Drugs / Tazemetostat
Tazemetostat
also known as
EPZ-6438 · Tazverik · CT-EPZ438EPZ-6438EPZ6438A-1623E-7438E7438 · E-7438 · E-7438 HYDROBROMIDE · EPZ-6438 HYDROBROMIDE · EPZ-6438 MONOHYDROBROMIDE · EZ-438 · +3 more
Small molecule targets EZH2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | TAZVERIK | — | 2020-01-23 | fda.gov ↗ |
Trials 53
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2026-03-09 | Ipsen | Regulatory Ipsen voluntarily withdraws Tazverik® (tazemetostat) in follicular lymphoma and epithelioid sarcoma ipsen.com ↗ |
| 2026-03-09 | Hutchison Medipharma Limited | Regulatory HUTCHMED Announces Update on Licensed Oncology Product TAZVERIK® in China hutch-med.com ↗
Consequently, HUTCHMED Limited has initiated a withdrawal and product recall from the Chinese mainland, Hong Kong and Macau, and is discontinuing all active tazemetostat clinical trials. |
| 2025-12-08 | Hutchison Medipharma Limited | Regulatory HUTCHMED Announces Expanded Coverage on National Reimbursement Drug List and Inclusion in the First Commercial Insurance Drug List in China hutch-med.com ↗
In addition, TAZVERIK® will be included in the first edition of the National Commercial Health Insurance Innovative Drug List (“Commercial Insurance Drug List”). |
| 2025-08-29 | Eisai Inc. | Regulatory Ministry Of Health, Labour and Welfare Grants Orphan Drug Designation in Japan to Anticancer Agent Tazemetostat for Unresectable INI1-Negative Epithelioid Sarcoma eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has received orphan drug designation for anticancer agent the EZH2 *1 inhibitor tazemetostat hydrobromide (generic name, product name “Tazverik ® Tablets 200 mg”, “tazemetostat”) for unresectable INI1 *2 -negative epithelioid sarcoma that has progressed after chemotherapy, from the Ministry of Health, Labour and Welfare (MHLW). |
| 2025-06-12 | Bristol-Myers Squibb | Results Bristol Myers Squibb Presents Data Across Targeted Protein Degradation Research Including CELMoD™ Agents and BCL6 Ligand-Directed Degrader at EHA 2025 bms.com ↗
50% for mezigdomide plus EZH2 inhibitor tazemetostat and dexamethasone (n=16) |
| 2025-03-21 | Hutchison Medipharma Limited | Regulatory HUTCHMED Announces NMPA Conditional Approval for TAZVERIK® (tazemetostat) for the Treatment of Relapsed or Refractory Follicular Lymphoma hutch-med.com ↗
HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the New Drug Application (“NDA”) for TAZVERIK® (tazemetostat) has been granted conditional approval in China for the treatment of adult patients with relapsed or refractory (“R/R”) follicular lymphoma (“FL”) with EZH2 mutation who have received at least two prior systemic therapies. |
| 2024-07-04 | Hutchison Medipharma Limited | Regulatory HUTCHMED Announces NDA Acceptance in China for Tazemetostat for the Treatment of Relapsed or Refractory Follicular Lymphoma with Priority Review Status hutch-med.com ↗
the New Drug Application (“NDA”) for tazemetostat for the treatment of adult patients with relapsed or refractory (“R/R”) follicular lymphoma (“FL”) has been accepted for review and granted Priority Review by the China National Medical Products Administration (“NMPA”). |
| 2022-06-01 | Hutchison Medipharma Limited | Regulatory HUTCHMED Announces TAZVERIK® Approved to be Used in Hainan Pilot Zone in China hutch-med.com ↗
The approval of TAZVERIK® in the Hainan Pilot Zone allows patients to gain early access to this first-in-class EZH2 inhibitor in China, as part of our commitment to bringing innovative medicines to people in need. |
| 2021-06-23 | Eisai Inc. | Regulatory ANTICANCER AGENT “TAZVERIK® TABLETS 200mg” (TAZEMETOSTAT HYDROBROMIDE) APPROVED IN JAPAN FOR EZH2 GENE MUTATION-POSITIVE FOLLICULAR LYMPHOMA eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has obtained manufacturing and marketing approval for the EZH2 inhibitor “Tazverik ® Tablets 200 mg” (tazemetostat hydrobromide) in Japan with the indication of relapsed or refractory EZH2 gene mutation-positive follicular lymphoma (only when standard treatment is not applicable). |
| 2020-07-08 | Eisai Inc. | Regulatory EISAI SUBMITS MARKETING AUTHORIZATION APPLICATION IN JAPAN FOR ANTICANCER AGENT TAZEMETOSTAT FOR EZH2 GENE MUTATION-POSITIVE FOLLICULAR LYMPHOMA eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has submitted a marketing authorization application in Japan for the EZH2 inhibitor tazemetostat hydrobromide (generic name, development code: E7438, “tazemetostat”) for EZH2 gene mutation-positive follicular lymphoma. |
All press releases naming this drug 18 releases
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 58 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tazemetostat | “Tazemetostat (Tazverik) 200 mg oral tablets; 800 mg by mouth twice daily for 28 days” NCT05567679 ↗55“Atezolizumab, Tazemetostat, Panobinostat, Olaparib” NCT05774886 ↗ |
| Known as | CT-EPZ438EPZ-6438EPZ6438A-1623E-7438E7438 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3414621 ↗ |
| Known as | E-7438 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3414621 ↗ |
| Known as | E-7438 HYDROBROMIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3414621 ↗ |
| Known as | EPZ-6438 | “Tazemetostat (EPZ-6438) is a selective small molecule inhibitor of the histone-lysine methyltransferase EZH2 gene.” NCT02860286 ↗1“Tazemetostat (EPZ-6438) is a selective small molecule inhibitor of the histone-lysine methyltransferase EZH2 gene” NCT03874455 ↗ |
| Known as | EPZ-6438 HYDROBROMIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3414621 ↗ |
| Known as | EPZ-6438 MONOHYDROBROMIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3414621 ↗ |
| Known as | EZ-438 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3414621 ↗ |
| Known as | TAZEMETOSTAT (EPZ-6438) | ChEMBL registry synonym — accepted as the source's own label CHEMBL3414621 ↗ |
| Known as | Tazemetostat Hydrobromide | “I. To identify a maximum tolerated dose for the EZH2 inhibitor, tazemetostat hydrobromide (tazemetostat), when used in combination with dual BRAF inhibitor (dabrafenib mesylate...” NCT04557956 ↗ |
| Known as | Tazemetostat monohydrobromide | ChEMBL registry synonym — accepted as the source's own label CHEMBL3414621 ↗ |
| Known as | Tazverik | “Tazemetostat (Tazverik) 200 mg oral tablets; 800 mg by mouth twice daily for 28 days” NCT05567679 ↗1“Tazverik (Tazemetostat)” NCT06068881 ↗ |
| Action | Inhibit | “selective inhibitor of EZH2” PMID 29650362 ↗ Apr 2018 |
| Modality | Small molecule | “selective small molecule inhibitor” NCT02601937 ↗ |
| Route | Oral | “Tazemetostat was administered orally” PMID 29650362 ↗ Apr 2018 |
| Target | EZH2 | “selective inhibitor of EZH2” PMID 29650362 ↗ Apr 2018 |