Tapinarof
- Generic Name
- Tapinarof
- Brand Names
- Vtama
- Drug Type
- Small Molecule
- Chemical Formula
- C17H18O2
- CAS Number
- 79338-84-4
- Unique Ingredient Identifier
- 84HW7D0V04
- Background
Tapinarof is a novel, first-in-class, small-molecule AhR agonist that is indicated for the treatment of adult psoriasis. It is available as a topical cream to be applied to the affected area once daily. Tapiranof was first discovered as a metabolite (3,5-dihydroxy-4-isopropylstilbene) produced in Photorhabdus luminescens, a gram-negative bacillus that lives ...
- Indication
Tapinarof is indicated for the topical treatment of plaque psoriasis in adults.
- Associated Conditions
- Psoriasis Vulgaris (Plaque Psoriasis)
- Associated Therapies
- -
FDA approves Organon's Vtama cream to treat atopic dermatitis in adults and children
FDA approves Organon's Vtama cream for atopic dermatitis in adults and children aged 2+. Approval based on positive phase 3 ADORING trials showing significant skin clearance and itch reduction. Vtama offers potential for powerful skin clearance without label warnings or restrictions.
FDA Approves Organon's Vtama Cream, 1% for Atopic Dermatitis
The FDA approved Organon’s Vtama cream for atopic dermatitis in adults and children aged 2 and older, offering a steroid-free option with no label warnings or restrictions. Approval was based on ADORING trials, showing significant improvement in skin clearance. Common adverse events were mild.
Discussing FDA Approval of Tapinarof Cream for Atopic Dermatitis, with John Browning, MD
FDA approved tapinarof cream 1% for atopic dermatitis in ages 2 and older, representing a non-steroidal option with a new mechanism of action. It improves skin barrier and reduces inflammation, showing a remittive effect. Over 80% of participants aged 2-17 in ADORING 3 trial achieved clear or almost clear skin, with 52% reporting completely clear skin.
FDA Approved VTAMA Cream for Treating Atopic Dermatitis in Adults, Children
FDA approved Vtama cream 1% for atopic dermatitis in adults & children aged 2+. ADORING trials showed nearly 50% achieved clear skin vs 14% placebo after 8 weeks. Long-term study confirmed safety & effectiveness over 48 weeks. Vtama addresses underrepresentation in dermatology research & is also approved for plaque psoriasis.
Vtama receives FDA approval for atopic dermatitis
FDA approves Vtama cream 1% for atopic dermatitis in adults and children aged 2+. Vtama, a nonsteroidal topical treatment, showed significant itch reduction and skin clearance in phase 3 trials.
FDA Approves Vtama (tapinarof) Cream for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older
FDA approves Vtama (tapinarof) cream for atopic dermatitis in adults and children 2+ years, offering potential for powerful skin clearance without restrictions on duration or body surface area affected. Vtama cream demonstrated significant improvements in AD symptoms in pivotal studies, with a safety profile consistent with short-term use.
FDA Takes Step Toward Removal of Ineffective Decongestants From the Market
FDA considers removing oral phenylephrine from OTC guidelines due to lack of efficacy, not safety concerns. Public comments invited until May 7, 2025, before final decision. Phenylephrine is in many nasal decongestants like Sudafed and Mucinex. FDA's proposal does not affect nasal spray decongestants.
Organon: FDA Extends Vtama Atopic-Dermatitis Review to March
Organon's FDA review for Vtama's expanded approval in atopic dermatitis extended by 3 months to March 12, impacting 2025 revenue and EBITDA margin forecasts.
Drug Development Updates
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