Clinical Trials

Numerous clinical trials, primarily sponsored by Hutchmed (Hutchison Medipharma Limited), evaluate the therapeutic profile, safety, pharmacokinetics, and efficacy of sovleplenib across Early Phase 1 through Phase 3 evaluations. These studies target primary immune thrombocytopenia, relapsed or refractory B-cell neoplasms, acute myeloid leukemia, rheumatoid arthritis, and pharmacokinetic assessments in healthy subjects. The trial portfolio encompasses completed, actively recruiting, and terminated studies assessing this targeted SYK inhibitor in hematologic and autoimmune disorders.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06291415 WITHDRAWN
Immune Thrombocytopenia; Blood Platelet Disorder; Hematologic Diseases; Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorder; Thrombotic Microangiopathies; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Skin Manifestations; Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic; Primary Immune Thrombocytopenia; ITP - Immune Thrombocytopenia
Hutchmed
 2024-04-02 PHASE1
NCT07348133 COMPLETED
Healthy
Hutchmed
 2025-12-11 PHASE1
NCT07331194 COMPLETED
Healthy
Hutchmed
 2025-10-28 PHASE1
NCT05535933 ACTIVE_NOT_RECRUITING
Warm Antibody Autoimmune Hemolytic Anemia
Hutchmed
 2022-09-30 PHASE2; PHASE3
NCT05029635 COMPLETED
Primary Immune Thrombocytopenia (ITP)
Hutchmed
 2021-10-27 PHASE3
NCT03779113 TERMINATED
Non Hodgkin Lymphoma
Hutchmed
 2019-09-26 PHASE1
NCT06291415 Recruiting
Immune Thrombocytopenia|Blood Platelet Disorder|Hematologic Diseases|Purpura Thrombocytopenic|Purpura|Blood Coagulation Disorder|Thrombotic Microangiopathies|Hemorrhagic Disorders|Autoimmune Diseases|Immune System Diseases|Hemorrhage|Pathologic Processes|Skin Manifestations|Thrombocytopenia|Purpura Thrombocytopenic Idiopathic|Primary Immune Thrombocytopenia|ITP - Immune Thrombocytopenia
Hutchmed
 2024-04-02 Phase 1
NCT05781906 COMPLETED
Imumune Thrombocytopenia(ITP) Human Mass Balance
Hutchmed
 2023-02-08 PHASE1
NCT05720767 COMPLETED
Relapsed or Refractory Lymphoma
Hutchmed
 2022-11-04 PHASE1
NCT05720767 Completed
Relapsed or Refractory Lymphoma
Hutchmed
 2022-11-04 Phase 1
NCT05571787 COMPLETED
Relapsed or Refractory Lymphoma
Hutchmed
 2022-07-13 PHASE1
NCT05318820 COMPLETED
Healthy Subject
Hutchison Medipharma Limited
 2022-06-01 EARLY_PHASE1
NCT05571787 Completed
Relapsed or Refractory Lymphoma
Hutchmed
 2022-07-13 Phase 1
NCT05318820 Completed
Healthy Subject
Hutchison Medipharma Limited|Hutchmed
 2022-06-01 Early Phase 1
NCT03951623 COMPLETED
Immune Thrombocytopenia (ITP)
Hutchison Medipharma Limited
 2019-08-12 PHASE1
NCT02857998 COMPLETED
Mature B-cell Neoplasms
Hutchison Medipharma Limited
 2016-12-27 PHASE1
NCT02503033 UNKNOWN
Hematologic Malignancies
Hutchison Medipharma Limited
 2015-11 PHASE1
NCT03483948 TERMINATED
Acute Myeloid Leukemia
Hutchison Medipharma Limited
 2018-10-09 PHASE1
NCT03483948 Terminated
Acute Myeloid Leukemia
Hutchison Medipharma Limited|Hutchmed
 2018-10-09 Phase 1
NCT02105129 COMPLETED
Rheumatoid Arthritis (RA)
Hutchison Medipharma Limited
 2014-05 PHASE1
NCT02105129 Completed
Rheumatoid Arthritis (RA)
Hutchison Medipharma Limited|Hutchmed
 2014-05 Phase 1

(data from https://clinicaltrials.gov, updated on 2025-09-16)

Check the Sovleplenib product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sovleplenib is a potent and selective spleen tyrosine kinase inhibitor that binds SYK with an IC50 of 0.025 μM, thereby blocking downstream B-cell receptor intracellular signaling cascades and promoting apoptotic cell death in malignant lymphocytes. By disrupting SYK-mediated immunoreceptor signal transduction, sovleplenib suppresses aberrant immune-mediated platelet clearance and tumor cell proliferation, providing a mechanistically targeted therapeutic approach for primary immune thrombocytopenia and mature B-cell malignancies.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.