NuGel (taurodeoxycholic acid) / Shaperon - LARVOL DELTA

Efficacy and Safety of a Topical inflammasome inhibitor targeting GPCR19 Agonist in Mild-to-Moderate Atopic Dermatitis: Results from Phase 2 Studies (ISDS 2025) - "Preclinical study demonstrated TDCA's dual-phase modulation: suppression of both priming inflammasome via cAMP–PKA–NF-κB pathway and activation phase of inflammasome via P2X7R–NLRP3 axis, ameliorating AD pathology induced by DNCB, Oxazolone or MC903 in mice model...Safety profiles were favorable, with no serious adverse events. These findings validate an inflammasome inhibitor targeting GPCR19 as a therapeutic for mild-to-moderate AD and support advancing 1% and 2% NuGel into Phase 2b Part 2, highlighting its potential as a novel, efficacious and well-tolerated topical therapy for mild-to-moderate AD."

Clinical • P2 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Pruritus • NLRP3

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2b Part 1 Study of a Topical GPCR19 Agonist in Patients with Mild-to-Moderate Atopic Dermatitis (EADV 2025) - "In this Phase 2b Part 1 study, NuGel was well tolerated and demonstrated consistent improvements across multiple clinician- and patient-reported outcomes in adults with mild-to-moderate AD. Notably, dose-dependent improvements were observed in IGA-TS, a primary endpoint commonly used in Phase 3 trials, supporting the potential for future clinical success. These findings highlight the clinical potential of NuGel and support the selection of the 1% and 2% concentrations for further evaluation in the ongoing Phase 2b Part 2 expansion cohort."

Clinical • P2b data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus • NLRP3

A phase 2a double-blind, placebo-controlled, randomized clinical trial evaluating the efficacy and safety of NuGel, a novel topical GPCR19-mediated inflammasome inhibitor, in patients with mild to moderate atopic dermatitis: a proof-of-concept study with Post-hoc biomarker analysis. (PubMed, Front Immunol) - P2 | "Further research is required to validate these findings in larger patient cohorts. https://clinicaltrials.gov/, identifier NCT04530643."

Biomarker • Clinical • Journal • P2a data • Retrospective data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Phase 2a Double-Blind, Placebo-Controlled, Randomized Clinical Trial Evaluating the Efficacy and Safety of NuGel, a Novel Topical GPCR19-Mediated Inflammasome Inhibitor, in Patients with Mild to Moderate Atopic Dermatitis: A Proof-of-Concept Study with Post-Hoc Biomarker Analysis (Frontiers) - P2 | N=80 | NCT04530643 | Sponsor: Shaperon | "This study assessed NuGel, a topical GPCR19 agonist, for efficacy, safety, and predictive baseline biomarkers in AD patients.In a multicenter, double-blind, randomized, placebo-controlled Phase 2a trial (August 2020-September 2021, five hospitals, 80 participants), patients received placebo, 0.3% NuGel, or 0.5% NuGel twice daily for four weeks. NuGel (0.3% [Nu0.3] and 0.5% [Nu0.5]) was well-tolerated, with no adverse drug reactions or serious adverse events. Nu0.3 showed a significant decrease in EASI score from baseline (-12.2%, [-30.3%, 5.9%], p = 0.04). Treatment with Nu0.5 resulted in a numerically decreased EASI score (-11.9%, [-34.9%, 11.1%], p > 0.05), which is comparable with placebo group (-2.9%, [-21.5%, 15.6%], p > 0.05). No significant difference was observed between groups (p>0.05)."

P2 data • Atopic Dermatitis

Hudson Therapeutics to Conduct Global Licensing Discussions for NuGel at Bio Europe Spring 2025 (EIN News) - "Hudson Therapeutics...announced today that Hudson Therapeutics and Shaperon are participating in Bio Europe Spring 2025, taking place from March 17–19 in Milan, Italy, where it is engaged in global licensing discussions for its next-generation atopic dermatitis treatment, NuGel....The company has a full schedule of partnering meetings with major global pharmaceutical and biotech companies, underscoring increasing interest in NuGel's unique mechanism and clinical progress."

Commercial • Atopic Dermatitis • Immunology

Hudson Therapeutics, the U.S. Subsidiary of Shaperon, Announces Initiation of Phase 2b Part 2 Clinical Trial for Nugel (EIN Presswire) - "Hudson Therapeutics...announced today that Shaperon will commence the Phase 2b Part 2 of its clinical trial for Nugel, a first-in-class inflammasome inhibitor designed to treat mild to moderate atopic dermatitis....Patient enrollment begins in March 2025, with dosing expected to conclude by December 2025. Final clinical data will be available in the first half of 2026."

Enrollment status • P2b data • Trial status • Atopic Dermatitis

Phase 2 Trial of HY209gel in Atopic Dermatitis Patients (clinicaltrials.gov) - P2 | N=210 | Recruiting | Sponsor: Shaperon | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Shaperon Enrolls Its First Patient in Phase 2 U.S. Clinical Trial for Atopic Dermatitis Therapy 'Nugel' (PRNewswire) - "Shaperon...announced the enrollment of the first patient in the Phase 2 clinical trial for Nugel, its therapy for Atopic Dermatitis. This milestone marks the start of a crucial phase in Shaperon’s effort to advance treatment for patients globally. With FDA approval secured for the Global Phase 2 Clinical Trials (IND) of Nugel in September 2023, Shaperon is dedicated to evaluating its efficacy in improving the Eczema Area Severity Index (EASI) across a diverse cohort of 210 patients with mild to moderate atopic dermatitis. Employing a rigorous double-blind, placebo-controlled methodology, the trial is anticipated to conclude by the first half of 2026."

Trial status • Atopic Dermatitis

A Novel Therapeutic Approach using Taurodeoxycholate, a GPCR19R Agonist, for Atopic Dermatitis: A Randomized, Double-Blind, PlaceboControlled Phase II Trial with Identification of Predictive Biomarkers (ISDS 2023) - "Importantly, no serious adverse events related to the drug were reported during the trial. This research introduces not only a novel AD treatment with good efficacy and excellent safety profiles, but also the first precision medicine approach for AD, which incorporates a biomarker-based patient classification system."

Biomarker • Clinical • P2 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • NLRP3

Phase 2 Trial of HY209gel in Atopic Dermatitis Patients (clinicaltrials.gov) - P2 | N=210 | Not yet recruiting | Sponsor: Shaperon

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

A Phase II Study of HY209 Gel for Atopic Dermatitis Patients (Shaperon) (clinicaltrials.gov) - P2 | N=80 | Completed | Sponsor: Shaperon | Recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Chaperone “Confirmed safety and efficacy of atopic dermatitis, interim results of phase 2” [Google translation] (Hankyung) - P2, N=60; NCT04530643; Sponsor: Shaperon; "Chaperon announced on the 9th that it has confirmed the safety and effectiveness of the domestic phase 2 clinical trial for NuGel, a treatment for atopic dermatitis....Interim results of analyzing patient data from 36 of them showed good safety and efficacy....Chaperone plans to pursue various measures, including phase 3 clinical trials in the future."

P2 data • Atopic Dermatitis • Dermatology

Shaperon: A Phase I Study of HY209 Gel in Healthy Male Volunteers for Atopic Dermatitis (clinicaltrials.gov) - P1; N=56; Completed; Sponsor: Shaperon; Enrolling by invitation ➔ Completed

Clinical • Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Phase II Study of HY209 Gel for Atopic Dermatitis Patients (Shaperon) (clinicaltrials.gov) - P2; N=75; Recruiting; Sponsor: Shaperon

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