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📌 Vitiligo Drug Pipeline Analysis - January 2026
Market Insights & Pharmaceutical Development Landscape | Q1, 2026
Welcome to the Vitiligo Research Foundation's excluisve Vitiligo Drug Pipeline Analysis — your authoritative guide to the global vitiligo therapeutic landscape, market dynamics, and emerging scientific breakthroughs, since 2017.
This January 2026 update synthesizes clinical trial data, regulatory filings, and strategic industry moves across 70+ pharmaceutical and biotech programs. Whether you're an investor evaluating market growth, a clinician implementing evidence-based care, or a patient advocate seeking transparency on treatment options, this report delivers institutional-grade intelligence grounded in peer-reviewed research and real-world outcomes.
Key themes: Combination therapy dominance, oral JAK inhibitors entering the market, IL-15 pathway breakthroughs, and the rise of AI-driven diagnostics reshaping patient access globally.
Quick Navigation
- Introduction: Combination Therapy
- Understanding the Patient
- Current Standard of Care
- Global Market Outlook
- Strategic Moves & Setbacks
- Off-Label Therapies
- Biologics & IL-15 Inhibition
- Market Access & Policy
- Digital Frontier & AI
- Complete Company Pipeline
- Conclusion & 2026 Catalysts
The following analysis is structured for both depth and scannability. Use the Table of Contents to jump to sections of immediate interest, or read sequentially to build a comprehensive understanding of the field's evolution.
Each company entry includes clinical status, funding milestones, and mechanism of action. Regulatory timelines reflect filings as of January 16, 2026. Where data conflicts or remains inconclusive, we flag uncertainty explicitly.
Introduction: Combination Therapy is King
The evidence is definitive. After decades of incremental progress, 2025 delivered a watershed moment: controlled clinical trials have decisively demonstrated that JAK inhibitors paired with phototherapy produce synergistic repigmentation outcomes unmatched by any monotherapy to date.
This is not incremental improvement. This is a paradigm shift in how we treat vitiligo — and it arrives precisely as the first oral JAK inhibitors enter the market and biologics targeting immune memory enter late-stage development.
The question is no longer whether combination therapy works. The question is: How quickly will patients and payers adopt this evidence-based standard? And Can the emerging IL-15 inhibitor class deliver on its promise of durable remission — treatment that resets immune memory rather than managing symptoms indefinitely?
The 2025 Data Revolution
Multiple controlled trials have decisively demonstrated that JAK inhibitors + phototherapy deliver synergistic results:
- Meta-analysis (Dec 2025): JAK inhibitors + NB-UVB achieved 6.87× higher chance of ≥50% repigmentation
- RCT (251 patients): Excimer laser + oral JAK showed 14.2% absolute improvement
- Incyte Study: NB-UVB added to ruxolitinib cream increased F-VASI75 from 0% to 19.2%
Oral vs. Topical: The Body Surface Area Paradigm
Opzelura (ruxolitinib cream) dominates the topical market at $508M revenue (2024, +50% YoY), but imminent oral JAK inhibitors will stratify the market:
- AbbVie's upadacitinib (RINVOQ®): Phase 3 success (October 2025) — first potential systemic therapy
- Pfizer's ritlecitinib (LITFULO™): Phase 3 vitiligo results March 2026
- China Medical System's povorcitinib: Breakthrough Therapy designation (Dec 2025)
The Search for Remission: IL-15 Inhibition as the Holy Grail
The ultimate unmet need is durable remission that resets immune memory. ~40% of patients relapse within 12 months after stopping treatment.
The industry's most-watched candidates:
- TEV-53408 (Teva): Secured $500M from Royalty Pharma (Jan 2026) for Phase 2b in 2026
- AMG 714 (Amgen): Phase 2 REVEAL trial completed May 2025
- FB-102 (Forte Biosciences): Phase 1b results expected 1H 2026
Understanding the Patient
Vitiligo affects 0.76-1.11% of U.S. population (nearly 40% undiagnosed) and 65-95 million people worldwide. China alone has 10.3 million patients.
Pathogenesis: The immune system mistakenly destroys melanocytes, causing progressive depigmentation. Onset typically occurs before age 20.
Psychosocial Burden: While not life-threatening, vitiligo carries profound emotional distress. Repigmentation success is highly location-dependent — facial/neck lesions respond best.
Current Standard of Care
First-Line Therapies
Topical Corticosteroids & Calcineurin Inhibitors: Widely used off-label for early-stage disease.
Opzelura® (ruxolitinib 1.5% cream) — The Only FDA-Approved Therapy
- FDA/EMA/Health Canada approved 2022-2023
- 2024 revenue: $508M (+50% YoY)
- 2025 guidance: $630-670M
- Reimbursed for ~85% of insured U.S. patients
Phototherapy: The Backbone of Combination Success
- Narrow-band UVB (NB-UVB): Gold standard, synergistic with topicals.
- 308nm Excimer Laser (STRATA XTRAC®): >75% repigmentation in 15-50% of patients within 15 weeks.
Combination with JAK Inhibitors (2025 RCT, 251 patients):
- 14.2% absolute improvement in repigmentation vs monotherapy
- 100% significant efficacy rate at 52 weeks
- 96.5% pigmentation stability at 1-year follow-up
- 8.8% relapse rate (combination group)
Global Market Outlook
| Metric | 2025 | 2032-2035 |
|---|---|---|
| Global Market Size | $1.25-1.31B | $2.04-2.76B |
| 7MM Market (US, EU5, Japan) | $402M | $915M (by 2034) |
| CAGR | 4.7-8% | |
Growth Drivers
- Rising prevalence & earlier diagnosis via AI-enabled tools
- JAK inhibitor adoption (Opzelura, upadacitinib, ritlecitinib, povorcitinib)
- Biologics pipeline expansion (anti-IL-15, anti-CXCL10, TYK2 inhibitors)
- Teledermatology & connected phototherapy
- APAC acceleration with fast-track regulatory pathways
Strategic Moves & Setbacks
Major Wins
AbbVie — Upadacitinib (RINVOQ®) ✅ Active
- Phase 3 success (October 2025): Two replicate trials met co-primary endpoints
- T-VASI50: 19.4% (Study 1), 21.5% (Study 2)
- Full data & regulatory filings expected 2026
Incyte — Opzelura (ruxolitinib cream) ✅ Active
- Q4 2024: $162M (+48% YoY); Full year: $508M (+50%)
- 2025 guidance: $630-670M
- Ex-U.S. growth: France, Spain, Italy, Canada
Major Setbacks
Vyne Therapeutics — VYN201 ✗ Discontinued
- Phase 2b missed primary endpoint (July 2025)
- Program discontinued; seeking development partner
Off-Label Therapies
- Tacrolimus (Astellas, Accord, Belcher, Glenmark): Non-steroidal mainstay
- Zerigo Health: FDA-cleared handheld NB-UVB with physician-prescribed mobile app
- STRATA XTRAC®: 308nm excimer laser (400+ peer-reviewed studies)
Biologics & IL-15 Inhibition
The ultimate unmet need is durable remission—treatment that resets immune memory without requiring continuous dosing.
🇮🇱🇺🇸 Teva — TEV-53408 ✅ Active
- Phase 1b vitiligo: Ongoing, results expected 2026
- $500M from Royalty Pharma (January 2026)
- $75M for Phase 2b vitiligo (target start 2026)
🇺🇸 Amgen — AMG 714 ? Pending Results
- Phase 2 REVEAL trial completed May 2025
- 60 patients, NIAID-sponsored
- No published results as of January 2026
🇺🇸 Forte Biosciences — FB-102 ✅ Active
- Phase 1b vitiligo: Underway
- Topline results expected 1H 2026
Market Access & Policy Risks
NICE UK Rejection
July 2025: NICE rejected ruxolitinib cream for NHS use despite patient advocacy. Sets precedent for future vitiligo therapies.
WHO Declaration
May 2025: 78th World Health Assembly declared skin diseases a global health priority, but vitiligo NOT specifically named.
The Digital Frontier: AI and Startups
AI-Driven Diagnostic Platforms
- YOLOv11: >90% accuracy, mobile deployment
- XGBoost: 0.99 AUC for vitiligo detection
- EfficientNet-B7: 95% accuracy in mobile proof-of-concept
Active Platforms
- Skinopathy (Canada): Purpose-built AI detection
- Zerigo Health (U.S.): FDA-cleared handheld NB-UVB with app control
- India: Clinikally (Clara AI), CureSkin, SkinKraft
- China: WeDoctor, Ping An Health, UMER Doctor
Complete Pharmaceutical Pipeline: All Companies
The clinical landscape features more than 40 active or recently shelved programs, ranging from stem cell therapies to biologics, cannabinoids, and AI-driven interventions.
AbbVie 🇺🇸 ✅
Upadacitinib (RINVOQ®), a selective JAK1 inhibitor, is in late-stage development for nonsegmental vitiligo. Two replicate Phase 3 trials in adults/adolescents (15 mg QD) met both co-primary endpoints at Week 48—T-VASI50 and F-VASI75—with a safety profile consistent with prior indications. Full results due 2026.
Ache Laboratorios Farmaceuticos 🇧🇷 ?
ACH24: Set aside $100M for vitiligo in 2016; faced significant setbacks when Brazil's ANVISA requested Phase 3 cancellation, requiring a Phase 1 restart. Following setbacks, Aché partnered with Sun Pharma Global FZE to develop AS012 in the early 2020s.
❓ Aclaris Therapeutics
ATI-50002 (Topical JAK1/JAK3 inhibitor): Phase 2 completed 2020; no advancement since. ATI-1777 (next-gen soft JAK1/3) Phase 2b positive in AD (Jan 2024); vitiligo expansion mentioned but no trials initiated as of Jan 2026.
Ahammune Biosciences 🇮🇳 ✅
AB1001 (Topical small molecule, T-cell activation inhibitor): Completed Phase I in January 2023. Phase 2 IND granted May 2025. $5M funding raised Sept 2024. Non-steroidal, non-immunosuppressive, disease-modifying therapy.
🇪🇸 Almirall ? Early Stage
Wnt pathway-targeting therapy (partnership with Inserm Transfert, May 2022): Led by Prof. Thierry Passeron; aims to deliver novel class for vitiligo. Status unclear; no trial updates.
🇺🇸 Alys Pharmaceuticals ? Pending
Emerged 2024 with $100M from Medicxi; pooled 6 biotech startups. Focus: inflammatory/autoimmune, dermatology for cancer patients, rare skin conditions. Goal: 7-10 clinical POC readouts next 3 years. Vitiligo interest unconfirmed.
🇺🇸 Amgen ? Pending Results
AMG 714 (Ordesekimab): Designed to block IL-15, targeting tissue resident memory T cells. Phase 2 trial completed May 2025; no published results as of October 2025.
❌ AnaptysBio ✗ Discontinued
Rosnilimab (Anti-PD-1 agonist): Moved to Phase 2b for RA (Q3 2023); vitiligo no longer acknowledged on website.
❌ Applied Biology / Safety Shot ✗ OTC Only
Photocil (NB-UVB filter cream): FDA-registered OTC for vitiligo, psoriasis, AD. Selectively transmits 311-313nm. Acquired by Jupiter Wellness (now Safety Shot) July 2022; rebranded PhotoFirst; CDSCO approval India Nov 2022. Not FDA-approved prescription therapy; positioned as adjunct.
🇺🇸 Arcutis Biotherapeutics ? Preclinical
ARQ-252 (SHR0302, JAK1 inhibitor licensed from Jiangsu Hengrui): Phase IIa terminated June 2021; back at preclinical stage for chronic hand eczema and vitiligo. Roflumilast 0.3% foam (PDE4 inhibitor): Phase 2 vitiligo & hidradenitis suppurativa studies ongoing.
❓ Arrien Pharmaceuticals ? IND-enabling
ARN-4079 (Oral JAK3/ITK inhibitor, Cys909 targeting): IND-enabling studies; seeking partners for Phase 1. Vitiligo among lead indications. $2M + undisclosed funding; no trial initiated.
🇬🇧 AstraZeneca ✅ Active
Anifrolumab (Saphnelo) — Phase 2 (NCT05917561) combining anifrolumab with NB-UVB for vitiligo. Approved for SLE 2021; exploring IFN-I pathway modulation.
🇺🇸 Avita Medical ✅ Active
RECELL® System: FDA-approved device (2023) for vitiligo. Creates autologous skin cell suspension in <30 min; apply to laser-prepared stable lesions. 36% achieved ≥80% repigmentation at 6 months in pivotal trials.
❌ AXIM Biotechnologies ✗ Inactive
AX-1602 (CBD/CBG topical): Initially patented for vitiligo; never advanced beyond single POC study. Program inactive; company focused on psoriasis, eczema, ophthalmology, neurology.
🇮🇱 Biolojic Design / Teva ? Early Stage
BD9 (Dual IL-13/TSLP antibody, AI-driven multibody platform): IND-enabling studies for AD and asthma. Vitiligo potential noted but no active trial.
🇺🇸 Bioniz Therapeutics / Almirall ? Phase 2-Ready
BNZ-1 (Multi-cytokine inhibitor: IL-2, IL-9, IL-15): Phase 2-ready; demonstrated safety in CTCL Phase 1/2. Vitiligo listed as lead indication but no active trials as of Jan 2026.
🇩🇪 Boehringer Ingelheim ? Early Interest
No proprietary trials for vitiligo. Early-stage interest; strong external partnering strategy. Focus on advocacy, pediatric support, foundational research. Future involvement likely via in-licensing.
❌ Boston Pharmaceuticals ✗ No Updates
BOS-475 (formerly GSK3183475): In-licensed from GSK after R&D restructuring. Not in active pipeline; no updates post-acquisition.
🇺🇸 Bristol Myers Squibb ✅ Active
Deucravacitinib (Sotyktu) (Oral TYK2 inhibitor): Phase 2/3 vitiligo + NB-UVB (NCT06327321). Approved for psoriasis 2022; PsA sNDA PDUFA March 6, 2026. Direct-to-patient platform launching Jan 2026. Vitiligo exploratory.
🇺🇸 CAGE Bio ✓ Active
CGB-600 (DNA aptamer targeting IFN-γ): Phase 2 initiated Oct 2025; 36 patients, facial NSV; topline Q3 2026. Licensed from TAGCyx (Japan); ionic liquid delivery. First DNA aptamer for vitiligo.
❓ Castle Creek Pharma ? Uncertain
CCP-070 (Peptide analogs): Preclinical program from Univ. of Cincinnati; aims to stimulate melanogenesis. No toxicology studies or timelines disclosed; focus shifted to gene therapies. Likely suspended.
🇨🇳 China Medical System ✓ Active
Ruxolitinib Phosphate Cream: Licensed from Incyte for mainland China, HK, Macau, Taiwan, SE Asia. NDA accepted by NMPA for vitiligo. Already approved HK/Macau for NSV with facial involvement (age 12+). Phase 3 AD trial positive (Jan 2026). Manufacturing scale-up completed locally.
Povorcitinib (Oral JAK1 inhibitor, licensed from Incyte): Breakthrough Therapy designation NMPA Dec 2025. Phase 3 global trial met primary endpoint March 2025. China Phase 3 initiated Aug 2025; NDA filed Sept 2024. HK/Macau approved via fast-track policy. If approved: first oral JAK for vitiligo in China.
🇨🇳 CSPC Ouyi Pharmaceutical ✓ Active
SYHX1901 (Oral TYK2 inhibitor): Phase 2 (NCT06511739) for vitiligo. Targets immune-mediated diseases; CSPC entry into immunodermatology market.
🇦🇺 Clinuvel ✓ Active
SCENESSE® (Afamelanotide 16mg) (α-MSH analog, SC implant): Phase 3 CUV105 enrollment completed May 2025 (200+ patients, 37 sites). Fitzpatrick III-VI focus; afamelanotide + NB-UVB vs NB-UVB alone. Full results 2H 2026. Early case reports: rapid repigmentation (as early as 4 weeks), though diffuse hyperpigmentation in lighter skin types is concern.
❌ Dermavant / Roivant / Organon ✗ Discontinued
Cerdulatinib (DMVT-504) (JAK/SYK inhibitor): Deprioritized July 2022 before entering trials. Absent from pipeline Oct 2025; R&D redirected to VTAMA® (tapinarof for psoriasis). Acquired by Organon 2024; no active vitiligo R&D.
🇨🇳 Dermavon (CMS Spin-off) ✓ Active
Povorcitinib (Oral JAK1 inhibitor, licensed from Incyte): Breakthrough Therapy designation NMPA Dec 2025. Phase 3 global trial met primary endpoint March 2025. China Phase 3 initiated Aug 2025; NDA filed Sept 2024. HK/Macau approved via fast-track policy. If approved: first oral JAK for vitiligo in China. Also co-develops MG-K10 (anti-IL-4Rα antibody) Phase 3 AD; potential extension to vitiligo.
🇮🇳 DRDO / AIMIL Pharma
Lukoskin (Ayurvedic polyherbal: ointment + oral liquid): Enhances photosensitivity, melanogenesis, immune modulation. Widely available in India; affordable, safe, culturally accepted. Clinical efficacy modest, comparable to other adjunctive herbal therapies.
🇨🇦 Edesa Biotech ✓ Active
EB06 (Anti-CXCL10 mAb): First-in-class blocking CXCL10 chemokine to disrupt T-cell recruitment. Phase 2 planned mid-2026 (~160 patients, moderate-to-severe NSV). CTA granted Health Canada (NCT05724952 active, not recruiting); IND in progress U.S. Dosing: IV q2 weeks x 24 weeks, then 12-week follow-up. Primary: F-VASI50 at Week 24. $15M funding to advance through fiscal 2026. Preclinical: reversed vitiligo in mouse models.
🇫🇷/🇺🇸 Eligo Bioscience ? Preclinical
CRISPR-guided microbiome therapies: Patents for Cutibacterium acnes engineering. Lead EB005: acne (preclinical/early patient data). Vitiligo in patent scope but no active clinical program as of 2025.
🇺🇸 Forte Biosciences ✓ Active
FB-102 (Anti-CD122 mAb): Phase 1b vitiligo underway; topline results 1H 2026. Targets IL-2/IL-15 receptor shared subunit (CD122). Phase 1b celiac disease positive data (June 2025): p=0.0099 on composite endpoint. Mechanism: Suppresses pathogenic CD8+ memory T cells and NK cells while sparing Tregs.
🇨🇳 Huahai Institute of Vitiligo Research
Founded 1994; leading center integrating TCM with modern biomedicine. Developed several patented oral, topical, injectable therapies. No internationally recognized clinical trials or peer-reviewed efficacy data as of 2025.
🇨🇭 Idorsia Pharmaceuticals ✓ Active
ACT-777991 (Oral CXCR3 antagonist): First-in-class dual targeting CD8+ CXCR3+ T cells + melanocytes. Proof-of-concept Phase 2 in preparation; trial initiation expected 2026. Aims to be first targeted systemic for immuno-dermatology. Preclinical: synergistic remission with anti-CD3 in T1D (82% remission vs 38% for anti-CD3 alone).
🇦🇺 Incannex Healthcare ? Clinical Stage
ReneCann (APIRx-1601) (CBD/CBG topical): Cannabinoid-based cream for vitiligo, psoriasis, and atopic dermatitis. Proof-of-concept study in the Netherlands showed ~10% disease score reduction and diffuse repigmentation, though relapse occurred. Manufacturing underway for confirmatory trials; regulatory filings in preparation.
🇨🇳 InnoCare Pharma ✓ Active
Soficitinib (ICP-332) (TYK2/JAK1 inhibitor): Vitiligo Phase 2/3 initiated May 2025 (China), enrollment underway. AD Phase 3 registrational trial accelerating; Phase 2 data (AAD 2025) outstanding efficacy. Prurigo nodularis Phase 2 global initiated Nov 2025. CSU Phase 2/3 IND approved Dec 2025. China-focused, global expansion planned.
🇨🇳 Issar Pharma / Zydus ✓ Active
Melgain (Decapeptide Topical): First peptide-based topical for vitiligo, stimulating melanocyte migration and repigmentation. Marketed in India by Zydus/Liva Healthcare; real-world data support limited use in adults and children. Zydus holds rights for potential international expansion.
🇨🇳 Jiangsu HengRui Medicine ✓ Active
SHR0302Base (Topical JAK1 inhibitor): Global Phase 2 trials for vitiligo. Oral counterpart in Phase 3 China for RA and AS. Arcutis licensed topical formulation 2018 (now ARQ-252); terminated Phase IIa mid-2021, re-evaluating at preclinical.
🇺🇸 JN Biosciences ? Early Stage
HuABC2 (Anti-CD122 mAb): Humanized mAb, available for out-licensing. Mouse vitiligo model: Reversed established disease; short-term treatment provided durable repigmentation. Non-human primate studies: Well-tolerated; CD122 occupancy >14 days. Seeking partners for human trials.
🇰🇼 🇳🇱 Kuwait University / Rebel-Nature
VT Treatment (Plant-based, two-phase topical): Natural photosensitizers + antioxidants/immunomodulators. Local trials Kuwait 2018-2019: safety & efficacy in NSV, Fitzpatrick III+. Positioned as safer alternative to PUVA/NB-UVB. Registered EU, UK, Saudi Arabia. Large-scale production faces raw material challenges.
🇩🇰 LEO Pharma
Tacrolimus (Protopic): Not pursuing proprietary vitiligo assets; Protopic widely used off-label. 65% improvement after 24 weeks (BID); ~40% relapse at 48 weeks. R&D focus: AD, psoriasis, inflammatory dermatoses.
🇬🇧 Life Science Investments
VitiLSi™ (Botanical gel): R&D facilities Guayaquil, Ecuador. Cosmeceutical using Coleus forskohlii and Cassia alata extracts. Controlled studies: up to 41% repigmentation after 8 weeks, especially with phototherapy. Positioned for acrofacial vitiligo. Long-term efficacy unproven.
❌ Merck ✗ Discontinued
MK-6194 (IL-2 mutein from Pandion): Acquired $1.85B in 2021; discontinued July 2025 after Phase 2 failure in lupus & vitiligo. Part of $3B cost-cutting initiative.
🇺🇸 Novartis ? Inconclusive
Ex-U.S. commercialization rights to ruxolitinib (Jakavi) for heme/onc; Incyte retains Opzelura globally. Secukinumab (Cosentyx) pilot trial (NCT05676333) in vitiligo: inconclusive results. IL-17A pathway challenged as treatment target; research suggests Th17.1/Th1 balance more critical. Broad immunology pipeline signals ongoing interest in immune-driven dermatology.
🇮🇱 Novoxel
Tixel Device (Thermomechanical ablation): Boosts topical drug absorption (betamethasone, tacrolimus). 2022 study: 6-8ms exposure, 400-600μm protrusion; faster repigmentation in stable/resistant vitiligo with mild reactions. No updates since 2022.
🇺🇸 Nektar Therapeutics ✓ Active
NKTR-0165 (TNFR2 agonist): First-in-class bivalent antibody activating Tregs via TNFR2. Aims to restore immune tolerance without broad suppression. Preclinical: enhanced Treg stability, reduced inflammation. Indications: ulcerative colitis, vitiligo. IND-enabling studies; first-in-human trials expected 2025 in collaboration with Biolojic Design.
🇺🇸 OM1 ✓ Active
Phenome AI Platform (Boston): Applies AI to millions of derm records, including AAD's DataDerm registry. Builds vitiligo-specific datasets & predictive models. Provides real-world evidence for regulatory filings, clinical decisions, outcomes research. De-risks vitiligo clinical trials via precise cohort identification.
❓ Ornovi ? No Updates
OR-101 (Oral covalent JAK3/ITK inhibitor, Cys909 targeting): Preclinical 2023: efficacy in vitiligo & alopecia areata. Designed for greater safety/selectivity than first-gen JAKs. No clinical updates >1 year; status unclear.
❓ Palatin Technologies ? No Vitiligo Trials
MC1R Agonist Peptides: Patent portfolio since 2013 for MC-1 peptides in vitiligo & EPP. Lead PL-8177 in early clinical for ulcerative colitis (anti-inflammatory). No active vitiligo trials as of 2025.
❌ Pandion Therapeutics / Merck ✗ Discontinued
MK-6194 (IL-2 mutein): See Merck above (acquired $1.85B 2021, discontinued July 2025)
🇫🇷 Pierre Fabre
Epidemiology, off-label use, repigmentation maintenance: RV5098A trial (topical for maintaining pigmentation in repigmented facial lesions) completed June 2024; results not posted. Produces 5% 5-fluorouracil used off-label India (limited tolerability). No new vitiligo drug programs; focus on epidemiology, existing derm products.
🇺🇸 Pfizer ✓ Active
Ritlecitinib (LITFULO™) (Oral JAK3/TEC inhibitor): Phase 3 TRANQUILLO program (~2,050 patients, 17 countries). Primary completion March 2026; extension trial (NCT07152626) initiated. Already approved for severe alopecia areata (U.S., Japan). Phase 2b: first oral JAK to show stabilization of active lesions AND repigmentation of stable ones.
Crisaborole (Topical PDE4 inhibitor): Phase 2 vitiligo as monotherapy & with NB-UVB wrapped March 2024; no results posted.
🇨🇳 Reistone Biopharma ✓ Active
Advancing small-molecule & biologic therapies for vitiligo; targeting JAK & BET proteins. Late-stage vitiligo data not yet public. JAK inhibitors in alopecia & other skin diseases may extend into vitiligo.
❌ Rheos Medicines ✗ Discontinued
Immunometabolism Platform (T-cell metabolism modulators): Raised $60M (Third Rock); $800M Roche collaboration 2019. No programs to clinic; company shut down 2023 amid funding challenges. All vitiligo development discontinued.
❌ Rhythm Pharmaceuticals ✗ No Vitiligo Development
Setmelanotide (MC4R agonist): Approved for rare monogenic obesity. Causes consistent skin darkening 56–78% patients via off-target MC1R activation. Pigmentation milder than afamelanotide but frequent. No current vitiligo development; repurposing theoretical.
🇺🇸 Safety Shot
Photocil — See Applied Biology above
🇪🇸 Sesderma
VITISES (Cosmeceutical line): Nanotechnology-based gels, lotions, supplements; liposome-encapsulated phenylalanine, khellin. Popular Middle East, Asia, Latin America; not actively marketed EU/USA due to regulatory/commercial hurdles. Cosmeceuticals, not approved medical treatments; evidence limited to small studies.
🇨🇦 Skinopathy ✓ Active
AI Dermatology Platform: GetSkinHelp app for vitiligo; mobile image analysis, remote consultations. Pilots with OBIO, peopleCare. Health Canada licensing confirms regulatory engagement. Large-scale peer-reviewed validation pending.
🇺🇸 Strata Skin Sciences ✓ Active
XTRAC® excimer laser (308nm UVB): FDA-cleared for vitiligo & psoriasis. Proven efficacy in stable cases, paired with topicals. TheraClear®X (acne system) added, expanding in-office dermatology. 400+ peer-reviewed studies.
🇮🇳 Sun Pharmaceuticals ✓ Active
Ruxolitinib 1.5% cream: Phase 3 CDSCO approval Aug 2025 (Protocol ICR/24/008). Comparator: Decapeptide (Melgain); standardized UVB/sunlight exposure. Patients 12+ with NSV. Also Phase 3 for AD (separate trial, Dec 2025 update).
🇺🇸 Temprian Therapeutics ✓ Preclinical
TT-01 (DNA-based therapy, modified HSP70i): Four needle-free DNA injections for whole-body repigmentation. Pre-IND meeting completed; $4M NIH grant. Aims for durable effect, including distant lesions. Late preclinical; human trials anticipated but not yet initiated. No updates since 2020.
🇮🇱 Teva Pharmaceuticals ✓ Active
TEV-53408 (Anti-IL-15 mAb): Phase 1b vitiligo (NCT06625177): Ongoing, results expected 2026. Major funding: $500M from Royalty Pharma (January 2026)—$75M for Phase 2b vitiligo (target start 2026), up to $425M additional. Mechanism: Subcutaneous mAb blocking IL-15 activity, reducing TRM cell survival. Fast Track designation (FDA, May 2025) for celiac disease; Phase 2a underway. Rationale: Mouse models show 8-week IL-15 blockade depletes autoreactive TRM cells, achieving sustained repigmentation even after treatment cessation.
🇺🇸 TeVido BioDevices ✓ Early Clinical
TruPigment (Autologous cell therapy): Office-based kit for melanocyte harvest & reapplication in stable, localized vitiligo. Designed for accessibility, lower cost. Not FDA-cleared as medical device; registered as Tissue Establishment. $1.4M private funding; early clinical use, limited U.S. availability as training & reimbursement expand.
🇮🇳 Uniza Healthcare
Vitellus (Palmitoyl tetrapeptide + pro-melanogenic/antioxidant supplements): Partnership with Lucas Meyer Cosmetics (Canada) & Amvigor Organics (India). Peptide-based lotions available India since 2004; efficacy often short of marketing claims.
❌ Vallaurix (Clinuvel Subsidiary) ✗ Suspended
VLRX001 (Topical melanocortin analogue): Announced 2020 as complement to systemic afamelanotide; maintenance therapy for vitiligo Fitzpatrick IV–VI. Early in vitro promise. No public updates, trials, or regulatory activity since. Likely suspended or deprioritized.
❌ Vilacto Bio ✗ Uncertain Prospects
Lactoactive Nanoparticle System: Promoted as nanotech platform from bovine colostrum for immunomodulation & skin regeneration. No evidence of advanced clinical/regulatory progress. Severe financial strain; vitiligo prospects highly uncertain.
❌ Villaris Therapeutics / Incyte ✗ On Hold
Auremolimab (VM6/INCA034460): Incyte acquired Villaris 2022 ($70M upfront). IND cleared and first patient dosed Phase 1 in 2023. Development paused October 2025 (pipeline prioritization). No longer in Oct 2025 portfolio; scientific rationale remains valid.
🇺🇸 Vyne Therapeutics ✗ Discontinued
VYN201 (repibresib) (BET Inhibitor): Topical "soft" pan-BET inhibitor for nonsegmental vitiligo. Phase 1b showed ~39% mean F-VASI improvement at highest dose with good tolerability; Phase 2b topline readout (July 2025) reported missed primary endpoint with high vehicle effect (placebo -25.6% vs active -43.6%) and high dropout (36.6% active vs 10.6% vehicle). Program discontinued; seeking development partner.
🇨🇳 Xinjiang Biomedicine Innovation Center
With Uzbek partners: reports early success adapting traditional Uygur medicine for vitiligo; herbal formulas + modern validation. Pilot studies suggest repigmentation benefits. No peer-reviewed data or regulatory filings; progress preliminary, regionally reported.
🇺🇸 Zerigo Health ✓ Active
Connected NB-UVB Phototherapy System: FDA-cleared handheld for at-home treatment (vitiligo, psoriasis, eczema, all skin types). Dosing controlled via physician-prescribed mobile app. Integration allows treatment schedules, progress photos, data sharing with care teams.
Conclusion: 2026 Catalysts & Market Outlook
The Vitiligo Inflection Point
The field has shifted from asking "What's coming?" to executing on evidence-based combination strategies that achieve unprecedented repigmentation rates.
The 2025 evidence is definitive: JAK inhibitors + phototherapy deliver synergistic results (6.87× higher ≥50% repigmentation vs monotherapy). This is the new standard of care.
Critical 2026 Catalysts
- AbbVie upadacitinib approval (first systemic therapy)
- Pfizer ritlecitinib Phase 3 readout (March 2026)
- Teva TEV-53408 Phase 2b initiation ($500M funding)
- Forte FB-102 Phase 1b topline (1H 2026)
- Amgen AMG 714 Phase 2 results publication
- CAGE Bio CGB-600 Phase 2 topline (Q3 2026)
- Clinuvel afamelanotide Phase 3 results (2H 2026)
- Edesa EB06 Phase 2 initiation (mid-2026)
The IL-15 Pathway: The Real Prize
IL-15 inhibition holds the key to durable remission. If TEV-53408, AMG 714, or FB-102 succeed in depleting tissue-resident memory T cells, we move from managing symptoms to resetting immune memory.
Market Trajectory
- 2026: $1.31B (Opzelura dominance, oral JAK launches)
- 2032: $2.76B (multi-drug competition, biologics entry)
- CAGR: 4.7-8% (driven by oral JAKs, biologics, AI diagnostics)
Yan Valle, Prof, CEO VR Foundation
Information current as of January 16, 2026. This report is informational only and not financial advice. Corrections welcome at yan@vrfoundation.org
FAQOther Questions
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