Numerous clinical trials spanning Early Phase 1 through Phase 3 evaluate tazemetostat as monotherapy and in combination therapies across diverse oncological and inflammatory conditions. These studies predominantly focus on relapsed or refractory malignancies, including advanced solid tumors, prostate cancer, and hematologic cancers such as follicular, diffuse large B-cell, and mantle cell lymphomas. Sponsored by pharmaceutical companies and academic cooperative groups, trial statuses range from recruiting and active to completed, terminated, or withdrawn.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05994235 | ACTIVE_NOT_RECRUITING | Follicular Lymphoma |
Weill Medical College of Cornell University |
2023-11-01 | PHASE2 |
| NCT06824701 | ACTIVE_NOT_RECRUITING | Relapsed or Refractory B-cell Non-Hodgkin Lymphoma |
University of Utah |
2025-09-12 | PHASE1 |
| NCT06068881 | WITHDRAWN | Follicular Lymphoma; Refractory Follicular Lymphoma |
Epizyme, Inc. |
2025-09-02 | PHASE2 |
| NCT06575686 | SUSPENDED | Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3a Follicular Lymphoma; Refractory Grade 1 Follicular Lymphoma; Refractory Grade 2 Follicular Lymphoma; Refractory Grade 3a Follicular Lymphoma |
City of Hope Medical Center |
2025-03-11 | PHASE2 |
| NCT05627232 | RECRUITING | Recurrent Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia |
Thomas Jefferson University |
2023-08-28 | PHASE1 |
| NCT07407283 | RECRUITING | Prostate Cancer |
Jiangsu HengRui Medicine Co., Ltd. |
2026-04-08 | PHASE1; PHASE2 |
| NCT06692452 | WITHDRAWN | Lymphoma; Peripheral T Cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; Enteropathy-Associated T-Cell Lymphoma; Monomorphic Epitheliotropic Intestinal T-Cell Lymphoma |
Eric Jacobsen, MD |
2024-12-24 | PHASE2 |
| NCT03854474 | ACTIVE_NOT_RECRUITING | Locally Advanced Urothelial Carcinoma; Metastatic Urothelial Carcinoma; Stage III Bladder Cancer AJCC v8; Stage IV Bladder Cancer AJCC v8 |
National Cancer Institute (NCI) |
2019-11-18 | PHASE1; PHASE2 |
| NCT04812366 | RECRUITING | Prostate Cancer |
University of British Columbia |
2021-09-21 | PHASE2 |
| NCT06242834 | ACTIVE_NOT_RECRUITING | B-Cell Non-Hodgkin Lymphoma |
Northwestern University |
2024-09-30 | PHASE2 |
| NCT04224493 | ACTIVE_NOT_RECRUITING | Relapsed/Refractory Follicular Lymphoma; Follicular Lymphoma; Refractory Follicular Lymphoma |
Epizyme, Inc. |
2020-06-11 | PHASE3 |
| NCT05407441 | ACTIVE_NOT_RECRUITING | Atypical Teratoid Rhabdoid Tumor; INI1 (SMARCB1)-Deficient Primary CNS Malignant Tumors; SMARCA4-deficient Primary CNS Malignant Tumors; Malignant Rhabdoid Tumor (MRT); Rhabdoid Tumor of the Kidney (RTK); Epithelioid Sarcoma; Chordoma |
Susan Chi, MD |
2023-08-10 | PHASE1; PHASE2 |
| NCT05890352 | RECRUITING | Grade 3b Follicular Lymphoma; High Grade B-Cell Lymphoma; High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements; Recurrent Diffuse Large B-Cell Lymphoma; Refractory Diffuse Large B-Cell Lymphoma; Transformed Non-Hodgkin Lymphoma |
SWOG Cancer Research Network |
2023-09-26 | PHASE2 |
| NCT05372354 | RECRUITING | Multiple Myeloma |
Bristol-Myers Squibb |
2022-10-18 | PHASE1; PHASE2 |
| NCT05627245 | ACTIVE_NOT_RECRUITING | Recurrent B-Cell Non-Hodgkin Lymphoma; Recurrent Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type; Recurrent Follicular Lymphoma; Recurrent Non-Hodgkin Lymphoma; Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma; Recurrent T-Cell Non-Hodgkin Lymphoma; Recurrent Transformed Non-Hodgkin Lymphoma; Refractory B-Cell Non-Hodgkin Lymphoma; Refractory Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type; Refractory Follicular Lymphoma; Refractory Non-Hodgkin Lymphoma; Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma; Refractory T-Cell Non-Hodgkin Lymphoma; Refractory Transformed Non-Hodgkin Lymphoma |
National Cancer Institute (NCI) |
2023-03-01 | PHASE1 |
| NCT05151588 | NOT_YET_RECRUITING | Sinonasal Carcinoma |
Dr. Victor H.F. Lee |
2023-09-01 | PHASE2 |
| NCT05934838 | ACTIVE_NOT_RECRUITING | Follicular Lymphoma; B-Cell Lymphoma; Mantle Cell Lymphoma; Diffuse Large B Cell Lymphoma |
Weill Medical College of Cornell University |
2023-10-04 | PHASE1 |
| NCT05551936 | ACTIVE_NOT_RECRUITING | Follicular Lymphoma |
Vaishalee Kenkre |
2023-01-26 | PHASE1; PHASE2 |
| NCT05023655 | TERMINATED | Solid Tumor; ARID1A Gene Mutation |
Prisma Health-Upstate |
2022-01-06 | PHASE2 |
| NCT05983965 | TERMINATED | T-cell Lymphoma |
University of Alabama at Birmingham |
2024-09-05 | PHASE1 |
| NCT07209163 | NOT_YET_RECRUITING | Peripheral T Cell Lymphoma |
Ruijin Hospital |
2025-10 | PHASE1; PHASE2 |
| NCT05618366 | TERMINATED | Lymphoma, Non-Hodgkin; Diffuse Large B Cell Lymphoma; Follicular Lymphoma |
Weill Medical College of Cornell University |
2023-06-07 | PHASE1 |
| NCT05353439 | ACTIVE_NOT_RECRUITING | Extensive Stage Lung Small Cell Carcinoma; Limited Stage Lung Small Cell Carcinoma; Platinum-Resistant Lung Small Cell Carcinoma; Platinum-Sensitive Lung Small Cell Carcinoma; Recurrent Extensive Stage Lung Small Cell Carcinoma; Recurrent Lung Small Cell Carcinoma |
National Cancer Institute (NCI) |
2022-07-27 | PHASE1 |
| NCT05567679 | WITHDRAWN | Prostate Cancer |
Edwin Posadas, MD |
2023-12 | EARLY_PHASE1 |
| NCT04557956 | ACTIVE_NOT_RECRUITING | Clinical Stage IV Cutaneous Melanoma AJCC v8; Metastatic Melanoma |
National Cancer Institute (NCI) |
2021-08-19 | PHASE1; PHASE2 |
| NCT02875548 | COMPLETED | Diffuse Large B-cell Lymphoma (DLBCL); Follicular Lymphoma (FL); Synovial Sarcoma; Epitheliod Sarcoma (ES); Mesothelioma; Advanced Solid Tumors; Renal Medullary Carcinoma; Non-Hodgkin Lymphoma (NHL) |
Epizyme, Inc. |
2016-08-30 | PHASE1; PHASE2 |
| NCT04846478 | ACTIVE_NOT_RECRUITING | Metastatic Prostate Cancer; Metastatic Castration-resistant Prostate Cancer |
Dana-Farber Cancer Institute |
2021-06-28 | PHASE1 |
| NCT03155620 | ACTIVE_NOT_RECRUITING | Advanced Malignant Solid Neoplasm; Ann Arbor Stage III Non-Hodgkin Lymphoma; Ann Arbor Stage IV Non-Hodgkin Lymphoma; Histiocytic Sarcoma; Juvenile Xanthogranuloma; Langerhans Cell Histiocytosis; Malignant Glioma; Recurrent Childhood Rhabdomyosarcoma; Recurrent Ependymoma; Recurrent Ewing Sarcoma; Recurrent Glioma; Recurrent Hepatoblastoma; Recurrent Langerhans Cell Histiocytosis; Recurrent Malignant Germ Cell Tumor; Recurrent Malignant Solid Neoplasm; Recurrent Medulloblastoma; Recurrent Neuroblastoma; Recurrent Non-Hodgkin Lymphoma; Recurrent Osteosarcoma; Recurrent Peripheral Primitive Neuroectodermal Tumor; Recurrent Primary Central Nervous System Neoplasm; Recurrent Rhabdoid Tumor; Recurrent Soft Tissue Sarcoma; Refractory Ewing Sarcoma; Refractory Glioma; Refractory Hepatoblastoma; Refractory Langerhans Cell Histiocytosis; Refractory Malignant Germ Cell Tumor; Refractory Malignant Solid Neoplasm; Refractory Medulloblastoma; Refractory Neuroblastoma; Refractory Non-Hodgkin Lymphoma; Refractory Osteosarcoma; Refractory Peripheral Primitive Neuroectodermal Tumor; Refractory Primary Central Nervous System Neoplasm; Refractory Rhabdoid Tumor; Refractory Rhabdomyosarcoma; Rhabdoid Tumor; Stage III Osteosarcoma AJCC v7; Stage III Soft Tissue Sarcoma AJCC v7; Stage IV Osteosarcoma AJCC v7; Stage IV Soft Tissue Sarcoma AJCC v7; Stage IVA Osteosarcoma AJCC v7; Stage IVB Osteosarcoma AJCC v7; Wilms Tumor |
National Cancer Institute (NCI) |
2017-07-31 | PHASE2 |
| NCT04241835 | TERMINATED | Hepatic Impairment; Advanced Malignant Solid Tumor |
Epizyme, Inc. |
2020-01-15 | PHASE1 |
| NCT04917042 | ACTIVE_NOT_RECRUITING | Peripheral Nerve Sheath Tumor |
University of Florida |
2021-08-25 | PHASE2 |
| NCT05713110 | COMPLETED | Relapsed/Refractory Lymphoma |
Hutchmed |
2023-02-13 | PHASE2 |
| NCT05152459 | WITHDRAWN | Recurrent Follicular Lymphoma; Refractory Follicular Lymphoma |
City of Hope Medical Center |
2023-05-01 | PHASE1; PHASE2 |
| NCT05604417 | WITHDRAWN | Relapsed Follicular Lymphoma; Refractory Follicular Lymphoma |
Jacob Soumerai, MD |
2023-01 | PHASE1; PHASE2 |
| NCT05467943 | COMPLETED | Relapsed/Refractory Follicular Lymphoma With EZH2 |
Hutchmed |
2022-07-29 | PHASE2 |
| NCT04179864 | TERMINATED | Metastatic Prostate Cancer; Metastatic Castration-resistant Prostate Cancer |
Epizyme, Inc. |
2019-11-18 | PHASE1; PHASE2 |
| NCT04204941 | TERMINATED | Advanced Soft-tissue Sarcoma; Advanced Epithelioid Sarcoma |
Epizyme, Inc. |
2019-12-19 | PHASE1 |
| NCT02601950 | COMPLETED | Malignant Rhabdoid Tumors (MRT); Rhabdoid Tumors of the Kidney (RTK); Atypical Teratoid Rhabdoid Tumors (ATRT); Selected Tumors With Rhabdoid Features; Synovial Sarcoma; INI1-negative Tumors; Malignant Rhabdoid Tumor of Ovary; Renal Medullary Carcinoma; Epithelioid Sarcoma; Poorly Differentiated Chordoma (or Other Chordoma With Sponsor Approval); Any Solid Tumor With an EZH2 GOF Mutation |
Epizyme, Inc. |
2015-12-22 | PHASE2 |
| NCT04705818 | COMPLETED | Advanced Solid Tumor; Advanced Colorectal Carcinoma; Advanced Soft-tissue Sarcoma; Advanced Pancreatic Adenocarcinoma; Adult Solid Tumor |
Institut Bergonié |
2021-07-23 | PHASE2 |
| NCT05018975 | WITHDRAWN | COVID-19 Acute Respiratory Distress Syndrome; Cytokine Release Syndrome |
Loma Linda University |
2022-01 | PHASE2 |
| NCT03348631 | ACTIVE_NOT_RECRUITING | Recurrent Endometrial Endometrioid Adenocarcinoma; Recurrent Malignant Uterine Corpus Neoplasm; Recurrent Ovarian Carcinoma; Recurrent Ovarian Clear Cell Adenocarcinoma; Recurrent Ovarian Endometrioid Adenocarcinoma |
National Cancer Institute (NCI) |
2019-05-01 | PHASE2 |
| NCT05205252 | WITHDRAWN | Relapsed Hematologic Malignancy; Refractory Hematologic Malignancy |
Epizyme, Inc. |
2021-12-22 | PHASE1; PHASE2 |
| NCT04537715 | COMPLETED | All Malignancies; Advanced Malignancies; Hematologic Malignancy; Solid Tumor; Follicular Lymphoma (FL); Non-Hodgkin Lymphoma (NHL); Diffuse Large B-Cell Lymphoma (DLBCL); Epithelioid Sarcoma (ES); Synovial Sarcoma; Renal Medullary Carcinoma; Mesothelioma; Rhabdoid Tumor |
Epizyme, Inc. |
2020-04-23 | PHASE1 |
| NCT02889523 | ACTIVE_NOT_RECRUITING | Lymphoma; DLBCL; Follicular Lymphoma |
The Lymphoma Academic Research Organisation |
2016-10 | PHASE1; PHASE2 |
| NCT04624113 | TERMINATED | Head and Neck Squamous Cell Carcinoma |
Washington University School of Medicine |
2021-04-14 | PHASE1 |
| NCT03213665 | COMPLETED | Advanced Malignant Solid Neoplasm; Ann Arbor Stage III Hodgkin Lymphoma; Ann Arbor Stage III Non-Hodgkin Lymphoma; Ann Arbor Stage IV Hodgkin Lymphoma; Ann Arbor Stage IV Non-Hodgkin Lymphoma; Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Low Grade Glioma; Recurrent Ependymoma; Recurrent Ewing Sarcoma; Recurrent Glioma; Recurrent Hepatoblastoma; Recurrent Hodgkin Lymphoma; Recurrent Langerhans Cell Histiocytosis; Recurrent Malignant Germ Cell Tumor; Recurrent Malignant Glioma; Recurrent Malignant Solid Neoplasm; Recurrent Medulloblastoma; Recurrent Neuroblastoma; Recurrent Non-Hodgkin Lymphoma; Recurrent Osteosarcoma; Recurrent Peripheral Primitive Neuroectodermal Tumor; Recurrent Primary Central Nervous System Neoplasm; Recurrent Rhabdoid Tumor; Recurrent Rhabdomyosarcoma; Recurrent Soft Tissue Sarcoma; Refractory Hodgkin Lymphoma; Refractory Langerhans Cell Histiocytosis; Refractory Malignant Germ Cell Tumor; Refractory Malignant Glioma; Refractory Malignant Solid Neoplasm; Refractory Medulloblastoma; Refractory Neuroblastoma; Refractory Non-Hodgkin Lymphoma; Refractory Osteosarcoma; Refractory Peripheral Primitive Neuroectodermal Tumor; Refractory Rhabdoid Tumor; Refractory Soft Tissue Sarcoma; Rhabdoid Tumor; Stage III Soft Tissue Sarcoma AJCC v7; Stage IV Soft Tissue Sarcoma AJCC v7; Wilms Tumor |
National Cancer Institute (NCI) |
2017-11-13 | PHASE2 |
| NCT04762160 | TERMINATED | Follicular Lymphoma |
Epizyme, Inc. |
2020-12-15 | PHASE2 |
| NCT03456726 | COMPLETED | Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma |
Eisai Co., Ltd. |
2018-04-09 | PHASE2 |
| NCT01897571 | COMPLETED | B-cell Lymphomas (Phase 1); Advanced Solid Tumors (Phase 1); Diffuse Large B-cell Lymphoma (Phase 2); Follicular Lymphoma (Phase 2); Transformed Follicular Lymphoma; Primary Mediastinal Large B-Cell Lymphoma |
Epizyme, Inc. |
2013-06-13 | PHASE1; PHASE2 |
| NCT02601937 | COMPLETED | Rhabdoid Tumors; INI1-negative Tumors; Synovial Sarcoma; Malignant Rhabdoid Tumor of Ovary |
Epizyme, Inc. |
2016-01-07 | PHASE1 |
| NCT02220842 | COMPLETED | Lymphoma |
Hoffmann-La Roche |
2014-12-18 | PHASE1 |
| NCT03028103 | COMPLETED | Diffuse Large B Cell Lymphoma; Primary Mediastinal Lymphoma; Mantle Cell Lymphoma; Advanced Solid Tumor; Marginal Zone Lymphoma |
Epizyme, Inc. |
2017-03-27 | PHASE1 |
| NCT03217253 | WITHDRAWN | Ann Arbor Stage III B-Cell Non-Hodgkin Lymphoma; Ann Arbor Stage IV B-Cell Non-Hodgkin Lymphoma; Metastatic Malignant Solid Neoplasm; Stage III Hepatocellular Carcinoma AJCC v7; Stage IIIA Hepatocellular Carcinoma AJCC v7; Stage IIIB Hepatocellular Carcinoma AJCC v7; Stage IIIC Hepatocellular Carcinoma AJCC v7; Stage IV Hepatocellular Carcinoma AJCC v7; Stage IVA Hepatocellular Carcinoma AJCC v7; Stage IVB Hepatocellular Carcinoma AJCC v7; Unresectable Solid Neoplasm |
National Cancer Institute (NCI) |
2018-03-16 | PHASE1 |
| NCT03010982 | COMPLETED | Diffuse Large B Cell Lymphoma; Primary Mediastinal Lymphoma; Mantle-Cell Lymphoma; Follicular Lymphoma; Marginal Zone Lymphoma; Advanced Solid Tumors |
Epizyme, Inc. |
2018-06-20 | PHASE1 |
| NCT02860286 | COMPLETED | Mesothelioma; BAP1 Loss of Function |
Epizyme, Inc. |
2016-07 | PHASE2 |
| NCT03009344 | COMPLETED | Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma |
Eisai Co., Ltd. |
2017-01-10 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-04-02)
Check the
EPZ-6438 (Tazemetostat)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
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>).
- EPZ-6438 (Tazemetostat) Mechanism of Action: EZH2 Inhibition in B-Cell Research
- EPZ-6438 (Tazemetostat): Selectivity & Specificity
- EPZ-6438 (Tazemetostat) Working Concentration | Cell Culture | Treatment
- EPZ-6438 (Tazemetostat) Solubility in DMSO
- EPZ-6438 (Tazemetostat) Stock Solution
- EPZ-6438 (Tazemetostat) Storage
- EPZ-6438 (Tazemetostat) Stability
- EPZ-6438 (Tazemetostat) VS GSK126 | 3-Deazaneplanocin A (DZNep) Hydrochloride
- EPZ-6438 (Tazemetostat) Molecular Weight
- EPZ-6438 (Tazemetostat) SMILES
- EPZ-6438 (Tazemetostat) CAS Number
- EPZ-6438 (Tazemetostat) Chemical Structure (2D and 3D)
- EPZ-6438 (Tazemetostat) IC50 for Cell-based and Cell-free Assays
- EPZ-6438 (Tazemetostat) Sigma (SBR00098)? Try a better option.
- EPZ-6438 (Tazemetostat) MedChemExpress (HY-13803)? Try a better option.
- EPZ-6438 (Tazemetostat) Cayman (16174)? Try a better option.
- EPZ-6438 (Tazemetostat) Tocris (8093)? Try a better option.
- EPZ-6438 (Tazemetostat) TargetMol (T1788)? Try a better option.
- EPZ-6438 (Tazemetostat) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.