Product image of Winlevi (Clascoterone) supplied by GNH India

Winlevi

Active Ingredient:
Clascoterone
Origin:
EU

Winlevi (Clascoterone)

Clascoterone, the active ingredient in Winlevi, is a steroidal antiandrogen presented as a 1% cream for topical use. It is indicated for the treatment of acne vulgaris in individuals aged 12 years and older. GNH India supplies Winlevi as a licensed, GDP-compliant international pharmaceutical supplier serving pharmacies and clinics worldwide.

Winlevi is a first-in-class topical androgen receptor inhibitor designed to reduce sebum production and inflammation associated with acne. It offers a novel approach to managing acne by targeting the underlying hormonal factors that contribute to the condition.

Manufacturer / TM Owner

Glenmark Pharmaceuticals Europe Limited

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Indications & Clinical Uses

Winlevi is used in the treatment of acne vulgaris, a common skin condition characterized by the presence of comedones, papules, pustules, and nodules. It is particularly effective in reducing sebum production, which is a key factor in the development of acne.

  • Acne vulgaris: Reduces sebum production and inflammation, helping to clear acne lesions and prevent new ones from forming.
  • Adolescent acne: Effective in managing acne in individuals aged 12 years and older.
  • Adult acne: Provides a treatment option for adults who suffer from persistent acne.

How It Works

  • Winlevi works by acting as a topical androgen receptor antagonist. It blocks the binding of dihydrotestosterone (DHT) to androgen receptors in the skin, thereby reducing sebum production and inflammation. This mechanism helps to address the hormonal factors that contribute to the development of acne.

Side Effects

Winlevi may cause certain side effects, although not everyone experiences them. Common Side Effects:

  • Reddening, scaling, or dryness of the skin being treated.
  • Itching of the skin being treated.
  • Skin irritation, including burning or peeling.

Serious or Rare Side Effects

  • Symptoms of adrenal insufficiency, such as fatigue, weakness, or weight loss.
  • Severe skin irritation or allergic reactions.
  • Eye, mouth, or vaginal irritation if the cream comes into contact with these areas.

Precautions & Warnings

Before using Winlevi, it is important to consider certain precautions to ensure safe and effective treatment. Consult your healthcare provider if you:

  • Have skin problems, including eczema, cuts, or sunburn.
  • Are pregnant or plan to become pregnant, as the safety of Winlevi during pregnancy is unknown.
  • Are breastfeeding or plan to breastfeed, as it is not known if Winlevi passes into breast milk.
  • Have a history of adrenal insufficiency or other hormonal disorders.
  • Are using other topical medications, as they may interact with Winlevi.
  • Store at room temperature: Keep in the original pack, protect from moisture and heat.

Avoid Interactions

Winlevi may interact with other medications, so it is important to inform your healthcare provider about all the medications you are taking. Major Interactions (Avoid):

  • Other topical medications that may cause skin irritation or dryness.
  • Systemic medications that affect adrenal function.

Moderate Interactions (Monitor Closely)

  • Topical corticosteroids, as they may increase the risk of skin irritation.
  • Other topical acne treatments, as they may exacerbate skin dryness or irritation.
  • Hormonal medications, as they may affect the efficacy of Winlevi.

Frequently Asked Questions

Winlevi is used to treat acne vulgaris in individuals aged 12 years and older. It works by reducing sebum production and inflammation, which are key factors in the development of acne. Winlevi is particularly effective in managing both adolescent and adult acne.

Clascoterone, the active ingredient in Winlevi, acts as a topical androgen receptor antagonist. It blocks the binding of dihydrotestosterone (DHT) to androgen receptors in the skin, thereby reducing sebum production and inflammation. This mechanism helps to address the hormonal factors that contribute to the development of acne.

The usual dose of Winlevi is determined by your healthcare provider based on your specific needs and the severity of your acne. It is typically applied topically to the affected areas once or twice daily. Always follow the instructions provided by your healthcare provider.

The safety of Winlevi during pregnancy or breastfeeding is unknown. It is important to consult your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding before using Winlevi. Your healthcare provider can provide guidance based on your specific situation.

To order Winlevi from GNH India, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India supplies hospitals, pharmacies, and procurement teams across international markets. The team will ask you to confirm your trade or institutional credentials and will reply with pricing, availability, shipping, and the necessary import paperwork.

Winlevi is a first-in-class topical androgen receptor inhibitor, making it unique among acne treatments. Unlike other topical treatments that primarily target bacteria or inflammation, Winlevi directly addresses the hormonal factors that contribute to acne. This makes it an effective option for both adolescent and adult acne.

Winlevi should be stored at room temperature, away from moisture and heat. Keep the cream in its original pack to protect it from contamination. Avoid freezing the cream and ensure it is kept out of reach of children. Always follow the storage instructions provided with the product.

Winlevi is applied topically to the affected areas of the skin. It is important to follow the instructions provided by your healthcare provider. Typically, a small amount of cream is applied to the affected areas once or twice daily. Avoid contact with the eyes, mouth, and vagina, as it may cause irritation.

The most serious risks associated with Winlevi include symptoms of adrenal insufficiency, such as fatigue, weakness, or weight loss. Severe skin irritation or allergic reactions are also possible. If you experience any of these symptoms, consult your healthcare provider immediately.

Winlevi should not be used by individuals under the age of 12, as its safety and effectiveness in this age group have not been established. It should also be used with caution in individuals with a history of adrenal insufficiency or other hormonal disorders. Always consult your healthcare provider before using Winlevi.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

References

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