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Also known as HMPL-523 Acetate Tablets (Test Formulation), HMPL-523 tablets, Sovleplenib
HMPL-523 · 8 trials · 7 indications
Platelet count ≥50×10\^9 /L on at least 4 of 6 scheduled visits of Week14-Week24 in the primary study
Phase II: Overall Hb response rate: the proportion of patients with overall Hb response by Week 24
Adverse Events evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Incidence of dose limited toxicities and associated dose of HMPL-523
| Arm | Type | Description |
|---|---|---|
| Drug: HMPL-523 | ACTIVE_COMPARATOR | Primacy study (Randomized, Double-Blind Phase): Eligible subjects receive 300 mg HMPL-523 treatment once daily for 24 weeks. Sub study (Open-label Phase): Eligible subjects receive 300 mg HMPL-523 treatment once daily for 76 weeks after the enrollment of the last patient enrolled in open-label phase. |
| Drug: placebo | PLACEBO_COMPARATOR | Primacy study (Randomized, Double-Blind Phase): Eligible subjects will receive 300 mg HMPL-523 matched placebo treatment once daily for 24 weeks. |
| HMPL-523 | EXPERIMENTAL | Phase II: Eligible subjects will receive 300 mg HMPL-523 treatment once daily for 8 weeks and at least 16 weeks open-label treatment. Phase III: Eligible subjects will receive 300 mg HMPL-523 treatment once daily for 24 weeks and enter open-label phase in the opinion of the Investigator. |
| Placebo | PLACEBO_COMPARATOR | Phase II: Eligible subjects will receive 300 mg HMPL-523 treatment once daily for 8 weeks and at least 16 weeks open-label treatment. Phase III: Eligible subjects will receive 300 mg HMPL-523 treatment once daily for 24 weeks and enter open-label phase in the opinion of the Investigator. |
| treatment arm | ACTIVE_COMPARATOR | Eligible subjects will be treated with planned dose of 100 mg, 200 mg and 300 mg HMPL-523 once daily for 8 weeks and 16 weeks open-label treatment. |
| placebo arm | PLACEBO_COMPARATOR | Eligible subjects will be treated with HMPL-523 matching placebo once daily for 8 weeks and 16 weeks open-label treatment. |
| Name | Type | Description |
|---|---|---|
| HMPL-523 | DRUG | HMPL-523(300mg PO QD) |
| Placebo | DRUG | Placebo(300mg PO QD) |
| HMPL-523(300mg PO QD) | DRUG | HMPL-523(300mg PO QD) |
| 150 µCi [14C]HMPL-523 | DRUG | D8: \[14C\] HMPL-523 Suspension 300 mg/150 μCi Single dose |
| Itraconazole | DRUG | Itraconazole is an FDA approved synthetic triazole antifungal agent |
| Rifampin | DRUG | Rifampin is an FDA approved semisynthetic antiobiotic derivative indicated in the treatment of both tuberculosis and meningococcal carrier state |
| Rabeprazole | DRUG | 40 mg of rabeprazole will be administered by mouth once daily in the morning from Day 20 to Day 26 |
Inclusion Criteria for double-blind phase: 1. Voluntary signature of written informed consent form; 2. Male or female aged 18\~75 years; 3. Performance Status score \[Eastern Cooperative Oncology Group (ECOG) score\] 0\~1; 4. Having been diagnosed as ITP prior to randomization, and duration of dise...
HMPL-523 is an investigational small molecule being studied in immune thrombocytopenia (ITP), warm antibody autoimmune hemolytic anemia, mature B-cell neoplasms, relapsed or refractory lymphoma, and rheumatoid arthritis. It is in clinical development and has not been approved for any indication.
HMPL-523 targets spleen tyrosine kinase (Syk), a kinase involved in immune cell signaling. By inhibiting Syk, HMPL-523 is designed to modulate immune responses, which is relevant to autoimmune and hematologic conditions.
HMPL-523 is being developed by HUTCHMED (China) Limited, a biopharmaceutical company listed on the Nasdaq under the ticker HCM.
HMPL-523 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA or any regulatory authority for any indication.
HMPL-523 has been studied in several clinical trials, including NCT05781906, a human mass balance study; NCT05720767, a drug interaction study; NCT05571787, a food effect and proton pump inhibitor study; and NCT05535933, a Phase 2 trial in warm antibody autoimmune hemolytic anemia.
Yes, HMPL-523 is also known as sovleplenib. Other names used in study protocols include HMPL-523 300 mg PO QD and HMPL-523 Acetate Tablets (Test Formulation).