Drug intelligence / Profile preview

tollb-001

Development stage
Phase 2
Lead developer
Toll Biotech Co., Ltd.
Modality
Small Molecules
Administration
Oral
01

Overview

TollB-001 is a novel small molecule drug developed by Toll Biotech for the treatment of autoimmune diseases, primarily rheumatoid arthritis. It acts as a selective modulator of toll-like receptor 8 (TLR8), representing a new mechanism among oral small molecules for immune regulation. Preclinical studies have demonstrated that TollB-001 has superior efficacy and safety compared to current first-line therapies for rheumatoid arthritis. The drug is designed to address limitations of existing treatments by achieving target selectivity within its class. As of mid-2025, it is in Phase 1 clinical trials evaluating its safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in healthy volunteers. In addition to rheumatoid arthritis, development efforts are underway for systemic scleroderma[1][2][3][4][7].

02

Targets

TLR8 (Toll-like receptor 8)

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