Drugs / AG-181
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | phenylketonuria | 2024-02-15 | “Filed an Investigational New Drug Application (IND) for AG-181, Agios’ PAH stabilizer for the treatment of phenylketonuria (PKU).” agios.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT07241234 | Apr 2026 → Jan 2028 expected | phenylketonuria | Agios Pharmaceuticals, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT06286033 | Feb 2024 → Oct 2025 | — | Agios Pharmaceuticals, Inc. | Completed | No outcome recorded |
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 | AG-181 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06286033 ↗ |
| Route | Oral | “after oral administration of single ascending dose (SAD) of AG-181” NCT06286033 ↗ |