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LEO LABORATORIES LIMITED

🇮🇪Ireland
Ownership
-
Employees
-
Market Cap
-
Website

Clinical Trials

220

Active:5
Completed:197

Trial Phases

6 Phases

Early Phase 1:1
Phase 1:74
Phase 2:52
+3 more phases

Drug Approvals

41

SFDA:25
EMC:13
NMPA:2
+1 more agencies

Drug Approvals

Fusidic Acid Cream

Product Name
立思丁
Approval Number
H20130928
Approval Date
Dec 21, 2018
NMPA

Sodium Fusidate Ointment

Product Name
立思丁
Approval Number
H20150160
Approval Date
Mar 27, 2015
NMPA

Clinical Trials

Distribution across different clinical trial phases (193 trials with phase data)• Click on a phase to view related trials

Phase 1
74 (38.3%)
Phase 2
52 (26.9%)
Phase 3
50 (25.9%)
Phase 4
14 (7.3%)
Not Applicable
2 (1.0%)
Early Phase 1
1 (0.5%)

A 16-week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream 20 mg/g in Adult Participants With Mild to Severe Palmoplantar Pustulosis

Phase 2
Recruiting
Conditions
Palmoplantar Pustulosis
Interventions
Drug: Vehicle cream
First Posted Date
2025-06-10
Last Posted Date
2025-08-29
Lead Sponsor
LEO Pharma
Target Recruit Count
135
Registration Number
NCT07013201
Locations
🇨🇦

LEO Pharma Investigational Site, Hamilton, Ontario, Canada

🇺🇸

LEO Pharma Investigation Site, Mayfield Heights, Ohio, United States

A Study to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of LEO 158968

Phase 1
Completed
Conditions
Gout Flares
Joint Pain
Joint Inflammation
Interventions
First Posted Date
2024-06-06
Last Posted Date
2025-09-17
Lead Sponsor
LEO Pharma
Target Recruit Count
6
Registration Number
NCT06444867
Locations
🇬🇧

LEO Pharma Investigational Site, London, United Kingdom

A phase 3 multi-center trial to evaluate the efficacy and safety of tralokinumab in combination with topical corticosteroids in children (age 2 to <12 years) and infants (age 6 months to <2 years) with moderate-to-severe atopic dermatitis. The trial is randomized, double blind, placebo-controlled, and parallel-group for children (age 2 to <12 years) and open-label and single-group for infants (age 6 months to <2 years).

Phase 2/3
Recruiting
Conditions
Treatment of moderate-to-severe Atopic dermatitis
First Posted Date
2024-10-07
Last Posted Date
2025-03-31
Lead Sponsor
Leo Pharma A/S
Target Recruit Count
112
Registration Number
2023-503630-44-00
Locations
🇨🇿

Kozni ambulance Kutna Hora s.r.o., Hlouska, Czechia

🇨🇿

Nemocnice AGEL Novy Jicin a.s., Novy Jicin, Czechia

🇩🇰

Region Hovedstaden, Copenhagen Nv, Denmark

and more 45 locations

A Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Delgocitinib Cream in Chinese Adults and Adolescents With Moderate to Severe Chronic Hand Eczema

Phase 3
Active, not recruiting
Conditions
Chronic Hand Eczema
Interventions
Other: Vehicle cream
First Posted Date
2023-08-22
Last Posted Date
2025-07-16
Lead Sponsor
LEO Pharma
Target Recruit Count
360
Registration Number
NCT06004050
Locations
🇨🇳

LEO Pharma Investigational Site, Zhenjiang, China

A 32-week Trial to Evaluate the Efficacy and Safety of Tralokinumab in Subjects With Moderate-to-severe Atopic Hand Eczema Who Are Candidates for Systemic Therapy

Phase 3
Active, not recruiting
Conditions
Atopic Dermatitis
Atopic Hand Eczema
Interventions
Drug: Placebo
First Posted Date
2023-07-24
Last Posted Date
2025-08-28
Lead Sponsor
LEO Pharma
Target Recruit Count
235
Registration Number
NCT05958407
Locations
🇬🇧

LEO Pharma Investigational Site, London, United Kingdom

🇪🇸

LEO Investigational Site, Badalona, Barcelona, Spain

🇪🇸

LEO Pharma Investigational site, Granada, Spain

and more 1 locations
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News

LEO Pharma's Temtokibart Meets Primary Endpoint in Phase 2b Atopic Dermatitis Trial

LEO Pharma's investigational monoclonal antibody temtokibart met its primary endpoint in a Phase 2b trial, demonstrating significant improvements in EASI scores for three highest doses in moderate-to-severe atopic dermatitis patients.

Orbital Therapeutics Appoints Adam Raff as Senior VP to Advance RNA Medicine Platform Toward Clinical Trials

Orbital Therapeutics has appointed Adam Raff, M.D., Ph.D., as Senior Vice President of Clinical Development to oversee clinical and regulatory strategy for the company's RNA medicine portfolio.

Targeted Protein Degradation Emerges as Multi-Billion Dollar Therapeutic Frontier with First PROTAC Approval Expected in 2026

Targeted protein degradation (TPD) has evolved from niche science to mainstream drug development, with over 40 PROTAC candidates in clinical testing and the first potential market approval expected for Arvinas/Pfizer's ARV-471 by June 2026.

LEO Pharma's Tralokinumab Meets All Endpoints in Phase 3b Hand Atopic Dermatitis Trial

LEO Pharma announced positive 16-week interim results from the phase 3b ADHAND trial, with tralokinumab meeting all primary and secondary endpoints for moderate to severe atopic dermatitis on the hands.

Biotech Industry Faces Wave of Strategic Layoffs as Companies Prioritize Efficiency and Pipeline Focus

Major pharmaceutical and biotech companies including Pfizer, Johnson & Johnson, Fate Therapeutics, and Generation Bio are implementing workforce reductions as part of industry-wide financial restructuring efforts.

uniQure Appoints Kylie O'Keefe as Chief Customer and Strategy Officer to Lead AMT-130 Commercialization for Huntington's Disease

uniQure has appointed Kylie O'Keefe as Chief Customer and Strategy Officer to lead the global commercialization strategy for AMT-130, the company's investigational gene therapy for Huntington's disease.

LEO Pharma Launches Phase 2a Trial of Delgocitinib Cream for Rare Skin Disease Palmoplantar Pustulosis

LEO Pharma has initiated the DELTA NEXT phase 2a trial to evaluate delgocitinib cream versus placebo in adults with mild to severe palmoplantar pustulosis, a rare inflammatory skin condition.

Robust Pipeline of 50+ Therapies Reshaping Moderate to Severe Atopic Dermatitis Treatment Landscape

• The moderate to severe atopic dermatitis market is experiencing significant growth with 45+ companies developing over 50 pipeline therapies, driven by rising global prevalence and increased awareness of the condition. • Recent advancements include promising biologics like rezpegaldesleukin (granted FDA fast-track designation), JAK inhibitors such as VC005 and QY201, and novel mechanisms targeting IL-4/IL-13 pathways, offering new hope for patients with inadequate response to current treatments. • Key players including Nektar Therapeutics, Corvus Pharmaceuticals, and Apogee Therapeutics are advancing clinical trials with significant milestones expected in late 2025, potentially transforming the therapeutic landscape for this chronic inflammatory skin condition.

LEO Pharma's Temtokibart Shows Promising Results in Phase 2b Trial for Moderate-to-Severe Atopic Dermatitis

LEO Pharma's investigational IL-22RA1 antagonist temtokibart achieved positive results for the primary endpoint at the three highest doses in a Phase 2b trial for moderate-to-severe atopic dermatitis.

LEO Pharma's Delgocitinib Cream Outperforms Alitretinoin in Landmark DELTA FORCE Trial for Chronic Hand Eczema

The phase 3 DELTA FORCE trial demonstrated superior efficacy of topical delgocitinib cream over oral alitretinoin capsules for severe chronic hand eczema, with results published in The Lancet.

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