Drugs / Tucidinostat
Tucidinostat
also known as
chidamide · HBI-8000 · CS055 · Chi · Chidamide (Tucidinostat) · CS055/HBI-8000 · Epidaza · Epidaza in china · +1 more
Small molecule targets HDAC1, HDAC3 via inhibition
Trials 254 · started per year
today
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News releases announcing trial results or a regulatory action · 33
| Date | Issuer | Release |
|---|---|---|
| 2026-07-15 | Chipscreen Biosciences, Ltd. | Results Chipscreen Biosciences' Partner HUYABIO Announces Positive Topline Data from Global Multicenter Phase III Trial of Chidamide (Epidaza®) in Melanoma chipscreen.com ↗
Patients treated with chidamide in combination with nivolumab achieved a median progression-free survival (mPFS) of 11.7 months, compared with 7.4 months for patients receiving placebo in combination with nivolumab, demonstrating a statistically significant and clinically meaningful improvement. |
| 2026-04-27 | Great Novel Therapeutics Biotech & Medicals Corporation | Results 華上生醫舉辦表觀遺傳調控劑開發學術研討會 com.tw ↗
本次學術研討會特別邀請雙和醫院乳癌專家趙祖怡教授，來分享剋必達®如何成功開發用於乳癌的治療，這也是這類表觀遺傳調控劑在全球首次在晚期乳癌獲得臨床三期試驗積極且正面的結果，藉由更深層的表觀遺傳獨特的機制，增加內分泌治療的敏感度，大幅提升抗乳癌的治療效益。 |
| 2026-04-23 | Chipscreen Biosciences, Ltd. | Results Published in JAMA ! Chidamide DEB Study Reshapes the First-Line Treatment Landscape for DE-DLBCL chipscreen.com ↗
The publication of this research result contributes high-quality evidence from China to the international diagnosis and treatment of lymphoma, demonstrating the leadership of Chinese scholars in clinical research on original anti-tumor drugs. |
| 2026-04-07 | Great Novel Therapeutics Biotech & Medicals Corporation | Results 剋必達提供晚期乳癌第一線CDK4/6聯合內分泌治療抗藥後的新選擇 com.tw ↗
這也是首次發現，「表觀遺傳調控劑Tucidinostat聯合CDK4/6抑制劑」的組合，用於第二線治療獲得突破性的優越療效，不需要再聯合內分泌治療。 |
| 2025-12-07 | Chipscreen Biosciences, Ltd. | Regulatory Chidamide is Included in the National Reimbursement Drug List (NRDL) as a Regular Category B Drug chipscreen.com ↗
Epidaza® (Chidamide Tablets), a first-in-class drug independently developed by Chipscreen Biosciences, has been included in the NRDL as a regular Category B drug. |
| 2025-11-03 | Chipscreen Biosciences, Ltd. | Results ESMO 2025 | Chidamide Combined with PD-1 Antibody Sets New Record in Treating Advanced Sarcoma: ORR 30.4%, DCR 73.9% chipscreen.com ↗
The data presented showed an objective response rate (ORR) of 30.4%, a disease control rate (DCR) of 73.9%, and a median progression-free survival (mPFS) of 7.1 months. |
| 2025-07-09 | Chipscreen Biosciences, Ltd. | Results A Milestone in First-Line DLBCL Treatment! Topline Results from Chidamide DEB Study Achieve Primary EFS Endpoint chipscreen.com ↗
The results showed that the experimental arm achieved significantly improved event-free survival (EFS) compared to the control arm, meeting the study’s primary endpoint. |
| 2025-06-15 | Ascentage Pharma Group Inc. | Results EHA 2025 | Multiple Studies Report Encouraging Data of Olverembatinib in Ph+ ALL ascentage.com ↗
Its combination with tucidinostat synergistically suppressed cell proliferation. |
| 2025-06-09 | Ascentage Pharma Group Inc. | Results Thirteen Studies of Ascentage Pharma’s Assets Including Olverembatinib and Lisaftoclax Selected for Presentations at 2025 European Hematology Association Annual Congress ascentage.com ↗
Embryonic Ectoderm Development (EED) Inhibitor APG-5918 Exhibits Potent Antitumor Activity and Synergizes with Histone Deacetylase Inhibitor Tucidinostat in PreclinicalT-Cell Lymphoma (TCL) Models |
| 2025-05-31 | Chipscreen Biosciences, Ltd. | Results ASCO 2025 Highlight | Complete Response Rate Surpasses 95%! Chidamide Combination Therapy Shows Promising Results in Oral Presentation for Untreated NK/T-Cell Lymphoma chipscreen.com ↗
The study evaluated Chidamide in combination with PD-1 therapy for patients with untreated NK/T-cell lymphoma, revealing outstanding results, Highlighting strong efficacy data. |
| 2024-11-18 | Chipscreen Biosciences, Ltd. | Regulatory Major NRDL Update｜Chipscreen’s Epidaza® Becomes the Only Oral Novel Drug for First-Line DLBCL, while Bilessglu® Retains Listing at Current Price chipscreen.com ↗
On November 28, Chipscreen Biosciences' self-developed innovative drug, Epidaza® (Chidamide tablets), received approval for its first-line DLBCL treatment indication and was successfully added to the 2024 National Reimbursement Drug List (NRDL) (hereinafter referred to as the “new NRDL”). |
| 2024-08-12 | Great Novel Therapeutics Biotech & Medicals Corporation | Results Tucidinostat用於治療復發或難治cHL發表在國際知名期刊 com.tw ↗
在一個臨床二期試驗的研究中顯示，94%病患可以在三聯藥物組合中獲得ORR，其中CR率高達50%，三聯藥物組合在安全性上病患可以耐受，安全可控。 |
| 2024-07-23 | Chipscreen Biosciences, Ltd. | Regulatory NMPA Approves Phase III Clinical Trial Application for Chipscreen’s Class I Innovative Anti-Tumor Drug Chidamide in Colorectal Cancer Treatment chipscreen.com ↗
received approval from the National Medical Products Administration (NMPA) to initiate a Phase III clinical trial of its Class I innovative anti-tumor drug, Chidamide |
| 2024-06-08 | Chipscreen Biosciences, Ltd. | Regulatory Chipscreen Biosciences' Chidamide tablets designated as a breakthrough therapy for advanced colorectal cancer chipscreen.com ↗
On June 8, Shenzhen Chipscreen Biosciences Co., Ltd. (“Chipscreen Biosciences”) announced that its innovative anti-cancer drug, Chidamide tablets, had been officially designated a “Breakthrough Therapy” by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). |
| 2024-05-06 | Great Novel Therapeutics Biotech & Medicals Corporation | Regulatory Tucidinostat提供MYC/BCL-2雙表達DLBCL病患新的治療選擇 com.tw ↗
近期接獲合作夥伴的通知，Tucidinostat聯合R-CHOP (Rituximab/Cyclophosphamide/Doxorubicin/Vincristine/Prednisolone)方案用於治療第一線MYC/BCL-2雙表達的瀰漫大B細胞淋巴癌 (DLBCL, Diffuse Large B-cell Lymphoma)新適應症的藥證，這是繼R-CHOP標準療法之後全球第一個獲得該適應症藥證。 |
| 2024-04-30 | Chipscreen Biosciences, Ltd. | Regulatory National Medical Products Administration (NMPA) Approves Chipscreen Bioscience’s Chidamide (Epidaza) combined with R-CHOP for the treatment of diffuse large B-cell lymphoma chipscreen.com ↗
On April 30, 2024, Shenzhen Chipscreen Biosciences Co., Ltd. (Chipscreen Biosciences, Stock Symbol: 688321.SH) announced that the company's lead innovative product Chidamide (Epidaza®) , an oral subtype-selective histone deacetylase (HDAC) inhibitor, combined with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone), has been officially approved by the National Medical Products Administration (NMPA) for treatment of previously untreated diffuse large B-cell lymphoma (DLBCL) with positive MYC and BCL2 expression. |
| 2024-03-04 | Chipscreen Biosciences, Ltd. | Results CAPability-01 study was published in Nature Medicine! Chidamide + sintilimab + bevacizumab explored "no man's land" for the treatment of intestinal cancer chipscreen.com ↗
Thus, this combined therapy is a promising treatment option for patients with MSS/pMMR advanced CRC. |
| 2023-07-25 | Ascletis Pharmaceuticals Co., Ltd. | Results Shanghai Public Health Clinical Center Presented Clinical Results of ASC22 (Envafolimab) in Combination with Chidamide for Functional Cure of HIV Infection at the 12th IAS Conference on HIV Science ascletis.com ↗
This Phase II study showed that combination treatment with ASC22 and Chidamide is well tolerated and effectively activated latent HIV reservoirs. |
| 2023-03-09 | Great Novel Therapeutics Biotech & Medicals Corporation | Regulatory 本公司申請國產新成分新藥「剋必達®/Kepida®」查驗登記，業已獲衛福部審核通過。 com.tw ↗ |
| 2022-05-11 | Great Novel Therapeutics Biotech & Medicals Corporation | Regulatory 本公司申請原料藥品項「Chidamide」GMP評鑑乙案，業已獲衛福部許可。 com.tw ↗
本公司委託台耀化學股份有限公司製造新藥「西達本胺」（台灣商品名：剋必達®/Kepida®）的原料藥「Chidamide」品項，申請原料藥GMP評鑑乙案，經衛福部查核結果，認定符合藥物優良製造準則之西藥藥品優良製造規範，取得許可。 |
| 2021-12-01 | Chipscreen Biosciences, Ltd. | Regulatory Licensing Partner of Shenzhen Chipscreen Biosciences - HUYABIO International, Receives Regulatory Approval for Chidamide Monotherapy of Peripheral T-Cell Lymphoma(PTCL) in Japan chipscreen.com ↗
The drug was approved based on data from a Phase 2b study that involved 55 patients with aggressive PTCL in Japan and Korea. |
| 2020-11-12 | Great Novel Therapeutics Biotech & Medicals Corporation | Regulatory 華上生醫申請「西達本胺/剋癌達TM」原料藥查驗登記暨DMF備查函 com.tw ↗
華上生醫(創櫃代號: 7427)10日宣布所研發的新一代表觀遺傳調控劑（Chidamide/Tucidinostat），日前向衛生褔利部食品藥物管理署 (TFDA) 申請原料藥查驗登記以及原料藥主檔案(DMF)備查函。 |
| 2020-06-24 | Chipscreen Biosciences, Ltd. | Regulatory Licensing Partner of Shenzhen Chipscreen Biosciences - HUYABIO International, Receives Regulatory Approval for Chidamide Monotherapy of Adult T-cell Leukemia/lymphoma in Japan chipscreen.com ↗
Shenzhen Chipscreen Biosciences' licensing partner, HUYABIO International (HUYABIO™), today announced the regulatory approval for Tucidinostat (also known as Chidamide, Epidaza ®, HBI-8000) monotherapy of relapsed or refractory (R/R) adult T-cell leukemia/lymphoma (ATL) by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). |
| 2020-02-10 | Great Novel Therapeutics Biotech & Medicals Corporation | Regulatory TFDA核准「剋癌達」恩慈治療外周T細胞淋巴癌 com.tw ↗
華上生醫宣布，「剋癌達TM」在今日獲得台灣TFDA核准用於恩慈治療，提供人道救援台灣之復發/難治的外周T細胞淋巴癌病患，凡有急需治療之病患將可透過申請獲得治療。 |
| 2019-12-03 | Great Novel Therapeutics Biotech & Medicals Corporation | Regulatory 西達本胺晚期乳癌第二適應症 中國獲批 com.tw ↗
11月29日，「西達本胺」聯合諾曼癌素 (exemestane, aromasin®)用於治療既往內分泌療法失敗或復發的賀爾蒙受體陽性(ER+)、Her-2陰性不可手術晚期乳癌適應症，已經獲得中國NMPA批准取得藥證。 |
| 2019-12-03 | Chipscreen Biosciences, Ltd. | Regulatory National Medical Products Administration (NMPA) Approves Chipscreen Bioscience's Chidamide (Epidaza) for Breast Cancer Indication chipscreen.com ↗ |
| 2019-04-29 | Great Novel Therapeutics Biotech & Medicals Corporation | Results 西達本胺樞紐三期結果正面 榮登刺胳針腫瘤學期刊 com.tw ↗
他指出，從本次研究結果顯示，試驗組與對照組相比，中位的PFS值分別為7.4個月和3.8個月，具有統計顯著差異。 |
| 2018-10-22 | Great Novel Therapeutics Biotech & Medicals Corporation | Results 西達本胺晚期乳癌樞紐三期 中國解盲達標 com.tw ↗
達到臨床試驗設計的主要療效指標終點、以及安全性符合預期。 |
| 2017-08-03 | Chipscreen Biosciences, Ltd. | Regulatory Chidamide is included in national health care, and the innovative medicine benefits vast number of patients chipscreen.com ↗
Chidamide (trade name: Epidaza?), a new anti-tumor drug originally developed by China, was successfully included in the newly selected national medical insurance list. |
| 2017-04-17 | Chipscreen Biosciences, Ltd. | Regulatory Phase III clinical trial of breast cancer approved by Taiwan TFDA in Chidamide chipscreen.com ↗
the application of Chidamide combined with aromasin? for the third phase of clinical trials of advanced breast cancer with hormone receptor positive and HER-2 negative was approved by Taiwan TFDA on April 07, 2017 |
| 2017-04-15 | Great Novel Therapeutics Biotech & Medicals Corporation | Regulatory 西達本胺獲TFDA核准乳癌臨床三期試驗 com.tw ↗
日前獲台灣TFDA核准進入乳癌臨床三期試驗，為西達本胺在國內開發的第二個適應症。 |
| 2015-02-02 | Great Novel Therapeutics Biotech & Medicals Corporation | Results 西達本胺閃耀第七屆T細胞淋巴瘤論壇 (T-cell Lymphoma Forum, 2015) com.tw ↗
西達本胺的客觀緩解率（ORR）達到28%，與國際上同類藥物的ORR相似。 |
| 2015-01-09 | Chipscreen Biosciences, Ltd. | Regulatory The world's first subtype of selective histone deacetylase oral inhibitor original new drug Chidamide ( Epidaza? ) approved! chipscreen.com ↗
Chidamide belongs to a completely new mechanism of action - epigenetic regulator anti-tumor drugs, which CFDA has approved this time to treat patients with relapsed and refractory peripheral T-cell lymphoma. |
All press releases naming this drug 43 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 266 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | tucidinostat | “our previous study found that HDACi tucidinostat/chidamide could restore the expression and functionality of IKZF1 in IKZF1del samples, including increased expression of CD19...” NCT06220487 ↗20“Oral histone deacetylase inhibitor tucidinostat (HBI-8000) in patients with relapsed or refractory adult T-cell leukemia/lymphoma: Phase IIb results.” PMID 35579212 ↗ Jun 2022 “Tucidinostat (formerly known as chidamide) is an oral subtype-selective histone deacetylase inhibitor.” PMID 31036468 ↗ Apr 2019 “oral HDACI tucidinostat (formerly known as chidamide)” PMID 33097085 ↗ Oct 2020 |
| Known as | Chi | “Chidamide (Chi)+VAH” NCT07643636 ↗ |
| Known as | chidamide | “Using the combined regimen of CHiR (chidamide, zanubrutinib, and lenalidomide) to treat newly diagnosed elderly patients with MYC- and BCL2-expressing positive diffuse large...” NCT06764017 ↗239“The combination of ASC22, an anti-PD-L1 antibody potentially enhancing HIV-specific immunity and chidamide, a HIV latency reversal agent, may serve as a strategy for...” PMID 39245675 ↗ Sep 2024 “This phase II study was designed to assess the efficacy and safety of the combination of Apatinib, Tucidinostat (chidamide), a histone deacetylase inhibitor in relapsed or...” NCT06125171 ↗ “Investigator's choice treatment with chidamide, golidocitinib, mitoxantrone hydrochloride liposome, or gemcitabine hydrochloride administered according to the respective...” NCT07639879 ↗ “Chidamide 20 mg orally;gemcitabine 1g/m2, twice a week, intravenous infusion on day 1, vinorelbine 20 mg/m2, infusion on day 1; Mitoxantrone Hydrochloride Liposome12 mg/m2,...” NCT06211881 ↗ “Chidamide: Administered at the maximum tolerated dose/recommended phase II dose (MTD/RP2D), orally twice weekly (on Days 1, 4, 8, 11, 15, and 18 of each cycle), 30 minutes after meals.” NCT06858969 ↗ “Patients received rituximab (375 mg/m2 intravenously on Day 1), lenalidomide (15 mg orally on Days 1-21), and chidamide (30 mg orally twice weekly) in 28-day cycles for up to 6 cycles.” PMID 42124356 ↗ May 2026 “The treatment option for the chidamide + sintilimab + bevacizumab (study group) is 200 mg of sintilimab IV Drip Q3W, 30 mg of chidamide PO BIW, and bevacizumab 7.5 mg/kg IV Drip Q3W” NCT05768503 ↗ “10 mg/kg UB-421 weekly intravenous infusion to substitute for antiretroviral therapy, and combined with oral 10 mg chidamide twice a week for 8 weeks.” NCT04985890 ↗ “R 375 mg/m2 D1 Pola 1.8mg/kg D1 CTX 750mg/m2 D2 ADR 50mg/m2 D2 Pred 60 mg/m2 D2-6 Chidamide 20mg/d D1,4,8,11 Lisaftoclax 600mg/d D1-21” NCT07552324 ↗ “Tucidinostat (chidamide)，30mg, po., biw PD-1 inhibitor (tislelizumab), 200mg, ivgtt. d1, q3w anlotinib, 12mg, po., d1-14, q3w” NCT06547476 ↗ |
| Known as | Chidamide (Tucidinostat) | “Chidamide (Tucidinostat)” NCT05632848 ↗ |
| Known as | CS055 | “Though it has been demonstrated that Chidamide (CS055/HBI-8000), a novel benzamide class of histone deacetylase (HDAC) subtype-selectively inhibitor, reveals better anticancer...” PMID 32653824 ↗ Jul 20201“Chidamide (CS055/HBI-8000) is a new benzamide class of histone deacetylase inhibitor” PMID 22362161 ↗ Feb 2012 |
| Known as | CS055/HBI-8000 | “chidamide (CS055/HBI-8000), a new member of the benzamide class of HDACi.” NCT03023358 ↗ |
| Known as | Epidaza | “Participants will take oral chidamide (Epidaza) until 180 days after allo-HSCT.” NCT05682755 ↗ |
| Known as | Epidaza in china | ChEMBL registry synonym — accepted as the source's own label CHEMBL3621988 ↗ |
| Known as | HBI-8000 | “Though it has been demonstrated that Chidamide (CS055/HBI-8000), a novel benzamide class of histone deacetylase (HDAC) subtype-selectively inhibitor, reveals better anticancer...” PMID 32653824 ↗ Jul 20208“Oral histone deacetylase inhibitor tucidinostat (HBI-8000) in patients with relapsed or refractory adult T-cell leukemia/lymphoma: Phase IIb results.” PMID 35579212 ↗ Jun 2022 “Chidamide (CS055/HBI-8000) is a new benzamide class of histone deacetylase inhibitor” PMID 22362161 ↗ Feb 2012 |
| Known as | tudicdinostat | “For HBI-8000: tudicdinostat; For nivolumab: OPDIVO®” NCT04674683 ↗ |
| Action | Inhibit | “Tucidinostat (formerly known as chidamide) is an oral subtype-selective histone deacetylase inhibitor.” PMID 31036468 ↗ Apr 2019 |
| Modality | Small molecule | “Chidamide is a novel benzamide chemical class of HDAC inhibitor” PMID 24721323 ↗ Mar 2014 |
| Route | Oral | “Given orally” NCT01836679 ↗ |
| Target | HDAC1 | “Chidamide was found to be a low nanomolar inhibitor of HDAC1, 2, 3, and 10” PMID 22080169 ↗ Nov 2011 |