Japan Approves VTAMA Cream 0.5% for Atopic Dermatitis in Children Under 12
核心洞察
Shionogi and Torii Pharmaceutical obtained Japanese manufacturing and marketing approval for VTAMA Cream (搜索) 0.5% (tapinarof) for atopic dermatitis (搜索) in pediatric patients under 12 years of age.
The approval was based on a domestic Phase 3 trial in children aged 2 to under 12 in which the drug met its primary efficacy endpoint versus vehicle cream.
Pooled Phase 3 ADORING data showed consistent vIGA-AD and EASI75 improvements across pediatric age groups, with responses observed as early as week 2.
Shionogi & Co., Ltd. and Torii Pharmaceutical Co., Ltd., a SHIONOGI Group company, announced on September 16, 2026 that they have obtained manufacturing and marketing approval in Japan for VTAMA® Cream 0.5% (generic name: tapinarof) for the indication of atopic dermatitis (搜索) in pediatric patients under 12 years of age.
The approval extends the tapinarof label in Japan, where VTAMA® Cream 1% is already approved for atopic dermatitis (搜索) in adults and pediatric patients aged 12 years and older, as well as for plaque psoriasis (搜索) in adults.
Mechanism and Rationale
Tapinarof is a nonsteroidal, small molecule therapeutic aryl hydrocarbon receptor (搜索) (AhR) modulating agent. According to the companies, it suppresses the production of inflammatory cytokines and induces gene expression of skin barrier function-related and antioxidant molecules through activation of AhR. In the United States, VTAMA cream (搜索) is described as the only steroid-free, topical AhR agonist approved by the FDA for the topical treatment of atopic dermatitis (搜索) in adults and pediatric patients two years of age and older and for the topical treatment of plaque psoriasis (搜索) in adults.
Phase 3 Evidence in Young Children
The Japanese approval is based on the results of a domestic Phase 3 clinical trial conducted in pediatric patients with atopic dermatitis (搜索) aged 2 to under 12 years (Japan Registry of Clinical Trials jRCT2031230139). In the trial, the efficacy and safety of the drug administered once daily for 8 weeks were evaluated in comparison with vehicle cream, and long-term safety of administration for up to 60 weeks was also evaluated. The primary efficacy endpoint was met, with the drug showing superiority over vehicle cream, and favorable tolerability was confirmed with respect to long-term safety.
Supporting data come from the ADORING Phase 3 program for VTAMA cream (搜索) in atopic dermatitis (搜索), which consisted of two 8-week pivotal trials, ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859), plus ADORING 3 (NCT05142774), a 48-week, open-label, long-term extension trial. A pooled analysis of these trials, presented at the Society for Pediatric Dermatology Annual Meeting in July 2026, reported that improvements were observed as early as week 2, the first post-treatment assessment across pediatric age groups, and continued through week 8.
At week 8, skin clearance measured by vIGA-AD response favored VTAMA cream (搜索) over vehicle across age groups: 56.3% versus 11.8% (P<0.0001) in patients aged 2–6 years; 44.9% versus 23.8% (P=0.0172) in those aged 7–11 years; 48.8% versus 13.4% (P<0.0001) in those aged 12–17 years; and 38.0% versus 18.1% (P=0.0280) in those aged 18 years and older.
Consistent improvements were also reported for the proportion of patients achieving at least a 75% reduction in EASI75 at week 8: 70.2% versus 20.5% (P<0.0001) for ages 2–6 years; 53.6% versus 31.3% (P=0.0158) for ages 7–11 years; 62.2% versus 18.3% (P<0.0001) for ages 12–17 years; and 50.8% versus 20.6% (P=0.0020) for those aged 18 years and older.
"What stands out in these data is not just the skin clearance patients achieved by week 8, but that these results were seen consistently across pediatric age groups as early as week 2," said Juan Camilo Arjona Ferreira, MD, Head of R&D and Chief Medical Officer at Organon. "Organon is committed to advancing dermatology care, and findings like these reinforce VTAMA cream (搜索) as a valuable nonsteroidal option for a wide range of patients."
Safety Profile
In the pooled atopic dermatitis (搜索) analysis, the most common treatment-emergent adverse events were folliculitis, headache, and nasopharyngitis, which were generally mild or moderate in severity. Treatment discontinuations due to treatment-related adverse events occurred less frequently with VTAMA cream (搜索) than with vehicle. The US prescribing information lists the most common adverse reactions (incidence ≥1%) in atopic dermatitis as upper respiratory tract infection, folliculitis, lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in extremity, and abdominal pain; in plaque psoriasis (搜索), the most common adverse reactions (incidence ≥1%) are folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza.
Disease Burden and Positioning
Atopic dermatitis (搜索) is a chronic and pruritic inflammatory skin disease. It is thought to develop through exposure to various irritants or allergens in patients with a physiological abnormality of the skin, including dry skin and abnormal skin barrier function. The disease occurs most frequently in children, affecting up to 20% worldwide, including nearly 10 million children in the U.S., and affects an estimated 26 million people in the U.S. alone and up to 10% of adults worldwide. Itching is an especially bothersome symptom and tends to worsen at night.
Atopic dermatitis (搜索) frequently develops in childhood, and with this approval the drug is expected to become a new treatment option for pediatric patients in Japan. The American Academy of Dermatology has provided strong recommendations for use of VTAMA cream (搜索) for the treatment of pediatric and adult atopic dermatitis patients.
Development and Commercial Background
In 2020, Japan Tobacco Inc. (whose pharmaceutical business has since been transferred to Shionogi) and Dermavant Sciences GmbH (later acquired by Organon & Co.) entered into an agreement for the exclusive development and commercialization rights of tapinarof for dermatological diseases in Japan, and JT and Torii Pharmaceutical entered into an agreement for its co-development and marketing in Japan. Tapinarof was approved in Japan in 2024 under the product name VTAMA® Cream 1%. Currently, Shionogi is the manufacturer and distributor and Torii Pharmaceutical is the distributor, with both companies co-promoting the product in Japan.
Shionogi and Torii stated they will continue to strive to deliver the drug as quickly as possible to contribute to the treatment and quality of life of pediatric patients with atopic dermatitis (搜索). The impact of this matter on Shionogi's consolidated financial results for the fiscal year ending March 2027 is expected to be minimal.