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Deuruxolitinib (Leqselvi)

A deuterated JAK1/2 inhibitor approved for severe alopecia areata in adults.

ApprovedOralJAK inhibitor
Developed by
Sun Pharmaceutical
Current phase
Approved

Cleared for sale for a hair-loss indication in at least one market.

Partners
Concert Pharmaceuticals
Indications
Alopecia areata
Also known as
CTP-543, Leqselvi
Last public activity
August 2026
Record confidence
High

How it is meant to work

Deuruxolitinib is a deuterated form of ruxolitinib — the same molecule with hydrogen atoms replaced by deuterium at positions that slow how fast the liver breaks it down. The point of the substitution is pharmacokinetic rather than mechanistic: it targets the same JAK1 and JAK2 kinases.

Where it is approved

Marketing authorisation is granted country by country, for a specific indication. A drug approved for hair loss in one market may be approved only for something else — or not at all — in another.

  • United StatesFDAApprovedLeqselvi· prescription only

    Severe alopecia areata in adults

    Regulator filing ↗

Development history

  1. Phase 2/3Phase 3

    First Phase 3 trial on record: NCT04518995 — Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA1)

    ClinicalTrials.gov ↗
  2. Phase 2Phase 2/3

    First Phase 2/3 trial on record: NCT03898479 — Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata

    ClinicalTrials.gov ↗
  3. Phase 2

    First Phase 2 trial on record: NCT03137381 — Study to Evaluate the Safety and Efficacy of CTP-543 in Adults With Moderate to Severe Alopecia Areata

    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.

  • NCT07617597Phase 3RECRUITING

    Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Japanese Adults With Severe Alopecia Areata

    Sun Pharma Japan Limited · n=78 · June 2026

  • NCT07133308Phase 3RECRUITING

    Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adolescents With Severe Alopecia Areata

    Sun Pharmaceutical Industries, Inc. · n=355 · August 2025

  • NCT05041803Phase 3COMPLETED🇫🇷 With a site in France

    European Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata

    Sun Pharmaceutical Industries, Inc. · n=407 · October 2021

  • NCT04797650Phase 3COMPLETED🇫🇷 With a site in France

    Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA2)

    Concert Pharmaceuticals · n=517 · June 2021

  • NCT04784533Phase 2COMPLETED

    A Study to Evaluate the Durability of Response of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata

    Concert Pharmaceuticals · n=317 · February 2021

  • NCT04518995Phase 3COMPLETED🇫🇷 With a site in France

    Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA1)

    Concert Pharmaceuticals · n=706 · November 2020

  • NCT03941548Phase 2COMPLETED

    Efficacy and Tolerability Study of Two Dosing Regimens of CTP-543 in Adults With Alopecia Areata

    Concert Pharmaceuticals · n=66 · May 2019

  • NCT03898479Phase 2/3ACTIVE NOT RECRUITING

    Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata

    Sun Pharmaceutical Industries, Inc. · n=1000 · April 2019

  • NCT03811912Phase 2COMPLETED

    Efficacy and Tolerability Study of Two Dose Regimens of CTP-543 in Adults With Alopecia Areata

    Concert Pharmaceuticals · n=57 · March 2019

  • NCT03137381Phase 2COMPLETED

    Study to Evaluate the Safety and Efficacy of CTP-543 in Adults With Moderate to Severe Alopecia Areata

    Concert Pharmaceuticals · n=149 · August 2017

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