Vitiligo
Vitiligo is a skin condition that leads to the loss of skin color or pigment, causing affected areas to appear lighter than the natural skin tone or turn white. The areas where pigment is lost are called macules if they are less than 1 centimeter wide, or patches if larger than 1 centimeter. If vitiligo affects areas of the body with hair, the hair may turn white or silver. This condition occurs when the body's immune system attacks and destroys melanocytes, the cells responsible for producing melanin, the pigment that gives skin color.
Symptoms:
Signs and symptoms of vitiligo include:
• Areas of skin or mucous membranes that lose pigment, appearing white or lighter than the natural skin tone.
• Patches of hair on the body that turn silver, gray, or white.
The severity of vitiligo can vary: some people may experience mild symptoms affecting only a small area, while others may see widespread depigmentation. In some cases, individuals with vitiligo may notice itching in the affected areas before the loss of pigment begins.
Drug Class Distribution and Development Phases
According to the AdisInsight database, the following is a detailed overview of drugs grouped into five major drug classes, along with their respective development phases. The small molecule class leads the market, with the highest number of drugs in both early-stage and late-stage clinical development, as well as one drug already launched.
Drug development phases Vs drug class
Fig 13: Development phases of drugs versus drug class distribution
The graph clearly shows that small molecules are leading in the development phase, with five drugs in early-stage clinical development, and four in late-stage clinical development.
Analysis of Development Phases and Routes of Administration
The graph shows that the oral route of administration is the most effective in treating vitiligo, with three drugs in late-stage clinical development and three drugs in early-stage development.
Drug development phases Vs RoA
Fig 14: Development phases of drugs versus RoA distribution
Drug development phases Vs formulation of drugs
Fig 15: Development phases of drugs versus formulation
Overview of Development Stages and Formulations
According to the AdisInsight database, tablet formulations are at the forefront of development, with two drugs in early-stage clinical trials and three in late-stage clinical trials.
Drugs Available for Licensing
Drugs for vitiligo are expected to dominate the market in the coming years, prompting many companies to seek acquisition opportunities in this therapeutic area. For example, Ruxolitinib, initially developed by Incyte Corporation, was granted the rights to develop and commercialize the drug in the US. Incyte later amended its Collaboration and License Agreement with Novartis. Ruxolitinib (Opzelura), a topical JAK inhibitor, was recently approved by the FDA for the treatment of vitiligo. Opzelura® (ruxolitinib) cream generated net revenues of $109 million in Q4'23 and $338 million for FY'23, driven by strong demand in atopic dermatitis and the successful launch in vitiligo. According to the AdisInsight database, the following drugs are available for licensing: two in early-stage clinical development and two in the preclinical phase.
Table 20- Drugs available for licensing for Vitiligo