The vitiligo treatment landscape is evolving with a shift towards targeted therapies, which have shown encouraging results in promoting repigmentation. Current pipeline developments reflect a move beyond conventional options like corticosteroids and phototherapy. With significant unmet medical needs and increasing disease awareness, emerging therapies have the potential to transform the standard of care.

DelveInsight’s 'Vitiligo Pipeline Insight 2025' report provides comprehensive global coverage of pipeline vitiligo therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the vitiligo pipeline domain.

Key Takeaways from the Vitiligo Pipeline Report: DelveInsight’s vitiligo pipeline report depicts a robust space with 18+ active players working to develop 20+ pipeline vitiligo drugs. Key vitiligo companies such as Vyne Therapeutics Inc., AbbVie, Teva Branded Pharmaceutical Products R&D, Inc., Pfizer, Incyte Corporation, Merck Sharp & Dohme LLC, Forte Biosciences, Dren Bio, Edesa Biotech, Suzhou Zelgen Biopharmaceuticals Co., Ltd., Genrix (Shanghai) Biopharmaceuticals, Odyssey Therapeutics, Clinuvel, and others are evaluating new vitiligo drugs to improve the treatment landscape. Promising pipeline vitiligo therapies, such as VYN201, Upadacitinib, TEV-53408, Ritlecitinib, Povorcitinib, MK-6194, FB102, DR-01, EB06, Gecacitinib, GR2301, OD-00910, Afamelanotide, and others, are in different phases of vitiligo clinical trials.

In May 2025, CLINUVEL met its recruitment target in its Phase III trial (CUV105) of SCENESSE® (afamelanotide 16mg) in vitiligo, with more than 200 patients enrolled. The last patient to enter the study is scheduled to complete screening in May 2025. First results from the study are expected in the second half of 2026.

In May 2025, VYNE Therapeutics announced its financial results as of and for the quarter ended March 31, 2025, and provided a business update, including that top-line results from the Phase IIb trial for the treatment of vitiligo are expected in mid-2025.

In May 2025, Edesa Biotech announced the completion of a USD 15 million equity financing from healthcare-focused institutional investors, existing Edesa shareholders, and insiders to support the development of the company’s vitiligo drug candidate EB06, anti-CXCL10 monoclonal antibody. The company has subsequently initiated outreach to potential investigators and manufacturing-related activities to support the US regulatory approval for a Phase 2 study in moderate-to-severe nonsegmental vitiligo patients.

In May 2025, Forte Biosciences announced that they have dosed the first patient in the FB102 vitiligo trial.

In March 2025, AbbVie presented new findings on Upadacitinib’s effects in nonsegmental vitiligo through a biomarker-driven approach at the 2025 American Academy of Dermatology (AAD) annual meeting.

In January 2025, VYNE Therapeutics, a clinical-stage biopharmaceutical company focused on developing differentiated therapies to treat chronic inflammatory and immune-mediated conditions with high unmet need, announced completion of enrollment in the Phase IIb trial evaluating VYN201 gel for the treatment of nonsegmental vitiligo.

Vitiligo is a non-contagious skin condition marked by the progressive loss of melanocytes—the cells responsible for skin pigmentation, leading to distinct, well-demarcated white patches or macules. These depigmented areas often manifest symmetrically and are especially noticeable in individuals with darker skin. The disorder frequently coexists with autoimmune diseases, most notably thyroid abnormalities. Lesions often first appear on the face, hands, feet, or in regions prone to friction or trauma, and may follow the Koebner phenomenon. Clinical subtypes include trichrome, inflammatory, and segmental variants. Though the exact underlying cause remains unclear, the disease’s unpredictable progression and psychosocial burden can substantially affect patients’ quality of life.

Vitiligo typically presents as pale or milky-white patches that contrast sharply with unaffected skin. These patches commonly emerge in sun-exposed areas, around body orifices, and within the mouth and nose. Hair growing from these regions may also lose pigment, turning white or gray. In some instances, depigmentation extends to the mucous membranes, including the lips, nose, and genitals. Although the condition is generally painless, some individuals may experience itching, redness, or minor alterations in eye color. The disease tends to evolve over time, with the size and number of patches increasing, and the severity varying greatly between individuals.

Considered a multifactorial polygenic disorder, vitiligo involves a combination of genetic and environmental influences that lead to the gradual destruction of melanocytes. Several mechanisms have been proposed, including autoimmune activity, cytotoxic responses, inherent melanocyte vulnerabilities, neural factors, and oxidative stress. For example, neurochemical substances may damage melanocytes, oxidative stress can impair pigment production pathways, and autoimmune processes may prompt the immune system to target these cells. Among these, autoimmune dysfunction is most prominently linked to vitiligo, especially the non-segmental type, which is frequently associated with other autoimmune conditions such as thyroid disease.

Treatment options for vitiligo are diverse and tailored to the disease extent and stability. Common approaches include topical therapies, such as corticosteroids, calcineurin inhibitors, and vitamin D analogs, especially in mild or early-stage cases. Narrowband UV-B phototherapy (311–312 nm) is now a mainstay for repigmentation, offering fewer side effects compared to psoralen UVA therapy. The excimer laser is useful for treating small, stable lesions, while combination therapies like tacrolimus with oral corticosteroids are considered for stubborn segmental cases. Newer treatments under investigation, including afamelanotide and JAK inhibitors like topical ruxolitinib, have shown encouraging outcomes. Surgical techniques such as punch grafts and epidermal cell suspensions are typically reserved for stable, localized patches, especially in areas that respond poorly to conventional therapy, such as the fingers, forehead, and ankles.

A snapshot of the Pipeline Vitiligo Drugs mentioned in the report:

| Drugs | Company | Phase | MoA | RoA |
|-------|--------|------|-----|-----|
| Afamelanotide | Clinuvel, Inc. | III | Melanocortin type 1 receptor agonists | Subcutaneous |
| Upadacitinib | AbbVie | III | Janus kinase 1 inhibitors | Oral |
| Ritlecitinib | Pfizer | III | Emt protein-tyrosine kinase inhibitors; Janus kinase 3 inhibitors | Oral |
| VYN201 | Vyne Therapeutics Inc. | II | Bromodomain and extraterminal domain protein inhibitors | Topical |
| FB102 | Forte Biosciences, Inc. | I | Interleukin-2 receptor beta subunit antagonists | Intravenous |
| TEV-53408 | Teva Pharmaceutical Industries | I | Interleukin 15 inhibitors | Subcutaneous |

The vitiligo pipeline report proffers an integral view of the emerging Vitiligo therapies segmented by stage, product type, molecule type, route of administration, and mechanism of action.

Coverage: Global
Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination
Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical
Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy
Therapeutics Assessment By Mechanism of Action: Melanocortin type 1 receptor agonists, Bromodomain and extraterminal domain protein inhibitors, Interleukin-2 receptor beta subunit antagonists, Janus kinase 1 inhibitors, Interleukin 15 inhibitors, Emt protein-tyrosine kinase inhibitors; Janus kinase 3 inhibitors
Key Vitiligo Companies: Vyne Therapeutics Inc., AbbVie, Teva Branded Pharmaceutical Products R&D, Inc., Pfizer, Incyte Corporation, Merck Sharp & Dohme LLC, Forte Biosciences, Dren Bio, Edesa Biotech, Suzhou Zelgen Biopharmaceuticals Co., Ltd., Genrix (Shanghai) Biopharmaceuticals, Clinuvel, and others.
Key Vitiligo Pipeline Therapies: VYN201, Upadacitinib, TEV-53408, Ritlecitinib, Povorcitinib, MK-6194, FB102, DR-01, EB06, Gecacitinib, GR2301, Afamelanotide, and others.

The vitiligo treatment landscape is shifting toward targeted therapies, moving beyond conventional treatments like corticosteroids and phototherapy. A comprehensive pipeline report by DelveInsight highlights 18+ active pharmaceutical companies developing 20+ pipeline drugs, including candidates in clinical trials such as VYN201, Upadacitinib, and Afamelanotide. Key developments in May and March 2025 include Clinuvel meeting recruitment targets for its Phase III trial of SCENESSE® (afamelanotide), Vyne Therapeutics reporting top-line results expected from its Phase IIb trial, Edesa Biotech completing a $15 million equity financing to support EB06 development, and Forte Biosciences dosing the first patient in its FB102 trial. AbbVie also presented new biomarker-driven findings on Upadacitinib at the 2025 AAD meeting. The report covers global pipeline activities by phase, mechanism of action, route of administration, and product type, reflecting a growing focus on immune-mediated and targeted therapies to address unmet medical needs in vitiligo.