Vitiligo - Pipeline Insight, 2025

DelveInsight's, "Vitiligo - Pipeline Insight, 2025" report provides comprehensive insights about 18+ companies and 20+ pipeline drugs in Vitiligo pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered:

• Global coverage

Vitiligo: Understanding

Vitiligo: Overview

Vitiligo is an acquired skin disorder characterized by the loss of melanocytes, resulting in well-defined white macules and patches on the skin. These depigmented areas often appear symmetrically and are more visible in individuals with darker skin tones. The condition is commonly associated with autoimmune diseases, particularly thyroid dysfunction. Lesions typically begin on the hands, face, feet, or areas prone to friction and trauma, sometimes following the Koebner phenomenon. Clinical variants include trichrome, inflammatory, and segmental types. While the exact cause is unknown, vitiligo can significantly impact quality of life due to its unpredictable progression and psychosocial effects.

Vitiligo typically presents as white or depigmented patches on the skin, which appear milky-white or significantly lighter than the surrounding areas. These patches commonly develop on sun-exposed areas, around body openings, and within the mouth and nose. Affected hair may also lose pigment, turning white or gray. In some cases, depigmentation can extend to the mucous membranes, including those of the mouth, nose, and genitals. Although usually asymptomatic, some individuals report itching, redness, or subtle changes in eye color. The condition often progresses over time, with patches increasing in size or number and varying widely in severity.

Vitiligo is recognized as a multifactorial polygenic disorder with a complex and not yet fully understood pathogenesis. It involves both genetic predispositions and non-genetic factors, leading to the progressive loss of melanocytes-the pigment-producing cells in the skin. The most accepted concept is that melanocyte destruction results in the characteristic depigmented patches. Several theories have been proposed to explain this destruction, including autoimmune responses, cytotoxicity, intrinsic melanocyte defects, neural involvement, and oxidative stress. For instance, neurochemical mediators may harm melanocytes, oxidative stress may damage them via melanin synthesis byproducts, and autoimmune mechanisms may trigger immune cells to attack melanocytes. Among these, the autoimmune hypothesis is particularly relevant, as nonsegmental vitiligo is often associated with other autoimmune conditions, such as thyroid disorders.

Vitiligo treatment encompasses a range of topical and systemic therapies, phototherapy, laser techniques, and surgical interventions, depending on disease extent and stability. Topical agents like corticosteroids, calcineurin inhibitors, and vitamin D analogs are commonly used, particularly in early or mild cases. Narrowband UV-B phototherapy (311-312 nm) is widely favored for inducing repigmentation and has largely replaced psoralen photochemotherapy due to fewer side effects. Excimer laser is effective for treating small, stable patches, and combination therapies-such as tacrolimus with systemic corticosteroids-are used for resistant segmental vitiligo. Emerging options like afamelanotide and JAK inhibitors, including topical ruxolitinib, show promising results. Surgical methods such as punch grafting or epidermal suspensions are reserved for localized, stable lesions, particularly in areas that typically resist repigmentation, like the forehead, fingers, and ankles.

"Vitiligo- Pipeline Insight, 2025" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Vitiligo pipeline landscape is provided which includes the disease overview and Vitiligo treatment guidelines. The assessment part of the report embraces, in depth Vitiligo commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Vitiligo collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights:

• The companies and academics are working to assess challenges and seek opportunities that could influence Vitiligo R&D. The therapies under development are focused on novel approaches to treat/improve Vitiligo.

Vitiligo Emerging Drugs Chapters

This segment of the Vitiligo report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, II, I, Preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Vitiligo Emerging Drugs

• Afamelanotide: Clinuvel, Inc.

Afamelanotide, developed by Clinuvel, Inc., is a synthetic analogue of alpha-melanocyte-stimulating hormone (a-MSH) designed to promote skin pigmentation in individuals with vitiligo. It works by activating melanocortin 1 receptors (MC1R) on melanocytes, stimulating melanin production and distribution in depigmented areas of the skin. Afamelanotide is administered via a subcutaneous implant, offering a systemic approach that may enhance repigmentation, particularly when used in combination with controlled UV light therapy. Its mechanism addresses the underlying pigment loss in vitiligo, aiming to restore skin tone more uniformly and effectively. Currently, the drug is in Phase III stage of its development for the treatment of Vitiligo.

• VYN201: Vyne Therapeutics Inc.

Repibresib is a pan-bromodomain BET inhibitor designed to be locally administered as a "soft" drug to address diseases involving multiple, diverse inflammatory cell signaling pathways, while providing low systemic exposure. BET proteins play a key role in regulating gene transcription via epigenetic interactions ("reading"). Recent research has identified a key role for these proteins in regulating activation of immune cells, including T cells and B cells, and subsequent inflammatory and fibrotic processes. As epigenetic readers, BET proteins regulate the recruitment of transcriptional factors that are key to the production of several pro-inflammatory cytokines. BET inhibitors have the potential to treat a range of immuno-inflammatory and fibrotic diseases by blocking pro-inflammatory cytokine transcription, with additional potential in myeloproliferative neoplastic disorders. In addition to demonstrating clinical proof-of-concept in vitiligo, repibresib has produced consistent reductions in pro-inflammatory and disease-related biomarkers and improvements in disease severity in several preclinical models (using several different routes of administration). Currently, the drug is in Phase II stage of its development for the treatment of Vitiligo.

• FB102: Forte Biosciences, Inc.

FB102 is a proprietary molecule with potentially broad autoimmune and autoimmune-related applications. The Company's FB102 program aims to address key pathways implicated in these indications with a CD122 antagonist. CD122 is a subunit of IL-2/IL-15 receptors which are key regulators of NK cells and certain T cell subsets. Significant reductions in NK cell pharmacodynamic marker of FB102 mechanism was observed supporting the in vitro as well as the NHP data and mechanism of action of FB102. A phase 1 healthy volunteer SAD/MAD study was successfully completed and demonstrated a good safety profile. Currently, the drug is in Phase I stage of its development for the treatment of Vitiligo.

Vitiligo: Therapeutic Assessment

This segment of the report provides insights about the different Vitiligo drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Vitiligo
• There are approx. 18+ key companies which are developing the therapies for Vitiligo. The companies which have their Vitiligo drug candidates in the most advanced stage, i.e. Phase III include, Clinuvel, Inc.
• Phases

DelveInsight's report covers around 20+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Vitiligo pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical
• Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
• Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Vitiligo: Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Vitiligo therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Vitiligo drugs.

Vitiligo Report Insights

• Vitiligo Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Vitiligo Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions:

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Vitiligo drugs?
• How many Vitiligo drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Vitiligo?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Vitiligo therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Vitiligo and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Vyne Therapeutics Inc.
• AbbVie
• Teva Branded Pharmaceutical Products R&D, Inc.
• Jiangsu HengRui Medicine Co., Ltd.
• Pfizer
• Incyte Corporation
• Merck Sharp & Dohme LLC
• Forte Biosciences, Inc.
• Dren Bio
• Clinuvel, Inc.

Key Products

• VYN201
• Upadacitinib
• TEV-53408
• SHR0302
• Ritlecitinib
• Povorcitinib
• MK-6194
• FB102
• DR-01
• Afamelanotide