Molibresib (I-BET-762) Clinical Trials

Size	Price	Qty
2mg	USD 227
10mg	USD 470

Clinical Trials

Multiple Phase 1 and Phase 2 clinical trials, primarily sponsored by GlaxoSmithKline and the National Cancer Institute, have evaluated Molibresib (GSK525762) in advanced malignant solid neoplasms, NUT midline carcinoma, refractory B-cell and T-cell non-Hodgkin lymphomas, and unresectable pancreatic carcinoma. While select studies successfully completed safety, pharmacokinetic, and clinical activity assessments in solid tumors, other trials were prematurely terminated or withdrawn. Furthermore, compassionate use protocols established for patients with NUT midline carcinoma are no longer available.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03925428	WITHDRAWN	Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Ann Arbor Stage III B-Cell Non-Hodgkin Lymphoma; Ann Arbor Stage III T-Cell Non-Hodgkin Lymphoma; Ann Arbor Stage IV B-Cell Non-Hodgkin Lymphoma; Ann Arbor Stage IV T-Cell Non-Hodgkin Lymphoma; Refractory B-Cell Non-Hodgkin Lymphoma; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Pancreatic Carcinoma; Refractory T-Cell Non-Hodgkin Lymphoma; Stage II Pancreatic Cancer AJCC v8; Stage IIA Pancreatic Cancer AJCC v8; Stage IIB Pancreatic Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Unresectable Pancreatic Carcinoma	National Cancer Institute (NCI)	2020-09-18	PHASE1
NCT04116359	WITHDRAWN	Metastatic NUT Carcinoma; Unresectable NUT Carcinoma	National Cancer Institute (NCI)	2020-09-18	PHASE1; PHASE2
NCT03266159	Withdrawn	Solid Tumours	GlaxoSmithKline	2017-11-27	Phase 2
NCT02964507	Terminated	Neoplasms	GlaxoSmithKline	2017-02-02	Phase 1
NCT01943851	Completed	Neoplasms	GlaxoSmithKline	2014-05-14	Phase 2
NCT01587703	Completed	Carcinoma Midline	GlaxoSmithKline	2012-03-28	Phase 1

(data from https://clinicaltrials.gov, updated on 2020-09-28)

Check the Molibresib (I-BET-762) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Molibresib (I-BET-762) selectively binds to bromodomain and extra-terminal (BET) family proteins, thereby disrupting their interaction with acetylated histones and downregulating the transcription of key oncogenic and proinflammatory genes. This transcriptional inhibition arrests cell cycle progression and promotes apoptosis in malignant cells, providing a biological rationale for its investigation in advanced solid tumors, NUT carcinoma, and refractory 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>).