Drugs / DNL201
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | — | 2017-12-20 | “FDA has removed the previously imposed partial clinical hold” denalitherapeutics.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT03710707 | Dec 2018 → Dec 2019 | Parkinson disease | Denali Therapeutics Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04551534 | Jun 2017 → Aug 2018 | — | Denali Therapeutics Inc. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2020-01-14 | Denali Therapeutics Inc. | Results Denali Therapeutics Announces Broad Pipeline Progress Including Positive Results From Its LRRK2 Program for Parkinson’s Disease denalitherapeutics.com ↗
Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (“BBB”) for neurodegenerative diseases, today announced the results of its Phase 1b clinical trial of LRRK2 inhibitor DNL201 in patients with Parkinson’s disease and its Phase 1 clinical trial of LRRK2 inhibitor DNL151 in healthy volunteers. |
| 2018-08-01 | Denali Therapeutics Inc. | Results Denali Therapeutics Announces Positive Clinical Results From LRRK2 Inhibitor Program for Parkinson’s Disease denalitherapeutics.com ↗
In a randomized, double blind, placebo-controlled, oral dose study in healthy subjects, DNL201 achieved its safety, pharmacokinetic, and pharmacodynamic objectives. |
| 2017-12-20 | Denali Therapeutics Inc. | Results Denali Therapeutics Announces Advancement and Expansion of Its LRRK2 Inhibitor Clinical Program for Parkinson’s Disease denalitherapeutics.com ↗
These data, in combination with pharmacokinetics/pharmacodynamics (PK/PD) modeling, indicate robust and sustained target engagement of LRRK2 in brain. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-01-14 | Denali Therapeutics Inc. | Denali Therapeutics Announces Broad Pipeline Progress Including Positive Results From Its LRRK2 Program for Parkinson’s Disease denalitherapeutics.com ↗ |
| 2018-12-10 | Denali Therapeutics Inc. | Denali Therapeutics Announces First Patient Dosed in Phase 1b Study of DNL201 for Parkinson’s Disease denalitherapeutics.com ↗ |
| 2018-08-01 | Denali Therapeutics Inc. | Denali Therapeutics Announces Positive Clinical Results From LRRK2 Inhibitor Program for Parkinson’s Disease denalitherapeutics.com ↗ |
| 2017-12-20 | Denali Therapeutics Inc. | Denali Therapeutics Announces Advancement and Expansion of Its LRRK2 Inhibitor Clinical Program for Parkinson’s Disease denalitherapeutics.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | DNL201 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03710707 ↗ |
| Known as | GNE-0877 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3122113 ↗ |
| Modality | Small molecule | — CHEMBL3122113 ↗ |
| Route | Oral | “Oral dose(s)” NCT04551534 ↗ |