Drugs / Amlenetug
Amlenetug
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06258720 | Mar → Sep 2024 | — | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 1 | NCT03611569 | Jul 2018 → Jul 2021 | Parkinson disease | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 21 trial · 1 missed | ||||||
| Phase 2 | NCT05104476 | Nov 2021 → Nov 2023 overdue | multiple system atrophy | H. Lundbeck A/S | Active not recruiting | Missed primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT06706622 | Dec 2024 → Feb 2028 expected | multiple system atrophy | H. Lundbeck A/S | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2025-02-12 | H. Lundbeck A/S | Regulatory Lundbeck’s potential treatment amlenetug for Multiple System Atrophy receives Fast Track Designation from the FDA lundbeck.com ↗
The FDA has granted Fast Track Designation to Lundbeck’s investigational drug, amlenetug, a potential new treatment option targeting Multiple System Atrophy (MSA). |
All press releases naming this drug 2 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Amlenetug | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06706622 ↗ |
| Known as | AF-82422 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594571 ↗ |
| Known as | Lu AF82422 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06258720 ↗ |
| Modality | Monoclonal antibody | — CHEMBL4594571 ↗ |
| Route | Intravenous | “Participants in the DBP will receive Lu AF82422 intravenous (IV) infusion every 4 weeks (Q4W) from Baseline for a minimum 48 weeks up to a maximum 72 weeks.” NCT05104476 ↗ |