Pulrodemstat (CC-90011) besylate Clinical Trials

Size	Price	Qty
5mg	USD 239
25mg	USD 719

Clinical Trials

Multiple Phase 1 and Phase 2 clinical trials, sponsored primarily by Celgene, have evaluated pulrodemstat (CC-90011) to assess safety, tolerability, pharmacokinetics, and efficacy across various oncological indications. These studies targeted advanced solid neoplasms, small cell lung carcinoma, non-Hodgkin lymphoma, myeloid leukemia, and prostatic neoplasms, including an evaluation of combination therapy with nivolumab. Overall recruitment across these early-phase programs reflects a mix of completed and terminated trials.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03850067	COMPLETED	Small Cell Lung Carcinoma	Celgene	2019-03-12	PHASE1
NCT02875223	TERMINATED	Lymphoma, Non-Hodgkin; Neoplasms	Celgene	2016-08-31	PHASE1
NCT04350463	COMPLETED	Neoplasms	Celgene	2020-07-14	PHASE2
NCT04628988	COMPLETED	Prostatic Neoplasms	Celgene	2021-07-28	PHASE1
NCT04748848	TERMINATED	Leukemia, Myeloid	Celgene	2021-10-14	PHASE1

(data from https://clinicaltrials.gov, updated on 2024-08-26)

Check the Pulrodemstat (CC-90011) besylate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pulrodemstat (CC-90011) besylate selectively binds to and inhibits lysine-specific demethylase-1 (LSD1), preventing the demethylation of mono- and di-methylated histone H3 at lysine 4 and lysine 9. This alteration of histone methylation patterns alters oncogenic gene expression and promotes cell differentiation, thereby suppressing cell proliferation in LSD1-dependent malignancies such as small cell lung carcinoma, myeloid leukemia, and prostatic neoplasms.

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>).