A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of HY209 Gel in Patients With Mild to Moderate Atopic Dermatitis(AD)

This is a randomized, double-blind, placebo-controlled, multi-center, phase 2 study in patients with mild to moderate Atopic Dermatitis(AD), which consists of 2 parts.

Start Date01 Mar 2024

Sponsor / Collaborator

Shaperon, Inc.

NCT06533878

/ Enrolling by invitationPhase 1

(Part A) A Non-randomized, Open, Single-dose Escalation to Evaluate Tolerability and Safety of Single Oral Dose of HY209; (Part B) A Block-randomized, Double-blinded, Placebo-controlled, Multiple-dose Escalation to Evaluate Tolerability and Safety of Multiple Oral Doses of HY209 Phase 1 Clinical Trial in Healthy Volunteers

* Primary study objectives in Parts A and B To determine the Maximum Tolerable Dose(MTD) of the study drug (repeated or single dose).
* Endpoint: • Adverse event(AEs), including objective and subjective symptoms, after the IP dosing as well as physical examinations, vital signs, ECGs, and laboratory tests findings related to the IP dosing
• Dose-limiting toxicities (DLTs)
* Justification for endpoints: The safety will be assessed comprehensively by performing safety assessment and evaluating relevant variables by dose group.
The tolerability will be assessed in DLT analysis set. In a first-in-human clinical trial, tolerability of the drug administered is usually assessed through determination of dose-limiting toxicity (DLT). An accurate dose proportionality of toxicity was not observed, but toxicity was found at high doses, not at low doses following IV and oral administrations, except transdermal treatment. Thus, a relationship between toxicity and doses was confirmed.
In addition, HY209 showed a dose dependence in some efficacy endpoints, including dose-dependent inhibition of release of Tumor Necrosis Factor(TNF)-α and Il-1β, key inflammation factors related to inflammatory bowel disease. Thus, evaluating the occurrence of DLTs through sequential dose escalation is determined appropriate to assess the tolerability and safety of HY209.
* Primary study objectives in Part A (Dose levels 4-6): To evaluate the effects of food on HY209 bioavailability (absorption rate and volume) following a single oral dose in healthy volunteers.
* Endpoint: PK of HY209 at a fasting condition and after a high-fat meal Point estimates for the geometric mean ratio of variables (Area under concentration-time curve;AUC₀-₆, AUCₗₐₛₜ, AUC₀-∞, and Cmax) and the 90% confidence interval(CI) and Tmax .
* Justification for endpoints: For oral drugs, effects of food on bioavailability of the drugs are usually evaluated. Especially, a systemic exposure to bile acid drugs of enterohepatic circulation can be explained with a spillover from the liver to systemic circulatory system. Thus, a systemic exposure is thought to be affected by food, but the actual effects of food are triggered by combination of factors that affect in vivo elution of a drug and absorption of the active pharmaceutical ingredient(API) of the drug. As estimating the extent of effects on bioavailability is difficult without conducting an actual food effect study, there is a need for clinical evaluation.

Start Date13 Sep 2023

Sponsor / Collaborator

Kukjeon Pharm Co., Ltd.

NCT05352347

/ RecruitingPhase 2/3

A Randomized, Double-blinded, Placebo-controlled, Parallel-treatment Group, Adaptive Design, Multi-center, Phase 2b/3 Trial to Evaluate Efficacy and Safety of NuSepin® Intravenous Infusion in COVID-19 Pneumonia Patients

Start Date12 Apr 2022

Sponsor / Collaborator

Shaperon, Inc.

100 Clinical Results associated with Taurodeoxycholic acid

100 Translational Medicine associated with Taurodeoxycholic acid

100 Patents (Medical) associated with Taurodeoxycholic acid

2,751

Literatures (Medical) associated with Taurodeoxycholic acid

01 Feb 2026·PHYTOTHERAPY RESEARCH

Chlorogenic Acid Regulates Macrophage Polarization in LUAD by Inhibiting Taurodeoxycholic Acid Metabolism to Block the TGR5 / STAT3 Signaling Pathway

Article

Author: Guan, Minyi ; Qi, Xiangjun ; Chen, Zhiqiang ; Rao, Xiwu ; Lin, Lizhu ; Wang, Shujing ; Sun, Lingling ; Wang, Jingrui ; Lin, Jietao ; An, Bo

ABSTRACT:

Lung adenocarcinoma (LUAD) poses a leading cause of cancer‐related mortality, necessitating the need for effective and less toxic therapies. Chlorogenic Acid (CGA), a naturally occurring polyphenol, has attracted attention for its potential anti‐tumor properties, but its efficacy and mechanisms in LUAD require thorough investigation. To evaluate CGA's potential, we conducted a comprehensive study in a LUAD mouse model. We performed CT scanning and histopathological analysis to confirm its dose‐dependent inhibition of tumor growth. Body weight monitoring assessed its lower systemic toxicity compared to cisplatin. Flow cytometry revealed CGA's unique ability to reprogram tumor‐associated macrophages by reducing immunosuppressive M2 polarization and promoting anti‐tumor M1 phenotypes. Metabolomic profiling identified a significant reduction in the pro‐tumor metabolite taurodeoxycholic acid (TDCA) upon CGA treatment. Subsequent in vitro co‐culture studies and western blot analysis demonstrated that CGA disrupts the TDCA‐activated TGR5/STAT3 signaling axis, which is crucial for M2 macrophage polarization. Our findings unveil a novel immunometabolic mechanism through which CGA suppresses LUAD by remodeling the tumor microenvironment, highlighting its promise as a therapeutic agent or adjunct with both efficacy and a favorable safety profile.

01 Feb 2026·INTERNATIONAL IMMUNOPHARMACOLOGY

Taurodeoxycholic acid alleviates intestinal inflammation by modulating gut microbiota and TGR5-NF-kappaB axis in DSS-induced colitis

Article

Author: Li, Shiyang ; Gao, Jiahui ; Zhao, Dong ; Zhao, Hongyu ; Wang, Xia ; Zhang, Shanshan ; Li, Yanqing ; Feng, Bingcheng ; Li, Lixiang ; Liu, Chang

Taurodeoxycholic acid (TDCA), a metabolite of cholesterol, has been shown to be able to regulate various inflammatory responses and improve intestinal inflammation. However, its potential to alleviate colitis through modulating the gut microbiota-bile acid axis remains unclear. Mice were simultaneously administered dextran sulfate sodium (DSS) and TDCA via drinking water to estimate the effect of TDCA on colitis. TDCA-treated mice showed markedly relieved DSS-induced colitis. 16S rDNA sequencing revealed TDCA selectively remodeled the gut microbiota, notably decreasing the abundances of Desulfovibrionaceae_unclassified, Escherichia-Shigella and increasing Akkermansia. Furthermore, the reshaping of the microbial community was functionally characterized by a marked alteration in the gut bile acid profile, specifically a significant increase in secondary bile acids. Fecal microbiota transplantation (FMT) confirmed the protective role of the TDCA-shaped microbiota, which also transferred the reduction of Desulfovibrionaceae_unclassified and the characteristic bile acid profile to recipient mice. Similarly, transplanting feces after TDCA intervention into recipient mice still increased secondary bile acid levels in the gut to a certain extent. Spearman's correlation analysis further solidified the negative correlation between Desulfovibrionaceae_unclassified and secondary bile acids. Mechanistically, the altered bile acid profiles restored the activation of the bile acid receptor TGR5, but not FXR, thereby inhibiting the NF-κB signaling pathway. The essential role of TGR5 was substantiated as its inhibitor, SBI-115, largely abolished the protective effects of TDCA. In conclusion, our findings demonstrate that TDCA alleviates colitis by orchestrating a microbiota-bile acid-TGR5 signaling cascade, positioning it as a promising therapeutic candidate for inflammatory bowel disease.

31 Dec 2025·Gut Microbes

The microbiota-derived bile acid taurodeoxycholic acid improves hepatic cholesterol levels in mice with cancer cachexia

Article

Author: Piron, Edwige ; Huot, Joshua R ; Roumain, Martin ; Bindels, Laure B ; Thissen, Jean-Paul ; Bonetto, Andrea ; Pin, Fabrizio ; Neyrinck, Audrey M ; Thibaut, Morgane M ; Loriot, Axelle ; Rodriguez, Julie ; Muccioli, Giulio G ; Delzenne, Nathalie M ; Gillard, Justine ; Massart, Isabelle

Alterations in bile acid profile and pathways contribute to hepatic inflammation in cancer cachexia, a syndrome worsening the prognosis of cancer patients. As the gut microbiota impinges on host metabolism through bile acids, the current study aimed to explore the functional contribution of gut microbial dysbiosis to bile acid dysmetabolism and associated disorders in cancer cachexia. Using three mouse models of cancer cachexia (the C26, MC38 and HCT116 models), we evidenced a reduction in the hepatic levels of several secondary bile acids, mainly taurodeoxycholic (TDCA). This reduction in hepatic TDCA occurred before the appearance of cachexia. Longitudinal analysis of the gut microbiota pinpointed an ASV, identified as Xylanibacter rodentium, as a bacterium potentially involved in the reduced production of TDCA. Coherently, stable isotope-based experiments highlighted a robust decrease in the microbial 7α-dehydroxylation (7α-DH) activity with no changes in the bile salt hydrolase (BSH) activity in cachectic mice. This approach also highlighted a reduced microbial 7α-hydroxysteroid dehydrogenase (7α-HSDH) and 12α-hydroxysteroid dehydrogenase (12α-HSDH) activities in these mice. The contribution of the lower production of TDCA to cancer cachexia was explored in vitro and in vivo. In vitro, TDCA prevented myotube atrophy, whereas in vivo hepatic whole transcriptome analysis revealed that TDCA administration to cachectic mice improved the unfolded protein response and cholesterol homeostasis pathways. Coherently, TDCA administration reversed hepatic cholesterol accumulation in these mice. Altogether, this work highlights the contribution of the gut microbiota to bile acid dysmetabolism and the therapeutic interest of the secondary bile acid TDCA for hepatic cholesterol homeostasis in the context of cancer cachexia. Such discovery may prove instrumental in the understanding of other metabolic diseases characterized by microbial dysbiosis. More broadly, our work demonstrates the interest and relevance of microbial activity measurements using stable isotopes, an approach currently underused in the microbiome field.

News (Medical) associated with Taurodeoxycholic acid

13 Nov 2025

·www.businesswire.com

Shaperon Attends 7 th Inflammasome Therapeutics Summit in Boston; CEO Dr. Seungyong Seong Delivers Keynote Presentation on GPCR19-Targeted Drug Development

SEOUL, South Korea--(BUSINESS WIRE)--Shaperon Inc. (KOSDAQ: 378800) a clinical-stage biotechnology company specializing in GPCR19-targeted immunomodulatory drugs, announced that it attended the 7th Inflammasome Therapeutics Summit held in Boston, Massachusetts, from November 4-6, 2025. During the event, CEO Dr. Seungyong Seong delivered a keynote presentation highlighting the company’s latest clinical and preclinical achievements in the development of inflammasome-modulating therapies for atopic dermatitis and alopecia areata. AI-driven innovation accelerating next-generation therapeutic development The Inflammasome Therapeutics Summit is a leading global conference dedicated to advances in inflammasome research and drug development. Shaperon’s participation and keynote presentation underscore the growing recognition of its GPCR19-based drug discovery platform as an emerging technology with the potential to reshape the treatment landscape for inflammatory and autoimmune diseases. In his keynote, Dr. Seong presented the company’s progress on GPCR19-targeted inflammasome modulation, a novel therapeutic strategy designed to control inflammation at its upstream initiation phase. Unlike conventional NLRP3 inhibitors that act downstream, Shaperon’s approach regulates the formation of the inflammasome complex itself, confirming the broad applicability of its inflammasome-targeted technology. Shaperon’s topical candidate NuGel, the world’s first GPCR19 agonist for atopic dermatitis, demonstrated positive efficacy and safety results in Phase 2b Part 1 clinical trials. The company also shared new preclinical data across acne, rosacea, and diabetic foot ulcers, confirming the broad applicability of its inflammasome-target technology. Shaperon’s proprietary AI-powered drug discovery platform integrates multi-parametric modeling to predict target suitability, pharmacokinetic properties and toxicity profiles, enabling faster and more reliable development decisions. One of its AI-derived candidates, Nualeratine, showed a 74% higher hair regrowth rate in preclinical models of autoimmune alopecia compared to competing compounds. “Our participation in this year’s Inflammasome Therapeutics Summit provided a valuable opportunity to share our scientific progress and connect with global partners,” said Dr. Seong. “Shaperon remains committed to advancing innovative inflammasome-targeted therapies and expanding global collaboration for commercialization.” ABOUT SHAPERON Shaperon is a clinical-stage biotech company focused on developing novel inflammasome inhibitors. Its unique GPCR19-P2X7 modulation mechanism suppresses a range of inflammatory cytokines, including IL-1β, IL-18, IL-6, and TNF-α, by targeting both priming and activation phases of the inflammasome. This pioneering approach addresses complex immune-mediated inflammatory disorders, with Shaperon currently advancing clinical programs in Atopic Dermatitis, Alopecia Areata, Alzheimer’s disease, and COVID-19 pneumonia, in addition to preclinical programs in MASH and obesity.

Phase 2Clinical Result

10 Mar 2025

·www.businesswire.com

Hudson Therapeutics, the U.S. Subsidiary of Shaperon, Announces Initiation of Phase 2b Part 2 Clinical Trial for NuGel

DURHAM, N.C. & CAMBRIDGE, Mass. & SEOUL, South Korea--(BUSINESS WIRE)--Hudson Therapeutics, the U.S. subsidiary of Shaperon, 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. A kickoff meeting was recently held in March in the United States, marking a significant milestone in the global clinical development of NuGel. The clinical trial will be conducted across 12 U.S. and South Korean clinical sites, enrolling 177 patients of diverse ethnic backgrounds. This study plans to evaluate the safety and efficacy of NuGel further following the successful completion of Phase 2b Part 1. 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. NuGel, a topically administered drug, utilizes inflammasome inhibition, a novel mechanism designed to reduce inflammation and potentially improve long-term safety for patients with atopic dermatitis. In Phase 2b Part 1, NuGel demonstrated an excellent safety profile and better efficacy compared to currently marketed treatments, with key findings including: Eczema Area and Severity Index (EASI) – NuGel showed better score improvement versus competitive treatments. EASI-50 Response Rate – 100% of patients in a specific NuGel dosage group achieved the EASI-50 criteria, representing a 56% improvement over the trial's placebo arm. IGA Treatment Success (IGA-TS) – NuGel achieved a 39% higher clinical remission rate versus the placebo, a key FDA approval benchmark. "We are excited to initiate Phase 2b Part 2 of NuGel’s clinical trial, building on the promising results from the previous phase," said Seung-Yong Seong, CEO of Shaperon. "This study will further validate NuGel’s efficacy and long-term safety, reinforcing its potential as a transformative treatment for atopic dermatitis. We are confident that this large-scale global trial will generate valuable clinical trial data, bringing us one step closer to delivering an innovative therapy to patients worldwide." To prepare for this next trial phase, Shaperon has partnered with leading U.S. clinical research institutions, including Cahaba Dermatology Skin Health Center and L.A. Universal Research Center, as well as eight additional clinical trial sites across the U.S. The trial will also be conducted in South Korea, with research sites at Seoul National University Hospital, Bundang Seoul National University Hospital, Severance Hospital, and Sejong Chungnam National University Hospital. With highly promising safety and efficacy results, Hudson Therapeutics, as the U.S. subsidiary of Shaperon, is actively pursuing global pharmaceutical partnerships for potential licensing and commercialization of NuGel. "Hudson Therapeutics is committed to advancing innovative therapies, and we recognize NuGel’s global potential in the mild to moderate atopic dermatitis market," said Janice Marie McCourt, CEO of Hudson Therapeutics. "We have strong interest from numerous specialty pharmaceutical companies and we are actively engaged in contracting a top tier partner to commercialize NuGel. The growing demand for thirty-five million patients globally with atopic dermatitis presents a significant market opportunity, and we believe NuGel has the potential to redefine the standard of care. Through global partnerships, we aim to accelerate its path to commercialization and bring this breakthrough therapy to patients worldwide." ABOUT SHAPERON Shaperon is a clinical-stage biotech company focused on developing novel inflammasome inhibitors. Its unique GPCR19-P2X7 modulation mechanism suppresses a range of inflammatory cytokines, including IL-1β, IL-18, IL-6, and TNF-α, by targeting both priming and activation phases of the inflammasome. This pioneering approach addresses complex immune-mediated inflammatory disorders, with Shaperon currently advancing clinical programs in Atopic Dermatitis, Alopecia Areata, Alzheimer’s disease, and COVID-19 pneumonia, in addition to preclinical programs in MASH and obesity. ABOUT Hudson Therapeutics Hudson Therapeutics, a US subsidiary of Shaperon, was established and incorporated in the US in 2023 to lead global clinical trials, commercial strategy, M&A, business development, and investor relations of Shaperon's assets. Hudson also plans to develop Shaperon's early-stage preclinical assets in the future.

Phase 2Clinical Result

18 Mar 2024

·www.biospace.com

Shaperon Enrolls Its First Patient in Phase 2 U.S. Clinical Trial for Atopic Dermatitis Therapy 'Nugel'

210 Patients With Multi-Racial Atopic Dermatitis...Phase 2 Clinical Trial Begins CAMBRIDGE, Mass. & SEOUL, South Korea--(BUSINESS WIRE)-- Shaperon, Inc. (Kosdaq: 378800), a biotechnology company developing innovative immune drugs, 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. Market research forecasts indicate a robust growth of over 8.7%, projecting the global atopic dermatitis market to reach $19.1 billion by 2030. Presently, patients rely on steroids and FDA-approved medications, yet there remains a pressing need for novel drugs due to their adverse effects and limited efficacy. Of particular note, more than 70% of patients exhibit positive responses to the biomarker discovered during Shaperon's phase 2 clinical trials in Korea, categorized as "A type A atopic patients." This treatment, distinguished by its superior safety and efficacy compared to existing JAK inhibitors or PDE4 inhibitors in the market, has garnered attention at U.S. and European forums. Shaperon has already initiated patent applications for this biomarker, enabling tailored treatments for patients showing exceptional responses to Nugel. Nugel represents a paradigm shift in atopic dermatitis therapy as the world's first inflammation control drug targeting 'GPCR19' action. Its unique mechanism of action, exclusive to immune-related cells, offers minimal side effects while effectively addressing inflammatory pathways. Beyond atopic dermatitis, Nugel holds promise for treating a spectrum of skin conditions, further underscoring its potential impact on global healthcare. Dr. Seung-Yong Seong, CEO of Shaperon, reaffirms Shaperon's commitment to advancing Nugel's global presence and facilitating technology transfer through the Phase 2 clinical trials. Leveraging innovative approaches such as a smartwatch-based AI medication management system demonstrates Shaperon's dedication to optimizing patient outcomes and data reliability. The establishment of Hudson Therapeutics, Shaperon's U.S.-based subsidiary, reinforces its strategic vision for global expansion and technology exports. ABOUT SHAPERON Shaperon is a clinical stage biotech company developing novel inflammasome inhibitors. Its unique mechanism of action of GPCR19-P2X7 modulation suppresses a broad spectrum of inflammatory cytokines including IL-1β, IL-18, IL-6, and TNF-α by controlling both priming and activation phase of inflammasome, whereas conventional approaches are designed to suppress only the activation phase. With this unique and novel modality which is best suited to address complex immune-mediated inflammatory disorders, Shaperon is currently developing multiple clinical programs in atopic dermatitis, cytokine release syndrome, Alzheimer’s disease, Obesity and MASH. ABOUT Hudson Therapeutics Hudson Therapeutics, a US subsidiary of Shaperon, was founded in 2023 to lead global clinical trials and business development of assets from Shaperon. Hudson’s pipeline includes immunology clinical assets in Atopic Dermatitis, Covid-19, Alzheimer’s Disease and preclinical programs focused in Obesity and other indications, combined with their nanobody platform. View source version on businesswire.com: Contacts Ellie Jung (ellie@hudsontherapeutics.com) Source: Shaperon View this news release online at:

Phase 2

100 Deals associated with Taurodeoxycholic acid

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 3	South Korea	Shaperon, Inc.	12 Apr 2022
Mild Atopic Dermatitis	Phase 2	United States	Shaperon, Inc.	01 Mar 2024
Mild Atopic Dermatitis	Phase 2	South Korea	Shaperon, Inc.	01 Mar 2024
Moderate Atopic Dermatitis	Phase 2	United States	Shaperon, Inc.	01 Mar 2024
Moderate Atopic Dermatitis	Phase 2	South Korea	Shaperon, Inc.	01 Mar 2024
Dementia	Phase 1	South Korea	Kukjeon Pharm Co., Ltd.	13 Sep 2023
Sepsis	Phase 1	South Korea	Shaperon, Inc.	05 Dec 2019
Alzheimer Disease	Phase 1	South Korea	Shaperon, Inc.	-
Idiopathic Pulmonary Fibrosis	Phase 1	-	Shaperon, Inc.	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04530643 (Phase 2a, Pubmed \| Front Immunol)	Phase 2	Moderate Atopic Dermatitis K2C5 \| ENTP6 \| CRK	80	Placebo	jswfzeahcd(gvsdmcpsml) = uolbqjmcgc nluaikkdaz (ppqowryrmc, -21.5% - 15.6%)	Positive	19 May 2025
				NuGel 0.3%	jswfzeahcd(gvsdmcpsml) = wmvqwapjnj nluaikkdaz (ppqowryrmc, -30.3% - 5.9%)
NCT03492398 (Shaperon, CTgov)	Phase 1	Dermatitis, Atopic	56	HY209 (Cohort A HY209 0.05% Gel)	pxndwidppf = wiusrzucld mjcreoospe (kidawxunlt, lpwpgloihj - okpsqgxalo) View more	-	19 Oct 2020
				HY209 (Cohort A HY209 0.1% Gel)	pxndwidppf = kbbpoxhzww mjcreoospe (kidawxunlt, raiayfvusx - rbacgnunuv) View more

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