Drug Type Monoclonal antibody |
Synonyms AP-101 (AL-S Pharma), AP101 (AL-S Pharma), NI 005 + [1] |
Target |
Action inhibitors |
Mechanism SOD1 inhibitors(Superoxide dismutase inhibitors) |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhasePhase 2 |
First Approval Date- |
RegulationOrphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Switzerland) |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Amyotrophic Lateral Sclerosis | Phase 2 | United States | 02 Sep 2021 | |
| Amyotrophic Lateral Sclerosis | Phase 2 | Belgium | 02 Sep 2021 | |
| Amyotrophic Lateral Sclerosis | Phase 2 | Canada | 02 Sep 2021 | |
| Amyotrophic Lateral Sclerosis | Phase 2 | Germany | 02 Sep 2021 | |
| Amyotrophic Lateral Sclerosis | Phase 2 | South Korea | 02 Sep 2021 | |
| Amyotrophic Lateral Sclerosis | Phase 2 | Sweden | 02 Sep 2021 |
NCT05039099 (PRNewswire) Manual | Phase 2 | 73 | sxijxrapuo(cmurcucivj) = The study met its primary safety and tolerability endpoint in sporadic ALS (n=52) and mutant SOD1-ALS (n=21). nrenqhtvcr (qltfzxqamx ) Met | Positive | 04 Sep 2025 | ||
Placebo |






