Acetylleucine 500 mg, 500 mg/5 mL Suppliers & Bulk Manufacturers

Available Forms: Tablets/ Injection

Available Strengths: 500 mg, 500 mg/5 mL

Reference Brands: Tanganil (EU)

Category: Neurology

Acetylleucine is a neurological drug used for the symptomatic treatment of vertigo and balance disorders of both central and peripheral origin. It helps stabilize nerve transmission in the vestibular system, improving balance and reducing dizziness.

Product Description:

Acetylleucine is the N-acetylated form of the amino acid leucine. The long-established product is the racemate, acetyl-DL-leucine, used in France and several other European markets for vertigo since the 1950s. Its mechanism was never fully settled; the working explanation is normalisation of membrane potential in hyperpolarised or depolarised vestibular neurons, which would account for its effect on acute vertigo without the sedation that accompanies antihistamine and benzodiazepine vestibular suppressants.

Interest revived when the L-enantiomer was studied in cerebellar ataxias and lysosomal storage disease. Levacetylleucine (N-acetyl-L-leucine) was approved by the FDA in 2024 for the neurological manifestations of Niemann-Pick disease type C, on the basis of a controlled trial — which the racemate has never had for vertigo.

Sourcing notes. The racemate and the single L-enantiomer are different products with different regulatory standing, and a buyer needs to know which is being quoted. The racemic tablet and injection are old, inexpensive and registered in a limited group of countries, mainly francophone; outside those markets registration is the obstacle rather than manufacture. The L-enantiomer is an originator orphan product with no generic. Enantiomeric purity is the specification to agree for any supply of the L-form, since the D-enantiomer is thought to accumulate and to oppose the active isomer.