Ruxotor Cream

Ruxotor is a generic version of OPZELURA (1.5% ruxolitinib cream) which is a JAK inhibitor indicated for short-term or occasional treatment of mild to moderate eczema and nonsegmental vitiligo patients.

Ruxotor inhibits IFN-γ mediated JAK-STAT signaling, a key driver of depigmentation in vitiligo.

Mild to Moderate Eczema (Atopic Dermatitis)

Atopic dermatitis (AD) is a chronic skin disease marked by itch, inflammation, and skin barrier dysfunction.

Dysregulation of inflammatory cytokines (IL-4, IL-13, IL-31, and TSLP) is believed to be involved in AD pathogenesis. These cytokines signal through the JAK-STAT pathway and are thought to perpetuate the cycle of itch and inflammation in AD.

MOA of Ruxotor Against AD

JAKs are intracellular signaling enzymes that act downstream of key cytokines (IL-4, IL-13, IL-31, and TSLP) and therefore are believed to play a key role in AD itch and inflammation. Especially IL-31 is a key cytokine believed to trigger itch. Ruxotor binds to the JAK enzyme, inhibiting both JAK and STAT activation. As a result, inflammatory mediators are interrupted.
Through topical JAK inhibition, Ruxotor targets the signaling of key cytokines believed to be a source of itch and inflammation.

How to Use Ruxotor in Atopic Dermatitis

  • Patients should apply a thin layer 2x a day directly to affected skin areas —up to 20% BSA
  • Patients should not use more than one 60 gram tube per week
  • Patients should use Ruxotor until signs and symptoms resolve
  • For topical use only. Not for ophthalmic, oral, or intravaginal use.
  • If signs and symptoms do not improve within 8 weeks, patients should be re-examined.

Nonsegmental Vitiligo

Depigmentation: Based on pre-clinical data,

  • Melanocyte stress leads to immune cell activation of CD8+ T-cells that target and destroy melanocytes
  • These T-cells also release IFN-γ, which activates the JAK-STAT pathway in keratinocytes, leading to production of CXCL9 and CXCL10
  • Continued signaling by IFN-γ and CXCL9/10 attracts more autoreactive T-cells, perpetuating an inflammatory cycle of melanocyte destruction.

MOA of Ruxotor Against Vitiligo

  • Now Ruxotor cream regulates IFN-γ mediated JAK-STAT signaling, which is thought to reduce CD8+ T-cell mediated destruction of melanocytes.
  • This may create a more stable environment enabling the return of melanocytes.

With reduced inflammation, melanocytes may slowly regenerate and migrate from hair follicles to produce pigment over time.

In short, Ruxolitinib, the active ingredient in Ruxotor, binds to the JAK1 and JAK2 enzymes and is thought to inhibit IFN-γ mediated JAK-STAT signaling.

Abbreviations: CD8+ T-cell, cytotoxic T lymphocyte; BSA, body surface area; CXCL, chemokine (C-X-C motif) ligand; IFN-γ, interferon gamma; JAK, Janus kinase; STAT, signal transducers and activators of transcription.

How to Use Ruxotor in Nonsegmental Vitiligo

Ruxotor is applied in a thin layer, twice daily to affected areas of up to 10% body surface area. It is designed for topical application across the body, including on sensitive skin areas like:
• around the eyes and mouth
• on the external genitals
Ruxotor is for topical use only. Ruxotor is not for ophthalmic, oral, or intravaginal use. Patients should not use more than one 60 gram tube per week.