COMPANY

IntraBio

FDA-approved therapeutic company Clinical Phase 3

Location: Austin, TX · source · Oct 14, 2026

Profile checked Oct 10, 2026

Keywords: Ataxia-Telangiectasia Type C Niemann-Pick Disease Ataxia Telangiectasia CACNA1A Spinocerebellar Ataxia Type 6 Episodic Ataxia Type 2 Familial Hemiplegic Migraine-1 GM2 Gangliosidosis Tay-Sachs Disease Sandhoff Disease N-Acetyl-L-Leucine IB1001 Levacetylleucine

7Trials (company is sponsor)

Timeline

Aug 17, 2026 Trial start Phase 3: Pivotal Study of N-acetyl-L-leucine for CACNA1A source ↗
Mar 18, 2025 Trial start Phase 3: A Pivotal Study of N-Acetyl-L-Leucine on Ataxia-Telangiectasia (A-T) source ↗
Jun 30, 2022 Trial start Phase 3: A Pivotal Study of N-Acetyl-L-Leucine on Niemann-Pick Disease Type C source ↗
Jan 8, 2020 Trial start Phase 2: N-Acetyl-L-Leucine for Ataxia-Telangiectasia (A-T) source ↗
Sep 4, 2019 Trial start Phase 2: N-Acetyl-L-Leucine for Niemann-Pick Disease, Type C (NPC) source ↗
Jun 7, 2019 Trial start Phase 2: N-Acetyl-L-Leucine for GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease) source ↗

Upcoming milestones

May 1, 2027 (ESTIMATED) · Phase 3 · Pivotal Study of N-acetyl-L-leucine for CACNA1A · NCT07221292
Dec 31, 2027 (ESTIMATED) · Phase 3 · A Pivotal Study of N-Acetyl-L-Leucine on Ataxia-Telangiectasia (A-T) · NCT06673056
Jun 12, 2030 (ESTIMATED) · Phase 3 · A Pivotal Study of N-Acetyl-L-Leucine on Niemann-Pick Disease Type C · NCT05163288

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 7

Record	Title	Phase	Status	Start	Primary completion
NCT07380165	Expanded Access Program (EAP) of Levacetylleucine for Ataxia-Telangiectasia (A-T)	Not listed	Approved for marketing	Not listed	Not listed
NCT07221292	Pivotal Study of N-acetyl-L-leucine for CACNA1A	Phase 3	Recruiting	Aug 17, 2026	May 1, 2027 (estimated)
NCT05163288	A Pivotal Study of N-Acetyl-L-Leucine on Niemann-Pick Disease Type C	Phase 3	Recruiting	Jun 30, 2022	Jun 12, 2030 (estimated)
NCT03759678	N-Acetyl-L-Leucine for Ataxia-Telangiectasia (A-T)	Phase 2	Terminated	Jan 8, 2020	Feb 11, 2025 (actual)
NCT06673056	A Pivotal Study of N-Acetyl-L-Leucine on Ataxia-Telangiectasia (A-T)	Phase 3	Active, not recruiting	Mar 18, 2025	Dec 31, 2027 (estimated)
NCT03759665	N-Acetyl-L-Leucine for GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease)	Phase 2	Completed	Jun 7, 2019	Jan 9, 2023 (actual)
NCT03759639	N-Acetyl-L-Leucine for Niemann-Pick Disease, Type C (NPC)	Phase 2	Completed	Sep 4, 2019	Nov 7, 2022 (actual)