Drugs / DNL952
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | glycogen storage disease II | 2026-01-06 | “the U.S. FDA has lifted the clinical hold on the Investigational New Drug (IND) application for DNL952” denalitherapeutics.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT07354724 | May 2026 → Aug 2028 expected | glycogen storage disease due to acid maltase deficiency, late-onset | Denali Therapeutics Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2026-01-06 | Denali Therapeutics Inc. | Regulatory Denali Therapeutics Announces Key Anticipated Milestones and Priorities for 2026 Including Commercial Launch of Tividenofusp Alfa for Hunter Syndrome denalitherapeutics.com ↗
Denali today announced that the U.S. FDA has lifted the clinical hold on the Investigational New Drug (IND) application for DNL952, and Denali will proceed with the Phase 1 study. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2026-01-06 | Denali Therapeutics Inc. | Denali Therapeutics Announces Key Anticipated Milestones and Priorities for 2026 Including Commercial Launch of Tividenofusp Alfa for Hunter Syndrome denalitherapeutics.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 | DNL952 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07354724 ↗ |
| Route | Intravenous | “Intravenous repeating dose” NCT07354724 ↗ |