izuforant (JW1601) / JW Pharma - LARVOL DELTA

Targeting Intracellular Pathways in Atopic Dermatitis with Small Molecule Therapeutics. (PubMed, Curr Issues Mol Biol) - "Although biologic agents such as dupilumab, tralokinumab, and lebrikizumab have revolutionized AD management, their high costs, injectable administration, and limited global accessibility highlight the need for alternative options...This review provides a comprehensive analysis of key agents including Janus kinase (JAK) inhibitors (upadacitinib, abrocitinib, baricitinib, ruxolitinib, delgocitinib), phosphodiesterase 4 (PDE4) inhibitors (crisaborole, difamilast, roflumilast, apremilast), as well as STAT6 degraders (KT621, NX3911), aryl hydrocarbon receptor modulators, histamine H4 receptor antagonists (adriforant, izuforant), and sphingosine-1-phosphate receptor modulators (etrasimod, BMS-986166). We summarize their mechanisms of action, pharmacological profiles, and pivotal clinical trial data, emphasizing their potential to address unmet therapeutic needs. Finally, we discuss safety concerns, long-term tolerability, and future directions for integrating small molecule..."

Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • STAT6

Pharmacokinetics, pharmacodynamics, and safety of izuforant, an H4R inhibitor, in healthy subjects: A phase I single and multiple ascending dose study. (PubMed, Clin Transl Sci) - "ESC inhibition was observed even at doses as low as 10 mg; however, this inhibition became stronger and lasted longer as the dose increased. All izuforant doses were well tolerated, and no discontinuations due to adverse events (AE) or deaths were reported."

Clinical • Journal • P1 data • PK/PD data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Pruritus

Trial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria (clinicaltrials.gov) - P2 | N=20 | Completed | Sponsor: LEO Pharma | Phase classification: P2a ➔ P2

Phase classification • Dermatology • Immunology • Urticaria

Targeting Histamine Receptor 4 in Cholinergic Urticaria with Izuforant (LEO 152020): Results from a Phase 2a, Randomised, Double-Blind, Placebo-Controlled, Multicentre, Crossover trial. (PubMed, Br J Dermatol) - P2a | "This was the first study to explore the role of H4R as a therapeutic target in urticaria. Targeting H4R with izuforant was well tolerated but did not demonstrate significant improvements in the primary endpoint and all but one prespecified exploratory endpoint in CholU vs placebo."

Journal • P2a data • Cardiovascular • Dermatology • Immunology • Inflammation • Pain • Urticaria

Efficacy and Safety of LEO 152020 Tablets for the Treatment of Adults With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=216 | Completed | Sponsor: LEO Pharma | Active, not recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Efficacy and Safety of LEO 152020 Tablets for the Treatment of Adults With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=224 | Active, not recruiting | Sponsor: LEO Pharma | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Efficacy and Safety of LEO 152020 Tablets for the Treatment of Adults With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=224 | Recruiting | Sponsor: LEO Pharma | Trial completion date: Jan 2023 ➔ Sep 2023 | Trial primary completion date: Dec 2022 ➔ Aug 2023

Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Trial to Evaluate the Effect of LEO 152020 on the Heart of Healthy People (clinicaltrials.gov) - P1 | N=28 | Completed | Sponsor: LEO Pharma | Recruiting ➔ Completed

Trial completion

A Trial to Evaluate the Effect of LEO 152020 on the Heart of Healthy People (clinicaltrials.gov) - P1 | N=28 | Recruiting | Sponsor: LEO Pharma | Not yet recruiting ➔ Recruiting

Enrollment open

Trial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria (clinicaltrials.gov) - P2a | N=20 | Completed | Sponsor: LEO Pharma | Recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Urticaria

A Trial to Evaluate the Effect of LEO 152020 on the Heart of Healthy People (clinicaltrials.gov) - P1 | N=28 | Not yet recruiting | Sponsor: LEO Pharma

New P1 trial

Trial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria (clinicaltrials.gov) - P2a | N=28 | Recruiting | Sponsor: LEO Pharma | Trial completion date: Mar 2022 ➔ Aug 2022 | Trial primary completion date: Mar 2022 ➔ Aug 2022

Trial completion date • Trial primary completion date • Dermatology • Urticaria

LEO Pharma Initiates a Phase 2b Dose-Ranging Clinical Trial With an Oral H4R Antagonist in Adult Patients With Moderate-to-Severe Atopic Dermatitis (AD) (Businesswire) - "LEO Pharma A/S...today announced it has enrolled the first patient in a Phase 2b dose-ranging clinical trial with an investigational oral histamine receptor 4 (H4R) antagonist (LEO 152020) for the potential treatment of adults with moderate-to-severe atopic dermatitis (AD)....The primary objective for the randomized, triple-blind, placebo-controlled, multi-center Phase 2b dose-ranging clinical trial is to evaluate the efficacy of LEO 152020 compared with placebo in the treatment of adults with moderate-to-severe AD. The primary endpoint of the trial is change in Eczema Area and Severity Index (EASI) from baseline to Week 16..."

Enrollment open • Atopic Dermatitis • Dermatology • Immunology

Efficacy and Safety of LEO 152020 Tablets for the Treatment of Adults With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2; N=224; Recruiting; Sponsor: LEO Pharma; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Trial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria (clinicaltrials.gov) - P2a; N=28; Recruiting; Sponsor: LEO Pharma; Trial completion date: Dec 2021 ➔ Mar 2022; Trial primary completion date: Dec 2021 ➔ Mar 2022

Clinical • Trial completion date • Trial primary completion date • Dermatology • Urticaria

Efficacy and Safety of LEO 152020 Tablets for the Treatment of Adults With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2; N=224; Not yet recruiting; Sponsor: LEO Pharma

Clinical • New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

JW Pharmaceutical’s atopic new drug cruises overseas in phase 2 clinical trials [Google translation] (CEO Score Daily) - "Phase 2 trials to be conducted in the Czech Republic are in the preparatory stage. This trial is...for adult patients with moderate to severe atopic dermatitis. In the Czech Republic, 28 people were set as the target number of subjects. In addition to the Czech Republic, the test is planned to be conducted in other countries such as France, Germany, Poland, Spain, Japan, the United States, Canada, and Australia, and in this case, the total number of subjects is expected to be about 200."

Enrollment status • Trial status • Atopic Dermatitis • Dermatology • Urticaria

Trial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria (clinicaltrials.gov) - P2a; N=28; Recruiting; Sponsor: LEO Pharma; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Dermatology • Urticaria

JW Overseas Pharmaceuticals, technology export atopy new drug clinical phase 1 (Betanews.net) - "JW Choongwae Pharmaceuticals said on the 16th that it has completed the clinical trial phase 1 of atopic dermatitis treatment JW1601 for Koreans, Caucasians, and Japanese in Korea and completed the clinical study report (CSR)."

Trial completion • Atopic Dermatitis • Dermatology