Birabresib (OTX015) Clinical Trials

Size	Price	Qty
2mg	USD 147
10mg	USD 447

Clinical Trials

Multiple Phase 1 and Phase 2 clinical trials, sponsored primarily by Oncoethix GmbH and Merck Sharp & Dohme LLC, have evaluated birabresib across various advanced solid tumors and hematologic malignancies. The evaluated indications include NUT midline carcinoma, castration-resistant prostate cancer, triple-negative breast cancer, non-small cell lung cancer, glioblastoma multiforme, acute myeloid leukemia, diffuse large B-cell lymphoma, and multiple myeloma. While several of these trials were completed, others were terminated or withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02698189	TERMINATED	AML Including AML de Novo and AML Secondary to MDS; DLBCL	Merck Sharp & Dohme LLC	2016-05-19	PHASE1
NCT02698176	TERMINATED	NUT Midline Carcinoma (NMC); Triple Negative Breast Cancer (TNBC); Non-small Cell Lung Cancer (NSCLC); Castration-resistant Prostate Cancer (CRPC)	Merck Sharp & Dohme LLC	2016-05-04	PHASE1
NCT02259114	COMPLETED	NUT Midline Carcinoma; Triple Negative Breast Cancer; Non-small Cell Lung Cancer With Rearranged ALK Gene/Fusion Protein or KRAS Mutation; Castrate-resistant Prostate Cancer; CRPC; Pancreatic Ductal Adenocarcinoma	Oncoethix GmbH, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	2014-10-23	PHASE1
NCT01713582	COMPLETED	Acute Myeloid Leukemia; Diffuse Large B-cell Lymphoma; Acute Lymphoblastic Leukemia; Multiple Myeloma	Oncoethix GmbH, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	2012-12-14	PHASE1
NCT02698176	Terminated	NUT Midline Carcinoma (NMC)\|Triple Negative Breast Cancer (TNBC)\|Non-small Cell Lung Cancer (NSCLC)\|Castration-resistant Prostate Cancer (CRPC)	Merck Sharp & Dohme LLC	2016-05-04	Phase 1
NCT02698189	Terminated	AML Including AML de Novo and AML Secondary to MDS\|DLBCL	Merck Sharp & Dohme LLC	2016-05-19	Phase 1
NCT02303782	WITHDRAWN	Acute Myeloid Leukemia	Oncoethix GmbH, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	2015-01	PHASE1; PHASE2
NCT02296476	TERMINATED	Glioblastoma Multiforme	Oncoethix GmbH, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	2014-10-29	PHASE2
NCT02296476	Terminated	Glioblastoma Multiforme	Oncoethix GmbH a subsidiary of Merck & Co. Inc. (Rahway New Jersey USA)	2014-10-29	Phase 2
NCT02259114	Completed	NUT Midline Carcinoma\|Triple Negative Breast Cancer\|Non-small Cell Lung Cancer With Rearranged ALK Gene/Fusion Protein or KRAS Mutation\|Castrate-resistant Prostate Cancer\|CRPC\|Pancreatic Ductal Adenocarcinoma	Oncoethix GmbH a subsidiary of Merck & Co. Inc. (Rahway New Jersey USA)	2014-10-23	Phase 1
NCT01713582	Completed	Acute Myeloid Leukemia\|Diffuse Large B-cell Lymphoma\|Acute Lymphoblastic Leukemia\|Multiple Myeloma	Oncoethix GmbH a subsidiary of Merck & Co. Inc. (Rahway New Jersey USA)	2012-12-14	Phase 1

(data from https://clinicaltrials.gov, updated on 2022-09-13)

Check the Birabresib (OTX015) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Birabresib selectively binds to the BET bromodomain proteins BRD2, BRD3, and BRD4, preventing their reader domain interactions with acetylated chromatin and suppressing downstream expression of oncogenic driver genes including NSD3. This transcriptional inhibition halts tumor cell proliferation and triggers apoptosis, underpinning its clinical evaluation in indications such as acute myeloid leukemia, NUT midline carcinoma, and castration-resistant prostate cancer.

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>).