Drugs / EVETIFATOR
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT06281158 | Mar → Apr 2024 | — | Denali Therapeutics Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05006352 | Aug 2021 → Dec 2022 | amyotrophic lateral sclerosis | Denali Therapeutics Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04581772 | Dec 2020 → Jun 2021 | — | Denali Therapeutics Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04268784 | Feb 2020 → Aug 2021 | — | Denali Therapeutics Inc. | Completed | No outcome recorded |
| Phase 2/32 trials · 2 missed | ||||||
| Phase 2/3 | NCT05842941 | May 2023 → Oct 2024 | amyotrophic lateral sclerosis | Merit E. Cudkowicz, MD | Completed | Missed primary |
| Phase 2/3 | NCT04297683 | Jun 2020 → Jul 2027 expected | amyotrophic lateral sclerosis | Merit E. Cudkowicz, MD | Recruiting | Missed primary |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2025-01-06 | Denali Therapeutics Inc. | Results Denali Therapeutics Announces Topline Results for Regimen G Evaluating eIF2B Agonist DNL343 in the Phase 2/3 HEALEY ALS Platform Trial denalitherapeutics.com ↗
The study did not meet the primary endpoint of efficacy in slowing disease progression as compared with placebo. |
| 2023-04-10 | Denali Therapeutics Inc. | Results Denali Therapeutics Announces New DNL343 (eIF2B Agonist) Phase 1b Data in ALS To Be Presented at the Upcoming AAN Annual Meeting denalitherapeutics.com ↗
Data show that DNL343 is generally well-tolerated at doses that demonstrate robust inhibition of biomarkers associated with the integrated stress response (ISR) |
| 2022-12-05 | Denali Therapeutics Inc. | Results Denali Therapeutics Announces DNL343 Interim Phase 1b Data in ALS and Entry into the HEALEY ALS Platform Trial denalitherapeutics.com ↗
today announced interim results from a Phase 1b study of its eIF2B agonist, DNL343, in participants with amyotrophic lateral sclerosis (ALS). |
| 2021-10-06 | Denali Therapeutics Inc. | Results Denali Therapeutics Announces Positive Clinical Results and Regulatory Progress for Development Programs in Amyotrophic Lateral Sclerosis (ALS) denalitherapeutics.com ↗
eIF2B activator DNL343 achieved safety and biomarker goals in a Phase 1 study in healthy volunteers; |
| 2021-05-03 | Denali Therapeutics Inc. | Results Denali Therapeutics Reports First Quarter 2021 Financial Results and Business Highlights denalitherapeutics.com ↗
Based on interim data from the ongoing Phase 1 single- and multiple-ascending-dose study of Denali’s small molecule EIF2B activator, DNL343, in healthy volunteers, safety and pathway engagement biomarker goals of the study were met. |
| 2020-01-14 | Denali Therapeutics Inc. | Regulatory Denali Therapeutics Announces Broad Pipeline Progress Including Positive Results From Its LRRK2 Program for Parkinson’s Disease denalitherapeutics.com ↗
Furthermore, a CTA for a Phase 1 first-in-human healthy volunteer study of EIF2B activator DNL343, intended for the treatment of ALS and other neurodegenerative diseases, has been approved. |
All press releases naming this drug 9 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | EVETIFATOR | ChEMBL registry synonym — accepted as the source's own label CHEMBL5569312 ↗ |
| Known as | DNL343 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06281158 ↗ |
| Modality | Small molecule | — CHEMBL5569312 ↗ |
| Route | Oral | “Single and repeating oral dose(s)” NCT04268784 ↗ |