Sovleplenib
drugOn this page
Also known as HMPL 523Hmpl-523HMPL523
Summary
Sovleplenib (CHEMBL5095034) is a phase-3 clinical-stage small molecule targeting SYK; indicated across 10 conditions including autoimmune thrombocytopenic purpura and neoplasm.
At a glance
- Status: Max clinical phase 3 (not approved)
- Modality: Small molecule
- Targets: 1 (SYK)
- Indications: 10 conditions
- Clinical trials: 14
- Chemistry: 482.6 Da · C24H30N6O3S
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL5095034 |
| Name | Sovleplenib |
| Type | Small molecule |
| Max phase | 3 |
| FDA approved | no |
| PubChem CID | 166625231 |
| Molecular formula | C24H30N6O3S |
| Molecular weight | 482.6 |
| InChIKey | BRCHZKBUGSKTND-FQEVSTJZSA-N |
SMILES: CS(=O)(=O)N1CCC(CC1)C2=CC=C(C=C2)C3=C(C4=NC=CN=C4C=N3)NC[C@@H]5CNCCO5
IUPAC name: 7-[4-(1-methylsulfonylpiperidin-4-yl)phenyl]-N-[[(2S)-morpholin-2-yl]methyl]pyrido[3,4-b]pyrazin-8-amine
Also known as: HMPL 523, Hmpl 523, Hmpl-523, HMPL-523, HMPL523, Sovleplenib, SOVLEPLENIB
Parent form; salt/anhydrous children: CHEMBL6068429
Patent coverage: 111 distinct patent families (377 SureChEMBL compound mentions), from 1 matched compound structure(s). Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.
Targets
Targets
Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).
| Gene | Target | Action | pAffinity | Cancer dependency | UniProt |
|---|---|---|---|---|---|
| SYK | spleen associated tyrosine kinase | Inhibition | 9 | 2% | P43405 |
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
Aggregated over 1 target gene(s): SYK.
Top Reactome pathways
47 total, by targets touching each:
| Pathway | Targets | Genes |
|---|---|---|
| Hemostasis | 1 | SYK |
| GPVI-mediated activation cascade | 1 | SYK |
| Cytokine Signaling in Immune system | 1 | SYK |
| Adaptive Immune System | 1 | SYK |
| Signal Transduction | 1 | SYK |
| Disease | 1 | SYK |
| Innate Immune System | 1 | SYK |
| Immune System | 1 | SYK |
| Fcgamma receptor (FCGR) dependent phagocytosis | 1 | SYK |
| FCGR activation | 1 | SYK |
| Regulation of actin dynamics for phagocytic cup formation | 1 | SYK |
| Role of phospholipids in phagocytosis | 1 | SYK |
| DAP12 interactions | 1 | SYK |
| DAP12 signaling | 1 | SYK |
| Fc epsilon receptor (FCERI) signaling | 1 | SYK |
| Role of LAT2/NTAL/LAB on calcium mobilization | 1 | SYK |
| FCERI mediated MAPK activation | 1 | SYK |
| FCERI mediated Ca+2 mobilization | 1 | SYK |
| Integrin signaling | 1 | SYK |
| Signaling by Interleukins | 1 | SYK |
| Interleukin-2 family signaling | 1 | SYK |
| Interleukin-3, Interleukin-5 and GM-CSF signaling | 1 | SYK |
| CLEC7A (Dectin-1) signaling | 1 | SYK |
| Dectin-2 family | 1 | SYK |
| C-type lectin receptors (CLRs) | 1 | SYK |
| Infectious disease | 1 | SYK |
| Platelet activation, signaling and aggregation | 1 | SYK |
| Platelet Aggregation (Plug Formation) | 1 | SYK |
| Interleukin-2 signaling | 1 | SYK |
| Regulation of signaling by CBL | 1 | SYK |
Dominant GO biological processes
| GO term | Targets |
|---|---|
| angiogenesis | 1 |
| cell activation | 1 |
| lymph vessel development | 1 |
| positive regulation of receptor internalization | 1 |
| stimulatory C-type lectin receptor signaling pathway | 1 |
| adaptive immune response | 1 |
| macrophage activation involved in immune response | 1 |
| neutrophil activation involved in immune response | 1 |
| leukocyte activation involved in immune response | 1 |
| serotonin secretion by platelet | 1 |
| cell surface pattern recognition receptor signaling pathway | 1 |
| negative regulation of inflammatory response to antigenic stimulus | 1 |
| protein phosphorylation | 1 |
| protein import into nucleus | 1 |
| leukocyte cell-cell adhesion | 1 |
Indications & clinical
Indications
10 indications (0 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| autoimmune thrombocytopenic purpura | 3 | MONDO:0008558 | EFO:0007160 |
| neoplasm | 2 | MONDO:0005070 | EFO:0000616 |
| autoimmune hemolytic anemia | 2 | MONDO:0020108 | EFO:1001264 |
| rheumatoid arthritis | 1 | MONDO:0008383 | EFO:0000685 |
| acute myeloid leukemia | 1 | MONDO:0018874 | EFO:0000222 |
| non-Hodgkin lymphoma | 1 | MONDO:0018908 | EFO:0005952 |
| lymphoma | 1 | MONDO:0005062 | EFO:0000574 |
| autoimmune disease | 1 | MONDO:0007179 | EFO:0005809 |
2 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.
Clinical trials
Total trials: 14.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE1 | 12 |
| PHASE3 | 1 |
| EARLY_PHASE1 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT05029635 | PHASE3 | COMPLETED | Phase III Study on HMPL-523 for Treatment of ITP |
| NCT02105129 | PHASE1 | COMPLETED | A Study of the Safety, Tolerability and Pharmacokinetics of HMPL-523 |
| NCT02503033 | PHASE1 | UNKNOWN | A Study of HMPL-523 in Relapsed or Refractory Hematologic Malignancies |
| NCT02857998 | PHASE1 | COMPLETED | A Study of Hutchison MediPharma Limited(HMPL)-523 in Patients With Relapsed or Refractory Mature B-cell Neoplasms |
| NCT03483948 | PHASE1 | TERMINATED | Phase I Study of HMPL-523+Azacitidine in Elderly Patients With Acute Myeloid Leukemia |
| NCT03779113 | PHASE1 | TERMINATED | An Open-label, Dose Escalation Trial to Evaluate the Safety and Pharmacokinetics of HMPL-523 in Patients With Lymphoma |
| NCT03951623 | PHASE1 | COMPLETED | The Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-523 in Immune Thrombocytopenia Patients |
| NCT05571787 | PHASE1 | COMPLETED | HMPL-523 Food Effect and Proton Pump Inhibitor Study |
| NCT05720767 | PHASE1 | COMPLETED | HMPL-523 CYP3A/P-gp Inhibitor and CYP Inducer Study |
| NCT05781906 | PHASE1 | COMPLETED | Human Mass Balance of [14C]HMPL-523 in Healthy Adult Male Chinese Subjects |
| NCT06291415 | PHASE1 | WITHDRAWN | The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult Subjects With Immune Thrombocytopenia (ITP) |
| NCT07331194 | PHASE1 | COMPLETED | Pharmacokinetics and Bioequivalence Study of HMPL-523 Acetate Tablets in Humans |
| NCT07348133 | PHASE1 | COMPLETED | Study of Food Effect on Pharmacokinetics of HMPL-523 Acetate Tablets |
| NCT05318820 | EARLY_PHASE1 | COMPLETED | A Clinical Study to Evaluate the Pharmacokinetics and Bioequivalence of HMPL-523 Tablets Produced by Two Different Manufacturers |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
Molecules sharing ≥1 of this drug’s curated primary targets, merged from two biobtree sources and ranked by shared-target count, then clinical phase: ChEMBL clinical-stage candidates (development phase ≥2) and PubChem drug-class bioactivity (approved / known drugs acting on the target). Deduplicated by drug name; the drug’s own salt forms are excluded. Note: for a drug with few primary targets a shared-target match can reflect off-target / promiscuous binding rather than the same therapeutic mechanism — the phase ordering surfaces bona-fide therapeutics first.
54 molecules share ≥1 primary target. Top 54 by shared-target count:
| Molecule | Source | Status | Shared targets |
|---|---|---|---|
| CRIZOTINIB | ChEMBL + PubChem | Phase 4 (approved) | SYK |
| FOSTAMATINIB | ChEMBL + PubChem | Phase 4 (approved) | SYK |
| PAZOPANIB | ChEMBL + PubChem | Phase 4 (approved) | SYK |
| BOSUTINIB | ChEMBL | Phase 4 (approved) | SYK |
| CERITINIB | ChEMBL | Phase 4 (approved) | SYK |
| DASATINIB | ChEMBL | Phase 4 (approved) | SYK |
| ENTRECTINIB | ChEMBL | Phase 4 (approved) | SYK |
| ERLOTINIB | ChEMBL | Phase 4 (approved) | SYK |
| FEDRATINIB | ChEMBL | Phase 4 (approved) | SYK |
| FOSTAMATINIB DISODIUM | ChEMBL | Phase 4 (approved) | SYK |
| GILTERITINIB | ChEMBL | Phase 4 (approved) | SYK |
| IMATINIB | ChEMBL | Phase 4 (approved) | SYK |
| INFIGRATINIB | ChEMBL | Phase 4 (approved) | SYK |
| MIDOSTAURIN | ChEMBL | Phase 4 (approved) | SYK |
| NERATINIB | ChEMBL | Phase 4 (approved) | SYK |
| CEDIRANIB | ChEMBL | Phase 3 | SYK |
| ENTOSPLETINIB | ChEMBL | Phase 3 | SYK |
| LESTAURTINIB | ChEMBL | Phase 3 | SYK |
| QUERCETIN | ChEMBL | Phase 3 | SYK |
| ADAVOSERTIB | ChEMBL | Phase 2 | SYK |
| APITOLISIB | ChEMBL | Phase 2 | SYK |
| AT-9283 | ChEMBL | Phase 2 | SYK |
| BERZOSERTIB | ChEMBL | Phase 2 | SYK |
| BI-2536 | ChEMBL | Phase 2 | SYK |
| CENISERTIB | ChEMBL | Phase 2 | SYK |
| CERDULATINIB | ChEMBL | Phase 2 | SYK |
| DANUSERTIB | ChEMBL | Phase 2 | SYK |
| FISETIN | ChEMBL | Phase 2 | SYK |
| FORETINIB | ChEMBL | Phase 2 | SYK |
| GENISTEIN | ChEMBL | Phase 2 | SYK |
| GLESATINIB | ChEMBL | Phase 2 | SYK |
| GUSACITINIB | ChEMBL | Phase 2 | SYK |
| ILORASERTIB | ChEMBL | Phase 2 | SYK |
| LANRAPLENIB | ChEMBL | Phase 2 | SYK |
| LUTEOLIN | ChEMBL | Phase 2 | SYK |
| MIVAVOTINIB | ChEMBL | Phase 2 | SYK |
| PELITINIB | ChEMBL | Phase 2 | SYK |
| R-112 | ChEMBL | Phase 2 | SYK |
| R-343 | ChEMBL | Phase 2 | SYK |
| R-406 | ChEMBL | Phase 2 | SYK |
| RAF-265 | ChEMBL | Phase 2 | SYK |
| REBASTINIB | ChEMBL | Phase 2 | SYK |
| TOP-1288 | ChEMBL | Phase 2 | SYK |
| TOZASERTIB | ChEMBL | Phase 2 | SYK |
| UCN-01 | ChEMBL | Phase 2 | SYK |
| Afatinib | PubChem | Approved | SYK |
| belumosudil | PubChem | Approved | SYK |
| Binimetinib | PubChem | Approved | SYK |
| dacomitinib | PubChem | Approved | SYK |
| Gefitinib | PubChem | Approved | SYK |
| Idelalisib | PubChem | Approved | SYK |
| regorafenib | PubChem | Approved | SYK |
| Selumetinib | PubChem | Approved | SYK |
| Trametinib | PubChem | Approved | SYK |
Related Atlas pages
- Genes: SYK
- Diseases: autoimmune thrombocytopenic purpura
- Drugs: Crizotinib, Fostamatinib, Pazopanib, Bosutinib, Ceritinib, Dasatinib, Entrectinib, Erlotinib, Fedratinib, Gilteritinib, Imatinib, Infigratinib, Midostaurin, Neratinib, Cediranib, Entospletinib, Lestaurtinib, Quercetin, Afatinib, belumosudil, Binimetinib, dacomitinib, Gefitinib, Idelalisib, regorafenib, Selumetinib, Trametinib