Drugs / DNL919
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | Alzheimer disease | 2022-01-13 | “the U.S. Food and Drug Administration (FDA) that the DNL919 (ATV:TREM2) Investigational New Drug (IND) application has been placed on clinical hold” denalitherapeutics.com ↗ “Received a formal clinical hold letter from the U.S. Food and Drug Administration (FDA) on the Investigational New Drug application for DNL919” denalitherapeutics.com ↗ “formal clinical hold letter on the Investigational New Drug (IND) application for DNL919 (ATV:TREM2) was received” denalitherapeutics.com ↗ |
| Filed | US (FDA) | — | Alzheimer disease | 2022-01-10 | “Denali submitted an investigational new drug (IND) application for DNL919 with the U.S. Food and Drug Administration (FDA)” denalitherapeutics.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT05450549 | Jul 2022 → Jun 2023 | — | Denali Therapeutics Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2022-02-28 | Denali Therapeutics Inc. | Regulatory Denali Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Business Highlights denalitherapeutics.com ↗
Announced that a formal clinical hold letter on the Investigational New Drug (IND) application for DNL919 (ATV:TREM2) was received. |
| 2022-01-13 | Denali Therapeutics Inc. | Regulatory Denali Therapeutics Announces FDA Clinical Hold on DNL919 Investigational New Drug (IND) Application denalitherapeutics.com ↗
The FDA indicated they will provide an official clinical hold letter to Denali in approximately 30 days. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-02-28 | Denali Therapeutics Inc. | Denali Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Business Highlights denalitherapeutics.com ↗ |
| 2022-01-13 | Denali Therapeutics Inc. | Denali Therapeutics Announces FDA Clinical Hold on DNL919 Investigational New Drug (IND) Application denalitherapeutics.com ↗ |
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | DNL919 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05450549 ↗ |