NHWD-870 Clinical Trials

Size	Price	Qty
5mg	USD 509
25mg	USD 1,770

Clinical Trials

Multiple clinical trials are currently evaluating NHWD-870 for the treatment of advanced malignancies. A Phase 2 trial sponsored by Zhejiang Wenda Pharma Technology LTD. is investigating the compound in adult and adolescent patients with advanced NUT cancer, though its recruitment status remains unknown. Additionally, a real-world study sponsored by Hunan Province Tumor Hospital is actively recruiting patients with advanced solid tumors or lymphomas harboring NUT gene rearrangements to assess clinical outcomes.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06527300	UNKNOWN	Advanced Solid Tumor (Phase 1)	Zhejiang Wenda Pharma Technology LTD.	2024-04-25	PHASE2

(data from https://clinicaltrials.gov, updated on 2025-01-24)

Check the NHWD-870 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

NHWD-870 selectively binds to the bromodomains of BET family proteins BRD2, BRD3, BRD4, and BRDT, thereby suppressing BRD4-mediated HIF1α activation and downregulating CSF1 expression to impede tumor-associated macrophage proliferation. This targeted inhibition of oncogenic transcription and immunosuppressive tumor microenvironment signaling underpins its therapeutic potential against advanced solid tumors and NUT-rearranged carcinomas or lymphomas.

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>).