Deuruxolitinib (Leqselvi)
Deuruxolitinib (Leqselvi) is approved in at least one market for alopecia areata, developed by Sun Pharmaceutical.
A deuterated JAK1/2 inhibitor approved for severe alopecia areata in adults in the United States in 2024 and the United Kingdom in 2026.
- Developed by
- Sun Pharmaceutical
- Current phase
- Approved
- Mechanism
- JAK inhibitor
- Partners
- Concert Pharmaceuticals
- Indications
- Alopecia areata
- Also known as
- CTP-543, Leqselvi
- Last public activity
- September 2026
- Copy last reviewed
- September 2026
- Record confidence
- High
Cleared for sale for a hair-loss indication in at least one market.
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
Deuruxolitinib is a deuterated analogue of ruxolitinib: the same scaffold with hydrogen atoms replaced by deuterium, Concert's technique for altering how a drug is metabolised. The target is unchanged, JAK1 and JAK2 above all, with some activity at TYK2 according to the US label.
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 KingdomMHRAApprovedLeqselvi· prescription only
Severe alopecia areata in adults
Approved via the International Recognition Procedure, relying on the FDA assessment.
Regulator filing ↗ - United StatesFDAApprovedLeqselvi· prescription only
Severe alopecia areata in adults
Regulator filing ↗
Development history
- 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 ↗ - 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 ↗ - 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.
Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Japanese Adults With Severe Alopecia Areata
Sun Pharma Japan Limited · n=78 · June 2026
Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adolescents With Severe Alopecia Areata
Sun Pharmaceutical Industries, Inc. · n=355 · August 2025
European Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata
Sun Pharmaceutical Industries, Inc. · n=407 · October 2021
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
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
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
Efficacy and Tolerability Study of Two Dosing Regimens of CTP-543 in Adults With Alopecia Areata
Concert Pharmaceuticals · n=66 · May 2019
Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata
Sun Pharmaceutical Industries, Inc. · n=1000 · April 2019
Efficacy and Tolerability Study of Two Dose Regimens of CTP-543 in Adults With Alopecia Areata
Concert Pharmaceuticals · n=57 · March 2019
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
- MHRA approves deuruxolitinib (Leqselvi) to treat severe alopecia areata in adults — Regulator filing, March 2026
- LEQSELVI (deuruxolitinib) — FDA approval letter, NDA 217900 — Regulator filing, July 2024
- LEQSELVI (deuruxolitinib) tablets — prescribing information — Regulator filing, July 2024
- Phase 2 randomized, dose-ranging trial of CTP-543, a selective Janus kinase inhibitor, in moderate-to-severe alopecia areata (deuterated JAK1/2 inhibitor) — Peer-reviewed, August 2022
Related programmes
Other programmes in the register with the same mechanism: JAK inhibitor.
Cite this page
Hair Pipeline, "Deuruxolitinib (Leqselvi) — development record", hairpipeline.com/pipeline/deuruxolitinib