DZD8586

Phase 3Small molecule

DZD8586 is one of 127 small molecule programs targeting Chronic Lymphocytic Leukemia/small Lymphocytic Lymphoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

126

Competitors

Pipeline

Status by Indication[3][1]

Indication

Chronic Lymphocytic Leukemia/small Lymphocytic LymphomaRecruiting

Immune ThrombocytopeniaRecruiting

Relapsed or RefractoryRecruiting

CLL/SLLRecruiting

ARTNot yet recruiting

Chronic Lymphocytic Leukemia/small Lymphocytic LymphomaPhase 2

Recruiting

Immune ThrombocytopeniaPhase 2

Recruiting

Relapsed or RefractoryPhase 2

Recruiting

CLL/SLLPhase 3

Recruiting

ARTPhase 1

Not yet recruiting

Competition

Competitive Landscape

91 competitors in ART

#DrugCompanyPhaseTrials

Belamaf

GSK

Phase 3

3 2

Venclexta

AbbVie

Phase 3

2 3

Rituxan

Roche

Phase 3

1 4

Attruby

NNavire Pharma Inc., a BridgeBio company

Phase 3

1 5

Brukinsa

BBeOne Medicines

Phase 3

1 6

Treanda

AAzurity Pharmaceuticals

Phase 3

1 7

Toradol

JJavelin Pharmaceuticals

Phase 3

1 8

Cysteine Hydrochloride

Novartis

Phase 2

1 9

DZD8586

DDizal Pharmaceuticals

Phase 3

1 10

Noradrenaline

IInstitute of Liver and Biliary Sciences, India

Phase 3

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

Timeline

Expected Milestones

Q4 2026

Phase 1Not yet recruiting

Study completion

NCT07888569

Q4 2027

Phase 2Recruiting

Immune Thrombocytopenia

NCT07294365

Q1 2028

Phase 2Recruiting

Relapsed or Refractory

NCT06539182

Q4 2029

Phase 3Recruiting

CLL/SLL

NCT07139873

Clinical

Trials by Indication[1]

CLL/SLL1 trial

A Study of DZD8586 Versus Investigator's Choice in r/r CLL/SLL (TAI-SHAN6)

Recruiting·DDizal (Jiangsu) Pharmaceutical Co., Ltd.·Phase 3·NCT07139873·250 enrolled

ART1 trial

A Mass Balance Study of DZD8586 in Healthy Male Participants (TAI-SHAN15)

Not yet recruiting·DDizal Pharmaceuticals·Phase 1·NCT07454863·6 enrolled

Immune Thrombocytopenia1 trial

A Study of DZD8586 in Adults With Primary Immune Thrombocytopenia (ITP) (TAI-SHAN11)

Recruiting·DDizal Pharmaceuticals·Phase 2·NCT07294365·60 enrolled

Relapsed or Refractory1 trial

DZD8586 in Patients With Relapsed or Refractory CLL/SLL (TAI-SHAN8)

Recruiting·DDizal Pharmaceuticals·Phase 2·NCT06539182·155 enrolled

Lymphoma1 trial

A Study of DZD8586 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (TAI-SHAN1)

Completed·DDizal Pharmaceuticals·Phase 1/2·NCT05844956·17 enrolled

5 more indications

Phase 11 trial

A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics of DZD8586 in Healthy Adult Participants

Completed·DDizal (Jiangsu) Pharmaceutical Co., Ltd.·Phase 1·NCT05176873·64 enrolled

Diffuse Large B-Cell Lymphoma1 trial

A Phase 2, Open-label, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of DZD8586 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma

Completed·DDizal Pharmaceuticals·Phase 2·NCT06539195·59 enrolled

Lymphoma, Non-Hodgkin1 trial

A Phase 1, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD8586 in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (B-NHL)

Completed·DDizal Pharmaceuticals·Phase 1·NCT05824585·17 enrolled

Chronic Lymphocytic Leukemia/small Lymphocytic Lymphoma1 trial

A Phase 2 Study of DZD8586 Combination Therapy in Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)

Recruiting·DDizal (Jiangsu) Pharmaceutical Co., Ltd.·Phase 2·NCT07154264·66 enrolled

Unspecified1 trial

A Single-sequence, Open-label, Three-period, Crossover Study to Evaluate the Effect of Rabeprazole, a Proton Pump Inhibitor, on Pharmacokinetics of DZD8586 (Birelentinib) in Healthy Participants

Not yet recruiting·DDizal Pharmaceuticals·Phase 1·NCT07888569·26 enrolled

Sources

References

[1]
ClinicalTrials.gov — 10 trial records for DZD8586. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — DZD8586 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for DZD8586. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Dizal Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: DDizal Pharmaceuticals

DZD8586

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Q1 2028

Q4 2029

Trials by Indication[1]

CLL/SLL1 trial

ART1 trial

Immune Thrombocytopenia1 trial

Relapsed or Refractory1 trial

Lymphoma1 trial

Phase 11 trial

Diffuse Large B-Cell Lymphoma1 trial

Lymphoma, Non-Hodgkin1 trial

Chronic Lymphocytic Leukemia/small Lymphocytic Lymphoma1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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