Last reviewed · How we verify
HBI-8000 in combination with nivolumab
HBI-8000 in combination with nivolumab is a HDAC inhibitor (in combination with PD-1 inhibitor) Small molecule drug developed by HUYABIO International, LLC.. It is currently in Phase 3 development for Advanced or metastatic solid tumors (Phase 3 development). Also known as: For HBI-8000: Chidamide, CS055; for nivolumab: OPDIVO, For HBI-8000: tudicdinostat; For nivolumab: OPDIVO®.
HBI-8000 is a histone deacetylase (HDAC) inhibitor that enhances immune response when combined with nivolumab, a PD-1 checkpoint inhibitor.
HBI-8000 is a histone deacetylase (HDAC) inhibitor that enhances immune response when combined with nivolumab, a PD-1 checkpoint inhibitor. Used for Advanced or metastatic solid tumors (Phase 3 development).
At a glance
| Generic name | HBI-8000 in combination with nivolumab |
|---|---|
| Also known as | For HBI-8000: Chidamide, CS055; for nivolumab: OPDIVO, For HBI-8000: tudicdinostat; For nivolumab: OPDIVO® |
| Sponsor | HUYABIO International, LLC. |
| Drug class | HDAC inhibitor (in combination with PD-1 inhibitor) |
| Target | Histone deacetylase (HDAC); combined with PD-1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
HBI-8000 inhibits histone deacetylases, leading to increased acetylation of histones and non-histone proteins, which can promote anti-tumor immune responses and increase T-cell activation. When combined with nivolumab (a PD-1 inhibitor that blocks immune checkpoint signaling), the dual mechanism aims to overcome resistance to checkpoint inhibition and enhance anti-tumor immunity.
Approved indications
- Advanced or metastatic solid tumors (Phase 3 development)
Common side effects
- Fatigue
- Nausea
- Diarrhea
- Immune-related adverse events (from nivolumab component)
Key clinical trials
- Study Comparing Investigational Drug HBI-8000 + Nivolumab vs. Placebo + Nivolumab in Patients With Advanced Melanoma (PHASE3)
- Study of HBI-8000 With Nivolumab in Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancer (PHASE1, 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:
- HBI-8000 in combination with nivolumab CI brief — competitive landscape report
- HBI-8000 in combination with nivolumab updates RSS · CI watch RSS
- HUYABIO International, LLC. portfolio CI
Frequently asked questions about HBI-8000 in combination with nivolumab
What is HBI-8000 in combination with nivolumab?
How does HBI-8000 in combination with nivolumab work?
What is HBI-8000 in combination with nivolumab used for?
Who makes HBI-8000 in combination with nivolumab?
Is HBI-8000 in combination with nivolumab also known as anything else?
What drug class is HBI-8000 in combination with nivolumab in?
What development phase is HBI-8000 in combination with nivolumab in?
What are the side effects of HBI-8000 in combination with nivolumab?
What does HBI-8000 in combination with nivolumab target?
Related
- Drug class: All HDAC inhibitor (in combination with PD-1 inhibitor) drugs
- Target: All drugs targeting Histone deacetylase (HDAC); combined with PD-1
- Manufacturer: HUYABIO International, LLC. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Advanced or metastatic solid tumors (Phase 3 development)
- Also known as: For HBI-8000: Chidamide, CS055; for nivolumab: OPDIVO, For HBI-8000: tudicdinostat; For nivolumab: OPDIVO®
- Compare: HBI-8000 in combination with nivolumab vs similar drugs
- Pricing: HBI-8000 in combination with nivolumab cost, discount & access