Delgocitinib (LEO 124249)

A pan-JAK inhibitor, the same class as the oral drugs approved for alopecia areata in the US and EU, formulated first as an ointment and later as a cream. Delgocitinib cream is approved for moderate to severe chronic hand eczema in the EU since September 2024 and in the United States, so this is not a molecule that failed on safety.

The Phase 2a randomised 31 patients with moderate to severe alopecia areata to the 30 mg/g ointment or vehicle, and the difference in mean SALT improvement at week 12 was not significant; a companion eyebrow study was stopped for futility. The authors attributed the miss to the ointment not penetrating deep enough into the scalp dermis and called for a different formulation. What makes the row worth keeping is what happened next: LEO Pharma itself ran a randomised Phase 2a of the 20 mg/g cream in frontal fibrosing alopecia, published in 2026 with the authors seeing potential, and academic investigators have since registered two more scarring-alopecia trials, one recruiting in central centrifugal cicatricial alopecia and lichen planopilaris with LEO as collaborator, one due in frontal fibrosing alopecia. The inflammation in those conditions sits higher in the follicle, which is the rationale.

1. January 2016
   Phase 2

   First Phase 2 trial on record: NCT02561585 — LEO 124249 Ointment in the Treatment of Alopecia Areata

   ClinicalTrials.gov ↗

• NCT07671157Phase 2Not yet recruiting

  Trial of Delgocitinib 20 mg/g Cream in Subjects With Frontal Fibrosing Alopecia (FFA)

  Maryanne Makredes Senna · n=30 · September 2026

• NCT07487948Phase 2Recruiting

  Safety and Biomarker Responses of Delgocitinib (JAK1,2,3/TYK2 Inhibitor) in Central Centrifugal Cicatricial Alopecia and Lichen Planopilaris

  Icahn School of Medicine at Mount Sinai · n=30 · May 2026

• NCT05332366Phase 2Completed

  A Trial to Assess the Effect of Delgocitinib Cream 20 mg/g on the Molecular Signature, Safety, and Efficacy in Adults With Frontal Fibrosing Alopecia

  LEO Pharma · n=35 · April 2022

• NCT03325296Phase 2Terminated early

  Efficacy of Twice Daily Application of LEO 124249 Ointment 30 mg/g for 12 Weeks on Eyebrow Alopecia Areata.

  LEO Pharma · n=13 · October 2017

• NCT02561585Phase 2Completed

  LEO 124249 Ointment in the Treatment of Alopecia Areata

  LEO Pharma · n=40 · January 2016

Listing a trial is not a recommendation to join one. Eligibility, risks and costs vary enormously — discuss any trial with your own doctor first.

• LEO 124249 ointment in alopecia areata — ClinicalTrials.gov
• Safety and Biomarker Responses of Delgocitinib in Central Centrifugal Cicatricial Alopecia and Lichen Planopilaris — ClinicalTrials.gov
• Phase 2 Open Label Trial of Delgocitinib 20 mg/g Cream in Frontal Fibrosing Alopecia — ClinicalTrials.gov
• ANZUPGO (delgocitinib) cream, US prescribing information (openFDA) — Regulator filing
• A Trial to Assess the Effect of Delgocitinib Cream 20 mg/g on the Molecular Signature, Safety, and Efficacy in Adults With Frontal Fibrosing Alopecia — ClinicalTrials.gov
• Delgocitinib cream in frontal fibrosing alopecia: a randomised Phase 2a trial, Martin et al. — Peer-reviewed, January 2026
• Anzupgo (delgocitinib), European public assessment report — Regulator filing, September 2024
• A phase 2a randomized vehicle-controlled multi-center study of the safety and efficacy of delgocitinib in subjects with moderate-to-severe alopecia areata — Peer-reviewed, March 2023

Other programmes in the register with the same mechanism: JAK inhibitor.

• Baricitinib (Olumiant)ApprovedEli Lilly
• Deuruxolitinib (Leqselvi)ApprovedSun Pharmaceutical
• JaktinibApprovedSuzhou Zelgen Biopharmaceuticals
• Ritlecitinib (Litfulo)ApprovedPfizer
• Upadacitinib (Rinvoq)ApprovedAbbVie
• Ivarmacitinib (ARQ-252)Filed with regulator