Drugs / LEPZACITINIB
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | immunodeficiency 11b with atopic dermatitis | 2020-07-07 | “today announced that it has submitted an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) for ATI-1777” aclaristx.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT05432596 | May 2022 → Oct 2023 | atopic eczema | Aclaris Therapeutics, Inc. | Completed | Met primary |
| Phase 2 | NCT04598269 | Sep 2020 → Apr 2021 | atopic eczema | Aclaris Therapeutics, Inc. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2024-01-10 | Aclaris Therapeutics, Inc. | Results Aclaris Therapeutics Announces Top-line Results from 4-Week Phase 2b Trial of ATI-1777 for Mild to Severe Atopic Dermatitis aclaristx.com ↗
today announced top-line results from its Phase 2b study of ATI-1777, an investigational topical “soft” JAK 1/3 inhibitor, in patients with mild to severe atopic dermatitis (AD) (ATI-1777-AD-202; NCT05432596). |
| 2023-12-19 | Aclaris Therapeutics, Inc. | Results Aclaris Therapeutics Provides Corporate Update aclaristx.com ↗
In the Phase 2a study, ATI-1777 demonstrated meaningful improvement in the modified Eczema Area and Severity Index (EASI) over 4 weeks of treatment and minimal measurable systemic exposure with a 2% formulation applied twice daily. |
| 2021-06-08 | Aclaris Therapeutics, Inc. | Results Aclaris Therapeutics Announces Positive Preliminary Topline Data from Phase 2a Trial of ATI-1777 for Moderate to Severe Atopic Dermatitis aclaristx.com ↗ |
| 2020-07-07 | Aclaris Therapeutics, Inc. | Regulatory Aclaris Therapeutics Submits Investigational New Drug Application for ATI-1777, a Topical “Soft” JAK1/3 Inhibitor, for the Treatment of Moderate to Severe Atopic Dermatitis aclaristx.com ↗
today announced that it has submitted an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) for ATI-1777 |
All press releases naming this drug 8 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | LEPZACITINIB | ChEMBL registry synonym — accepted as the source's own label CHEMBL5856622 ↗ |
| Known as | ATI-1777 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05432596 ↗ |
| Action | Inhibit | “ATI-1777, a potent and selective Jak1/3 inhibitor” PMID 38299059 ↗ Nov 2023 |
| Modality | Small molecule | — CHEMBL5856622 ↗ |
| Route | Topical | “ATI-1777 topical solution 2.0% w/w” NCT04598269 ↗ |
| Target | JAK1 | “ATI-1777, a potent and selective Jak1/3 inhibitor” PMID 38299059 ↗ Nov 2023 |