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    Ampholipad

    Amphotericin B Liposome for Injection

    Description

    Generic of AmBisome®

    Development Status

    Marketed

    Advantages

    • Reduced toxicity
    • Enhanced efficacy
    • Improved tolerability
  • Overview
  • Overview

    Systemic fungal infections

    Potentially deadly conditions that affect millions of people worldwide

    Systemic fungal infections, also known as systemic mycoses, are serious infections that affect multiple organs and tissues in the body. Unlike superficial fungal infections that affect the skin, hair, or nails, systemic fungal infections can impact vital organs such as the lungs, liver, brain, and heart.


    Risk Factors

    Systemic fungal infections are more likely to occur in individuals with weakened immune systems. This includes people with HIV/AIDS, cancer patients undergoing chemotherapy, organ transplant recipients, and those taking immunosuppressive medications. Other risk factors include prolonged hospital stays, especially in intensive care units, and the use of medical devices like catheters.


    Symptoms

    The symptoms of systemic fungal infections vary depending on the organs affected but can include:

    • Fever and chills
    • Cough and chest pain
    • Shortness of breath
    • Headache and confusion
    • Skin lesions
    • Abdominal pain


    According to The Lancet, fungal infections affect more than a billion people each year, resulting in approximately 11.5 million life-threatening infections and more than 1.5 million deaths annually.

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    Ampholipad: treating life-threatening fungal infections

    with reduced toxicity, enhanced efficacy, and improved tolerability

    Gilead Sciences' AmBisome® is the most popular antifungal medication used for serious fungal infections and leishmaniasis, with global sales reaching US$420 million in 2018. Although decades have passed since AmBisome first entered the market, generic versions have only recent begun to emerge worldwide due to its complex formulation and chemistry and manufacturing control techniques. TLC's Ampholipad® is a generic of AmBisome and has been approved and marketed in Taiwan for several years. Ampholipad is also approved in two other major countries, with more approvals pending globally. 


    Ampholipad has several advantages over traditional amphotericin B. Traditional amphotercin B is known for its significant side effects, particularly nephrotoxicity, or kidney damage. TLC's unique formulation reduces these toxic effects by altering the drug's distribution in the body, while helping to deliver the drug more effectively to the site of infection, improving its antifungal activity. Patients generally tolerate liposomal amphotericin B better, experiencing fewer infusion-related reactions compared to the conventional form. 


    Ampholipad is used to treat a variety of severe fungal infections, including:

    • Mucormycosis
    • Aspergillosis
    • Blastomycosis
    • Candidiasis
    • Coccidioidomycosis
    • Cryptococcosis


    Indication

    Preclinical
    Phase 1
    Phase 2
    Phase 3
    NDA
    Market

    Systemic fungal infections

    Marketed