Vtama (tapinarof) / Japan Tobacco, Guanhao Biotech, Organon - LARVOL DELTA

Baseline AHR expression shapes immune response to pharmacological modulation in PBMCs from pancreatic cancer patients. (PubMed, Front Immunol) - "Peripheral blood mononuclear cells (PBMCs) from patients with PDAC and healthy donors were isolated and treated ex vivo with two AHR agonists (Carbidopa and Tapinarof) and one antagonist (BAY 2416964). Baseline AHR expression critically shapes the immune response to pharmacological modulation in PBMCs from PDAC patients. These findings suggest that AHR profiling may serve as a clinically relevant biomarker for stratifying patients and guiding personalized immunotherapy approaches for PDAC."

IO biomarker • Journal • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • AHR • IL10 • PD-1 • PD-L1

Adoring: A Study to Investigate Safety and Efficacy of Tapinarof Cream, 1% in Participants Ages 3 Months to < 24 Months With Atopic Dermatitis (clinicaltrials.gov) - P3 | N=180 | Not yet recruiting | Sponsor: Organon and Co

New P3 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pediatrics

Pharmacovigilance of Tapinarof Adverse Effects Utilizing the FAERS Database (ISDS 2025) - "Early data suggests most side effects of Tapinarof are related to application site folliculitis and headache, consistent with the side effect profile of Tapinarof. Pharmacovigilance can provide helpful information to either confirm established side effects or potentially provide insight on previously unstudied effects. With increasing use, pharmacovigilance via the FAERS database can provide increased insights into Tapinarof reactions, both rare and common."

Adverse events • Atopic Dermatitis • Contact Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus • Psoriasis

The AhR agonist tapinarof suppresses human skin inflammation by inducingmetabolic reprogramming and reducing production of mitochondrial pro-inflammatory DAMPs (ISDS 2025) - "Tapinarof-induced AhR signaling reduced HIF1α and mTOR expression in T cells, limiting glucose uptake, glycolytic capacity, and FA metabolism, while also impairing mitochondrial respiration and ATP production, producing marked metabolic dysfunction. In summary, tapinarof acts at the level of the mitochondria to reduce DAMP sensing via reduced ROS production and mtDNA release, thus markedly reducing inflammatory tone, and by blocking multiple metabolic pathways, thus blocking the cells' ability to use and generate energy in the hypoxic skin microenvironment."

Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Metabolic Disorders • Psoriasis • HIF1A • mTOR • STING

A Case of Palmoplantar Psoriasis Successfully Treated With Tapinarof Cream. (PubMed, J Dermatol) - No abstract available

Journal • Dermatology • Immunology • Psoriasis

CDSCO Panel Asks Pure and Cure Healthcare To Revise Phase III Protocol of Tapinarof Cream 1% for Adult Psoriasis (Medical Dialogues) - "During the SEC meeting held on 08 October 2025, the expert panel reviewed the submission in detail. Following deliberation, the committee made the following observations:1) Not to include very severe patients of plaque psoriasis and to revise the inclusion criteria accordingly; 2) A washout period should be defined for severe patients who are already on treatment with other drugs, and ethical considerations of the same should be justified; 3) The firm has not mentioned any concomitant medication (like moisturizer); 4) The age of the patients should be revised to 18-60 years; 5) Quantity of application should be defined by fingertip unit (FTU)....Accordingly, the expert panel suggested that the firm should submit the revised protocol for further review by the committee."

New P3 trial • Psoriasis

A systems biology approach to identify key targets in KRAS/BRAF-mutated colorectal cancer. (PubMed, Discov Oncol) - "This study sheds light on the molecular mechanisms of KRAS-mutated CRC, emphasizing IL1B as a prognostic marker. Among the identified therapeutic agents, Omeprazole demonstrated the strongest interaction with AHR, suggesting a potential for repurposing in CRC treatment, while IL1B-targeting inhibitors such as Canakinumab emerged as selective candidates for modulating tumor-promoting inflammation. Novel genes such as EPSTI1, COL20A1, CDH1, and SOX9 warrant further investigation."

Journal • Colorectal Cancer • Infectious Disease • Novel Coronavirus Disease • Oncology • Respiratory Diseases • Solid Tumor • BRAF • CDH1 • EGF • EPSTI1 • IL1B • KRAS • SOX9

Tapinarof Cream 1%, Shows Early and Durable Response in Children With Atopic Dermatitis (Patient Care) - "A new sub-analysis of pooled data from the phase 3 ADORING 1 and 2 trials found that tapinarof (VTAMA) cream, 1%, provided early and consistent efficacy for children aged 2 to 17 with moderate-to-severe atopic dermatitis (AD)....The findings, presented at the 2025 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting, analyzed 654 children randomized to tapinarof cream 1% or vehicle once daily for 8 weeks. Early improvements in skin clearance were observed...Among children with atopic comorbidities, 42.3% of those treated with tapinarof cream achieved vIGA-AD response compared with 11.8% receiving vehicle (P < 0.0001). In those without comorbidities, response rates were 49.5% with tapinarof vs 14.8% with vehicle (P < 0.0001)."

Retrospective data • Atopic Dermatitis

Impact of Dietary Modifications on Severe Treatment-Resistant Atopic Dermatitis (ACAAI 2025) - "Her disease was refractory to topical and systemic steroids, topical tacrolimus, dupilumab, upadacitinib, and UVB phototherapy...She initially responded to cyclosporine but quickly recrudesced. Tapinarof provided modest improvement but required more dosing than dispensations permitted...Discussion Guidelines recommend against elimination diets in AD given risk of food allergy development. The potential benefits of low-carbohydrate, preservative-free and plastic-free diets warrant further investigation."

Atopic Dermatitis • Dermatitis • Dermatology • Dermatopathology • Eosinophilia • Food Hypersensitivity • Immunology • CARD11 • IL13 • IL5

Product Theater 4 (non-CME) - Organon : Unlock the Potential of VTAMA (ACAAI 2025) - "Sponsored by Organon Description"

Tapinarof Cream 1% Once Daily In Children With Atopic Dermatitis With Or Without Atopic Comorbidities (ACAAI 2025) - "Tapinarof was well tolerated, regardless of atopic comorbidities history. Conclusion Tapinarof demonstrated consistent, clinically meaningful efficacy, improvement in PROs, and was well tolerated in children aged 2-17 years, regardless of atopic comorbidities."

Clinical • Late-breaking abstract • Allergic Rhinitis • Asthma • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Respiratory Diseases

Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects (clinicaltrials.gov) - P3 | N=58 | Active, not recruiting | Sponsor: Organon and Co | Recruiting ➔ Active, not recruiting | N=100 ➔ 58

Enrollment change • Enrollment closed • Dermatology • Immunology • Pediatrics • Psoriasis

Acute Generalized Exanthematous Pustulosis Secondary to Application of Tapinarof Cream 1. (PubMed, Cutis) - No abstract available

Journal • Immunology

Benvitimod ameliorates MC903-induced mouse atopic dermatitis-like lesions and regulates skin barrier proteins (ISAD-RAJKA 2025) - "Benvitimod treatment reduced mast cell and T cells and regulated keratinocyte differentiation and skin barrier pathways. Benvitimod downregulated Th2 cells while upregulating Treg cells in AD lesions of mice."

Preclinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Psoriasis

High Efficacy of 1% Benvitimod Cream in Pediatric Patients with AD: a Post-hoc Analysis of a Phase III Trial (ISAD-RAJKA 2025) - "More pronounced efficacy was found in pediatric patients than adult patients. The safety profile was favorable and consistent across age groups, supporting benvitimod as a novel treatment for pediatric and adult patients with AD."

Clinical • P3 data • Retrospective data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Pediatrics • Psoriasis

Beneficial effects of aryl hydrocarbon receptor activation on post-infarction myocardial metabolism, inflammation and fibrosis: implications from multi-omics. (PubMed, J Mol Cell Cardiol) - "The AHR activation by ITE mitigates inflammation and fibrosis, improves cardiac structure and function by promoting HK2 and glucose metabolism after MI."

Journal • Cardiovascular • Fibrosis • Immunology • Inflammation • Myocardial Infarction

Efficacy and Safety of Tapinarof for Atopic Dermatitis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. (PubMed, Cureus) - "It was generally well tolerated, supporting its use as a non-steroidal topical therapy in this patient population. Protocol registered in International Prospective Register of Systematic Reviews (PROSPERO) (CRD420251000807), with risk of bias assessed using the Cochrane risk-of-bias (RoB 2) tool and certainty of evidence appraised using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework."

Journal • Retrospective data • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus

Organon Canada Announces the Availability of NDUVRA (Tapinarof Cream), 1%, for the Topical Treatment of Plaque Psoriasis in Adults (Canada Newswire)

Launch Canada • Psoriasis

Clinical Efficacy, Safety Profile, and Systemic Exposure of Benvitimod Cream 1% Twice-Daily in Pediatric Atopic Dermatitis: Results from a Phase 3 Trial in China (EADV 2025) - "This Phase 3 trial demonstrates that benvitimod cream 1% twice-daily is an effective and well-tolerated treatment for pediatric patients (2–17 years) with moderate-to-severe AD. Significant improvements in EASI75 and IGA response rates were observed, particularly in children aged 7–11 years. The favorable safety profile, with mostly mild or moderate TEAEs and minimal systemic exposure, supports its use as a promising topical therapy for pediatric AD."

Clinical • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pediatrics

Safety and efficacy of non-steroidal topical aryl hydrocarbon receptor agonists for the treatment of atopic dermatitis: a systematic review and meta-analysis of randomised controlled trials (EADV 2025) - "Materials & We performed a systematic review and meta-analysis of seven randomised controlled trials (RCT) comparing topical aryl hydrocarbon receptor agonists (TAHRA), including tapinarof and benvitimod cream, to vehicle at different concentrations and application frequencies in patients with AD, which evaluated outcomes such as Investigator Global Assessment (IGA) scores/Validated Investigator's Global Assessment (vIGA), the Eczema Area and Severity Index (EASI-75), change from baseline in body surface area (BSA) and pruritus score (PS) and safety profiles... Our findings support the efficacy of TAHRA among different metrics with minimal and tolerable AEs and its use as a valuable new non-steroidal option for the treatment of AD."

Retrospective data • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus

Local Tolerability of Benvitimod Cream 1% Twice Daily in Adults and Children with Atopic Dermatitis: Results from a Phase 3 Randomized Trial (EADV 2025) - "Benvitimod cream demonstrated excellent local tolerability from the first application through Week 8, including in sensitive skin areas. These findings support its use in the management of atopic dermatitis in both adults and children."

Clinical • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pediatrics • Pruritus

Benvitimod Treatment Improves Lichenification Across All Body Regions in Atopic Dermatitis [WITHDRAWN] (EADV 2025) - No abstract available

Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Observed Improvement in Atopic Hand Eczema with Benvitimod Cream: Findings within a Phase 3 Atopic Dermatitis Trial [WITHDRAWN] (EADV 2025) - No abstract available

P3 data • Atopic Dermatitis • Contact Dermatitis • Dermatitis • Dermatology • Immunology

Efficacy and safety of benvitimod 1% cream for atopic dermatitis in patients aged 2 years and older: A phase III randomized clinical trial. (PubMed, Chin Med J (Engl)) - "Benvitimod 1% cream demonstrated favorable efficacy and safety in adult and pediatric patients with AD, supporting its potential as a novel topical treatment option."

Clinical • Journal • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pediatrics • Pruritus • Psoriasis

The AhR agonist tapinarof suppresses human skin inflammation by inducing metabolic reprogramming and reducing production of mitochondrial pro-inflammatory DAMPs (EADV 2025) - "In summary, tapinarof acts at the level of the mitochondria to reduce DAMP sensing via reduced ROS production and mtDNA release, thus markedly reducing inflammatory tone, and by blocking multiple metabolic pathways, thus blocking the cells' ability to use and generate energy in the hypoxic skin microenvironment. These findings provide mechanistic insights into the therapeutic efficacy of tapinarof and highlight the relevance of targeting immunometabolism in chronic inflammatory skin diseases."

Atopic Dermatitis • Dermatitis • Dermatology • Inflammation • Metabolic Disorders • Psoriasis • HIF1A • mTOR • STING