CpG-D35

**CpG-D35** is a synthetic type D CpG oligodeoxynucleotide (ODN) immunomodulator optimized for human use, featuring the sequence GGtgcatcgatgcaggggGG with phosphorothioate and phosphodiester backbones, formulated in 5% maltose to minimize aggregation. Developed by the Drugs for Neglected Diseases initiative (DNDi) in partnership with GeneDesign, Inc. (Ajinomoto Bio-Pharma Services) and the University of Tokyo, with support from GHIT Fund, it acts as a **TLR9 agonist** that selectively stimulates plasmacytoid dendritic cells (pDCs) to produce type I interferons (IFNα), IFN-inducible genes, pro-inflammatory cytokines like IFNγ and IL-12, and promotes maturation of monocytes into dendritic cells and NK cell activation. Primarily indicated as an adjunct to chemotherapy (e.g., low-dose pentavalent antimonials like sodium stibogluconate) for **complicated cutaneous leishmaniasis** (CL; large/multiple lesions, treatment failures, relapses, chronic lesions due to *L. braziliensis*/*L. tropica*, leishmania recidivans) and **post-kala-azar dermal leishmaniasis (PKDL)**, preclinical studies in nonhuman primates showed it reduces lesion size, accelerates re-epithelization, and enhances antimonial efficacy without toxicity even at 10x doses; Phase I trials (single and multiple ascending dose) confirmed safety and tolerability, with ongoing multiple ascending dose study in CL patients in Colombia targeting completion by end-2024.

Other names

D35D-35D 35