Drugs / ZEN-3694
Trials 21
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2026-10-08 | Zenith Epigenetics | Regulatory Zenith Epigenetics Receives FDA Clearance for Registration Enabling Study of ZEN-3694 in NUT Carcinoma zenithepigenetics.com ↗
“Receiving clearance and reaching consensus on the design of a registration enabling trial mark significant milestones in our clinical development,” said Donald McCaffrey, President & CEO of Zenith Epigenetics. |
| 2026-04-09 | Zenith Epigenetics | Results Zenith Epigenetics Provides Update on ZEN-3694 NUT Carcinoma Program zenithepigenetics.com ↗
2 patients who received both ZEN-3694 and abemaciclib had positive treatment responses (67% of those who received this combination) |
| 2025-10-27 | Zenith Epigenetics | Regulatory Zenith Epigenetics’ ZEN-3694 Receives Orphan Drug Designation from FDA zenithepigenetics.com ↗
Zenith Epigenetics Ltd. (“Zenith” or the “Company”) is pleased to announce that the U.S. Food and Drug Administration (“FDA”) has granted Orphan Drug designation to ZEN-3694 for treatment of NUT carcinoma. |
| 2025-07-14 | Zenith Epigenetics | Regulatory FDA grants Zenith’s ZEN-3694 Fast Track Status zenithepigenetics.com ↗
FDA officials concluded that ZEN-3694, in combination with abemaciclib, meets the criteria for Fast Track designation for the treatment of metastatic or unresectable NUT carcinoma in patients who have received at least one line of prior chemotherapy. |
| 2023-06-01 | Zenith Epigenetics | Results Zenith Epigenetics Reports Advancement of ZEN-3694 in NUT Carcinoma zenithepigenetics.com ↗
Zenith Epigenetics has provided ZEN-3694 to two NC patients for compassionate use and both experienced significant clinical benefit and durable reduction of their tumors. |
| 2022-06-21 | Zenith Epigenetics | Results Zenith Epigenetics Triple Negative Breast Cancer Clinical Data Highlighted in an Oral Discussion at the American Society of Clinical Oncology Conference (ASCO) zenithepigenetics.com ↗
This combination is active with a manageable safety profile and warrants continued clinical evaluation |
| 2021-08-17 | Zenith Epigenetics | Results Zenith Epigenetics Announces a Publication in the Journal of Cancer Gene Therapy with Compelling Data for the Treatment of ER-Positive Breast Cancer Patients zenithepigenetics.com ↗
The study shows that the combination can reverse acquired CDK4/6i resistance by targeting key oncogenic pathways involved in cell cycle regulation, cellular growth, proliferation, apoptosis, inflammation, and cellular immune response. |
| 2021-06-24 | Zenith Epigenetics | Results Zenith Epigenetics Announces a Publication Highlighting the Role of ZEN-3694 in Overcoming Resistance to Therapies in Metastatic Castration-Resistant Prostate Cancer zenithepigenetics.com ↗
Furthermore, this was supported by clinical data from ZEN-3694 Phase 1b/2a mCRPC study which showed that ZEN-3694 was most effective in patients whose tumors were less dependent on androgen receptor signaling and did not respond to prior ARSi. |
| 2020-07-29 | Zenith Epigenetics | Results Zenith Epigenetics Advances ZEN-3694 in Multiple Cancer Programs zenithepigenetics.com ↗
Clinical data to date shows that the combination is active and well tolerated. |
| 2019-12-19 | Zenith Epigenetics | Results Zenith Epigenetics Announces Clinical Advancement of ZEN-3694 zenithepigenetics.com ↗
In these poor prognosis patients, where there is no standard of care, the data show that ZEN-3694 + enzalutamide provided a significant and meaningful radiographic progression-free survival benefit of approximately 44 weeks compared to approximately 24 weeks for patients receiving only the AR antagonist. |
| 2019-03-18 | Zenith Epigenetics | Regulatory Zenith Epigenetics Announces U.S. FDA Clearance of Investigational New Drug Application for ZEN-3694 in TNBC Program zenithepigenetics.com ↗ |
| 2018-09-04 | Zenith Epigenetics | Results Zenith Epigenetics Announces Publication of a Case Study From its Ongoing mCRPC Clinical Study zenithepigenetics.com ↗
Using CURATE.AI-suggested dosing of ZEN-3694 and enzalutamide, the patient achieved a durable response now ongoing for > 16 months. |
All press releases naming this drug 20 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 23 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ZEN-3694 | “To define the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of BET bromodomain inhibitor ZEN-3694 (ZEN003694) when used in combination with cetuximab and encorafenib.” NCT06102902 ↗ |
| Known as | Bet bromodomain inhibitor zen-3694 | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068600 ↗ |
| Known as | ZEN003694 | “BET bromodomain inhibitor ZEN-3694 (ZEN003694) used in combination with pembrolizumab and nab-paclitaxel in patients with locally advanced or metastatic triple...” NCT05422794 ↗11“This phase I trial tests the safety, side effects, and best dose of ZEN003694 in combination with cisplatin and etoposide or carboplatin and paclitaxel in treating patients...” NCT05019716 ↗ “Phase I Trial of ZEN003694 (ZEN-3694) in Combination With Capecitabine in Patients With Solid Tumors” NCT05803382 ↗ “ZEN003694 is a protein inhibitor that binds to BET proteins.” NCT06102902 ↗ |
| Action | Inhibit | “ZEN-3694 is an orally bioavailable small molecule BET inhibitor currently being evaluated in Phase 1/2 clinical trials (NCT03901469).” PMID 34385584 ↗ Aug 2021 |
| Modality | Small molecule | “ZEN-3694 is an orally bioavailable small molecule BET inhibitor currently being evaluated in Phase 1/2 clinical trials (NCT03901469).” PMID 34385584 ↗ Aug 2021 |
| Route | Oral | “ZEN003694 will be administered orally as a single agent once daily in 28-day cycles” NCT02705469 ↗ |
| Target | MYC | “ZEN-3694 blocks the expression of the MYC gene” NCT04471974 ↗ |