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

Targeting the Aryl Hydrocarbon Receptor to Attenuate IGF1R Signaling in Thyroid Eye Disease. (PubMed, Thyroid) - "OFs were treated with the AHR ligands 6-formylindolo[3,2-b]carbazole (FICZ) or tapinarof with or without IGF1...Through modulation of GSK3β-mediated pathways, AHR activation may target additional pathologically relevant pathways beyond those affected by direct IGF1R inhibitors. This research provides novel insights into TED pathophysiology and offers a potential avenue for developing therapies to improve patient outcomes."

Journal • Fibrosis • Immunology • Inflammation • Ocular Inflammation • Ophthalmology • Thyroid Eye Disease • AHR • CRABP2 • IGF1R • IRS2 • SOD3 • TUBA1B • TUBA1C

The aryl hydrocarbon receptor: a rehabilitated target for therapeutic immune modulation. (PubMed, Nat Rev Drug Discov) - "Indeed, the first AHR-activating drug (tapinarof) was recently approved for the treatment of psoriasis...This Review outlines the molecular mechanism of AHR action, and describes how it regulates the immune response. We also discuss links to disease and AHR-targeting therapeutics that have been tested in past and ongoing clinical trials."

Journal • Review • Dermatology • Immune Modulation • Immunology • Infectious Disease • Oncology • Psoriasis

Health Canada Approves NDUVRA (Tapinarof Cream), 1%, for the Topical Treatment of Plaque Psoriasis in Adults (Canada Newswire) - "Organon Canada, a global healthcare company with a mission to improve the health of women throughout their lives, today announced that Health Canada has approved NDUVRA (tapinarof cream), 1%, the first in a novel class of aryl hydrocarbon receptor agonists to be approved in Canada, for the topical treatment of plaque psoriasis in adults....The approval of NDUVRA is based on the results from two randomized, double-blind, multicenter, vehicle-controlled trials conducted to evaluate the safety and efficacy of tapinarof cream for the treatment of adults with plaque psoriasis (symptoms varying from mild to severe)."

Canada approval • Psoriasis

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. (PubMed, Australas J Dermatol) - "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."

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

Conduit Pharmaceuticals Announces Novel Cocrystal Patent Filing For VTAMA (tapinarof) with Enhanced Therapeutic and Market Extension Prospects (GlobeNewswire) - "Conduit Pharmaceuticals Inc...today announces the filing of two groundbreaking patents for tapinarof (VTAMA), including a dual active cocrystal, pairing the drug currently approved in the US for psoriasis and atopic dermatitis with a complementary drug substance known to address key patient needs in inflammatory skin conditions. The Company anticipates this combination drug approach could offer enhanced patient benefits over existing tapinarof formulations by addressing both therapeutic needs and known side effects, such as pain and itch, which are a known priority to sufferers of these conditions but typically overlooked by standard treatments that focus on the underlying disease alone.... This comes at a critical juncture for VTAMA, a drug that has demonstrated blockbuster potential through Organon's $1.2 billion acquisition from Dermavant Sciences yet could face imminent generic competition upon exclusivity expiry in 2027."

Patent • Atopic Dermatitis • Psoriasis

A Multicenter Study on the Impact of Long-Term and Proactive Intermittent Maintenance Treatment with Benvitimod on Psoriasis Recurrence (ChiCTR) - P4 | N=120 | Not yet recruiting | Sponsor: Peking University Third Hospital; Peking University Third Hospital

New P4 trial • Dermatology • Immunology • Psoriasis

Real world study of Benvitimod cream in the treatment of chronic simple lichen (ChiCTR) - P4 | N=80 | Recruiting | Sponsor: Taizhou Central Hospital; Taizhou Central Hospital

New P4 trial

Tapinarof Cream 1%: Pediatric First Approval. (PubMed, Paediatr Drugs) - "In December 2024, it was approved in the USA for the topical treatment of AD in adults and pediatric patients 2 years of age and older. This article summarizes the milestones in the development of tapinarof cream 1% leading to this first pediatric approval."

Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pediatrics • Psoriasis

Maximal Usage Trial of Tapinarof Cream 1% Once Daily in Pediatric Patients Down to 2 Years of Age with Extensive Atopic Dermatitis. (PubMed, Am J Clin Dermatol) - P2 | "Tapinarof cream exhibits highly favorable safety and pharmacokinetics in adolescents and children down to age 2 years with extensive AD."

Journal • Atopic Dermatitis • Contact Dermatitis • Dermatitis • Dermatology • Immunology • Pediatrics

New Analysis of Organon’s VTAMA (tapinarof) cream, 1% Phase 3 Data Shows Atopic Dermatitis Disease Activity Remained Low After Treatment-Free Interval in Adults and Children 2 Years of Age and Older (Businesswire) - P3 | N=728 | ADORING 3 (NCT05142774) | Sponsor: Dermavant Sciences, Inc.| "The new results demonstrate that, at the end of the first treatment-free interval, which lasted an average of 79.8 consecutive days, 84% of patients had a vIGA-AD score of 2 (mild). Itch, which was assessed with the patient reported Peak Pruritus Numerical Rating Scale (PP-NRS) score ranging from 0 to 10, remained low with a mean weekly PP-NRS score of 2.9. The mean Eczema Area and Severity Index (EASI) score was 3.4, indicating mild disease."

Late-breaking abstract • P3 data • Atopic Dermatitis

Rural-urban disparities in the use of FDA-approved steroid-sparing topical medications for inflammatory dermatologic conditions: A DataDerm study (AAD 2025) - " Compared to rural patients, urban patients were more likely to be prescribed 3 of 6 topicals queried: crisaborole (OR 1.46, p<0.001), roflumilast (OR 11603130, p<0.001), and tacrolimus (OR 1.57, p<0.001). While odds ratios for pimecrolimus, tapinarof, and tazarotene also exceeded 1.0, no statistically significant differences were observed for these medications. There is an evident disparity in prescribing patterns for steroid-sparing topical medications between urban and rural populations, with the former being less likely to incur steroid-related adverse effects such as dermal atrophy. This could be attributable to differences in the concentration of dermatologists between these areas (4), with rural patients encountering significantly more obstacles in accessing dermatologic care."

Atopic Dermatitis • Dermatitis • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation • Psoriasis

Tapinarof Cream 1% Once Daily for Atopic Dermatitis: Validated Investigator Global Assessment for Atopic Dermatitis™ x Body Surface Area (vIGA-AD™xBSA) Composite in Two Pivotal Phase 3 Trials in Adults and Children Down to 2 Years of Age (AAD 2025) - "The vIGA-AD™ primary endpoint was achieved by 45.4% and 46.4% versus 13.9% and 18.0%; EASI75 was achieved by 55.8% and 59.1% versus 22.9% and 21.2% at Week 8 (tapinarof vs vehicle; all P<0.0001). Tapinarof cream 1% QD demonstrated consistent, robust efficacy across all measures, including vIGA-AD™, EASI75, and vIGA-AD™xBSA in adults and children with AD."

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

Tapinarof Cream 1% Once Daily: Maintenance of Low Disease Activity Including Pruritus Through End of the Treatment-free Interval in a Long-term Extension Trial in Patients Down to 2 Years of Age... (AAD 2025) - No abstract available

Clinical • Late-breaking abstract • Dermatology • Pruritus

Tapinarof cream (Vtama) for atopic dermatitis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Therapeutic Advancements in Psoriasis and Psoriatic Arthritis. (PubMed, J Clin Med) - "Current topical therapies-including corticosteroids, vitamin D analogs, tapinarof, and roflumilast-remain the mainstay for mild disease, while oral systemic and biologic options are for moderate to severe cases. In contrast, oral IL-17 inhibitors and TYK-2 inhibitors are effective but may present side effects that could impact their acceptability. It is essential to balance efficacy, safety, and patient preferences to guide the selection of appropriate therapies."

Journal • Review • Cardiovascular • Dermatology • Immunology • Infectious Disease • Inflammatory Arthritis • Oncology • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL12A • IL17A • IL23A • TNFA • TYK2

The Aryl Hydrocarbon Receptor (AHR): Peacekeeper of the Skin. (PubMed, Int J Mol Sci) - "The clinical development of tapinarof, the first topical AHR modulating drug for inflammatory skin disease, approved by the FDA for mild-to-moderate psoriasis and poised for approval in atopic dermatitis, supports the therapeutic targeting of the AHR pathway to harness its beneficial effect in skin inflammation. Here, we describe how a tightly controlled, physiological activation of the AHR pathway maintains skin homeostasis, and discuss how the pathway is dysregulated in psoriasis and atopic dermatitis, identifying areas offering opportunities for alternative therapeutic approaches, for further investigation."

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

Use Of Tapinarof, An Aryl Hydrocarbon Agonist, To Treat Adult-Onset Atopic Dermatitis (AAAAI-WAO 2025) - No abstract available

Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Tapinarof Cream 1% Once Daily: Consistent Efficacy Across All Body Regions, Including Head And Neck, In Adults And Children Down To 2 Years Of Age With Atopic Dermatitis (AAAAI-WAO 2025) - "Tapinarof was well tolerated across sensitive areas, including the face/neck. Conclusions Tapinarof demonstrated consistent efficacy and was well tolerated across body regions, including the head/neck, supporting its use in treating patients with AD down to age 2 years."

Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Organon Reports Results for the Fourth Quarter and Full Year Ended December 31, 2024 (GlobeNewswire) - "Biosimilars revenue increased 12% on both an as-reported and ex-FX basis for full year 2024, compared with the prior year, primarily driven by growth in Hadlima, following its U.S. launch in July 2023. Renflexis and Ontruzant declined 1% ex-FX and 9% ex-FX, respectively, as both products are in the mature phase of their product life cycles and face significant competitive pricing pressure. Established Brands revenue grew 2% both on an as-reported basis and ex-FX in the fourth quarter of 2024, primarily related to the revenue contribution of Emgality (galcanezumab-gnlm) and Vtama (tapinarof), which together more than offset the impact of the loss of exclusivity ('LOE') of Atozet (ezetimibe and atorvastatin) in key markets in Europe and in Japan."

Commercial • Ankylosing Spondylitis • Atherosclerosis • Atopic Dermatitis • Breast Cancer • Crohn's disease • Dyslipidemia • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • HER2 Positive Breast Cancer • Migraine • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

Structural basis for the ligand-dependent activation of heterodimeric AHR-ARNT complex. (PubMed, Nat Commun) - "Crystal structures of the AHR-ARNT-DNA complexes, bound with each of six established AHR ligands, including Tapinarof, 6-formylindolo[3,2-b]carbazole (FICZ), benzo[a]pyrene (BaP), β-naphthoflavone (BNF), Indigo and Indirubin, reveal an unconventional mode of subunit assembly with intimate association between the PAS-B domains of AHR and ARNT...Our findings further reveal the structural underpinnings of a ligand-driven activation mechanism, whereby a segment of the AHR protein undergoes a structural transition from chaperone engagement to ARNT heterodimer stabilization, to generate the transcriptionally competent assembly. Our results provide key information for the future development of AHR-targeting drugs."

Journal • ARNT

Clinical observation of sequential topical Mometasone Furoate Cream versus Tapinarof in the treatment of atopic dermatitis in adults (ChiCTR) - P4 | N=60 | Sponsor: Xiangya Hospital of Central South University; CHINA ASSOCIATION OF MEDICAL EQUIPMENT

New P4 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Real-World Use of Tapinarof Cream 1% Once Daily in Patients with Seborrheic Dermatitis: A Case Series. (PubMed, J Clin Aesthet Dermatol) - "Topical roflumilast foam was approved for the treatment of SD in 2023, but additional options are needed. The efficacy and potential remittive effect may be attributed to the unique mechanism of action and clinical profile of tapinarof cream. Tapinarof is a novel topical therapy that may be beneficial for patients with SD."

Journal • Real-world evidence • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Psoriasis • Seborrheic Dermatitis

Tapinarof cream 1% once daily was well tolerated in adults and children with atopic dermatitis in two phase 3 randomized trials. (PubMed, J Dermatolog Treat) - P3 | "Across sensitive skin, investigators reported no-to-minimal irritation from first application through Week 8 (mean scores [Tapinarof versus vehicle]: 0-0.3 versus 0-1.0). Tapinarof was well tolerated locally from first application through Week 8, including on sensitive skin areas. Clinicaltrials.gov numbers NCT05014568, NCT05032859."

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

Tapinarof Improved Outcomes and Sleep for Patients and Families in Two Phase 3 Atopic Dermatitis Trials in Adults and Children. (PubMed, Dermatol Ther (Heidelb)) - P3 | "Tapinarof significantly improved QoL across PROs, including sleep and family impact, regardless of age, from week 1 (the earliest evaluation) through week 8. Tapinarof is a once-daily, non-steroidal cream that rapidly improves AD symptoms, sleep, and QoL in patients down to age 2 years with AD."

Journal • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Activation of aryl hydrocarbon receptor ameliorates degranulation of LL-37 induced mast cells in rosacea through enhancing autophagy. (PubMed, Int Immunopharmacol) - "The present study showed that activation of AhR ameliorated degranulation of LL-37-induced mast cells in rosacea through enhancing autophagy, offering a new option for rosacea treatment."

Journal • Dermatitis • Dermatology • Immunology • Rosacea • IL6 • MMP9 • TNFA • TPSAB1