Drug intelligence / Profile preview

TLX-031

Development stage
Preclinical
Lead developer
Tulex Pharmaceuticals
Modality
Small Molecules
Administration
Oral
01

Overview

TLX-031 is a clinical-stage modified-release formulation of methylphenidate hydrochloride developed by Tulex Pharmaceuticals for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). As a product from a company specializing in complex oral solid dosage forms and controlled-release technologies, TLX-031 is designed as a generic or improved version of existing extended-release stimulants, with clinical bioequivalence studies (e.g., NCT04843423) comparing it to the reference drug Ritalin LA. Methylphenidate, the active ingredient, is a central nervous system stimulant that acts as a norepinephrine-dopamine reuptake inhibitor (NDRI). It works by blocking the dopamine transporter (DAT) and the norepinephrine transporter (NET), thereby increasing the synaptic concentrations of these neurotransmitters. This mechanism enhances neurotransmission in the prefrontal cortex, leading to improved attention, focus, and behavioral control in patients with ADHD.

02

Targets

DAT (Dopamine plasma membrane transport protein)NET (Norepinephrine Transporter)

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