2 completed, 2 recruiting, 1 active not recruiting, 1 approved for marketing. 3 Phase 2, 3 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 3 | Completed 2, Terminated 1 |
| Phase 3 | 3 | Recruiting 2, Active not recruiting 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Pivotal Study of N-acetyl-L-leucine for CACNA1A N-Acetyl-L-Leucine, Placebo - CACNA1A, Spinocerebellar Ataxia Type 6 | Phase 3 | Recruiting | IntraBio Inc | 60 | 2026-08-17 | 2026-09-08 |
| A Pivotal Study of N-Acetyl-L-Leucine on Ataxia-Telangiectasia (A-T) N-Acetyl-L-Leucine, Placebo - Ataxia-Telangiectasia, Ataxia-Telangiectasia (A-T) | Phase 3 | Active not recruiting | IntraBio Inc | 60 | 2025-03-18 | 2025-07-03 |
| A Pivotal Study of N-Acetyl-L-Leucine on Niemann-Pick Disease Type C N-Acetyl-L-Leucine, Placebo - Niemann-Pick Disease, Type C | Phase 3 | Recruiting | IntraBio Inc | 53 | 2022-06-30 | 2026-04-03 |
| N-Acetyl-L-Leucine for Ataxia-Telangiectasia (A-T) IB1001 - Ataxia Telangiectasia | Phase 2 | Terminated | IntraBio Inc | 17 | 2020-01-08 | 2026-03-25 |
| N-Acetyl-L-Leucine for Niemann-Pick Disease, Type C (NPC) IB1001 - Niemann-Pick Disease, Type C | Phase 2 | Completed | IntraBio Inc | 33 | 2019-09-04 | 2023-11-28 |
| N-Acetyl-L-Leucine for GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease) IB1001 - GM2 Gangliosidosis, Tay-Sachs Disease | Phase 2 | Completed | IntraBio Inc | 30 | 2019-06-07 | 2024-03-12 |
| Expanded Access Program (EAP) of Levacetylleucine for Ataxia-Telangiectasia (A-T) Levacetylleucine - Ataxia-Telangiectasia (A-T) | Approved for marketing | IntraBio Inc | 2026-09-28 |
Ataxia Telangiectasia (3) · Niemann-Pick Disease, Type C (2) · Episodic Ataxia, Type 2 (1) · Gangliosidoses, GM2 (1) · Sandhoff Disease (1) · Spinocerebellar Ataxias (1) · Tay-Sachs Disease (1)
acetylleucine (7) · IB1001 (5)
Germany (6) · United Kingdom (6) · United States (6) · Spain (4) · Slovakia (3) · Switzerland (3) · Australia (1) · Austria (1) · Czechia (1) · Greece (1) · Italy (1) · Netherlands (1)
PMID 33482890, PMID 34349180, PMID 34387740, PMID 40739200, PMID 30115089, PMID 33738443, PMID 34620022, PMID 36456200, PMID 38294974, PMID 40513057, PMID 42309084, PMID 42467089
2025 (1)