Drugs / Sovleplenib
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | primary thrombocytopenia | — | “HUTCHMED filed a New Drug Application in China in January 2024 for sovleplenib.” hutch-med.com ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 110 trials | ||||||
| Phase 1 | NCT07348133 | Dec 2025 → Jan 2026 | — | Hutchmed | Completed | No outcome recorded |
| Phase 1 | NCT06291415 | Apr 2024 → Apr 2026 | autoimmune thrombocytopenia, platelet disorder, undefined, primary thrombocytopenia, skin disorder +1 | Hutchmed | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT05781906 | Feb → Jun 2023 | autoimmune thrombocytopenia | Hutchmed | Completed | No outcome recorded |
| Phase 1 | NCT05720767 | Nov 2022 → Feb 2023 | lymphoma | Hutchmed | Completed | No outcome recorded |
| Phase 1 | NCT05571787 | Jul → Sep 2022 | lymphoma | Hutchmed | Completed | No outcome recorded |
| Phase 1 | NCT03779113 | Sep 2019 → Feb 2025 | non-Hodgkin lymphoma | Hutchmed | Terminated | No outcome recorded |
| Phase 1 | NCT03483948 | Oct 2018 → Sep 2019 | acute myeloid leukemia | Hutchison Medipharma Limited | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02857998 | Dec 2016 → Jun 2021 | neoplasm of mature B-cells | Hutchison Medipharma Limited | Completed | No outcome recorded |
| Phase 1 | NCT02503033 | Nov 2015 → Dec 2020 | hematopoietic and lymphoid system neoplasm | Hutchison Medipharma Limited | Unknown | No outcome recorded |
| Phase 1 | NCT02105129 | May 2014 → Dec 2015 | rheumatoid arthritis | Hutchison Medipharma Limited | Completed | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT05535933 | Sep 2022 → Nov 2025 overdue | autoimmune hemolytic anemia, warm type | Hutchmed | Active not recruiting | Met primary |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT03951623 Comparator | Aug 2019 → Oct 2021 | autoimmune thrombocytopenia | Hutchison Medipharma Limited | Completed | No outcome recorded |
| Phase 3 | NCT05029635 Comparator | Oct 2021 → May 2025 | autoimmune thrombocytopenia | Hutchmed | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2026-06-12 | Hutchison Medipharma Limited | Results HUTCHMED Highlights Sovleplenib ESLIM-02 Phase III Data in Warm Antibody Autoimmune Hemolytic Anemia Presented at EHA 2026 Congress hutch-med.com ↗
HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces results from the Phase III part of the ESLIM‑02 study of sovleplenib in patients with warm antibody autoimmune hemolytic anemia (“wAIHA”) in China were presented on Thursday, June 11, 2026 during the European Hematology Association (“EHA”) Congress in Stockholm, Sweden. |
| 2026-04-29 | Hutchison Medipharma Limited | Regulatory HUTCHMED Announces NDA Acceptance in China with Priority Review Status and Breakthrough Designation for Sovleplenib for the Treatment of Warm Antibody Autoimmune Hemolytic Anemia hutch-med.com ↗
has been accepted for review and granted priority review by the China National Medical Products Administration (“NMPA”). |
| 2026-01-07 | Hutchison Medipharma Limited | Results HUTCHMED Announces Positive Topline Results of Phase III Part of ESLIM-02 Trial of Sovleplenib for Warm Antibody Autoimmune Hemolytic Anemia in China hutch-med.com ↗ |
| 2024-11-06 | Hutchison Medipharma Limited | Results HUTCHMED Highlights Clinical Data to be Presented at the 2024 ASH Annual Meeting and the 2024 ESMO Asia Congress hutch-med.com ↗
The follow-on sub-study data demonstrated that long-term treatment with sovleplenib was effective in increasing and maintaining platelet count in adults with chronic primary ITP in China. |
| 2024-06-17 | Hutchison Medipharma Limited | Results HUTCHMED Highlights Publication of Phase III ESLIM-01 Results in The Lancet Haematology hutch-med.com ↗
HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that results from ESLIM-01, HUTCHMED’s Phase III trial of sovleplenib (HMPL-523), in adult patients with primary immune thrombocytopenia (“ITP”) in China, were published in The Lancet Haematology. |
| 2024-05-17 | Hutchison Medipharma Limited | Results HUTCHMED Highlights Sovleplenib Phase III ESLIM-01 Study and Hematological Malignancy Programs Data to be Presented at the upcoming EHA2024 Congress hutch-med.com ↗
In 188 patients randomized to receive oral sovleplenib or placebo, sovleplenib demonstrated a clinically meaningful early and sustained durable platelet response in patients with primary ITP with durable response rate of 48.4% compared to zero with placebo (p<0.0001). |
| 2024-01-11 | Hutchison Medipharma Limited | Regulatory HUTCHMED Announces NDA Acceptance in China for Sovleplenib for the Treatment of Primary Immune Thrombocytopenia with Priority Review Status hutch-med.com ↗
HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the New Drug Application (“NDA”) for sovleplenib for the treatment of adult patients with primary immune thrombocytopenia (“ITP”) has been accepted for review and granted priority review by the China National Medical Products Administration (“NMPA”). |
| 2023-08-21 | Hutchison Medipharma Limited | Results HUTCHMED Announces that the Sovleplenib Phase III ESLIM-01 Study Met Its Primary Endpoint in Primary Immune Thrombocytopenia in China hutch-med.com ↗
The trial met its primary endpoint of demonstrating a clinically meaningful and a statistically significant increase in durable response rate in patients treated with sovleplenib as compared to patients treated with placebo. |
| 2022-01-12 | Hutchison Medipharma Limited | Regulatory HUTCHMED Receives Breakthrough Therapy Designation in China for HMPL-523 for Treatment of Primary Immune Thrombocytopenia hutch-med.com ↗ |
| 2021-12-14 | Hutchison Medipharma Limited | Results HUTCHMED Highlights HMPL-523 Clinical Data Presented at the 2021 ASH Annual Meeting hutch-med.com ↗
During the subsequent 16-week open-label phase of the study, one additional patient initially randomized to receive the RP2D experienced a response. |
| 2016-12-06 | Hutchison Medipharma Limited | Results Chi-Med Presents Pre-clinical Data for Selective Syk Inhibitor HMPL-523 at the 2016 American Society of Hematology Annual Meeting hutch-med.com ↗
In vitro in B-cell lymphoma cell lines with Syk/BCR dysregulation, HMPL-523 was found to block phosphorylation of B-cell linker protein as well as inhibit cell viability by inhibiting cell survival and increasing apoptotic rate. |
| 2016-11-14 | Hutchison Medipharma Limited | Results Chi-Med Presents Phase I Clinical Data for Selective Syk Inhibitor HMPL-523 at the 2016 ACR/ARHP Annual Meeting hutch-med.com ↗
The treatment was generally well tolerated without material off-target toxicities, including lower rates of diarrhea and hypertension compared to what had been observed in first-generation Syk inhibitors. |
All press releases naming this drug 23 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | sovleplenib | “Sovleplenib (HMPL-523), a novel Syk inhibitor, for patients with primary immune thrombocytopenia in China: a randomised, double-blind, placebo-controlled, phase 1b/2 study.” PMID 37028433 ↗ Apr 20232“The purpose of this study is to determine whether HMPL-523 (sovleplenib) is safe and effective in the treatment of chronic Immune Thrombocytopenic Purpura (ITP).” NCT05029635 ↗ “Sovleplenib (HMPL-523) is a selective spleen tyrosine kinase (Syk) inhibitor with anti-tumor activity in preclinical models of B-cell malignancy.” PMID 38235512 ↗ Jul 2024 |
| Known as | HMPL-523 | “Sovleplenib (HMPL-523), a novel Syk inhibitor, for patients with primary immune thrombocytopenia in China: a randomised, double-blind, placebo-controlled, phase 1b/2 study.” PMID 37028433 ↗ Apr 2023 |
| Known as | HMPL-523 Acetate | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095034 ↗ |
| Known as | SOVLEPLENIB ACETATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095034 ↗ |
| Action | Inhibit | “Sovleplenib (HMPL-523) is a selective spleen tyrosine kinase (Syk) inhibitor” PMID 38235512 ↗ Jul 2024 |
| Modality | Small molecule | “selective small-molecule SYK inhibitor” NCT05720767 ↗ |
| Route | Oral | “Oral administration” NCT02105129 ↗ |
| Target | SYK | “Sovleplenib (HMPL-523) is a selective spleen tyrosine kinase (Syk) inhibitor” PMID 38235512 ↗ Jul 2024 |