Drugs / ODITRASERTIB
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | frontotemporal dementia and/or amyotrophic lateral sclerosis | — | “submitted an investigational new drug (IND) application for DNL788 ( SAR443820 )” denalitherapeutics.com ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT05797753 | Feb → Jul 2022 | amyotrophic lateral sclerosis | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT04982991 | Aug → Oct 2021 | — | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT05797701 | Jul → Sep 2021 | amyotrophic lateral sclerosis | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT05795907 | Nov 2020 → Jul 2021 | amyotrophic lateral sclerosis | Sanofi | Completed | No outcome recorded |
| Phase 22 trials · 2 missed | ||||||
| Phase 2 | NCT05630547 | Dec 2022 → Nov 2024 | multiple sclerosis | Sanofi | Terminated | Missed primary |
| Phase 2 | NCT05237284 | Apr 2022 → Mar 2024 | amyotrophic lateral sclerosis | Sanofi | Terminated | Missed primary |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2021-10-06 | Denali Therapeutics Inc. | Regulatory Denali Therapeutics Announces Positive Clinical Results and Regulatory Progress for Development Programs in Amyotrophic Lateral Sclerosis (ALS) denalitherapeutics.com ↗
Fast Track designation granted by the U.S. Food and Drug Administration (FDA) to SAR443820 /DNL788, a RIPK1 inhibitor, for the treatment of ALS; |
All press releases naming this drug 2 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ODITRASERTIB | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314474 ↗ |
| Known as | C19061501-F | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314474 ↗ |
| Known as | DN-2489 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314474 ↗ |
| Known as | DN0002489 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314474 ↗ |
| Known as | DNL788 | “SAR443820 (DNL788) is a selective, orally bioavailable, brain penetrant inhibitor of receptor-interacting serine/threonine protein kinase 1 (RIPK1).” PMID 38010108 ↗ Dec 2023 |
| Known as | RA-15804589 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314474 ↗ |
| Known as | SAR443820 | “Single Ascending Dose Study of SAR443820 in Healthy Adult Chinese and Japanese Female and Male Participants” NCT04982991 ↗ |
| Action | Inhibit | “RIPK1 inhibitor” NCT04982991 ↗ |
| Modality | Small molecule | — CHEMBL5314474 ↗ |
| Route | Oral | “ascending single oral doses” NCT04982991 ↗ |
| Target | RIPK1 | “RIPK1 inhibitor” NCT04982991 ↗ |