DeepMed Research

Sovleplenib

Generic Name: Sovleplenib

Drug Type: Small Molecule

Chemical Formula: C_₂₄H_₃₀N_₆O_₃S

CAS Number: 1415792-84-5

Unique Ingredient Identifier: 9CL6353KHO

Background: Sovleplenib is a novel, investigational, selective small molecule inhibitor for oral administration targeting spleen tyrosine kinase (Syk). It is under investigation in clinical trial NCT03483948 (Phase I Study of Hmpl-523+azacitidine in Elderly Patients With Acute Myeloid Leukemia).

Clinical Trials

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

Phase 1

Recruiting

Conditions: Blood Platelet Disorder
Immune System Diseases
Skin Manifestations
Thrombocytopenia
Immune Thrombocytopenia
Autoimmune Diseases
Hemorrhage
Hematologic Diseases
Primary Immune Thrombocytopenia
ITP - Immune Thrombocytopenia

Interventions: Drug: HMPL-523

First Posted Date: 2024-03-04

Last Posted Date: 2024-08-15

Lead Sponsor: Hutchmed

Target Recruit Count: 48

Registration Number: NCT06291415

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
University of Washington (UW) Medical Center, Seattle, Washington, United States
🇦🇺
The Perth Blood Institute (PBI) Hollywood Specialist Centre, West Perth, Western Australia, Australia

and more 25 locations

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

Phase 1

Completed

Conditions: Imumune Thrombocytopenia(ITP) Human Mass Balance

Interventions: Drug: HMPL-523
Drug: 150 µCi [14C]HMPL-523

First Posted Date: 2023-03-23

Last Posted Date: 2024-07-16

Lead Sponsor: Hutchmed

Target Recruit Count: 6

Registration Number: NCT05781906

Locations: 🇨🇳
The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China

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

Phase 1

Completed

Conditions: Relapsed or Refractory Lymphoma

Interventions: Drug: HMPL-523
Drug: Rifampin
Drug: Itraconazole

First Posted Date: 2023-02-09

Last Posted Date: 2023-03-01

Lead Sponsor: Hutchmed

Target Recruit Count: 28

Registration Number: NCT05720767

Locations: 🇺🇸
PPD Austin, Austin, Texas, United States

HMPL-523 Food Effect and Proton Pump Inhibitor Study

Phase 1

Completed

Conditions: Relapsed or Refractory Lymphoma

Interventions: Drug: HMPL-523
Drug: Rabeprazole

First Posted Date: 2022-10-07

Last Posted Date: 2023-02-23

Lead Sponsor: Hutchmed

Target Recruit Count: 26

Registration Number: NCT05571787

Locations: 🇺🇸
PPD Austin, Austin, Texas, United States

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

Early Phase 1

Completed

Conditions: Healthy Subject

Interventions: Drug: HMPL-523

First Posted Date: 2022-04-08

Last Posted Date: 2023-04-25

Lead Sponsor: Hutchison Medipharma Limited

Target Recruit Count: 39

Registration Number: NCT05318820

Locations: 🇨🇳
Shanghai Xuhui Central Hospital, Shanghai, China

Phase III Study on HMPL-523 for Treatment of ITP

Phase 3

Active, not recruiting

Conditions: Primary Immune Thrombocytopenia (ITP)

Interventions: Drug: Placebo
Drug: HMPL-523

First Posted Date: 2021-08-31

Last Posted Date: 2025-03-17

Lead Sponsor: Hutchison Medipharma Limited

Target Recruit Count: 272

Registration Number: NCT05029635

Locations: 🇨🇳
First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
🇨🇳
The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China
🇨🇳
Beijing Chaoyang Hospital of Capital Medical University, Beijing, Beijing, China

and more 34 locations

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

Phase 1

Completed

Conditions: Immune Thrombocytopenia (ITP)

Interventions: Drug: HMPL-523
Drug: Placebo

First Posted Date: 2019-05-15

Last Posted Date: 2024-07-16

Lead Sponsor: Hutchison Medipharma Limited

Target Recruit Count: 45

Registration Number: NCT03951623

Locations: 🇨🇳
Blood diseases hospital, Chinese academy of medical university, Tianjin, Tianjin, China

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

Phase 1

Active, not recruiting

Conditions: Non Hodgkin Lymphoma

Interventions: Drug: HMPL-523

First Posted Date: 2018-12-19

Last Posted Date: 2024-02-09

Lead Sponsor: Hutchmed

Target Recruit Count: 140

Registration Number: NCT03779113

Locations: 🇫🇮
Helsingin yliopistollinen keskussairaala, Helsinki, Finland
🇪🇸
Institut Català d'Oncologia, Barcelona, Spain
🇵🇱
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego, Wrocław, Poland

and more 29 locations

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

Phase 1

Terminated

Conditions: Acute Myeloid Leukemia

Interventions: Drug: HMPL-523
Drug: Azacitidine

First Posted Date: 2018-03-30

Last Posted Date: 2019-11-20

Lead Sponsor: Hutchison Medipharma Limited

Target Recruit Count: 7

Registration Number: NCT03483948

Locations: 🇨🇳
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, Tianjin, China

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

Phase 1

Completed

Conditions: Mature B-cell Neoplasms

Interventions: Drug: HMPL-523

First Posted Date: 2016-08-05

Last Posted Date: 2024-07-16

Lead Sponsor: Hutchison Medipharma Limited

Target Recruit Count: 134

Registration Number: NCT02857998

Locations: 🇨🇳
Fudan University Shanghai Cancer Hospital, Shanghai, China
🇨🇳
BeijingCancer Hospital, Beijing, Beijing, China

Drug Development Updates

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