The race to treat vitiligo is accelerating, with up to $1.8 billion market poised for steady growth. This exclusive analysis provides a strategic overview of the current landscape: the patient base, standard of care, emerging therapies, market dynamics, key players, AI tools and platforms, and a spotlight on the most promising clinical candidates.

Understanding the Patient 

Vitiligo is a chronic autoimmune skin disorder in which the immune system mistakenly destroys melanocytes, the pigment-producing cells, leading to progressive depigmentation. Onset typically occurs before age 20 and is influenced by both genetics and environment, including stress, skin trauma, chemical exposure, and hormonal shifts. Vitiligo affects an estimated 0.76–1.11% of the U.S. population, with nearly 40% of cases going undiagnosed, and impacts 65–95 million people worldwide. (1, 2, 3) Though not life-threatening, vitiligo carries a significant psychosocial burden, fueling demand for therapies that offer both efficacy and durability.

 

Current Standard of Care

While there is no definitive cure for vitiligo, current treatments focus on three core objectives: halting autoimmune inflammation, stimulating repigmentation, and preventing relapse.(1, 2, 3) Repigmentation success remains highly location-dependent. Facial and neck lesions typically respond best, often achieving near-complete repigmentation. Trunk and limb involvement shows variable results, while wrists, elbows, and extremities like hands and feet remain the most resistant to treatment. 

• First-line: Topical corticosteroids and calcineurin inhibitors remain widely used off-label, especially in early-stage or localized disease.
• Opzelura® (ruxolitinib 1.5% cream): The first FDA/EMA/Health Canada-approved treatment for nonsegmental vitiligo. It is reimbursed for approximately 85% of insured U.S. patients and 70% in the EU.
• Phototherapy: Narrow-band UVB (NB-UVB) remains a gold standard, often combined with topical agents for synergistic effect.
• Combination Approaches: Integrated regimens (topical + NB-UVB) can achieve repigmentation in up to 75% of patients within 12 months. However, relapse rates remain significant—estimated at 50% or higher within 3-5 years.

Next-Generation Approaches

Innovation in vitiligo therapy is increasingly focused on durable remission and personalized delivery strategies.

• Stem Cell Therapies: Mesenchymal stem cells (MSCs) are under investigation for their dual ability to modulate immune responses and regenerate melanocytes, with the goal of long-lasting repigmentation.
• Gene Editing: Early-stage CRISPR-Cas9 programs are exploring targets such as NLRP1 and TYR, though still in preclinical development.
• Microbiome Modulation: Emerging biotech platforms, including Eligo Bioscience, are studying CRISPR-guided interventions to reprogram C. acnes and other skin microbiota, with the aim of reshaping immune signaling and pigment biology from the outside-in.
• Cosmeceutical Innovation: Companies like Sesderma (VITISES) and Life Science Investments (VitiLSi) are developing botanical and liposomal formulations—such as khellin, phenylalanine, and herbal extracts—to stimulate melanogenesis. Though not FDA-approved, these products are marketed as adjuncts to therapy, with clinical evidence still limited to small trials.
• Enhanced Drug Delivery — Devices such as Tixel (thermal ablation), fractional lasers, and microneedling systems are gaining traction for their ability to boost penetration of topicals like corticosteroids and calcineurin inhibitors. These methods aim to amplify the efficacy of current treatments without introducing new systemic risks.
• Connected Phototherapy: App‑controlled NB‑UVB systems (e.g., Zerigo Health) bring clinic‑grade phototherapy into patients’ homes, improving adherence and long‑term outcomes.
   

Global Market Outlook

The vitiligo treatment market stands at $1.5-1.8 billion in 2025 (1, 2, 3), projected to reach $2.5 billion by 2033 (CAGR: 6.1%).

Growth drivers:

• Rising prevalence and earlier diagnosis.
• Expanding adoption of JAK inhibitors and advanced biologics.
• Growing role of teledermatology and connected care.
• Expansion of specialty dermatology clinics in APAC.

North America and Europe are expected to maintain leading positions in the market, supported by high healthcare expenditure and robust pharmaceutical infrastructure. The Asia-Pacific region is emerging rapidly, driven by both conventional and Ayurvedic innovations.

 

Strategic Moves and Setbacks

• AbbVie: Evaluating upadacitinib (RINVOQ®), a selective JAK1 inhibitor, in a Phase 3 trial.
• Incyte: Opzelura remains the market leader with strong sales; auremolimab, added via the Villaris acquisition, appears to remain preclinical or delayed.
• Pfizer: Advancing ritlecitinib (Litfulo) in Phase 3, targeting systemic treatment.
• Merck: Discontinued MK-6194 after Phase 2 failures in vitiligo/lupus; asset removed from pipeline (July 2025).

No major new approvals or late-stage clinical trials reported for vitiligo in 2025; research continues to confirm efficacy and safety in pediatric and localized cases.

 

Off-Label Therapies: A Robust Secondary Market

Despite new approvals, off-label therapies remain widely used. Key contributors include: Allergan (prostaglandins), Astellas/Accord (tacrolimus), Bausch Health (methoxsalen), Bristol-Myers Squibb (abatacept), Celgene (apremilast), Dr. Reddy’s (Melgain), Mylan (pimecrolimus), Pierre Fabre (fluorouracil), and Teva (betamethasone).

Tacrolimus: The Non-Steroidal Mainstay

Topical tacrolimus, marketed by multiple companies including Astellas, Accord, Belcher Pharma, and Glenmark, continues to lead the non-steroidal treatment category. It is especially effective for pediatric patients and for facial and genital lesions. Its position is reinforced by 2025 reimbursement approvals in markets like France, alongside meta-analyses confirming both safety and corticosteroid-sparing benefits. New liposomal and nano-formulations are under development to improve absorption and clinical outcomes.

Differentiation Through Delivery and Cosmeceuticals

Companies such as Pierre Fabre, Sesderma, Dr. Reddy’s, and Teva are differentiating through advanced delivery systems and cosmeceutical portfolios. These innovations support patient adherence and long-term engagement while JAK inhibitors capture broader market share.

 

Late-Stage Pipeline Watchlist

• AbbVie – Upadacitinib (RINVOQ®): Phase 3; promising repigmentation results, with readouts due 2026.
• Amgen – AMG-714: IL-15 blocker, Phase 2 completion expected in late 2025.
• Incyte – Povorcitinib: Oral JAK1 inhibitor, mid-to-late stage, potential whole-body repigmentation.

Challenges remain around durability of effect and safety, but these programs are positioned to redefine treatment standards.

 

The Digital Frontier: AI and Startups

Smaller innovators are reshaping vitiligo care with AI‑driven tools for diagnosis, monitoring, and patient management. These platforms are gaining traction with both clinicians and consumers, though accuracy, validation, and regulatory integration vary.

Key Platforms:

• Skinopathy (Canada): Purpose‑built for vitiligo, offering AI‑based detection, depigmentation measurement, and treatment recommendations. Widely marketed and adopted for patient monitoring.
• MetaOptima / DermEngine (Canada): Clinician‑focused teledermatology platform with AI support for diagnosing pigmentary disorders, including vitiligo. Actively used in dermatology clinics for documentation and follow‑up.
• Skinive (Netherlands): Consumer app with validated algorithms for hypopigmentation disorders, including vitiligo.
• SkinVision (Netherlands): Known for melanoma screening but also flags vitiligo‑like “white spots,” advising specialist follow‑up rather than providing diagnostic‑grade accuracy.
• PanDerm (Australia): Multimodal AI trained on 2M+ dermatology cases. While best known for melanoma, its dataset includes vitiligo, improving clinician accuracy in depigmentation cases.

Other AI-derm platforms include: Revieve (Finland), Perfect Corp. (Taiwan), Haut.AI (Estonia), L’Oréal/ModiFace (Canada), Cetaphil / MySkin (USA), DermaSensor (USA), ScanDerm (Russia). Primarily focused on skin cancer detection, or aesthetic and cosmetic skin analysis. As of August 2025, these platforms do not offer clinically validated vitiligo diagnostics.

India & China: Expanding Frontiers in AI Dermatology

India and China are emerging as the twin powerhouses of AI‑driven dermatology, fueled by high mobile penetration, rising demand for skin health solutions, and significant gaps in specialist access outside major urban centers. Both countries are deploying localized algorithms trained on regional skin tones and disease patterns, giving domestic platforms a clear edge over generic international tools.

• 🇮🇳 In India, platforms such as Clinikally (with its Clara AI facial‑scan system), Kaya Clinic, Skin Beyond Borders (SkinBB), CureSkin, and SkinKraft are setting the pace with instant skin assessments, dermatologist consultations, and personalized care pathways for conditions including vitiligo.
• 🇨🇳 China has rapidly scaled nationwide teledermatology networks through platforms like WeDoctor, Ping An Health (pioneering generative AI‑powered doctor avatars), and UMER Doctor. These systems leverage vast databases such as the Chinese Skin Image Database (CSID) to deliver AI‑enabled detection and monitoring of pigmentary disorders, including vitiligo.

 

Pharmaceutical Pipeline Highlights

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 is evaluating upadacitinib (RINVOQ®), a selective JAK1 inhibitor, in a Phase 3 trial for nonsegmental vitiligo. Phase 2b data showed dose-dependent repigmentation, and interim Phase 3 results confirm continued improvement through 52 weeks. Upadacitinib, previously successful in atopic dermatitis and rheumatoid arthritis, is one of the most advanced oral JAK1 inhibitors in late-stage testing for vitiligo. Safety remains consistent with the broader JAK class. Full results due in 2026.

🇧🇷 Ache Laboratorios Farmaceuticos set aside $100M for vitiligo candidate drug ACH24 in 2016, expected to complete trials in 2023, but program faced significant setbacks when the Brazilian regulatory agency ANVISA requested cancellation of the Phase 3 study, requiring the company to conduct a Phase 1 study first. Following the setbacks with ACH24, Aché partnered with Sun Pharma Global FZE to develop AS012 in early 2020's (see below).  

❓Aclaris Therapeutics’ topical JAK1/JAK3 inhibitor, ATI-50002, completed a Phase 2 trial for non-segmental vitiligo in 2020, but has not advanced further in development. In January 2024, the company reported positive top-line results from a Phase 2b trial of ATI-1777, a next-generation “soft” topical JAK1/3 inhibitor, in patients with mild to severe atopic dermatitis. While Aclaris has indicated potential expansion of ATI-1777 into vitiligo based on its mechanism of action, no clinical studies for this indication have been initiated as of August 2025. 

🇮🇳 Ahammune Biosciences is developing AB1001, a topical small molecule targeting T cell activation in early-stage vitiligo. Designed as a non-steroidal, non-immunosuppressive, disease-modifying therapy, AB1001 completed Phase I in January 2023. The company raised $5M in September 2024 to fund Phase II, expand IP, and advance its immuno-dermatology pipeline, with regulatory clearance granted in May 2025. 

🇪🇸 Almirall, a global dermatology-focused biopharma, is expanding collaborations to tackle unmet needs in skin diseases, including vitiligo. In May 2022, it partnered with Inserm Transfert, the private arm of France’s Inserm, to develop Wnt pathway–targeting therapies for skin repigmentation. The program, led by Prof. Thierry Passeron, aims to deliver a novel class of vitiligo treatments. 

🇺🇸 Alys Pharmaceuticals emerged as a new player in dermatology, pooling the strengths of six biotech startups with a $100M boost from Medicxi. Alys aims to expand its focus on inflammatory and autoimmune diseases, dermatology care for cancer patients, and rare skin conditions. The company's goal is to deliver seven to ten clinical Proof-of-Concept readouts in the next three years, potentially advancing at least one program to further studies. 

🇺🇸 Amgen is developing AMG 714, an experimental drug designed to block IL-15, a chemical signal involved in the activity of tissue resident memory (Trm) immune cells that are believed to attack pigment-producing melanocytes in vitiligo. By inhibiting IL-15 signaling, AMG 714 could potentially halt the immune system's attack on melanocytes, allowing for repigmentation of the skin. The drug is currently in Phase 2 trials, with completion expected by May 2025.

❌ AnaptysBio with its Rosnilimab (formerly ANB030, Anti-PD-1 Agonist) program has moved into P2b initiation phase for rheumatoid arthritis in Q3 2023; interest in vitiligo is no longer acknowledged on the company's website. 

❌ Applied Biology developed Photocil, a sunscreen with a 308 nm “therapeutic window” mimicking narrowband phototherapy. Marketed as “phototherapy in a bottle” for psoriasis and vitiligo, it was acquired by Jupiter Wellness, now Safety Shot, in July 2022 and rebranded as PhotoFirst, gaining CDSCO approval in India in November 2022. 

🇺🇸 Arcutis Biotherapeutics in-licensed SHR0302 (ARQ-252), a potent JAK1 inhibitor from Jiangsu Hengrui, positioned to avoid JAK2-related hematopoietic risks. Backed by $166M to advance three dermatology assets, Arcutis terminated its Phase IIa trial in June 2021 but continues to consider ARQ-252 a promising approach for chronic hand eczema and vitiligo, now back at the preclinical stage.

❓Arrien Pharmaceuticals is developing ARN-4079, a first-in-class oral JAK3/ITK inhibitor targeting the Cys909 residue, for autoimmune diseases including vitiligo, rheumatoid arthritis, and atopic dermatitis. Backed by $2M and additional undisclosed funding, the company is conducting IND-enabling studies and seeking partners to advance ARN-4079 into Phase 1 trials, with vitiligo among its lead indications.

🇺🇸 Avita Medical’s RECELL® System, the first FDA-approved device for vitiligo, enables clinicians to create an autologous skin cell suspension in under 30 minutes and apply it to laser-prepared stable lesions. In pivotal trials, 36% of lesions achieved ≥80% repigmentation at 6 months in resistant cases, with durable results at 12 months. Positioned as a one-time, minimally invasive option, RECELL targets patients unresponsive to topicals or phototherapy.

❌ AXIM Biotechnologies — AX‑1602 (CBD/CBG topical): Initially patented for vitiligo and other skin diseases; never advanced beyond a single small proof‑of‑concept study. As of 2025, the program is inactive, with the company focusing on psoriasis, eczema, ophthalmology, and neurology.

 🇮🇱 Biolojic Design / Teva Pharmaceuticals — BD9, a dual-specific antibody targeting TSLP and IL‑13, is in IND-enabling studies ahead of first-in-human trials. Developed on Biolojic’s AI-driven “multibody” platform, it features programmable binding that adjusts to cytokine fluctuations, aiming to deliver more effective control than single-target biologics. The program is initially focused on atopic dermatitis and asthma, with potential future application in vitiligo.

 🇺🇸 Bioniz Therapeutics / Almirall— BNZ‑1 is a first‑in‑class multi‑cytokine inhibitor targeting IL‑2, IL‑9, and IL‑15, with demonstrated safety and preliminary efficacy in cutaneous T-cell lymphoma (CTCL) from Phase 1/2 studies. The candidate is Phase 2‑ready for autoimmune dermatologic indications. Vitiligo is listed as a lead indication, but no active clinical trials are underway as of the date of writing.

❌ Boston Pharmaceuticals in-licensed BOS-475 (formerly GSK3183475), a topical compound originally developed by GSK for vitiligo and psoriasis. The asset was divested following GSK’s R&D restructuring under new management. However, BOS-475 has not appeared in Boston Pharmaceuticals’ active pipeline since the acquisition, and no clinical development updates have been reported recently.

❓Castle Creek Pharma — CCP‑070 (Peptide Analogs): Preclinical vitiligo/EPP program in‑licensed from Univ. of Cincinnati, aiming to stimulate melanogenesis via peptide analogs. No disclosed toxicology studies or timelines; company focus has shifted to gene therapies (e.g., D‑Fi).

🇨🇳 China Medical System — Ruxolitinib Phosphate Cream (Topical JAK Inhibitor). CMS holds an exclusive license from Incyte to develop and commercialize ruxolitinib cream (Opzelura®) in mainland China, Hong Kong, Macau, Taiwan, and parts of Southeast Asia, and has completed manufacturing scale-up locally. 

📌 Situation in China: fast‑track programs, including the Hainan Boao pilot zone and Greater Bay Area access schemes, enable early vitiligo treatments ahead of full NMPA approval. CMS has filed for ruxolitinib cream, with Chinese trials showing ~50% F‑VASI‑75 at 24 weeks. If approved, it would be the first topical JAK therapy in China—though adoption will hinge on safety monitoring, reimbursement, and dermatologist access.

🇦🇺 Clinuvel’s Scenesse® is a synthetic analog of alpha-melanocyte-stimulating hormone (α-MSH, Afamelanotide 16mg). Pivotal Phase 3 (CUV105) with NB‑UVB in Fitzpatrick III–VI vitiligo patients (200+ enrolled across 37 sites). Early data show rapid repigmentation, especially in darker skin types, with good tolerability. Full results due 2H 2026; durability remains under review, and risk of diffuse hyperpigmentation in lighter skin types is a key concern. 

❌ Dermavant (see also Roviant Sciences) — DMVT‑504 (Cerdulatinib, JAK/SYK inhibitor): Once in‑licensed from Portola Pharmaceuticals for vitiligo and other inflammatory skin diseases, the program was deprioritized in July 2022 before entering clinical trials. As of Aug 2025, absent from Dermavant’s pipeline, with R&D redirected to VTAMA®. 

🇨🇳 Dermavon Dermavon (CMS Spin‑off) — Founded in 2020, Dermavon leads CMS’s dermatology arm with China rights to topical ruxolitinib (NDA filed Sept 2024) and oral JAK1 inhibitor povorcitinib in late‑stage trials. It also co‑develops MG‑K10, an anti‑IL‑4Rα antibody in Phase III for atopic dermatitis, with potential extension to vitiligo and other type 2 inflammatory diseases.

🇮🇳 DRDO / AIMIL Pharma — Lukoskin: Ayurvedic polyherbal formulation (ointment + oral liquid) for vitiligo, designed to enhance photosensitivity, melanogenesis, and immune modulation. Widely available in India and recognized for affordability, safety, and cultural acceptance. Clinical efficacy remains modest, with results comparable to other adjunctive herbal therapies.

🇨🇦 Edesa Biotech — EB06 (anti‑CXCL10 mAb): First-in-class monoclonal antibody targeting CXCL10 to block autoreactive T‑cell recruitment and prevent melanocyte destruction in vitiligo. Launched as a Phase 2 trial under NCT05724952; Health Canada approved the study on February 1, 2023, and it remains listed as active, not recruiting, with no topline data yet released. The company has raised $15M in private placement funding to advance EB06 through IND submission and clinical development through fiscal 2026.

🇫🇷/🇺🇸 Eligo Bioscience has secured patents for CRISPR/Cas‑based genetic engineering of Cutibacterium acnes, enabling targeted microbiome therapies for skin disorders. Lead EB005 candidate is focused on moderate‑to‑severe acne (preclinical/early patient data). Vitiligo included in patent scope, but no active clinical program as of 2025.

🇺🇸 Forte Biosciences — FB‑102 (Anti‑CD122 mAb): Clinical‑stage program targeting CD122 (the shared subunit of IL-15/IL-2 receptors), aiming to modulate pathogenic T cells and NK cells implicated in pigment loss. Phase 1/1b trial in non‑segmental vitiligo underway; topline data expected 1H 2026.

🇨🇳 Huahai Institute of Vitiligo Research (founded in 1994) is one of China’s leading centers for vitiligo care and research, integrating Traditional Chinese Medicine (TCM) with modern biomedical approaches. It has developed several patented oral, topical, and injectable therapies. Despite its national prominence, no internationally recognized clinical trials or peer‑reviewed efficacy data are available as of 2025.

🇨🇭 Idorsia Pharmaceuticals — ACT‑777991 (CXCR3 Antagonist): First‑in‑class oral therapy blocking CD8+ T‑cell migration, a key driver of melanocyte destruction. Proof‑of‑concept Phase 2 in vitiligo planned; aims to be the first targeted systemic for immuno‑dermatology. Initial data expected within two years.

🇺🇸 Incyte developed Opzelura, (1.5% ruxolitinib cream) is the first and only FDA/EMA/Health Canada-approved prescription treatment for nonsegmental vitiligo. Opzelura targets the overactive TH1 immune response driving depigmentation. In clinical trials, 30% of patients achieved >75% facial repigmentation at 24 weeks, with a larger proportion reaching ≥50% improvement. Q2 2025 sales reached $164M (+35% Y/Y), with annual revenue projected at $1.4B by 2029, including >$600M from vitiligo. In 2022, Incyte also acquired Villaris Therapeutics and its anti-IL-15Rβ mAb, auremolimab (VM6), which has shown preclinical efficacy in vitiligo (see details below).

🇨🇳 InnoCare Pharma — soficitinib (ICP‑332, TYK2 inhibitor): Developing a selective TYK2 inhibitor for non-segmental vitiligo, with Phase II/III trials initiated May 2025 and first patient dosed. Licensed regionally, benefiting from accelerated regulatory pathways and initial data aligning with global efficacy benchmarks (e.g. F‑VASI‑75 ~50%). Also being evaluated for atopic dermatitis; high potential if enrollment continues and data remain consistent.

🇮🇳 Issar Pharma / Zydus — 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.

🇦🇺 Incannex Healthcare — 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.

🇺🇸 JN Biosciences — HuABC2 (Anti‑CD122 mAb): Humanized antibody suppressing pathogenic CD8+ memory T cells and NK cells while sparing regulatory T cells. Demonstrated efficacy in mouse models of vitiligo and other autoimmune models; well tolerated in non‑human primates. Available for out‑licensing; partners sought to advance into human trials.

🇰🇼 🇳🇱 Kuwait University / Rebel‑Nature — VT Treatment (Plant‑Based Regimen): Two‑phase topical system combining natural photosensitizers with antioxidants and immunomodulators, designed to correct oxidative imbalance in vitiligo.
Local trials in Kuwait (2018–2019) reported safety and efficacy, especially in non‑segmental vitiligo and Fitzpatrick III+. Positioned as a safer, plant‑based alternative to conventional PUVA/nb‑UVB, though large‑scale production faces raw material challenges. Registered in EU, UK, and Saudi Arabia. 

🇺🇸 Merck enhanced its vitiligo candidate portfolio in 2021 by acquiring Pandion Therapeutics, whose lead candidate is an engineered IL-2 mutein, designed to selectively activate and expand regulatory T cells (Tregs). However, as of July 2025, Merck has discontinued clinical development of MK-6194 due to lack of clinical benefit over placebo. The asset is no longer listed in the company’s pipeline, and Merck has shifted focus away from late-stage autoimmune biologics, redirecting resources towards oncology, HIV, and infectious disease.

 🇩🇰 LEO Pharma — Tacrolimus (Protopic, Off‑Label): Not pursuing proprietary vitiligo assets, but Protopic remains widely used off‑label. Clinical data show 65% of patients improve after 24 weeks of twice‑daily use, with ~40% relapse at 48 weeks. Official R&D focus stays on atopic dermatitis, psoriasis, and other inflammatory dermatoses; vitiligo interest noted mainly through conference sponsorships and anecdotal use.

🇬🇧 Life Science Investments — VitiLSi™ (Botanical Gel): UK‑based company with R&D facilities in Guayaquil, Ecuador. Cosmeceutical gel using Coleus forskohlii and Cassia alata extracts to activate melanocyte precursors and stimulate melanogenesis. Controlled studies show up to 41% repigmentation after 8 weeks, especially with phototherapy. Positioned for acrofacial vitiligo; safety supported, though long‑term efficacy and ideal patient profiles remain unproven.

🇮🇱 Novoxel — Tixel Device for Enhanced Topical Delivery. Tixel uses thermomechanical ablation to boost topical drug absorption—particularly corticosteroids like betamethasone—for vitiligo treatment. A 2022 study (no update since) applied 6–8 ms exposure and 400–600 μm protrusion, showing faster repigmentation in stable or resistant vitiligo with only mild, short‑lived reactions. Early clinical data suggest improved repigmentation in stable or resistant cases, with minimal side effects. 

📌 Not every breakthrough comes from a brand‑new drug—some of the most promising advances are in how existing treatments are delivered. Devices like Tixel, fractional lasers, and microneedling create microchannels in the skin, boosting absorption of topicals such as corticosteroids or calcineurin inhibitors. At the same time, nanocarrier and liposomal platforms like Sesderma’s VITISES line target deeper, sustained release of actives such as phenylalanine and khellin. These approaches don’t replace new drugs, but they make today’s therapies work harder—helping maximize repigmentation while next‑generation treatments like JAK and BET inhibitors move through clinical trials.

🇺🇸 Nektar Therapeutics — NKTR‑0165 (TNFR2 Agonist): First‑in‑class bivalent antibody designed to activate Tregs via TNFR2, aiming to restore immune tolerance without broad suppression. Preclinical data show enhanced Treg stability and reduced inflammation; indications include ulcerative colitis and vitiligo. Currently in IND‑enabling studies; first‑in‑human trials expected in 2025 in collaboration with Biolojic Design.

🇺🇸 OM1— Phenome AI Platform: Boston‑based company applying AI to millions of dermatology records, including AAD’s DataDerm registry. Builds vitiligo‑specific datasets and predictive models to identify patient cohorts and optimize treatment pathways. Provides real‑world evidence for regulatory filings, clinical decisions, and outcomes research, with the ability to de‑risk vitiligo clinical trials through precise cohort identification and predictive modeling.

❓Ornovi — OR‑101: Oral, covalent JAK3/ITK inhibitor targeting Cys909; preclinical data in 2023 showed efficacy in vitiligo and alopecia areata. Designed for greater safety and selectivity than first‑gen JAKs. No clinical updates or pipeline disclosures in over a year; current status unclear.

❓Palatin Technologies — MC1R Agonist Peptides: Patent portfolio for melanocortin receptor-1 peptides (MC-1) proposed for vitiligo and erythropoietic protoporphyria (EPP) since 2013. Lead candidate PL‑8177 has entered early clinical studies for ulcerative colitis, showing anti‑inflammatory activity. No active trials or disclosed development for vitiligo as of 2025. 

❌ Pandion Therapeutics — MK‑6194 (IL‑2 mutein): Acquired for $1.85B in 2021 but discontinued in July 2025 after Phase 2 failure in vitiligo and lupus. Asset removed from Merck’s autoimmune pipeline; company has shifted focus to oncology and infectious diseases.

🇫🇷 Pierre Fabre — Epidemiology, Off‑Label Use & Repigmentation Maintenance. Pierre Fabre remains engaged in vitiligo through research and repositioning efforts. A clinical trial of RV5098A, a topical product adapted for maintaining pigmentation in repigmented facial lesions, wrapped in June 2024, though results are not yet posted. The company also produces 5% 5‑fluorouracil used off‑label in India, but tolerability is limited. No new vitiligo drug programs are disclosed, with focus staying on epidemiology and existing dermatology products.

🇺🇸 Pfizer's Ritlecitinib (LITFULO™), an oral JAK3/TEC inhibitor approved for severe alopecia areata in the U.S. and Japan, is also in development for vitiligo. It was the first oral JAK inhibitor to show stabilization of active lesions and repigmentation of stable ones in a completed Phase 2b trial. A global Phase 3 trial (NCT05583522) in nonsegmental vitiligo is ongoing, with primary completion expected in December 2025. No top-line or interim data have been released to date.

🇨🇳 Reistone Biopharma is advancing small‑molecule and biologic therapies for vitiligo, targeting immune pathways such as JAK and BET proteins. While late‑stage vitiligo data are not yet public, the company’s JAK inhibitors in alopecia and other skin diseases may extend into vitiligo. Its approach combines molecular immunology and clinical development to expand treatment options for pigmentary disorders.

❌ Rheos Medicines — Immunometabolism Platform: Biotech developing T‑cell metabolism modulators for autoimmune diseases, including vitiligo. Raised $60M (Third Rock) and struck an $800M collaboration with Roche in 2019, but no programs advanced to clinic. Company shut down in 2023 amid funding challenges; all vitiligo development discontinued.

❌ Rhythm Pharmaceuticals — Setmelanotide (MC4R Agonist): Approved for rare monogenic obesity; causes consistent skin darkening in 56–78% of patients through off‑target MC1R activation, with effects ranging from generalized hyperpigmentation to lip and hair changes. Pigmentation is milder than afamelanotide but frequent enough to require monitoring. No current development in vitiligo; repurposing remains theoretical.

❌ Roivant / Dermavant — Cerdulatinib (JAK/Syk Inhibitor): Originally in‑licensed from Portola for vitiligo and other inflammatory dermatoses; early studies showed promise but the program was deprioritized and discontinued in 2022. Dermavant redirected resources to VTAMA® (tapinarof), now marketed for psoriasis and in trials for atopic dermatitis. Acquired by Organon in 2024; no active vitiligo R&D programs remain. 

📌 Industry Trends: Dermavant’s pivot to VTAMA highlights a broader trend: prioritizing late‑stage or already approved assets with clear commercial paths, while exiting early‑stage, higher‑risk programs like vitiligo JAK/Syk inhibitors.

🇺🇸 Safety Shot — Photocil (NB‑UVB Filter Cream): Acquired from Applied Biology after FDA registration as an OTC topical for vitiligo, psoriasis, and atopic dermatitis. Photocil selectively transmits therapeutic NB‑UVB (311–313 nm), allowing at‑home phototherapy with natural sunlight. Clinical data show repigmentation comparable to conventional NB‑UVB in lighter phototypes, especially when combined with monitored sun exposure. While FDA‑registered, Photocil is not a sunscreen, nor a substitute for medical‑grade phototherapy; real‑world effectiveness depends heavily on consistent sunlight, limiting utility outside sun‑abundant regions near the equator.

📌 Photocil is FDA-registered as an over-the-counter skin protectant, allowing marketing for vitiligo, psoriasis, and atopic dermatitis when used with managed phototherapy. It does not hold prescription approval for vitiligo or related conditions. Standard phototherapy with medical-grade NB-UVB devices remains the gold standard, with Photocil positioned as an adjunct for patients who lack access to clinic-based treatment, not as a replacement.

🇪🇸 Sesderma — VITISES (Cosmeceutical Line): Nanotechnology‑based gels, lotions, and supplements using liposome‑encapsulated actives like phenylalanine and khellin to support melanogenesis and repigmentation in vitiligo. Popular in select markets (Middle East, Asia, Latin America) but not actively marketed in EU/USA due to regulatory and commercial hurdles. Categorized as cosmeceuticals, not approved medical treatments; evidence limited to small studies and anecdotal use.  It’s a missed opportunity, as Sesderma has shown genuine interest in vitiligo research long before most other market entrants.

📌 Regulatory vs. Clinical Status. VITISES is marketed as a cosmeceutical skin‑care line rather than a prescription drug. It has no formal regulatory approval in the EU or US for treating vitiligo, with claims based mainly on small studies rather than large randomized controlled trials. The products are intended as an adjunct to phototherapy or other treatments, not as a standalone medical therapy.

🇨🇦 Skinopathy — AI Dermatology Platform: Skinopathy develops AI‑powered tools for dermatology, with algorithms designed for conditions including vitiligo. Its GetSkinHelp app enables mobile‑based image analysis and remote consultations, already in use for patient triage and specialist referrals. Independent pilots with partners such as OBIO and peopleCare support its role in teledermatology and wound care, while Health Canada licensing confirms regulatory engagement. Despite promising integration into clinical workflows, large‑scale peer‑reviewed validation of its vitiligo algorithms is still pending.

🇺🇸 Strata Skin Sciences — Phototherapy Devices: Developer of the FDA‑cleared XTRAC® excimer laser, delivering targeted 308 nm UVB therapy for vitiligo and psoriasis with proven efficacy in stable cases, often paired with topicals. Recently added the TheraClear®X system for acne, expanding into broader in‑office dermatology. Strata remains a key player in physician‑directed light‑based treatments for pigmentary and inflammatory skin diseases.

🇮🇳 Sun Pharmaceuticals — The Phase 2 trial of vitiligo candidate AS012 wrapped up in 2024, but the path forward remains unclear. No Phase 3 plans or efficacy outcomes have been disclosed, and the asset is still listed as “Pending” in development databases. The pause likely reflects broader dermatology pipeline challenges, including recent setbacks with SCD‑044 for psoriasis.

🇺🇸 Temprian Therapeutics — TT‑01 (DNA‑Based Therapy): TT‑01 is an experimental vitiligo treatment developed from the research of Prof. Caroline Le Poole. It encodes a modified heat shock protein (HSP70i) delivered via four needle‑free DNA injections, aiming to suppress autoimmune melanocyte destruction and achieve durable, whole‑body repigmentation, including distant lesions. Backed by a $4M NIH grant, TT‑01 has shown encouraging preclinical results and completed a pre‑IND FDA meeting. Presntly, the program remains in late preclinical development, with human trials anticipated but not yet initiated.

🇮🇱 Teva Pharmaceuticals is advancing TEV‑53408 (subcutaneous), a first‑in‑class anti‑IL‑15 monoclonal antibody for vitiligo, now in a Phase 2 U.S. trial (NCT06625177) running through 2027. The program targets immune pathways driving melanocyte destruction, offering a novel alternative to JAK inhibitors. With Fast Track status for celiac disease and strategic focus on dermatology, Teva is one of the few large pharmas pursuing a dedicated biologic in vitiligo.

🇺🇸 TeVido BioDevices — TruPigment (Autologous Cell Therapy): TruPigment is an office‑based kit for autologous skin cell transplantation in stable, localized vitiligo, enabling dermatologists to harvest and reapply melanocytes without the need for specialized labs or costly equipment. Designed for accessibility and lower cost, the procedure targets patients unresponsive to conventional therapy. Backed by $1.4M in private funding, TruPigment is in early clinical use with limited U.S. availability as training and reimbursement models expand.

📌 Regulatory Note: TruPigment system is not FDA‑cleared or approved as a medical device for vitiligo treatment. Instead, the company is registered with the FDA as a Tissue Establishment, ensuring compliance with standards for processing human cells and tissues. TruPigment is marketed as a tissue processing service rather than a 510(k)‑cleared or PMA‑approved medical device, even though it uses proprietary in‑office techniques to expand access to autologous cell therapy.

🇮🇳  Uniza Healthcare, a pharmaceutical venture of Pashupati Group, has launched Vitellus, a combination of palmitoyl tetrapeptide with pro-melanogenic and antioxidant supplements, in partnership with Canadian company Lucas Meyer Cosmetics and Indian company Amvigor Organics. While peptide-based lotions for vitiligo have been available in India since 2004, their efficacy has often fallen short of marketing claims.

❌ Vallaurix (Clinuvel Subsidiary) — VLRX001: Announced in 2020 as a topical melanocortin analogue designed to complement systemic afamelanotide and serve as a maintenance therapy for vitiligo in Fitzpatrick IV–VI patients. Despite early in vitro promise, no public updates, clinical trials, or regulatory activity have surfaced since, indicating the program has likely been suspended or deprioritized.

❌ Vilacto Bio — Lactoactive Nanoparticle System: Promoted as a nanotechnology‑based platform derived from bovine colostrum for immunomodulation and skin regeneration, with proposed applications in vitiligo and other inflammatory dermatoses. Despite these claims, Vilacto shows no evidence of advanced clinical or regulatory progress. The company faces severe financial strain, leaving its vitiligo prospects highly uncertain.

 ❌ Villaris Therapeutics / Incyte — Auremolimab (VM6): Led by Dr. John Harris, Villaris developed auremolimab, an anti‑IL‑15Rβ monoclonal antibody targeting resident memory T cells implicated in vitiligo. Incyte acquired Villaris in 2022 for $70M upfront (milestones up to $1.36B), planning to start clinical trials in 2023. As of August 2025, no trials have been registered or reported, and Incyte has provided no pipeline updates—suggesting the program remains preclinical, on hold, or delayed for strategic reasons despite the company’s continued focus on vitiligo with Opzelura.

 🇺🇸 Vyne Therapeutics — VYN201 (repibresib): A topical “soft” pan‑BET inhibitor for nonsegmental vitiligo. Phase 1b showed ~39% mean F‑VASI improvement at the highest dose with good tolerability; Phase 2b topline readout (mid‑2025) reported missed primary endpoint but secondary efficacy signals. Backed by $88M financing, once-daily VYN201 gel repibresib remains the leading BET inhibitor candidate in vitiligo.

📌 BET Inhibitors vs. JAK Inhibitors

Vitiligo drug development is moving along two main paths. JAK inhibitors like ruxolitinib (Opzelura) are already in clinical use, quickly blocking cytokine signals to suppress the immune attack on melanocytes. They work fast, but relapse is common once treatment ends. BET inhibitors such as VYN201 (repibresib) take a broader approach, dialing down entire networks of inflammatory genes. Formulated as “soft” topicals to maximize skin effects while minimizing systemic exposure, they may offer more durable repigmentation—though their long‑term safety is still under study.

🇨🇳 Xinjiang Biomedicine Innovation Center, with Uzbek partners, reports early success in adapting traditional Uygur medicine for vitiligo, blending herbal formulas with modern validation. Pilot studies suggest repigmentation benefits, but no peer‑reviewed data or regulatory filings currently exist. Progress remains preliminary and regionally reported.

🇺🇸 Zerigo Health — Connected NB‑UVB Phototherapy System: Offers the first FDA‑cleared handheld NB‑UVB phototherapy device for at-home treatment of vitiligo, psoriasis, and eczema across all skin types, with dosing controlled through a physician-prescribed mobile app. Integration with the Zerigo app allows patients to manage treatment schedules, capture progress photos, and share data with care teams — bridging convenience and medical oversight.

Conclusion

Vitiligo drug development has never been more dynamic. With multiple Phase 2 and 3 readouts expected in the next 12–18 months, the field is set for meaningful disruption. AbbVie, Amgen, Incyte and Pfizer remain leaders to watch, while digital-first players from Canada, China and India may redefine patient care delivery. For investors, the next two years could mark a turning point for both therapeutic innovation and commercial expansion.

Yan Valle, Prof, CEO VR Foundation

Note: All prices in USD. Information current as of August 1, 2025. This report is informational only and not financial advice. Corrections welcome at yan@vrfoundation.org 

Further Reading

• Ongoing Clinical Studies and Trials in Vitiligo
• Biologic Therapies for Vitiligo: A New Era of Hope
• Do AI Models Really Understand the World of Vitiligo?
• The Real Price Tag of Treating Vitiligo: What You Need to Know

Podcast

• Pharma, Startups, and AI: From 2024 to 2025. Deep Dive in Vitiligo, Episode 17 

 

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