Ruxolitinib cream (alopecia areata)
Development of Ruxolitinib cream (alopecia areata) for alopecia areata was discontinued by Incyte.
The topical JAK inhibitor now sold in the US and EU as Opzelura for eczema and vitiligo failed a placebo-controlled Phase 2 in alopecia areata, and Incyte let the indication go.
This programme is no longer being actively pursued.
- Developed by
- Incyte
- Current phase
- Discontinued
- Mechanism
- JAK inhibitor
- Indications
- Alopecia areata
- Also known as
- INCB018424, INCB18424, ruxolitinib phosphate cream, ruxolitinib cream, INCB018424 cream
- Last public activity
- December 2020
- Copy last reviewed
- September 2026
- Record confidence
- High
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.
How it is meant to work
Ruxolitinib 1.5% cream inhibits JAK1 and JAK2 in the skin. Oral ruxolitinib had produced regrowth in small academic case series of alopecia areata; the question was whether a cream could reach the follicle. Delgocitinib and ATI-50002, also in this register, asked the same question and got the same answer.
Why it matters
Ninety adults in two parts: twelve treated open-label, then 78 randomised to ruxolitinib cream or vehicle for 24 weeks. Incyte terminated the study after a planned interim analysis, and the 2020 paper in the Journal of the American Academy of Dermatology reports no significant difference from vehicle in the share reaching a 50% SALT improvement. The same cream was later approved in the United States and the European Union as Opzelura for atopic dermatitis and vitiligo; alopecia areata is not among its indications in either market and Incyte has not returned to it. Listed apart from oral ruxolitinib, whose use in alopecia areata remains off-label and confined to academic reports.
Development history
- Phase 2
First Phase 2 trial on record: NCT02553330 — A Study With Ruxolitinib Phosphate Cream Applied Topically to Subjects With Alopecia Areata (AA)
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.
A Study With Ruxolitinib Phosphate Cream Applied Topically to Subjects With Alopecia Areata (AA)
Incyte Corporation · n=90 · November 2015
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
- A Study With Ruxolitinib Phosphate Cream Applied Topically to Subjects With Alopecia Areata (AA) — ClinicalTrials.gov
- Ruxolitinib cream for the treatment of patients with alopecia areata: a 2-part, double-blind, randomized, vehicle-controlled phase 2 study — Peer-reviewed
- Opzelura (ruxolitinib) cream, US prescribing information — Regulator filing
- Opzelura, European public assessment report — Regulator filing, April 2023
Related programmes
Other programmes in the register with the same mechanism: JAK inhibitor.
Cite this page
Hair Pipeline, "Ruxolitinib cream (alopecia areata) — development record", hairpipeline.com/pipeline/ruxolitinib-cream-aa