Drug intelligence / Profile preview

TP04HN106

Development stage
Phase 2
Lead developer
Talengen
Administration
Intravenous
01

Overview

TP04HN106 is an experimental drug currently in clinical development for the treatment of Amyotrophic Lateral Sclerosis (ALS). It is being developed by Talengen Institute of Life Sciences Co., Ltd. The drug is currently undergoing a Phase 1/2 clinical trial (NCT06726577) which is a randomized, double-blind, placebo-controlled, multicenter study evaluating its safety, efficacy, and pharmacokinetic characteristics in patients with ALS. The trial started in December 2024 and has an expected enrollment of 60 participants. Patients in the experimental group receive intravenous injections of TP04HN106 at a dose of 0.83mL/kg, while the placebo group receives saline. All participants also receive Liraglutide tablets as standard baseline treatment. The trial includes screening, treatment (12 weeks, 3 cycles), extension (12 weeks, 3 cycles), and follow-up (4 weeks) periods. Some participants also undergo single-dose and multiple-dose pharmacokinetic studies. As of May 2025, TP04HN106 remains in Phase 1/2 clinical trials for ALS and is in the recruiting stage.

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