Tapinarof

Tapinarof is an aryl hydrocarbon receptor (AhR) agonist. The specific mechanisms by which VTAMA cream exerts its therapeutic actions are unknown.

• VTAMA cream, 1% is an aryl hydrocarbon receptor agonist indicated for: the topical treatment of plaque psoriasis in adults. ( 1.1 ) the topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older.ICD-10: L20.9, L40.9

• None. None.contraindicated

Apply a thin layer of VTAMA cream to affected areas once daily. Wash hands after application, unless VTAMA cream is for treatment of the hands. VTAMA cream is not for oral, ophthalmic, or intravaginal use. Apply a thin layer of VTAMA cream to affected areas once daily. ( 2 ) VTAMA cream is not for oral, ophthalmic, or intravaginal use. ( 2 )

In plaque psoriasis, the most common adverse reactions (incidence ≥ 1%) were folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza. ( 6.1 ) In atopic dermatitis, the most common adverse reactions (incidence ≥ 1%) were upper respiratory tract infection, folliculitis, lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in extremity, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co., at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Plaque Psoriasis Clinical Trials In two randomized, double-blind, multicenter, vehicle-controlled clinical trials (PSOARING 1 and PSOARING 2), 1025 adults with plaque psoriasis were treated with VTAMA cream or received vehicle cream once daily for up to 12 weeks. Subjects ranged in age from 18 to 75 years, with an overall median age of 51 years. The majority of subjects were White (85%) and male (57%); and 85% identified as non-Hispanic or Latino. Table 1 presents adverse reactions that occurred in at least 1% of subjects treated with VTAMA cream, and for which the rate exceeded the rate for vehicle.

8.1 Pregnancy Risk Summary The available data on VTAMA cream use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, subcutaneous administration of tapinarof to pregnant rats and rabbits during the period of organogenesis resulted in no significant adverse effects at doses 264 and 16 times, respectively, the maximum recommended human dose (MRHD) ( see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of major birth defects, loss, and other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In an embryofetal development study in rats, tapinarof was administered by subcutaneous injection to pregnant animals at doses of 1.2, 6.9 and 34 mg/kg/day during the period of organogenesis. Tapinarof was not associated with embryofetal lethality or fetal malformations. Tapinarof increased the incidence of skeletal variations (incomplete ossification of nasal bones) at the dose of 34 mg/kg/day (264 times the MRHD based on AUC comparisons).

Metabolism

The plasma concentrations of tapinarof were higher in pediatric subjects 2 years of age and older with atopic dermatitis when compared to adult subjects with plaque psoriasis. Absorption Adults with Plaque Psoriasis No accumulation was observed with repeat topical application.

• May 23, 2022NDANDA215272Organon Llc

1. 1Folliculitis28217%
2. 2Pruritus19712%
3. 3Headache1609.5%
4. 4Dermatitis Contact1257.4%
5. 5Rash1247.4%
6. 6Erythema1096.5%
7. 7Drug Ineffective1036.1%
8. 8Skin Burning Sensation814.8%
9. 9Psoriasis684.0%
10. 10Application Site Erythema583.5%
11. 11Off Label Use563.3%
12. 12Application Site Pruritus553.3%
13. 13Application Site Pain513.0%
14. 14Application Site Folliculitis432.6%
15. 15Pain Of Skin432.6%

The 10 most recently updated of 28 ClinicalTrials.gov registrations naming Tapinarof as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Efficacy of Topical Tapinarof Versus Betamethasone in the Treatment of Plaque Psoriasis
  Not yet recruiting · Phase 4 · Interventional · 120 enrolled · Pakistan Institute of Medical Sciences
  NCT07635043updated 2026-06-09
• A Study to Investigate Safety and Efficacy of Tapinarof Cream, 1% in Participants Ages 3 Months to < 24 Months With Atopic Dermatitis
  Recruiting · Phase 3 · Interventional · 180 enrolled · Organon and Co
  NCT07265479updated 2026-06-04
• Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
  Not yet recruiting · Phase 4 · Interventional · 10 enrolled · University of California, San Francisco
  NCT07352566updated 2026-06-03
• Tapinarof for Cutaneous Lupus Erythematosus
  Enrolling by invitation · Early phase 1 · Interventional · 10 enrolled · Northwestern University
  NCT06661213updated 2026-04-29
• A Study Comparing Tapinarof Cream 1% and Vtama® Cream 1% in the Treatment of Plaque Psoriasis.
  Completed · Phase 1 · Interventional · 575 enrolled · Sun Pharmaceutical Industries, Inc.
  NCT07546214updated 2026-04-22
• Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects
  Active not recruiting · Phase 3 · Interventional · 58 enrolled · Organon and Co
  NCT05172726updated 2026-04-17
• Study to Evaluate the Safety and Efficacy of Tapinarof in Adults With Palmoplantar Keratoderma
  Recruiting · Phase 2 · Interventional · 6 enrolled · Indiana University
  NCT06561321updated 2026-03-04
• Comparison of Post-Inflammatory Pigment Alteration After Psoriasis Treatment (PIPA - Dermavant)
  Enrolling by invitation · Phase 2 · Phase 3 · Interventional · 40 enrolled · Wake Forest University Health Sciences
  NCT05981118updated 2025-12-17
• Study Comparing Tapinarof Cream 1% To VTAMA ® (Tapinarof Cream 1%) In the Treatment of Plaque Psoriasis
  Completed · Phase 3 · Interventional · 560 enrolled · Teva Pharmaceuticals USA
  NCT06742957updated 2025-12-17
• Maximal Use Study of Tapinarof Cream, 1% in Pediatric Subjects With Extensive Atopic Dermatitis
  Completed · Phase 2 · Interventional · 36 enrolled · Organon and Co
  NCT05186805updated 2025-09-05

Frequently asked questions

How does Tapinarof work?

Tapinarof is an aryl hydrocarbon receptor (AhR) agonist. The specific mechanisms by which VTAMA cream exerts its therapeutic actions are unknown.

What is Tapinarof used for?

According to FDA labeling, Tapinarof carries indications including: VTAMA cream, 1% is an aryl hydrocarbon receptor agonist indicated for: the topical treatment of plaque psoriasis in adults. ( 1.1 ) the topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Tapinarof?

Tapinarof is classified as Other antipsoriatics for topical use, Aryl Hydrocarbon Receptor Agonist, Aryl Hydrocarbon Receptor Agonists, Increased Immunologic Activity.

What are the brand names for Tapinarof?

Tapinarof is marketed under brand names including Vtama.

What are the contraindications for Tapinarof?

Tapinarof labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.