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HMPL-523
HMPL-523 is a selective inhibitor of focal adhesion kinase (FAK) that disrupts tumor cell adhesion and migration signaling.
HMPL-523 is a selective inhibitor of focal adhesion kinase (FAK) that disrupts tumor cell adhesion and migration signaling. Used for Advanced solid tumors (Phase 3 development), Non-small cell lung cancer (NSCLC).
At a glance
| Generic name | HMPL-523 |
|---|---|
| Also known as | HMPL-523 Acetate, sovleplenib, Sovleplenib, HMPL-523 acetate, HMPL-523 tablets |
| Sponsor | Hutchison Medipharma Limited |
| Drug class | FAK inhibitor |
| Target | FAK (Focal Adhesion Kinase) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
FAK is a non-receptor tyrosine kinase that plays a critical role in cell adhesion, migration, and survival pathways. By inhibiting FAK, HMPL-523 impairs tumor cell motility and promotes apoptosis, potentially reducing metastatic potential and enhancing anti-tumor immunity. This mechanism is particularly relevant in solid tumors where FAK-mediated signaling supports tumor progression and the immunosuppressive microenvironment.
Approved indications
- Advanced solid tumors (Phase 3 development)
- Non-small cell lung cancer (NSCLC)
Common side effects
- Diarrhea
- Nausea
- Fatigue
- Elevated liver enzymes
Key clinical trials
- HMPL-523 (Sovleplenib) in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (PHASE2, PHASE3)
- An Open-label, Dose Escalation Trial to Evaluate the Safety and Pharmacokinetics of HMPL-523 in Patients With Lymphoma (PHASE1)
- Pharmacokinetics and Bioequivalence Study of HMPL-523 Acetate Tablets in Humans (PHASE1)
- Study of Food Effect on Pharmacokinetics of HMPL-523 Acetate Tablets (PHASE1)
- The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult Subjects With Immune Thrombocytopenia (ITP) (PHASE1)
- Phase III Study on HMPL-523 for Treatment of ITP (PHASE3)
- A Study of Hutchison MediPharma Limited(HMPL)-523 in Patients With Relapsed or Refractory Mature B-cell Neoplasms (PHASE1)
- The Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-523 in Immune Thrombocytopenia Patients (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |