HMPL-523

Phase 1Small molecule

HHutchison Medipharma Limited

HMPL-523 is one of 115 small molecule programs targeting B-cell neoplasm. It is currently in Phase 1.

Indications

Total Trials

Active Trials

114

Competitors

Pipeline

Status by Indication[3][1]

Indication

B-Cell NeoplasmActive, not recruiting

Hemolytic AnemiaActive, not recruiting

LymphomaActive, not recruiting

Acute Myeloid LeukemiaActive, not recruiting

Immune ThrombocytopeniaActive, not recruiting

B-Cell NeoplasmPhase 1

Active, not recruiting

Hemolytic AnemiaPhase 2/Phase 3

Active, not recruiting

LymphomaPhase 1

Active, not recruiting

Acute Myeloid LeukemiaPhase 1

Active, not recruiting

Immune ThrombocytopeniaPhase 1

Active, not recruiting

Competition

Competitive Landscape

1774 competitors in Lymphoma

#DrugCompanyPhaseTrials

Blenoxane

SSequus Pharmaceuticals

Preclinical

25 2

Zofran

Novartis

Preclinical

2 3

HMPL-523

HHutchison Medipharma Limited

Phase 1

1 4

Nuvigil

NNuvo Research GmbH

Preclinical

1 5

PEG-Intron

Merck & Co.

Preclinical

1 6

Elitek

AAzienda U.S.L. 1 di Massa e Carrara

Systemic Therapy

1 8

Rhg-CSF

CCSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Preclinical

3 9

Stem Cells

KKang Stem Biotech Co., Ltd.

Preclinical

2 10

Immune Checkpoint Inhibitor

IImmuneSensor Therapeutics Inc.

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 2/3Active, not recruiting

Hemolytic Anemia

NCT05535933

Clinical

Trials by Indication[1]

Tics3 trials

A Clinical Study to Evaluate the Pharmacokinetics and Bioequivalence of HMPL-523 Tablets Produced by Two Different Manufacturers

Completed·HHutchison Medipharma Limited·Phase 1·NCT05318820·39 enrolled

A Study of the Safety, Tolerability and Pharmacokinetics of HMPL-523

Completed·HHutchison Medipharma Limited·Phase 1·NCT02105129·118 enrolled

Study of Food Effect on Pharmacokinetics of HMPL-523 Acetate Tablets

Completed·HHutchmed·Phase 1·NCT07348133·18 enrolled

Immune Thrombocytopenia2 trials

The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult Subjects With Immune Thrombocytopenia (ITP)

Withdrawn·HHutchmed·Phase 1·NCT06291415

The Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-523 in Immune Thrombocytopenia Patients

Completed·HHutchison Medipharma Limited·Phase 1·NCT03951623·45 enrolled

Adult1 trial

Human Mass Balance of [14C]HMPL-523 in Healthy Adult Male Chinese Subjects

Completed·HHutchmed·Phase 1·NCT05781906·6 enrolled

Humans1 trial

Pharmacokinetics and Bioequivalence Study of HMPL-523 Acetate Tablets in Humans

Completed·HHutchmed·Phase 1·NCT07331194·54 enrolled

Acute Myeloid Leukemia1 trial

Phase I Study of HMPL-523+Azacitidine in Elderly Patients With Acute Myeloid Leukemia

Terminated·HHutchison Medipharma Limited·Phase 1·NCT03483948·7 enrolled

6 more indications

Lymphoma1 trial

An Open-label, Dose Escalation Trial to Evaluate the Safety and Pharmacokinetics of HMPL-523 in Patients With Lymphoma

Terminated·HHutchmed·Phase 1·NCT03779113·69 enrolled

Treatment1 trial

Phase III Study on HMPL-523 for Treatment of ITP

Active, not recruiting·HHutchison Medipharma Limited·Phase 3·NCT05029635·272 enrolled

Relapsed or Refractory Hematologic Malignancies1 trial

A Study of HMPL-523 in Relapsed or Refractory Hematologic Malignancies

Unknown status·HHutchison Medipharma Limited·Phase 1·NCT02503033·78 enrolled

B-cell neoplasm1 trial

A Study of Hutchison MediPharma Limited(HMPL)-523 in Patients With Relapsed or Refractory Mature B-cell Neoplasms

Completed·HHutchison Medipharma Limited·Phase 1·NCT02857998·134 enrolled

Hemolytic Anemia1 trial

HMPL-523 (Sovleplenib) in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

Active, not recruiting·HHutchison Medipharma Limited·Phase 2/3·NCT05535933·110 enrolled

Unspecified2 trials

HMPL-523 CYP3A/P-gp Inhibitor and CYP Inducer Study

Completed·HHutchmed·Phase 1·NCT05720767·28 enrolled

HMPL-523 Food Effect and Proton Pump Inhibitor Study

Completed·HHutchmed·Phase 1·NCT05571787·26 enrolled

Sources

References

[1]
ClinicalTrials.gov — 15 trial records for HMPL-523. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — HMPL-523 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for HMPL-523. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Hutchison Medipharma Limited company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 1[1]
Company: HHutchison Medipharma Limited

HMPL-523

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Tics3 trials

Immune Thrombocytopenia2 trials

Adult1 trial

Humans1 trial

Acute Myeloid Leukemia1 trial

Lymphoma1 trial

Treatment1 trial

Relapsed or Refractory Hematologic Malignancies1 trial

B-cell neoplasm1 trial

Hemolytic Anemia1 trial

Unspecified2 trials

References

Drug Info

Quick Facts

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