TheraRadar
Data updated: May 26, 2026

TAZVERIK (tazemetostat hydrobromide)

Trial Activity: Stable 20 active trials
First-in-Class Orphan Drug Priority Review Accelerated Approval
Oncology Approved 2020-01-23

TAZVERIK is indicated for the treatment of Epithelioid Sarcoma; Follicular Lymphoma.

Source: FDA Label • EPIZYME INC
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How TAZVERIK Works

Tazemetostat is an inhibitor of the methyltransferase EZH2 (and some gain-of-function mutations). EZH2 serves as the catalytic subunit of the Polycomb Repressive Complex 2 (PRC2), which mediates the mono-, di-, and trimethylation of lysine 27

Source: FDA Label

Development Insights

Epizyme, Inc. conducting 16 trials (31%)
185 indications explored (Broad Platform)
→ follicular lymphoma (6 trials)
→ refractory follicular lymphoma (5 trials)
→ synovial sarcoma (5 trials)
2
Indications
--
Phase 3 Trials
2
Priority Reviews
6
Years on Market

Details

Status
Prescription
First Approved
2020-01-23
Patent Cliff
2038

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
TABLET

Companies

EPIZYME INC
Active Ingredient: TAZEMETOSTAT HYDROBROMIDE

TAZVERIK Approval History

2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2020 to 2024
Aug 2024 SUPPL
Label · Labeling
FDA Letter Label
Nov 2023 SUPPL
Label · Labeling
FDA Letter Label
Jun 2020 ORIGINAL Priority
Update · Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval
FDA Letter Label

What TAZVERIK Treats

2 indications

TAZVERIK is approved for 2 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Epithelioid Sarcoma
  • Follicular Lymphoma
Source: FDA Label

TAZVERIK Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

IDELALISIB
NATCO
2026 3 indic.
COLUMVI
Roche
2023 2 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in TAZVERIK's indications

See all emerging drugs →

Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TAZVERIK treats. First-in-class if their pivotal trials read out positive.

Tiragolumab MTIG7192A / RG6058 ~ Mixed — Ph3 readout
Hoffmann-La Roche
TIGIT · monoclonal antibody (anti-TIGIT) · 10 Phase 3 trials

Drugs Similar to TAZVERIK

3 of 9

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

COLUMVI
GLOFITAMAB-GXBM
1 shared
Roche
Shared indications:
Follicular Lymphoma
EPKINLY
EPCORITAMAB-BYSP
1 shared
GENMAB US, INC.
Shared indications:
Follicular Lymphoma
GAZYVA
OBINUTUZUMAB
1 shared
Roche
Shared indications:
Follicular Lymphoma
View all 9 similar drugs Pro
📋

Clinical Trial Registry

49 trials
Trial Sponsor ID Phase Status Title
NCT05353439 NCI-2022-03215 NCI-2022-03215, 22-C-0005 Ph 1 active not recruiting Testing of Tazemetostat in Combination With Topotecan and Pembrolizumab in Patients With Recurrent Small Cell Lung Cancer
NCT03854474 NCI-2019-01035 NCI-2019-01035, ETCTN 10183 Ph 1, Ph 2 active not recruiting Testing the Addition of Tazemetostat to the Immunotherapy Drug, Pembrolizumab (MK-3475), in Advanced Urothelial Carcinoma
NCT05627245 NCI-2022-05327 NCI-2022-05327, CUMC-AAAT9882 Ph 1 active not recruiting Testing the Safety of the Anti-cancer Drugs Tazemetostat and Belinostat in Patients With Lymphomas That Have Resisted Treatment
NCT04846478 21-086 Ph 1 active not recruiting Phase Ia/Ib Talazoparib + Tazemetostat for mCRPC
NCT06242834 NU 23H05 NCI-2024-00285, STU00220351 Ph 2 active not recruiting Pembrolizumab and Tazemetostat to Overcome Immune Tolerance Following ASCT or CAR T-cell Therapy in Patients With Aggressive B-Cell Non-Hodgkin's Lymphoma
NCT03155620 results posted NCI-2017-01251 NCI-2017-01251, APEC1621SC Ph 2 active not recruiting Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)
NCT03348631 results posted NCI-2017-02147 NCI-2017-02147, NRG-GY014 Ph 2 active not recruiting Tazemetostat in Treating Patients With Recurrent Ovarian or Endometrial Cancer
NCT07407283 SHR-4394-201 Ph 1, Ph 2 recruiting A Clinical Study of SHR-4394 in Combination With Anti-tumor Therapy in Prostate Cancer
NCT04224493 SYMPHONY-1 EZH-302 2019-003333-42, 2024-510690-16-00 Ph 3 active not recruiting A Study to Assess the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Tazemetostat in Combination With Lenalidomide Plus Rituximab Versus Placebo in Combination With Lenalidomide Plus Rituximab in Adult Patients at Least 18 Years of Age With Relapsed/Refractory Follicular Lymphoma.
NCT05983965 IRB-300011353 Robert Award Ph 1 terminated Study of Tazemetostat in Lymphoid Malignancies
NCT04241835 EZH-1201 2019-003368-36, 2024-517141-13-00 Ph 1 terminated A Study to Compare the Blood Levels and Safety of Tazemetostat in Participants With Advanced Cancer and Moderate/Severe Liver Impairment to Participants With Advanced Cancer and Normal Liver Function
NCT05407441 22-041 Ph 1, Ph 2 active not recruiting Tazemetostat+Nivo/Ipi in INI1-Neg/SMARCA4-Def Tumors
NCT03213665 results posted NCI-2017-01245 NCI-2017-01245, APEC1621C Ph 2 completed Tazemetostat in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With EZH2, SMARCB1, or SMARCA4 Gene Mutations (A Pediatric MATCH Treatment Trial)
NCT06824701 TARZAN HCI183680 Ph 1 suspended Tazemetostat in Combination With Zanubrutinib and Anti-CD20 Monoclonal Antibody in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
NCT04557956 NCI-2020-07044 NCI-2020-07044, 202103077 Ph 1, Ph 2 active not recruiting Testing the Addition of the Anti-cancer Drug, Tazemetostat, to the Usual Treatment (Dabrafenib and Trametinib) for Metastatic Melanoma That Has Progressed on the Usual Treatment
NCT05618366 22-04024678 Ph 1 terminated Tazemetostat and Venetoclax in Relapsed/Refractory Non-Hodgkin Lymphoma
NCT06692452 24-462 Ph 2 withdrawn Tazemetostat Plus CHOP in 1L T-cell Lymphoma
NCT05023655 EPZ-IST-001 Ph 2 terminated Phase II Study of Tazemetostat in Solid Tumors Harboring an ARID1A Mutation
NCT05627232 22G.769 JT 24252, 4100095617 Ph 1 recruiting Tazemetostat and Palbociclib With CPX-351for R/R AML
NCT04179864 CELLO-1 results posted EZH-1101 2019-003649-14 Ph 1, Ph 2 terminated A Study of Tazemetostat With Enzalutamide or Abiraterone/Prednisone in Participants With Advanced Prostate Cancer
NCT04705818 CAIRE IB2019-04 2019-003303-35 Ph 2 completed Combining Epigenetic And Immune Therapy to Beat Cancer.
NCT05551936 BTCRC LYM20-463 Ph 1, Ph 2 active not recruiting A Study of Tazemetostat With Rituximab and Abbreviated Bendamustine in the Frontline Treatment of High Tumor Burden Follicular Lymphoma
NCT04917042 results posted UF-SC-001 IRB202100865, OCR40197 Ph 2 active not recruiting Tazemetostat in Malignant Peripheral Nerve Sheath Tumors
NCT06575686 23820 NCI-2024-06708, 23820 Ph 2 suspended Epcoritamab and Tazemetostat for the Treatment of Relapsed or Refractory Grade I-IIIa Follicular Lymphoma
NCT04204941 EZH-301 2019-003648-55 Ph 1 terminated Tazemetostat in Combination With Doxorubicin as Frontline Therapy for Advanced Epithelioid Sarcoma
NCT02875548 TRuST EZH-501 2015-004984-35, 2023-510553-41-00 Ph 1, Ph 2 completed A Study to Assess Long-term Safety of Tazemetostat in Adult Participants of All Ages With Any Disease Treated With Tazemetostat in a Previous Clinical Study
NCT05890352 S2207 NCI-2023-02518, S2207 Ph 2 recruiting Study Adding Drugs to Usual Treatment for Large B-Cell Lymphoma That Returned or Did Not Respond to Treatment
NCT07209163 PTCL-EZH2 Ph 1, Ph 2 not yet recruiting Combination Therapy With Tazemetostat in Relapsed and Refractory Peripheral T-cell Lymphoma
NCT05372354 CA057-003 2023-509384-25, U1111-1269-5704 Ph 1, Ph 2 recruiting A Study to Evaluate Safety, Drug Levels and Effectiveness of CC-92480 (BMS-986348) in Combination With Other Treatments in Participants With Relapsed or Refractory Multiple Myeloma
NCT02601950 results posted EZH-202 2015-002469-41 Ph 2 completed A Study of Tazemetostat in Adult Participants With Soft Tissue Sarcoma
NCT04537715 results posted EZH-108 2020-002669-33 Ph 1 completed Effects of Itraconazole and Rifampin on the Blood Tazemetostat Levels
NCT05467943 2021-TAZ-00CH1 Ph 2 completed Tazemetostat for the Treatment of Relapsed/Refractory Follicular Lymphoma
NCT05713110 2021-TAZ-00CH2 Ph 2 completed A Study of Tazemetostat in Combination With HMPL-689 in Patients With Relapsed/Refractory Lymphoma
NCT02889523 Epi-RCHOP Epi-RCHOP Ph 1, Ph 2 active not recruiting Study of Tazemetostat in Newly Diagnosed Diffuse Large B Cell and Follicular Lymphoma Patients Treated by Chemiotherapy
NCT02601937 results posted EZH-102 2015-002468-18 Ph 1 completed EZH2 Inhibitor Tazemetostat in Pediatric Subjects With Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma
NCT01897571 results posted E7438-G000-101 2012-004083-21 Ph 1, Ph 2 completed Study of Tazemetostat as Single Agent in Solid Tumors or B-cell Lymphomas and in Combination With Prednisolone in DLBCL
NCT04762160 results posted EZH-1401 Ph 2 terminated SYMPHONY-2, A Trial to Examine Combination of Tazemetostat With Rituximab in Subjects With Relapsed/Refractory Follicular Lymphoma
NCT04624113 202011174 Ph 1 terminated Tazemetostat and Pembrolizumab in Patients With Pembrolizumab- or Nivolumab-Resistant, Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma
NCT05205252 ARIA EZH-1501 Ph 1, Ph 2 withdrawn A Study of Tazemetostat in Combination With Various Treatments in Participants With Blood Cancer.
NCT05604417 22-103 Ph 1, Ph 2 withdrawn Zandelisib + Tazemetostat in R/R Follicular Lymphoma
NCT03028103 results posted EZH-105 Ph 1 completed Open-Label, Multicenter, Two-Part, Phase 1 Study to Characterize Effects of a Moderate CYP3A Inhibitor on PK of Tazemetostat, Effects of Tazemetostat on PK of CYP2C8 and CYP2C19 Substrates, and Effect of Increased Gastric pH on PK of Tazemetostat in B-cell Lymphoma or Advanced Solid Tumor Patients
NCT05152459 21303 NCI-2021-12560, 21303 Ph 1, Ph 2 withdrawn Tazemetostat in Combination With Umbralisib and Ublituximab for the Treatment Relapsed or Refractory Follicular Lymphoma
NCT05151588 SMART-PNS Ph 2 not yet recruiting Induction Chemotherapy and Tazemetostat for Locally Advanced SMARCB1-deficient Sinonasal Carcinoma
NCT03456726 results posted E7438-J081-206 Ph 2 completed Study of Tazemetostat in Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma With EZH2 Gene Mutation
NCT03009344 results posted E7438-J081-106 Ph 1 completed A Study of Tazemetostat in Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
NCT05018975 IST 2210094 Ph 2 withdrawn Tazemetostat for the Treatment of Moderate to Severe COVID-19 Infection
NCT02860286 results posted EZH-203 Ph 2 completed Study of the EZH2 Inhibitor Tazemetostat in Malignant Mesothelioma
NCT03217253 NCI-2017-01231 NCI-2017-01231, PJC-025 Ph 1 withdrawn Tazemetostat in Treating Patients With Metastatic or Unresectable Solid Tumors or B-Cell Lymphomas With Liver Dysfunction
NCT02220842 GO29383 2014-001812-21 Ph 1 completed A Safety and Pharmacology Study of Atezolizumab (MPDL3280A) Administered With Obinutuzumab or Tazemetostat in Participants With Relapsed/Refractory Follicular Lymphoma and Diffuse Large B-cell Lymphoma
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

TAZVERIK FDA Label Details

Indications & Usage

FDA Label (PDF)

TAZVERIK is indicated for the treatment of Epithelioid Sarcoma; Follicular Lymphoma.

View full patent landscape →
27 OB patents · 7 families · 463 international docs across 38 countries

TAZVERIK Patents & Exclusivity

Latest Patent: May 2038
Exclusivity: Jun 2027

Patents (27 active)

US12168014 Expires May 3, 2038
US10786511 Expires Dec 19, 2035
US9889138 Expires Oct 16, 2035
US10369155 Expires Oct 16, 2035
US9688665 Expires Aug 22, 2034
US12162865 Expires Jun 12, 2034
US8410088 Expires Jan 23, 2034
US10245269 Expires Apr 11, 2033
US9394283 Expires Apr 11, 2033
US11491163 Expires Apr 11, 2033
US10821113 Expires Apr 11, 2033
US10155002 Expires Sep 12, 2031
US9549931 Expires Sep 12, 2031
US9855275 Expires Sep 12, 2031
US10420775 Expires Sep 12, 2031
US11052093 Expires Sep 12, 2031
US8765732 Expires Sep 12, 2031
US9334527 Expires Sep 12, 2031
US9333217 Expires Sep 12, 2031
US8691507 Expires Sep 12, 2031
US9175331 Expires Sep 12, 2031
US8895245 Expires Sep 12, 2031
US9949999 Expires Sep 12, 2031
US12161645 Expires Sep 12, 2031
US12168016 Expires Sep 12, 2031
US9090562 Expires Sep 12, 2031
US12168015 Expires Sep 12, 2031

Exclusivity

ODE-299 Until Jan 2027
ODE-314 Until Jun 2027
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for TAZVERIK

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2038
  • • 46 active patents

Trial Analysis

  • • 52 total trials
  • • Stage: Stable

Competitive Landscape

  • • 9 similar drugs
  • • Same target/indication analysis
Unlock Full Intelligence

Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA211723 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment