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N-Acetyl-L-Leucine
N-Acetyl-L-Leucine is a Amino acid metabolic enhancer Small molecule drug developed by IntraBio Inc. It is currently in Phase 3 development for Cerebellar ataxia, Vertigo and balance disorders, Spinocerebellar ataxia. Also known as: IB1001, levacetylleucine.
N-Acetyl-L-Leucine enhances mitochondrial energy metabolism and reduces neuroinflammation to improve vestibular and cerebellar function.
N-Acetyl-L-Leucine enhances mitochondrial energy metabolism and reduces neuroinflammation to improve vestibular and cerebellar function. Used for Cerebellar ataxia, Vertigo and balance disorders, Spinocerebellar ataxia.
At a glance
| Generic name | N-Acetyl-L-Leucine |
|---|---|
| Also known as | IB1001, levacetylleucine |
| Sponsor | IntraBio Inc |
| Drug class | Amino acid metabolic enhancer |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
N-Acetyl-L-Leucine is a branched-chain amino acid derivative that acts as a metabolic enhancer, particularly in the mitochondria of vestibular and cerebellar neurons. It increases ATP production and reduces oxidative stress while modulating neuroinflammatory pathways, thereby improving balance, coordination, and vertigo symptoms in patients with central nervous system disorders affecting these regions.
Approved indications
- Cerebellar ataxia
- Vertigo and balance disorders
- Spinocerebellar ataxia
Common side effects
- Gastrointestinal disturbances
- Headache
- Fatigue
Key clinical trials
- Pivotal Study of N-acetyl-L-leucine for CACNA1A (PHASE3)
- N-Acetyl-L-Leucine for Ataxia-Telangiectasia (A-T) (PHASE2)
- Expanded Access Program (EAP) of Levacetylleucine for Ataxia-Telangiectasia (A-T)
- Vision Preservation and Restoration Following a 6 Month Trial of GlaucoCetin (NA)
- A Pivotal Study of N-Acetyl-L-Leucine on Ataxia-Telangiectasia (A-T) (PHASE3)
- A Pivotal Study of N-Acetyl-L-Leucine on Niemann-Pick Disease Type C (PHASE3)
- N-Acetyl-L-Leucine for GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease) (PHASE2)
- N-Acetyl-L-Leucine for Niemann-Pick Disease, Type C (NPC) (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- N-Acetyl-L-Leucine CI brief — competitive landscape report
- N-Acetyl-L-Leucine updates RSS · CI watch RSS
- IntraBio Inc portfolio CI
Frequently asked questions about N-Acetyl-L-Leucine
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Is N-Acetyl-L-Leucine also known as anything else?
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Related
- Drug class: All Amino acid metabolic enhancer drugs
- Manufacturer: IntraBio Inc — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Cerebellar ataxia
- Indication: Drugs for Vertigo and balance disorders
- Indication: Drugs for Spinocerebellar ataxia
- Also known as: IB1001, levacetylleucine
- Compare: N-Acetyl-L-Leucine vs similar drugs
- Pricing: N-Acetyl-L-Leucine cost, discount & access