Sepantronium Bromide (YM155) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Sepantronium bromide (YM155) has been evaluated in several clinical trials across Phase I and Phase II for conditions such as high-grade B-cell lymphoma, unresectable melanoma, non-small cell lung cancer, and hormone-refractory prostate cancer. Funded by industry sponsors including Astellas Pharma and Cothera Bioscience, as well as government organizations like the National Cancer Institute, these studies range in status from actively recruiting and completed to terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05263583	ACTIVE_NOT_RECRUITING	High-grade B-cell Lymphoma; Burkitt Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphatic Diseases; Lymphoma, High-Grade; C-MYC/BCL2 Double-Hit High-Grade B-Cell Lymphoma; C-MYC/BCL6 Double-Hit High-Grade B-Cell Lymphoma; C-Myc Gene Rearrangement	Cothera Bioscience, Inc	2022-12-09	PHASE2
NCT05263583	Recruiting	High-grade B-cell Lymphoma\|Burkitt Lymphoma\|Lymphoma B-Cell\|Lymphoma Large B-Cell Diffuse\|Lymphatic Diseases\|Lymphoma High-Grade\|C-MYC/BCL2 Double-Hit High-Grade B-Cell Lymphoma\|C-MYC/BCL6 Double-Hit High-Grade B-Cell Lymphoma\|C-Myc Gene Rearrangement	Cothera Bioscience Inc	2022-12-09	Phase 2
NCT01007292	COMPLETED	Non-Hodgkin's Lymphoma	Astellas Pharma Inc	2009-11	PHASE2
NCT01100931	COMPLETED	NSCLC; Solid Tumors	National Cancer Institute (NCI)	2010-02	PHASE1; PHASE2
NCT01038804	COMPLETED	Breast Cancer	Astellas Pharma Inc	2009-12	PHASE2
NCT01009775	COMPLETED	Melanoma	Astellas Pharma Inc	2009-11	PHASE2
NCT00818480	COMPLETED	Prostate Cancer; Melanoma; Non-Hodgkin's Lymphoma	Astellas Pharma Inc	2006-02	PHASE2
NCT00514267	COMPLETED	Prostate Cancer; Tumors	Astellas Pharma Inc	2007-05	PHASE1; PHASE2
NCT01023386	COMPLETED	Cancer	Astellas Pharma Inc	2009-11	PHASE1
NCT01023386	Completed	Cancer	Astellas Pharma Inc	2009-11	Phase 1
NCT00498914	TERMINATED	Lymphoma, Large-Cell, Diffuse; Lymphoma, B-Cell Refractory	Astellas Pharma Inc	2007-06	PHASE2
NCT00328588	COMPLETED	Lung Cancer; Cancer of Lung; Cancer of the Lung; Non-Small Cell Lung Carcinoma; Carcinoma, Non-Small Cell Lung	Astellas Pharma Inc	2006-12	PHASE2
NCT00281541	COMPLETED	Melanoma	Astellas Pharma Inc	2005-11	PHASE2
NCT00257478	COMPLETED	Prostate Cancer; Cancer of Prostate; Prostatic Cancer; Cancer of the Prostate	Astellas Pharma Inc		PHASE2

(data from https://clinicaltrials.gov, updated on 2025-01-14)

Check the Sepantronium Bromide (YM155) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sepantronium bromide selectively suppresses survivin promoter activity to downregulate expression of the anti-apoptotic protein survivin, thereby triggering cell apoptosis, modulating autophagy, and inducing DNA damage in tumor cells. By neutralizing survivin-dependent survival pathways, the compound inhibits tumor growth and provides therapeutic relevance across conditions evaluated in clinical trials, including high-grade B-cell lymphoma, non-small cell lung cancer, and prostate cancer.

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>).