Drugs / AG-519
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | — | 2016-12-14 | “verbal notification of a clinical hold from the U.S. Food and Drug Administration” agios.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT02630927 | Dec 2015 → Dec 2016 | anemia | Agios Pharmaceuticals, Inc. | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2016-12-15 | Agios Pharmaceuticals, Inc. | Regulatory Agios Provides Update on PKR Program agios.com ↗ |
| 2016-12-04 | Agios Pharmaceuticals, Inc. | Results Agios Announces New Data from AG-348 and AG-519 Demonstrating Potential for First Disease-modifying Treatment for Patients with PK Deficiency agios.com ↗
AG-519 Is Well-Tolerated and Demonstrates Robust Dose-Dependent Changes in ATP and 2,3-DPG Blood Levels in Normal Healthy Volunteers Consistent with PKR Enzyme Activation |
| 2016-06-09 | Agios Pharmaceuticals, Inc. | Results Agios Reports Initial Data from Phase 1 Study of AG-519 in Healthy Volunteers agios.com ↗
These data provide early proof-of-mechanism for AG-519, a potent, oral, selective second pyruvate kinase-R (PKR) activator that is wholly owned by Agios. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2016-12-15 | Agios Pharmaceuticals, Inc. | Agios Provides Update on PKR Program agios.com ↗ |
| 2016-12-04 | Agios Pharmaceuticals, Inc. | Agios Announces New Data from AG-348 and AG-519 Demonstrating Potential for First Disease-modifying Treatment for Patients with PK Deficiency agios.com ↗ |
| 2016-06-09 | Agios Pharmaceuticals, Inc. | Agios Reports Initial Data from Phase 1 Study of AG-519 in Healthy Volunteers agios.com ↗ |
| 2016-05-19 | Agios Pharmaceuticals, Inc. | Agios to Present Clinical and Preclinical Data from PKR Activators AG-348 and AG-519 at the 21st Congress of the European Hematology Association agios.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AG-519 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02630927 ↗ |
| Route | Oral | “administered by mouth (orally)” NCT02630927 ↗ |