Drugs / AP-101
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03981536 | Oct 2019 → Nov 2020 | amyotrophic lateral sclerosis | AL-S Pharma | Unknown | No outcome recorded |
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT05039099 | Sep 2021 → Aug 2025 | amyotrophic lateral sclerosis | AL-S Pharma | Completed | Met primary |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2025-12-05 | Neurimmune AG | Results AL-S Pharma Reports Positive Results from Phase 2 Study of AP-101 for the Treatment of ALS, Supporting Plans for a Confirmatory Phase 3 Study neurimmune.com ↗
The analysis of an exploratory composite endpoint revealed that early treatment with AP-101 prolonged survival and delayed ventilatory support in comparison to study participants receiving placebo for 6 months followed by 6 months of treatment with AP-101. |
| 2025-09-04 | Neurimmune AG | Results AL-S Pharma announces positive topline results from Phase 2 study of AP-101 for the treatment of amyotrophic lateral sclerosis (ALS) neurimmune.com ↗
AL-S Pharma today announced positive topline results from the Phase 2 clinical study evaluating AP-101, a potential first-in-class, disease-modifying treatment for amyotrophic lateral sclerosis (ALS). |
All press releases naming this drug 2 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AP-101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03981536 ↗ |
| Route | Intravenous | “Administered by intravenous infusion (IV)” NCT03981536 ↗ |