This section highlights FDA-related milestones and regulatory updates for drugs developed by Aclaris Therapeutics (ACRS).
Over the past two years, Aclaris Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ATI-045, ATI-052, and ATI-2138. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ATI-045 - FDA Regulatory Timeline and Events
ATI-045 is a drug developed by Aclaris Therapeutics for the following indication: In Atopic Dermatitis (AD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ATI-045
- Announced Date:
- June 2, 2025
- Indication:
- In Atopic Dermatitis (AD)
Announcement
Aclaris Therapeutics, Inc. announced that it has initiated a randomized, double-blind, placebo-controlled Phase 2 trial of bosakitug (ATI-045) in patients with moderate-to-severe atopic dermatitis (AD).
AI Summary
Aclaris Therapeutics recently announced the start of a Phase 2 clinical trial for bosakitug (ATI-045), an investigational monoclonal antibody, in patients with moderate-to-severe atopic dermatitis (AD). The trial is randomized, double-blind, and placebo-controlled, aiming to evaluate both the efficacy and safety of bosakitug. This study builds on promising early results from a previous Phase 2a trial, where significant improvements were observed in measures such as the Eczema Area and Severity Index (EASI) and Investigator Global Assessment (IGA) scores. Approximately 90 patients will be enrolled, and the primary endpoint will focus on the percent change from baseline in EASI at week 24. Top line results from the trial are expected in the second half of 2026, potentially positioning bosakitug as a best-in-class treatment option for AD.
Read Announcement- Drug:
- ATI-045
- Announced Date:
- February 27, 2025
- Indication:
- In Atopic Dermatitis (AD)
Announcement
Aclaris Therapeutics, Inc. provided a corporate update.
AI Summary
Aclaris Therapeutics, Inc. provided a corporate update highlighting its transformative progress in 2024. The company reported strong financial results along with multiple clinical catalysts expected in 2025. In partnership with Chia Tai Tianqing Pharmaceutical Group, phase 2 data for bosakitug is anticipated in the first half of 2025 from trials in severe asthma and chronic rhinosinusitis with nasal polyps. This upcoming data is seen as crucial for guiding future development in respiratory diseases. Additionally, Aclaris plans to start enrollment in a phase 2b trial for bosakitug in patients with atopic dermatitis during the same period, and expects top-line data from a phase 2a trial of ATI-2138 for atopic dermatitis. The update also detailed recent licensing achievements, a successful $80 million private placement, and leadership changes, with Dr. Neal Walker named CEO, reinforcing the company’s commitment to innovation in immuno-inflammatory treatments.
Read Announcement
ATI-052 - FDA Regulatory Timeline and Events
ATI-052 is a drug developed by Aclaris Therapeutics for the following indication: bispecific anti-TSLP/IL-4R monoclonal antibody.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ATI-052
- Announced Date:
- June 23, 2025
- Indication:
- bispecific anti-TSLP/IL-4R monoclonal antibody.
Announcement
Aclaris Therapeutics, Inc. announced that it has initiated a placebo-controlled Phase 1a/1b program for ATI-052, the Company's potential best-in-class investigational bispecific anti-TSLP/IL-4R antibody.
AI Summary
Aclaris Therapeutics, Inc. has initiated a placebo-controlled Phase 1a/1b clinical trial for its investigational bispecific antibody, ATI-052. This potential best-in-class therapy is designed to block both thymic stromal lymphopoietin (TSLP) and interleukin-4 receptor (IL-4R), targeting key drivers of Th2-mediated inflammation and allergic diseases.
The early phase study is divided into two parts. The Phase 1a portion involves single and multiple ascending dose testing in healthy volunteers to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ATI-052. The company expects to complete this initial stage by the end of 2025, with early results anticipated in early 2026. The subsequent Phase 1b trial will provide proof-of-concept data in up to two conditions, further assessing the drug’s potential to offer improved treatment options in immune-mediated diseases.
Read Announcement- Drug:
- ATI-052
- Announced Date:
- April 22, 2025
- Estimated Event Date Range:
- April 1, 2025 - June 30, 2025
- Target Action Date:
- Q2 - 2025
- Indication:
- bispecific anti-TSLP/IL-4R monoclonal antibody.
Announcement
Aclaris Therapeutics, Inc. announced that Initiation of Upcoming Phase 1a/1b Clinical Trial Expected in the Second Quarter of 2025 -
AI Summary
Aclaris Therapeutics, Inc. has received FDA clearance for its Investigational New Drug (IND) application, allowing the company to launch a Phase 1a/1b clinical trial for ATI-052. This investigational treatment is a bispecific antibody designed to block both the TSLP ligand and the IL-4 receptor, which are involved in key inflammatory pathways. The randomized, blinded, placebo-controlled trial will assess both single and multiple ascending doses of ATI-052, followed by a proof-of-concept study in an undisclosed immuno-inflammatory indication.
Aclaris plans to start the clinical trial in the second quarter of 2025. The company emphasizes that this study is an important milestone, as it may help determine the safety, proper dosage, and potential effectiveness of ATI-052 in treating a range of immune-mediated diseases. This move highlights the ongoing efforts to develop novel immunotherapies and improve treatment options for patients.
Read Announcement- Drug:
- ATI-052
- Announced Date:
- April 22, 2025
- Indication:
- bispecific anti-TSLP/IL-4R monoclonal antibody.
Announcement
Aclaris Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase 1a/1b clinical trial of ATI-052, a potential best-in-class bispecific anti-TSLP/IL-4R monoclonal antibody.
AI Summary
Aclaris Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase 1a/1b clinical trial of ATI-052. This potential best-in-class bispecific monoclonal antibody targets both the TSLP ligand and the IL-4 receptor, blocking two key components in the inflammatory process. The trial, which is randomized, blinded, and placebo-controlled, will assess single and multiple ascending doses, followed by a proof-of-concept study in an undisclosed indication. ATI-052’s dual mechanism of action may offer improved effectiveness compared to traditional treatments, marking a significant step forward in the treatment of immuno-inflammatory diseases. The trial is expected to begin in the second quarter of 2025, highlighting the company’s commitment to advancing innovative therapies in the field of immunotherapy.
Read Announcement
ATI-2138 - FDA Regulatory Timeline and Events
ATI-2138 is a drug developed by Aclaris Therapeutics for the following indication: For the Treatment of Moderate to Severe Atopic Dermatitis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ATI-2138
- Announced Date:
- February 12, 2025
- Indication:
- For the Treatment of Moderate to Severe Atopic Dermatitis
Announcement
Aclaris Therapeutics, Inc. announced the availability of a new publication describing the unique properties of Aclaris Therapeutics' ATI-2138, a novel investigational covalent inhibitor of interleukin-2-inducible T cell kinase (ITK) and Janus kinase 3 (JAK3) in development for the treatment of autoimmune and inflammatory diseases.
AI Summary
Aclaris Therapeutics, Inc. has released a new publication in The Journal of Pharmacology and Experimental Therapeutics that highlights the unique properties of its investigational drug, ATI-2138. This novel compound is a covalent inhibitor that targets interleukin-2-inducible T cell kinase (ITK) and Janus kinase 3 (JAK3), two enzymes involved in key immune cell functions. The publication details how ATI-2138 effectively and selectively blocks the activity of these enzymes, leading to the inhibition of Th1, Th2, and Th17 cells, which play significant roles in many autoimmune and inflammatory diseases. Preclinical data in animal models have shown promising results, supporting ongoing Phase 2a clinical trials in atopic dermatitis. The findings also underline ATI-2138’s potential safety, tolerability, and pharmacological profile, making it a promising candidate for future treatments of conditions such as allergic and autoimmune diseases.
Read Announcement- Drug:
- ATI-2138
- Announced Date:
- September 17, 2024
- Indication:
- For the Treatment of Moderate to Severe Atopic Dermatitis
Announcement
Aclaris Therapeutics, Inc. announced that the first patient has been dosed in Aclaris' Phase 2a clinical trial of ATI-2138, an investigational oral covalent inhibitor of interleukin-2-inducible T cell kinase (ITK) and Janus kinase (JAK) 3, for the treatment of moderate to severe atopic dermatitis (AD).
AI Summary
Aclaris Therapeutics, Inc. has begun dosing the first patient in its Phase 2a clinical trial for ATI-2138, a new investigational drug aimed at treating moderate to severe atopic dermatitis. ATI-2138 is an oral covalent inhibitor that targets both interleukin-2-inducible T cell kinase (ITK) and Janus kinase (JAK) 3. This dual-action mechanism is designed to interfere with T cell signaling, offering a unique treatment approach for patients with this condition.
The open-label study will assess the drug’s safety, tolerability, pharmacokinetics, efficacy, and pharmacodynamics over a 12-week period. Approximately 15 patients in the United States are expected to participate. Early data regarding the drug’s potential to improve symptoms, measured using several Eczema Area and Severity Index (EASI) responses and related endpoints, is anticipated in the first half of 2025.
Read Announcement
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