Ozmosi | Entinostat Drug Profile

Product Description

Syndax is developing Entinostat. Entinostat, is a selective, oral, once-weekly, class I HDAC inhibitor that has been studied in multiple solid tumors in combination with hormone therapy and several approved PD-1/PD-L1 antagonists. (Sourced from: https://syndax.com/pipeline/entinostat/)

Mechanisms of Action: HDAC Inhibitor

Novel Mechanism: No

Modality: Small Molecule

Route of Administration: Oral

FDA Designation: *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Known Adverse Events: None

Company: Syndax
Company Location: WALTHAM MA 02451
Company CEO: Michael A. Metzger
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Entinostat

Countries in Clinic: China, Israel, Japan, South Korea, Sweden, United States

Active Clinical Trial Count: 9

Recent & Upcoming Milestones

Highest Development Phases

Phase 3: Breast Cancer

Phase 2: Lymphoma|Non-Small-Cell Lung Cancer|Renal Cell Carcinoma|Uveal Melanoma

Trial ID	Trial	Phase	Trial Status	Disease	Primary Completion Date	Probability of Success	Latest Trial Update Date	Data Updated
NCT03501381	HCRN GU17-289	P2	Active, not recruiting	Renal Cell Carcinoma	2023-01-20	61%	2023-09-02
NCT03179930	NCT03179930	P2	Active, not recruiting	Lymphoma	2026-06-01	12%	2025-07-24	Primary Endpoints
NCT03280563	MORPHEUS HR+BC	P2	Completed	Breast Cancer	2024-09-26	66%	2025-11-11
NCT01928576	NA_00084192	P2	Completed	Non-Small-Cell Lung Cancer	2023-04-04	46%	2024-05-04	Patient Enrollment\|Primary Endpoints\|Treatments
NCT02697630	PEMDAC	P2	Completed	Uveal Melanoma	2023-01-31	50%	2025-08-27	Primary Endpoints\|Treatments
CTR20171558	CTR20171558	P3	Recruiting	Breast Cancer	None		2025-04-29	Patient Enrollment\|Treatments\|Trial Status
JapicCTI-173703	JapicCTI-173703	P2	Active	Breast Cancer	2021-11-01
CTR20200467	CTR20200467	P3	Active, not recruiting	Breast Cancer	None		2025-04-29	Treatments
JapicCTI-153066	JapicCTI-153066	P1	Active	Breast Cancer	2019-02-01

Recent News Events

Date	Type	Title
04/15/2025	News Article	Predictive Oncology Develops Novel Approach to Identifying Clinically Viable Abandoned Drugs
05/03/2024	PubMed	HDAC inhibitors activate lipid peroxidation and ferroptosis in gastric cancer.
04/30/2024	PubMed	Differential Effects of HDAC6 Inhibition Versus Knockout During Hepatic Ischemia-reperfusion Injury Highlight Importance of HDAC6 C-terminal Zinc-finger Ubiquitin-binding Domain.
02/22/2024	PubMed	Construction of a Novel MitochondriaAssociated Gene Model for Assessing ESCC Immune Microenvironment and Predicting Survival.
06/01/2023	News Article	Zenith Epigenetics Reports Advancement of ZEN-3694 in NUT Carcinoma
07/06/2022	News Article	Zenith Epigenetics Announces Start of Several National Cancer Institute (NCI)-Sponsored Oncology Clinical Trials
05/24/2022	News Article	No Stomach For Cancer Grant for Gastric Cancer Innovation, Education, and Opportunity Funds

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Entinostat

Alternative Names: entinostat, ms-275, sndx-275, bay 86-5274, khk-2375, khk2375, khk 2375 Clinical Status: Active Latest Update: 2025-12-03 Latest Update Note: Clinical Trial Update