NCT00724841	TERMINATED	Metastatic Melanoma	Gemin X	2008-06	PHASE1; PHASE2
NCT00360035	COMPLETED	Myelofibrosis	Gemin X	2006-07	PHASE2
NCT00438178	COMPLETED	Hematological Malignancies	Gemin X	2005-10	PHASE1
NCT00359892	COMPLETED	Hodgkin's Lymphoma	Gemin X	2006-07	PHASE2
NCT00600964	COMPLETED	Chronic Lymphocytic Leukemia	Gemin X	2004-09	PHASE1
NCT00438178	Completed	Hematological Malignancies	Gemin X\|Teva Branded Pharmaceutical Products R&D Inc.	2005-10	Phase 1
NCT00600964	Completed	Chronic Lymphocytic Leukemia	Gemin X\|Teva Branded Pharmaceutical Products R&D Inc.	2004-09	Phase 1

(data from https://clinicaltrials.gov, updated on 2012-08-15)

Check the Obatoclax Mesylate (GX15-070) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Obatoclax mesylate acts as a pan-antagonist of anti-apoptotic Bcl-2 family proteins, binding targets such as Bcl-2, Mcl-1, and Bfl-1 to disrupt their inhibition of pro-apoptotic BH3-domain factors. This blockade promotes outer mitochondrial membrane permeabilization and the release of apoptogenic factors, ultimately inducing apoptotic cell death to suppress malignant cell growth in clinical conditions such as chronic lymphocytic leukemia and lymphoma.

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>).