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Chidamide
Chidamide is a Small molecule drug developed by Sun Yat-sen University. It is currently in Phase 3 development for Peripheral T-cell lymphoma, Relapsed or refractory T-cell leukemia-lymphoma. Also known as: Epidaza, HDACi Chidamide, CS055, HBI-8000.
Chidamide is a small molecule histone deacetylase inhibitor (HDI) that targets Class I and Class IIb histone deacetylases. It is being studied in clinical trials for various conditions, including Peripheral T-Cell Lymphoma, Metastatic Colorectal Cancer, and others, often in combination with other treatments.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Chidamide |
|---|---|
| Also known as | Epidaza, HDACi Chidamide, CS055, HBI-8000, HDACi |
| Sponsor | Sun Yat-sen University |
| Target | Nicotinamide phosphoribosyltransferase, Histone deacetylase 1, Histone deacetylase 10 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Approved indications
- Peripheral T-cell lymphoma
- Relapsed or refractory T-cell leukemia-lymphoma
Common side effects
Key clinical trials
- Genotype-guided Targeted Agents Plus EZH2i for Primary Refractory PTCL (PHASE1, PHASE2)
- Chidamide Combination With R-mini CHOP Followed by Chidamide+CD20 Maintenance in Elderly Newly Diagnosed MYC/BCL2+ DLBCL (PHASE2)
- Chidamide for Maintenance Treatment of HBV-infected Diffuse DLBCL in Patients Initially Treated With R-CHOP (PHASE3)
- Maintenance Therapy of Chidamide in Patients With HBV Positive Diffuse Large B-cell Lymphoma (PHASE2)
- Enhancing CAR-T Cell Therapy Efficacy in B-cell Lymphoma Via Chidamide and PD-1 Inhibitor Combination. (PHASE2)
- Chidamide in Combination With Toripalimab and Anlotinib in Recurrent/Metastatic Nasopharyngeal Carcinoma. (PHASE1, PHASE2)
- PD-1 Antibody-based Therapy With Concurrent RT for Early-stage NKTCL (PHASE2)
- A Multicenter RCT of "3+7" vs Venetoclax + CACAG in Newly Diagnosed Mid/High-Risk AML Patients (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Chidamide CI brief — competitive landscape report
- Chidamide updates RSS · CI watch RSS
- Sun Yat-sen University portfolio CI
Frequently asked questions about Chidamide
What is Chidamide?
What is Chidamide used for?
Who makes Chidamide?
Is Chidamide also known as anything else?
What development phase is Chidamide in?
What does Chidamide target?
Related
- Target: All drugs targeting Nicotinamide phosphoribosyltransferase, Histone deacetylase 1, Histone deacetylase 10
- Manufacturer: Sun Yat-sen University — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Peripheral T-cell lymphoma
- Indication: Drugs for Relapsed or refractory T-cell leukemia-lymphoma
- Also known as: Epidaza, HDACi Chidamide, CS055, HBI-8000, HDACi
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing