S55746 Clinical Trials

Size	Price	Qty
5mg	USD 157
25mg	USD 490

Clinical Trials

Multiple clinical trials sponsored by Novartis Pharmaceuticals and Institut de Recherches Internationales Servier have evaluated S55746 across various hematologic malignancies, including acute myeloid leukemia, myelodysplastic syndrome, chronic lymphocytic leukemia, B-cell non-Hodgkin lymphoma, mantle cell lymphoma, follicular lymphoma, and multiple myeloma. These completed Phase 1 and Phase 1b dose-escalation evaluations investigated S55746 both as a monotherapy and in combination with idelalisib.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02920697	COMPLETED	Chronic Lymphocytic Leukaemia (CLL); B-Cell Non-Hodgkin Lymphoma (NHL); Multiple Myeloma (MM)	Institut de Recherches Internationales Servier	2014-03	PHASE1
NCT02603445	Completed	Follicular Lymphoma Mantle Cell Lymphoma	Novartis Pharmaceuticals\|Novartis	2015-11-16	Phase 1
NCT02920541	Completed	Acute Myeloid Leukaemia (AML)\|Myelodysplastic Syndrome (MDS)	Institut de Recherches Internationales Servier\|ADIR a Servier Group company\|Servier	2015-01	Phase 1
NCT02920697	Completed	Chronic Lymphocytic Leukaemia (CLL)\|B-Cell Non-Hodgkin Lymphoma (NHL)\|Multiple Myeloma (MM)	Institut de Recherches Internationales Servier\|ADIR a Servier Group company\|Servier	2014-03	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-07-25)

Check the S55746 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

S55746 acts as a potent and selective BCL-2 inhibitor with a Ki of 1.3 nM that directly binds to the BH3-binding groove of BCL-2, thereby disrupting its binding to pro-apoptotic proteins and initiating mitochondrial outer membrane permeabilization to induce apoptosis. This targeted activation of programmed cell death suppresses tumor cell proliferation in BCL-2-dependent malignancies, providing clinical relevance for treating acute myeloid leukemia, chronic lymphocytic leukemia, non-Hodgkin lymphoma, and multiple myeloma.

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>).