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Opzelura FDA Approval History

Last updated by Judith Stewart, BPharm on July 20, 2022.

FDA Approved: Yes (First approved September 21, 2021)
Brand name: Opzelura
Generic name: ruxolitinib
Dosage form: Cream
Company: Incyte Corporation
Treatment for: Atopic Dermatitis, Vitiligo

Opzelura (ruxolitinib) cream is a topical Janus kinase (JAK) inhibitor used for the treatment of atopic dermatitis and nonsegmental vitiligo.

  • Opzelura is indicated for:
    • the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.
    • the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.
  • Opzelura (ruxolitinib) is the first and only topical Janus kinase (JAK) inhibitor approved for use in the United States. The oral formulation of ruxolitinib was first approved under the brand name Jakafi in 2011 and is used for the treatment of myelofibrosis, polycythemia vera, and graft-versus-host disease.
  • Over-activity of the JAK signaling pathway has been shown to drive inflammation in atopic dermatitis and vitiligo. Opzelura works to reduce inflammation by inhibiting JAK.
  • Opzelura is administered topically. Patients should not use more than one 60 gram tube per week or one 100 gram tube per 2 weeks.
    • Atopic Dermatitis: Opzelura is administered by applying a thin layer twice daily to affected areas of up to 20% of the body surface area.
    • Nonsegmental Vitiligo: Opzelura is administered by applying a thin layer twice daily to affected areas of up to 10% body surface area.
  • Warnings and precautions associated with Opzelura include serious infections; non-melanoma skin cancers; thrombosis; and thrombocytopenia, anemia and neutropenia. The Opzelura product label carries a boxed warning for serious infections leading to hospitalization or death; higher rate of all-cause mortality, including sudden cardiovascular death; lymphoma and other malignancies; higher rate of major adverse cardiovascular events (including cardiovascular death, myocardial infarction, and stroke); and thrombosis (including deep venous thrombosis, pulmonary embolism, and arterial thrombosis).
  • Common adverse reactions in atopic dermatitis patients include nasopharyngitis, diarrhea, bronchitis, ear infection, eosinophil count increased, urticaria, folliculitis, tonsillitis, and rhinorrhea. Common adverse reactions in nonsegmental vitiligo patients include application site acne, application site pruritus, nasopharyngitis, headache, urinary tract infection, application site erythema, and pyrexia.

Development timeline for Opzelura

DateArticle
Jul 18, 2022Approval Incyte Announces U.S. FDA Approval of Opzelura (ruxolitinib) Cream for the Treatment of Vitiligo
Sep 21, 2021Approval FDA Approves Opzelura (ruxolitinib) Cream for the Treatment of Atopic Dermatitis (AD)
Jun 11, 2021Incyte Announces U.S. FDA Has Extended the New Drug Application Review Period for Ruxolitinib Cream for the Treatment of Atopic Dermatitis
May 17, 2021Incyte Announces Positive Results from Phase 3 TRuE-V Program Evaluating Ruxolitinib Cream in Patients with Vitiligo
Feb 19, 2021Incyte Announces Acceptance and Priority Review of NDA for Ruxolitinib Cream for Atopic Dermatitis
Jan 28, 2020Incyte Announces that the TRuE-AD2 Pivotal Trial of Ruxolitinib Cream Met its Primary Endpoint in Patients with Atopic Dermatitis
Sep 25, 2019Incyte Announces First Patient Treated in Phase 3 Clinical Trial Program Evaluating Ruxolitinib Cream in Patients with Vitiligo
Dec 20, 2018Incyte Announces First Patient Treated in Phase 3 Clinical Trial Program for Ruxolitinib Cream in Atopic Dermatitis
Sep 13, 2018Incyte Announces Positive Data from Phase 2b Trial of Ruxolitinib Cream in Patients with Atopic Dermatitis

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.