Summary
Ritlecitinib has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Vitiligo would be drug repurposing rather than first-in-human development. This does not mean it is approved for Vitiligo. ClinicalTrials.gov lists 4 registered trials linking Ritlecitinib to Vitiligo: 1 is currently recruiting; 2 are active or not yet recruiting; 1 has completed. The most advanced is Phase 3 (NCT06072183). It plans or enrolled 1571 participants. Registration activity spans 2022 to 2026. The literature layer holds 8 publications for this pair: 2 Cochrane reviews, 1 meta-analysis and 5 clinical trial publications. Publication years run from 2023 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Vitiligo ranks 50 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Spontaneous complete repigmentation extremely rare (<1%); partial spontaneous repigmentation possible in small lesions; progressive without treatment in most patients.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 62.5 (trials 18.5, literature 24.0, tier 15, approved bonus 5.0) |
| Registered trials | 4 total: 1 recruiting, 2 active / not yet recruiting, 1 completed, 0 other |
| Linked publications | 8 (5 clinical trial publications, 2 Cochrane reviews, 1 meta-analysis) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | inhibitor |
| Data sources | DGIdb |
| Linked via biomarker / target | BTK |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT06072183 | A 104-Week Study of Ritlecitinib Oral Capsules in Adults With Nonsegmental Vitiligo (Active and Stable) Tranquillo 2 2023 | active, not recruiting | Phase 3 | 1,571 |
| NCT06163326 | A 52-Week Study to Learn About the Safety and Effects of Ritlecitinib in Participants With Nonsegmental Vitiligo 2024 | active, not recruiting | Phase 3 | 394 |
| NCT05583526 | A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents With Nonsegmental Vitiligo (Active and Stable) Tranquillo 2022 | completed | Phase 3 | 607 |
| NCT07152626 | Combination Approach With Ritlecitinib and nbUVB Compared to Ritlecitinib Alone for Treating Vitiligo 2026 | recruiting | Phase 2 | 56 |
Published literature
- Cochrane review Large-scale meta-analysis of infection risk with JAK-STAT inhibitors in 29,000 patientsKrebs M, Gulyás L, Fazekas KK et al. · Journal of the European Academy of Dermatology and Venereology : JEADV · 2026 · PMID 42187316
- Clinical trial publication Response to ritlecitinib with or without narrow-band ultraviolet B add-on therapy in patients with active nonsegmental vitiligo: Results from a phase 2b extension studyYamaguchi Y, Peeva E, Adiri R et al. · Journal of the American Academy of Dermatology · 2025 · PMID 39709084
- Meta-analysis Relative Impact of Monotherapies for Vitiligo: A Network Meta-Analysis StudyGupta AK, Bamimore MA, Seneschal J et al. · Journal of cosmetic dermatology · 2025 · PMID 40013382
- Clinical trial publication Efficacy and safety of ritlecitinib in vitiligo patients across Fitzpatrick skin types with biomarker analysesPeeva E, Yamaguchi Y, Ye Z et al. · Experimental dermatology · 2024 · PMID 39304339
- Clinical trial publication Ritlecitinib, a JAK3/TEC family kinase inhibitor, stabilizes active lesions and repigments stable lesions in vitiligoYamaguchi Y, Peeva E, Duca ED et al. · Archives of dermatological research · 2024 · PMID 39023568
- Clinical trial publication Improvements in immune/melanocyte biomarkers with JAK3/TEC family kinase inhibitor ritlecitinib in vitiligoGuttman-Yassky E, Del Duca E, Da Rosa JC et al. · The Journal of allergy and clinical immunology · 2024 · PMID 37777018
- Cochrane review Protocol for a systematic review and meta-analysis on Janus kinase inhibitors in the management of vitiligoPranić S, Pulumati A, Vuković D · Systematic reviews · 2024 · PMID 38641831
- Clinical trial publication Efficacy and safety of oral ritlecitinib for the treatment of active nonsegmental vitiligo: A randomized phase 2b clinical trialEzzedine K, Peeva E, Yamaguchi Y et al. · Journal of the American Academy of Dermatology · 2023 · PMID 36370907
Mechanism and notes
Recorded mechanism or class: inhibitor.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target BTK. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Ritlecitinib approved for Vitiligo?
Ritlecitinib has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Vitiligo would be drug repurposing rather than first-in-human development. This does not mean it is approved for Vitiligo. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Ritlecitinib in clinical trials for Vitiligo?
ClinicalTrials.gov lists 4 registered trials linking Ritlecitinib to Vitiligo: 1 is currently recruiting; 2 are active or not yet recruiting; 1 has completed. The most advanced is Phase 3 (NCT06072183). It plans or enrolled 1571 participants. Registration activity spans 2022 to 2026.
What does the evidence show for Ritlecitinib in Vitiligo?
Ritlecitinib has both completed registered trials and synthesis-level publications linked to Vitiligo. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target BTK. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-06. Page built 2026-10-07.