Zelenirstat (PCLX-001) Clinical Trials

Size	Price	Qty
5mg	USD 270
25mg	USD 697

Clinical Trials

Multiple early-phase clinical trials sponsored by Pacylex Pharmaceuticals are evaluating Zelenirstat (PCLX-001), a dual N-myristoyltransferase inhibitor, for the treatment of hematologic malignancies and advanced solid tumors. These studies include completed and actively recruiting phases focusing on patients with relapsed or refractory B-cell non-Hodgkin lymphoma, advanced solid malignancies, and relapsed adult acute myeloid leukemia. Together, these clinical trials highlight efforts to establish the oral agent's therapeutic potential in aggressive cancers.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06613217	RECRUITING	Relapsed Adult AML	Pacylex Pharmaceuticals	2025-03-03	PHASE1
NCT04836195	COMPLETED	B-cell Non Hodgkin Lymphoma; Advanced Solid Tumor	Pacylex Pharmaceuticals	2021-09-14	PHASE1
NCT04836195	Recruiting	B-cell Non Hodgkin Lymphoma\|Advanced Solid Tumor	Pacylex Pharmaceuticals	2021-09-14	Phase 1

(data from https://clinicaltrials.gov, updated on 2025-03-10)

Check the Zelenirstat (PCLX-001) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Zelenirstat selectively binds and inhibits N-myristoyltransferase 1 and N-myristoyltransferase 2 with IC50 values of 5 nM and 8 nM, respectively, blocking downstream protein lipid modifications and early B-cell receptor signaling. This disruption of essential oncogenic signaling triggers cell death and impairs tumor cell proliferation, providing the therapeutic rationale for its clinical investigation in B-cell non-Hodgkin lymphoma, advanced solid tumors, and relapsed acute myeloid leukemia.

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>).