NAIROBI, Kenya — An oral medicine used to modify immune-system activity has shown potential to restore skin pigmentation in people with non-segmental vitiligo, according to results from two large Phase 3 clinical trials.
The drug, upadacitinib, was tested in the Viti-Up clinical programme involving 614 people aged 12 and above with non-segmental vitiligo. Participants were randomly assigned to receive either 15mg of upadacitinib once daily or a placebo for 48 weeks.
The findings showed that significantly more patients receiving upadacitinib achieved clinically meaningful repigmentation of both the body and face than those given placebo.
The results were presented at the 2026 annual meeting of the American Academy of Dermatology and have subsequently supported regulatory action in Europe.
What the trials found
In the first Viti-Up study, 19.4% of patients taking upadacitinib achieved at least a 50% reduction in the extent of vitiligo across the body after 48 weeks, compared with 5.9% of those receiving placebo.
In the second study, the corresponding figures were 21.5% and 5.9%.
The medicine also produced notable improvements in facial pigmentation.
At least 75% improvement in facial vitiligo was recorded in 25.2% of patients in the first study and 23.4% in the second, compared with 5.9% and 6.9%, respectively, among those receiving placebo.
Researchers also reported that repigmentation continued to improve during the 48-week treatment period rather than reaching an obvious plateau.
That finding is significant because vitiligo treatment can require prolonged therapy, particularly among people with extensive disease.
How does upadacitinib work?
Vitiligo is a chronic autoimmune condition in which the immune system attacks melanocytes — cells responsible for producing melanin, the pigment that gives skin its colour.
When melanocytes are damaged or destroyed, areas of skin lose pigmentation and develop characteristic white patches.
Upadacitinib belongs to a class of medicines known as Janus kinase (JAK) inhibitors. It works by blocking specific signalling pathways involved in immune and inflammatory responses.
The approach therefore targets part of the underlying immune process rather than simply treating the visible appearance of the condition.
Earlier Phase 2 research had already suggested that upadacitinib could promote repigmentation in adults with extensive non-segmental vitiligo.
Not everyone responded
Despite the encouraging results, the findings should not be interpreted as meaning that upadacitinib restores pigmentation in most patients.
The majority of people receiving the drug did not reach the trials’ primary thresholds for repigmentation after 48 weeks.
This means the treatment is not a cure and will not necessarily work for everyone. Researchers are still investigating why some patients respond more strongly than others and how durable the restored pigmentation will be.
The participants who completed the initial 48-week period entered an open-label extension in which they can receive upadacitinib for a further 112 weeks, allowing researchers to assess outcomes for up to 160 weeks in total.
Safety remains an important consideration
Upadacitinib affects the immune system, meaning its potential risks need to be considered alongside its benefits.
In the Phase 3 studies, the most frequently reported adverse events included upper respiratory tract infections, acne and nasopharyngitis, an inflammation of the nose and throat. Researchers reported no new safety signals during the 48-week period.
However, longer-term monitoring remains important because people receiving systemic JAK inhibitors may require treatment for extended periods.
The Phase 2 research also highlighted the need for continued safety assessment, particularly because serious adverse events can occur with medicines that alter immune activity.
Patients should therefore not take upadacitinib for vitiligo without assessment and prescription by an appropriately qualified clinician.
European approval marks a significant development
The treatment has already moved beyond the experimental stage in Europe.
On 29 July 2026, the European Commission approved upadacitinib, marketed as RINVOQ, for adults and adolescents aged 12 and above with non-segmental vitiligo who are candidates for systemic treatment. AbbVie said it is the first systemic medicine approved in the European Union specifically for this indication.
The European approval was supported by the Viti-Up Phase 3 data showing statistically significant improvements in total-body and facial repigmentation compared with placebo.
Availability and regulatory status, however, differ between countries. Approval in Europe does not automatically mean that the medicine is approved or routinely available for vitiligo treatment elsewhere.
Why the findings matter
Vitiligo is sometimes dismissed as a cosmetic condition, but its effects can extend well beyond changes in appearance.
People living with the condition can experience stigma, discrimination, anxiety, reduced self-esteem and difficulties in social and professional settings.
The psychological burden can be particularly significant when pigmentation changes are extensive or affect highly visible areas such as the face.
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The development of systemic treatments such as upadacitinib reflects a broader shift in how researchers understand vitiligo — from a condition involving pigmentation alone to an autoimmune disease in which inflammation and immune signalling play central roles.
Upadacitinib is not the only emerging treatment. Other JAK inhibitors, including topical therapies, are also being investigated or used in different regulatory settings for vitiligo. Recent research has increasingly focused on controlling the immune response while allowing melanocytes to recover or repopulate affected skin.
What happens next?
The extended Viti-Up follow-up will provide important information about whether repigmentation can be maintained over several years, how continued treatment affects safety and which groups of patients are most likely to benefit.
Researchers will also need to establish how the medicine performs in routine clinical practice, including among populations that may be under-represented in clinical trials.
For people living with vitiligo, the results represent another potentially important treatment option rather than a definitive cure.
The evidence so far suggests that upadacitinib can produce meaningful repigmentation in a proportion of adolescents and adults with non-segmental vitiligo. But its long-term benefits, risks, cost and availability will determine how widely it can ultimately be used.
Medical note: This article reports findings from clinical research and should not be taken as medical advice. Anyone considering treatment for vitiligo should consult a dermatologist or other qualified healthcare professional.
