Sovleplenib

Sovleplenib
Clinical data
Other names	HMPL-523
Legal status
Legal status	investigational;
Identifiers
	IUPAC name 7-[4-(1-methylsulfonylpiperidin-4-yl)phenyl]-N-[[(2S)-morpholin-2-yl]methyl]pyrido[3,4-b]pyrazin-5-amine;
CAS Number	1415792-84-5;
PubChem CID	71113742;
IUPHAR/BPS	11886;
DrugBank	DB17557;
ChemSpider	115010433;
UNII	9CL6353KHO;
KEGG	D12953;
ChEBI	CHEBI:758620;
ChEMBL	ChEMBL5641911;
Chemical and physical data
Formula	C24H30N6O3S
Molar mass	482.60 g·mol−1
3D model (JSmol)	Interactive image;
	SMILES CS(=O)(=O)N1CCC(CC1)C2=CC=C(C=C2)C3=CC4=NC=CN=C4C(=N3)NC[C@@H]5CNCCO5;
	InChI InChI=InChI=1S/C24H30N6O3S/c1-34(31,32)30-11-6-18(7-12-30)17-2-4-19(5-3-17)21-14-22-23(27-9-8-26-22)24(29-21)28-16-20-15-25-10-13-33-20/h2-5,8-9,14,18,20,25H,6-7,10-13,15-16H2,1H3,(H,28,29)/t20-/m0/s1; Key:NJIAKNWTIVDSDA-FQEVSTJZSA-N;

Sovleplenib is an investigational new drug that is being evaluated by Hutchison MediPharma^[1] for the treatment of immune thrombocytopenia (ITP)^[2] and warm antibody autoimmune hemolytic anemia (WAIHA).^[3] It has also been shown preclinically to have activity against B-cell lymphoma.^[4] Sovleplenib is a tyrosine-protein kinase SYK inhibitor.^[4]

Clinical trials

Sovleplenib has completed a phase 3 clinical trial for ITP.^[5] Another phase 3 trial for WAIHA is on going.^[6]

↑ "Sovleplenib - Hutchison MediPharma". AdisInsight. Springer Nature Switzerland AG.
↑ Heidari A, Mazid AS, Behroozfar M, Ghotbi N, Fathabadi F, Eghbali S, et al. (2025). "Efficacy and Safety of Syk and BTK Inhibitors in Immune Thrombocytopenia: A Comprehensive Review of Emerging Evidence". Mediators of Inflammation. 2025 5578929. doi:10.1155/mi/5578929. PMC 12084790. PMID 40385351.
↑ Costa A, Mulas O, Mereu AM, Schintu M, Greco M, Caocci G (2025). "Beneath the surface in autoimmune hemolytic anemia: pathogenetic networks, therapeutic advancements and open questions". Frontiers in Immunology. 16 1624667. doi:10.3389/fimmu.2025.1624667. PMC 12350407. PMID 40821796.
1 2 Yang N, Deng W, Sun Q, Liang J, Wang L, Fan S, et al. (December 2016). "HMPL-523, a novel SYK inhibitor showed anti-tumor activities in vitro and in vivo". Blood. 128 (22): 3970. doi:10.1182/blood.V128.22.3970.3970.
↑ Clinical trial number NCT05029635 for "Phase III Study on HMPL-523 for Treatment of ITP" at ClinicalTrials.gov
↑ Clinical trial number NCT05535933 for "HMPL-523 (Sovleplenib) in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia" at ClinicalTrials.gov