pp-216 Gel
Dossier type
CTD
Dossier status
Under development
Country of origin
South Korea
GMP approvals
PICS
Comments
Indication: Moderate-to-severe atopic dermatitis (topical treatment)
Clinical stage: Phase 2b — Part 2 enrollment complete February 2026
Modality: Small molecule (taurodeoxycholic acid; GPCR19 agonist / NLRP3 inflammasome inhibitor — NCE)
Mechanism / Target: GPCR19 (TGR5 bile acid receptor) agonist and NLRP3 inflammasome inhibitor; dual anti-inflammatory mechanism; reduces IL-1β, IL-18, and type 2 inflammatory cytokines; addresses both pruritus (itch) and skin barrier dysfunction; topical NuGel formulation optimised for skin penetration and drug concentration
Route / form: Topical gel (applied to affected skin areas; twice daily)
Differentiation: First GPCR19/NLRP3 dual-mechanism topical therapy for atopic dermatitis;
Manufacturer #39352
Publicly listed South Korean clinical-stage biotech developing Rx small molecule NLRP3 inflammasome inhibitors for immunological and inflammatory diseases. Lead program advances novel inflammasome-targeting approaches through clinical trials. Focused on delivering next-generation immunology therapeutics for chronic and acute inflammatory conditions.
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