Drugs / ATI-2138
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | psoriasis | — | “Aclaris submitted an Investigational New Drug Application (IND) for ATI-2138 for the treatment of psoriasis in October 2021.” aclaristx.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT06585202 | Aug 2024 → Mar 2025 | atopic eczema | Aclaris Therapeutics, Inc. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2026-08-06 | Aclaris Therapeutics, Inc. | Regulatory Aclaris Therapeutics Receives Fast Track Designation for Modzatinib (ATI-2138) for Moderate to Severe Lichen Planus (LP) aclaristx.com ↗
Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today announced that the U.S. Food and Drug Administration (the "FDA") has granted Fast Track Designation for modzatinib (ATI-2138) for moderate to severe lichen planus (LP) including oral erosive LP, cutaneous LP, and lichen planopilaris. |
| 2026-03-27 | Aclaris Therapeutics, Inc. | Results Results Presented at 2026 American Academy of Dermatology (AAD) Annual Meeting Provide Additional Support for the Therapeutic Potential of ATI-2138 aclaristx.com ↗
patients receiving ATI-2138 experienced substantial improvements in disease severity, itch, affected percentage of body surface area, and disease-related quality of life measures. |
| 2026-01-27 | Aclaris Therapeutics, Inc. | Results Aclaris Therapeutics’ Novel ITK/JAK3 Inhibitor ATI-2138 Demonstrates Rapid and Sustained Hair Regrowth in Validated Murine Model of Alopecia Areata (AA) aclaristx.com ↗ |
| 2025-08-07 | Aclaris Therapeutics, Inc. | Results Aclaris Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update aclaristx.com ↗
Positive Clinical Results from Phase 2a Trial of ITK/JAK3 Inhibitor ATI-2138 Confirm Tolerability Profile, Show Strong Efficacy Signal, and Validate ITK as Therapeutic Target |
| 2025-07-29 | Aclaris Therapeutics, Inc. | Results Aclaris Therapeutics Announces Positive Top-Line Results from Open-Label Phase 2a Trial of ATI-2138, a Potent and Selective Investigational Inhibitor of ITK and JAK3; Trial Achieves Primary and Key Secondary Endpoints aclaristx.com ↗ |
| 2025-02-12 | Aclaris Therapeutics, Inc. | Results New Publication Highlights Unique Properties of ATI-2138, a Potent and Selective Inhibitor of ITK and JAK3 aclaristx.com ↗
ATI-2138 dose-dependently decreased JAK1/JAK3-dependent IL-2-stimulated STAT5 phosphorylation in human peripheral blood mononuclear cells (PBMCs) with low-nanomolar potency while having no inhibitory effect on the JAK1/JAK2-dependent IFNγ-induced STAT1 phosphorylation or the JAK2/Tyk2-dependent IL-12-induced STAT4 phosphorylation, consistent with JAK3 selectivity. |
| 2023-09-18 | Aclaris Therapeutics, Inc. | Results Aclaris Therapeutics Announces Positive Results from Phase 1 Multiple Ascending Dose Trial of ATI-2138, an Investigational Oral Covalent ITK/JAK3 Inhibitor aclaristx.com ↗
Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced positive results from ATI-2138-PKPD-102, a Phase 1 Multiple Ascending Dose (MAD) trial of the investigational compound ATI-2138. |
| 2021-11-18 | Aclaris Therapeutics, Inc. | Regulatory Aclaris Therapeutics to Host Virtual R&D Day on December 7, 2021 aclaristx.com ↗
Investigational New Drug Application for ATI-2138 Allowed |
| 2021-11-02 | Aclaris Therapeutics, Inc. | Regulatory Aclaris Therapeutics Reports Third Quarter 2021 Financial Results and Provides a Corporate Update aclaristx.com ↗
This quarter we are pleased to announce the submission of an investigational new drug application for ATI-2138, our investigational oral ITK/TXK/JAK3 inhibitor, the third novel clinical candidate generated by our proprietary KINect® drug discovery platform, |
All press releases naming this drug 13 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ATI-2138 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06585202 ↗ |
| Route | Oral | “ATI-2138 Oral Tablets BID” NCT06585202 ↗ |