HBI-8000

Phase 3Small molecule

HHUYABIO International, LLC.

HBI-8000 is one of 109 small molecule programs targeting Lymphoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

108

Competitors

Pipeline

Status by Indication[3][1]

Indication

LymphomaActive, not recruiting

Non-Small Cell Lung CancerActive, not recruiting

Breast CancerActive, not recruiting

MelanomaActive, not recruiting

LymphomaPhase 2

Active, not recruiting

Non-Small Cell Lung CancerPhase 2

Active, not recruiting

Breast CancerPhase 1

Active, not recruiting

MelanomaPhase 3

Active, not recruiting

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

HBI-8000

HHUYABIO International, LLC.

Phase 3

1 2

Halaven

Eisai

Preclinical

38 3

Lexiscan

Astellas

Preclinical

1 4

Blenoxane

Bristol-Myers Squibb

Preclinical

1 5

Tricor

JJagotec

Preclinical

1 6

Nubain

AAultman Health Foundation

Preclinical

1 7

Zoladex

Luye Pharma Group Ltd.

Preclinical

8 8

Beta Blocker

WWeill Medical College of Cornell University

Preclinical

1 9

Conventional Chemotherapy

SShanghai Jiao Tong University School of Medicine

Preclinical

1 10

Lipegfilgrastim

Merck & Co.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Melanoma

NCT04674683

Clinical

Trials by Indication[1]

Lymphoma3 trials

Safety Study of HBI-8000 in Japanese Patients With Non Hodgkin's Lymphoma

Completed·HHUYABIO International, LLC.·Phase 1·NCT02697552·13 enrolled

Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Adult T Cell Lymphoma (ATL)

Completed·HHUYABIO International, LLC.·Phase 2·NCT02955589·23 enrolled

Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

Completed·HHUYABIO International, LLC.·Phase 2·NCT02953652·55 enrolled

Non-Small Cell Lung Cancer2 trials

Study of HBI-8000 With Nivolumab in Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancer

Completed·HHUYABIO International, LLC.·Phase 1/2·NCT02718066·96 enrolled

A Study of HBI-8000 (Tucidinostat) With Pembrolizumab in Non-Small Cell Lung Cancer

Terminated·HHUYABIO International, LLC.·Phase 2·NCT05141357·5 enrolled

Breast Cancer1 trial

Dose Escalation Study of HBI-8000 in Combination With Paclitaxel and Trastuzumab in Women With Advanced or Metastatic HER2+ Breast Cancer

Withdrawn·HHUYABIO International, LLC.·Phase 1·NCT02569489

Melanoma1 trial

Study Comparing Investigational Drug HBI-8000 + Nivolumab vs. Placebo + Nivolumab in Patients With Advanced Melanoma

Active, not recruiting·HHUYABIO International, LLC.·Phase 3·NCT04674683·450 enrolled

Sources

References

[1]
ClinicalTrials.gov — 7 trial records for HBI-8000. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — HBI-8000 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for HBI-8000. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — HUYABIO International, LLC. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: HHUYABIO International, LLC.

HBI-8000

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Lymphoma3 trials

Non-Small Cell Lung Cancer2 trials

Breast Cancer1 trial

Melanoma1 trial

References

Drug Info

Quick Facts

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