ZEN-3694 (BET-IN-19) Clinical Trials

Size	Price	Qty
5mg	USD 179
25mg	USD 537

Clinical Trials

Numerous Phase 1 and Phase 2 clinical trials, sponsored by organizations including the National Cancer Institute and academic cancer centers, are evaluating ZEN-3694 across several advanced malignancies, notably metastatic castration-resistant prostate, refractory colorectal, triple-negative breast, pancreatic, and platinum-resistant ovarian cancers. These protocols, which encompass active recruiting, active not recruiting, and suspended recruitment statuses, primarily investigate ZEN-3694 combination regimens involving agents such as enzalutamide, pembrolizumab, capecitabine, and binimetinib.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05253131	RECRUITING	MPNST; NF1; Sarcoma	University of Alabama at Birmingham	2026-08-04	PHASE2
NCT06922318	RECRUITING	Metastatic Castration-resistant Prostate Cancer	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	2025-08-19	PHASE2
NCT04840589	SUSPENDED	Metastatic Malignant Solid Neoplasm; Recurrent Malignant Solid Neoplasm; Recurrent Platinum-Resistant Ovarian Carcinoma; Refractory Ovarian Carcinoma	National Cancer Institute (NCI)	2022-02-02	PHASE1
NCT04471974	ACTIVE_NOT_RECRUITING	Castration-Resistant Prostate Carcinoma; Metastatic Prostate Adenocarcinoma; Metastatic Prostate Small Cell Carcinoma; Stage IV Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8	Rahul Aggarwal	2021-01-26	PHASE2
NCT05053971	RECRUITING	Advanced Malignant Solid Neoplasm; Locally Advanced Pancreatic Carcinoma; Metastatic Pancreatic Carcinoma; Refractory Malignant Solid Neoplasm; Refractory Pancreatic Carcinoma; Stage II Pancreatic Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Unresectable Pancreatic Carcinoma	National Cancer Institute (NCI)	2022-11-16	PHASE1; PHASE2
NCT05803382	RECRUITING	Metastatic Colorectal Carcinoma; Metastatic Malignant Solid Neoplasm; Stage IV Colorectal Cancer AJCC v8; Unresectable Colorectal Carcinoma; Unresectable Malignant Solid Neoplasm	National Cancer Institute (NCI)	2023-11-08	PHASE1
NCT05950464	RECRUITING	Recurrent Endometrial Carcinoma; Recurrent Endometrial Clear Cell Adenocarcinoma; Recurrent Endometrial Endometrioid Adenocarcinoma; Recurrent Endometrial Low Grade Endometrioid Adenocarcinoma; Recurrent Ovarian Clear Cell Adenocarcinoma; Recurrent Ovarian Endometrioid Adenocarcinoma; Recurrent Ovarian High Grade Serous Adenocarcinoma; Recurrent Ovarian Low Grade Endometrioid Adenocarcinoma; Recurrent Platinum-Resistant Ovarian Carcinoma	National Cancer Institute (NCI)	2023-12-18	PHASE1
NCT05019716	RECRUITING	Advanced NUT Carcinoma; Metastatic NUT Carcinoma; Unresectable NUT Carcinoma	National Cancer Institute (NCI)	2022-07-13	PHASE1; PHASE2
NCT05372640	RECRUITING	Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Breast Carcinoma; Metastatic Malignant Solid Neoplasm; Metastatic NUT Carcinoma; Unresectable Breast Carcinoma; Unresectable Malignant Solid Neoplasm; Unresectable NUT Carcinoma	National Cancer Institute (NCI)	2023-08-10	PHASE1
NCT05422794	RECRUITING	Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Locally Advanced Triple-Negative Breast Carcinoma; Metastatic Triple-Negative Breast Carcinoma; Unresectable Triple-Negative Breast Carcinoma	National Cancer Institute (NCI)	2023-05-18	PHASE1
NCT05111561	RECRUITING	Advanced Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm; Refractory Malignant Solid Neoplasm; Triple-Negative Breast Carcinoma; Unresectable Malignant Solid Neoplasm	National Cancer Institute (NCI)	2022-08-02	PHASE1
NCT06102902	SUSPENDED	Metastatic Colorectal Adenocarcinoma; Recurrent Colorectal Adenocarcinoma; Refractory Colorectal Adenocarcinoma; Stage IV Colorectal Cancer AJCC v8	National Cancer Institute (NCI)	2024-06-05	PHASE1
NCT05327010	RECRUITING	Advanced Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm; Unresectable Malignant Solid Neoplasm	National Cancer Institute (NCI)	2022-11-14	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-24)

Check the ZEN-3694 (BET-IN-19) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

ZEN-3694 acts as a selective bromodomain and extra-terminal inhibitor that binds to BET family proteins, thereby disrupting their interaction with acetylated lysine residues on histones and preventing downstream gene transcription machinery assembly. Consequently, chromatin accessibility is restricted and transcription of key oncogenic drivers such as androgen receptor signaling genes is downregulated, inhibiting cellular proliferation and promoting tumor regression in metastatic castration-resistant prostate cancer and solid 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>).