Levacetylleucine bulk supplier for pharma manufacturers

Levacetylleucine 310 mg, 500 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 310 mg, 500 mg

Reference Brands: Aqneursa (US)

Category: Neurology

Levacetylleucine is a Neurology product available as Tablets in strengths 310 mg, 500 mg. It corresponds to the reference brand Aqneursa (US). Verified GMP manufacturers and suppliers on PharmaTradz offer it in bulk for import worldwide, with regulatory documentation and dossier support available on request.

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Product Description:

Levacetylleucine, also known as N-acetyl-L-leucine and marketed under the brand name Aqneursa, is an orally administered medication used for the treatment of neurological manifestations associated with Niemann-Pick disease type C. It is the L-enantiomer of acetylleucine, a modified form of the amino acid leucine, which allows for improved bioavailability and targeted neurological activity. Levacetylleucine is believed to modulate neuronal function and enhance central nervous system stability, helping to reduce symptoms such as ataxia, imbalance, and impaired coordination. Its oral formulation provides a convenient administration route, making it suitable for long-term management of neurological symptoms in patients with Niemann-Pick disease type C. By supporting neuronal function, levacetylleucine contributes to improved mobility, daily functioning, and overall quality of life for affected individuals.

How Levacetylleucine is supplied today, and licensing ahead of patent expiry

Levacetylleucine is a patented innovator medicine. Where its patents are in force, which today includes most major markets, it can only be supplied by the originator or its licensees, through the routes below. Patents do expire, though, and generic development and licensing deals for post-patent markets start years in advance. If you are developing Levacetylleucine, hold a dossier for it or want to license it, talk to us.

Where levacetylleucine is approved

Checked 3 Oct 2026

Market	Status	Brand · regulator · date
United States	Approved	Aqneursa · FDA · Sep 2024
Generic / biosimilar	None	None approved as of the check date

Not approved in your country? A hospital or doctor can often still import it for a named patient, through a special-access, import-permit or compassionate-use route. We confirm which route applies in your country and the documents needed before quoting. Ask about named-patient supply →

Named-patient import Where a patient needs the product in a market where it is not registered, named-patient import is the lawful route. It requires the treating physician's documentation and authorisation from the destination regulator. We handle this pathway. Named-patient access

Authorised distribution For registered markets, supply runs through the manufacturer's authorised distribution channel. We can identify the authorised route for your market and tell you whether the product is registered there at all. Innovator sourcing

A genericised alternative Where the clinical requirement is the drug class rather than this specific molecule, there is often an off-patent alternative that is faster to register and materially cheaper. Tell us the indication and target market and we will say plainly whether one exists. Discuss alternatives

Licensing and generic development Patents expire country by country, and in many countries development and dossier filing can start before expiry under research and regulatory-review exemptions. We connect manufacturers developing this molecule, dossier holders, licensees and tech-transfer partners for markets where it is, or will become, off-patent. Partner on this molecule

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Frequently Asked Questions

Levacetylleucine (Aqneursa) treats the neurological symptoms of Niemann-Pick disease type C (NPC), a rare inherited disorder, in adults and in children who weigh at least 15 kg. The US FDA approved it in September 2024.

No. Tanganil is acetyl-DL-leucine, a mix of the L and D forms, sold in France for vertigo. Levacetylleucine is the pure L form (N-acetyl-L-leucine), developed by IntraBio for Niemann-Pick disease type C. They are different products.

As granules mixed with water into a suspension, taken by mouth or through a feeding tube. The dose depends on body weight.

Aqneursa, in the United States.

Aqneursa (Levacetylleucine) is developed and sold by IntraBio. PharmaTradz handles enquiries for authorised supply of the originator product, named-patient import where it is not registered, and licensing or development work ahead of patent expiry.