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Drugs / IFIDANCITINIB
last change Oct 2019 re-read 3 minutes ago

IFIDANCITINIB

also known as ATI-50002 · ATI 502 · A-301

Small molecule

Developed for
alopecia totalis · alopecia universalis · alopecia areata · androgenetic alopecia · atopic eczema · vitiligo
Investigated by
Aclaris Therapeutics, Inc.

Trials 6

today NCT03759340 · Ph 2 NCT03585296 · Ph 2 NCT03551821 · Ph 2 NCT03495817 · Ph 2 NCT03468855 · Ph 2 NCT03315689 · Ph 2
2018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 26 trials
Phase 2 NCT03759340 Jan → Sep 2019 alopecia areata, alopecia totalis, alopecia universalis Aclaris Therapeutics, Inc. Terminated No outcome recorded Stop: Business
Phase 2 NCT03585296 Jul 2018 → Apr 2019 atopic eczema Aclaris Therapeutics, Inc. Completed No outcome recorded
Phase 2 NCT03551821 Apr → Nov 2018 alopecia areata, alopecia totalis, alopecia universalis Aclaris Therapeutics, Inc. Completed No outcome recorded
Phase 2 NCT03495817 Mar 2018 → Oct 2019 androgenetic alopecia Aclaris Therapeutics, Inc. Completed No outcome recorded
Phase 2 NCT03468855 Mar 2018 → Oct 2019 vitiligo Aclaris Therapeutics, Inc. Completed No outcome recorded
Phase 2 NCT03315689 Dec 2017 → Jun 2019 alopecia totalis, alopecia universalis Aclaris Therapeutics, Inc. Completed No outcome recorded
Comparator or background therapy1 trial
Phase 2 NCT03354637 Comparator Nov 2017 → Apr 2019 alopecia areata Aclaris Therapeutics, Inc. Terminated No outcome recorded

News releases announcing trial results or a regulatory action · 8

DateIssuerRelease
2019-08-08 Aclaris Therapeutics, Inc. Results Aclaris Therapeutics Reports Second Quarter 2019 Financial Results, Provides Business Strategy Update and Provides Update on Clinical and Commercial Developments aclaristx.com ↗
7 of the 17 evaluable subjects, or 41%, met the secondary endpoint of achieving a PGA score of less than or equal to 1, with at least a two point change in the PGA score.
2019-06-26 Aclaris Therapeutics, Inc. Results Aclaris Therapeutics Announces Phase 2 Clinical Trial of ATI-502 Topical in Patients with Alopecia Areata Did Not Meet Endpoints aclaristx.com ↗
ATI-502 did not achieve statistical superiority at the primary or secondary endpoints due to high rates of disease resolution in vehicle-treated patients.
2019-06-17 Aclaris Therapeutics, Inc. Results Aclaris Therapeutics Announces Positive 6-Month Results from a Phase 2 Open-Label Clinical Trial of ATI-502 Topical in Patients with Androgenetic Alopecia (Male/Female Pattern-Baldness) aclaristx.com ↗
2018-12-17 Aclaris Therapeutics, Inc. Results Aclaris Therapeutics Provides Update on Oral and Topical JAK 1/3 Inhibitor Clinical Trials aclaristx.com ↗
2018-07-09 Aclaris Therapeutics, Inc. Regulatory FDA grants Fast Track Designation to Aclaris Therapeutics’ Investigational JAK Inhibitor for the treatment of Alopecia Areata aclaristx.com ↗
2018-06-28 Aclaris Therapeutics, Inc. Results Aclaris Therapeutics Announces Positive Interim Data from Phase 2 study of ATI-502 (a topical JAK inhibitor) in Patients with Alopecia Areata aclaristx.com ↗
Today, we report interim results for 6 of the 11 enrolled patients; data from the full cohort will be reported in the future.
2018-03-09 Aclaris Therapeutics, Inc. Regulatory Aclaris Therapeutics Announces Issuance of U.S. Patent Covering a JAK Inhibitor for Treating Hair Loss Disorders aclaristx.com ↗
2017-08-02 Aclaris Therapeutics, Inc. Regulatory Aclaris Therapeutics Submits Investigational New Drug Application for ATI-50002 to Treat Alopecia Areata aclaristx.com ↗

All press releases naming this drug 10 releases

DateIssuerRelease

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 8 sources stand behind the page.

FieldValueCited text
Known as IFIDANCITINIB ChEMBL registry synonym — accepted as the source's own label CHEMBL4594441 ↗
Known as A-301 ChEMBL registry synonym — accepted as the source's own label CHEMBL4594441 ↗
Known as ATI 502 “Enrolled subjects will apply ATI-502 Topical Solution, 0.46% BID to the entire scalp and if applicable, the eyebrow(s) and return for safety and efficacy assessments as...” NCT03759340 ↗
2

“ATI 502 0.46% Topical Solution” NCT03759340 ↗

NCT03585296 ↗
Known as ATI-50002 ClinicalTrials.gov intervention name — accepted as the source's own label NCT03315689 ↗
4

NCT03551821 ↗

NCT03495817 ↗

NCT03468855 ↗

NCT03354637 ↗
Modality Small molecule — CHEMBL4594441 ↗
Route Topical “ATI-50002 Topical Solution” NCT03315689 ↗