GSK2879552 Dihydrochloride Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 447

Clinical Trials

Multiple clinical trials, primarily sponsored by GlaxoSmithKline alongside industry partners such as Parexel, evaluated GSK2879552 across Phase 1 and Phase 1/2 studies targeting hematologic malignancies and solid tumors. Focusing on acute myelocytic leukemia, myelodysplastic syndrome, and small cell carcinoma, these now-terminated protocols evaluated dose escalation, safety, pharmacokinetics, and the therapeutic potential of irreversible LSD1 inhibition.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02929498	TERMINATED	Myelodysplastic Syndrome; Myelodysplastic Syndromes	GlaxoSmithKline	2017-07-31	PHASE1; PHASE2
NCT02177812	TERMINATED	Leukaemia, Myelocytic, Acute	GlaxoSmithKline	2014-08-27	PHASE1
NCT02929498	Terminated	Myelodysplastic Syndrome\|Myelodysplastic Syndromes	GlaxoSmithKline\|Parexel	2017-07-31	Phase 1\|Phase 2
NCT02034123	TERMINATED	Carcinoma, Small Cell	GlaxoSmithKline	2014-02-04	PHASE1
NCT02177812	Terminated	Leukaemia Myelocytic Acute	GlaxoSmithKline	2014-08-27	Phase 1
NCT02034123	Terminated	Carcinoma Small Cell	GlaxoSmithKline	2014-02-04	Phase 1

(data from https://clinicaltrials.gov, updated on 2019-05-14)

Check the GSK2879552 Dihydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

GSK2879552 dihydrochloride acts as a selective, irreversible inhibitor of lysine-specific demethylase 1 (LSD1), preventing the demethylation of histone H3K4 and H3K9 to disrupt aberrantly active gene silencing complexes. This blockade leads to accumulated activating histone marks, reactivation of silenced tumor suppressor genes, and induction of cell differentiation, thereby limiting proliferation in malignancies such as acute myelocytic leukemia, myelodysplastic syndrome, and small cell lung carcinoma.

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>).