ATI-501
Development of ATI-501 for alopecia areata was discontinued by Aclaris Therapeutics.
The oral sibling of ATI-50002, taken to phase 2 in alopecia areata and not registered since.
This programme is no longer being actively pursued.
- Developed by
- Aclaris Therapeutics
- Current phase
- Discontinued
- Mechanism
- JAK inhibitor
- Indications
- Alopecia areata
- Last public activity
- September 2020
- Copy last reviewed
- September 2026
- Record confidence
- Medium
Development stopped.
Calms the immune attack on the follicle by blocking JAK signalling - the class that transformed alopecia areata.
A research record, not medical advice: being listed here says nothing about whether a treatment works or whether it is right for you. Talk to a dermatologist about your own case.
Why it matters
Aclaris ran the same JAK inhibitor by mouth and on the scalp at the same time: ATI-501 is an oral prodrug converted in the body to ATI-502, the JAK1/3 inhibitor in the topical. The oral arm answered the question the topical could not: in the 87-patient Phase 2, all three dose groups improved SALT significantly against placebo, by the sponsor's July 2019 account and the posted registry results, with no serious adverse events reported. Both programmes nonetheless stopped; Aclaris sought a partner that August and none was announced. Listed as discontinued on the evidence of no registered study since 2019 rather than a sponsor announcement, hence MEDIUM.
Development history
- Phase 2
First Phase 2 trial on record: NCT03594227 — ATI-501 Oral Suspension Compared to Placebo in Subjects With Alopecia Areata, Alopecia Universalis or Alopecia Totalis
ClinicalTrials.gov ↗
Registered trials
Pulled automatically from ClinicalTrials.gov. Matching is by name and development code, so occasional gaps are possible — tell us if you spot one.
ATI-501 Oral Suspension Compared to Placebo in Subjects With Alopecia Areata, Alopecia Universalis or Alopecia Totalis
Aclaris Therapeutics, Inc. · n=87 · June 2018
Listing a trial is not a recommendation to join one. Eligibility, risks and costs vary enormously — discuss any trial with your own doctor first.
Sources
- ATI-501 in alopecia areata, alopecia totalis and alopecia universalis — ClinicalTrials.gov
- Aclaris Therapeutics announces Phase 2 clinical trial of ATI-501 oral in patients with alopecia areata met primary endpoint — Company release, July 2019
- ATI-501 study protocol (ATI-501-AUAT-201): oral prodrug converted to the JAK1/3 inhibitor ATI-502 — ClinicalTrials.gov, June 2018
Related programmes
Other programmes in the register with the same mechanism: JAK inhibitor.
Cite this page
Hair Pipeline, "ATI-501 — development record", hairpipeline.com/pipeline/ati-501