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Trenonacog alfa

Alternative Names: trenonacog alfa, N-Acetyl-L-Leucine, ib-1001, ib1001, ib 1001
Latest Update: 2024-12-06
Latest Update Note: Clinical Trial Update

Product Description

IB1001, N-acetyl-L-leucine, is an orally administered modified amino acid. In vivo studies have identified N-acetyl-L-leucine to be the active isomer of N-acetyl-DL-leucine that can restore neuronal function and protect against/delay disease progression in multiple neurological circuits of the brain. The mechanism of N-acetyl-L-leucine is multi-modal, including altered glucose and antioxidant metabolism, reduced lysosomal storage, and the reduction of neuroinflammation in the cerebellum, leading to the attenuation of cell death. (Sourced from: https://intrabio.com/2021/08/19/intrabio-reports-statistically-significant-and-clinically-meaningful-improvements-in-the-use-of-ib1001-for-treatment-of-gm2-gangliosidosis/)

Mechanisms of Action: FIX Analogue

Novel Mechanism: Yes

Modality: Small Molecule

Route of Administration: Oral

FDA Designation: None *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Known Adverse Events: None

Company: IntraBio
Company Location:
Company CEO:
Additonal Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Trenonacog alfa

Countries in Clinic: Australia, Brazil, Czech Republic, Georgia, Germany, Moldova, Netherlands, Slovakia, South Africa, Spain, Switzerland, Turkey, Ukraine, United Kingdom, United States

Active Clinical Trial Count:

Highest Development Phases

Phase 3: Aphasia, Primary Progressive|Ataxia Telangiectasia|Cerebellar Ataxia|Frontotemporal Dementia|Hemophilia A|Hemophilia B|Niemann-Pick Disease, Type A|Niemann-Pick Disease, Type C|Niemann-Pick Diseases|Pick Disease of the Brain|Telangiectasis

Phase 2: Gangliosidoses|Gangliosidosis, GM2|Sandhoff Disease|Tay-Sachs Disease

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

IB1001-303

P3

Not yet recruiting

Cerebellar Ataxia|Telangiectasis|Ataxia Telangiectasia

2027-12-31

IB1001-301

P3

Unknown Status

Niemann-Pick Disease, Type C|Niemann-Pick Diseases

2027-12-31

2021-005356-10

P3

Active, not recruiting

Niemann-Pick Disease, Type C|Niemann-Pick Diseases

2025-01-25

IB1001-203

P2

Recruiting

Ataxia Telangiectasia|Cerebellar Ataxia|Telangiectasis

2024-12-01

32%

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