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Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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Related Experiment Video

Updated: Nov 10, 2025

Optimized LC-MS/MS Method for the High-throughput Analysis of Clinical Samples of Ivacaftor, Its Major Metabolites, and Lumacaftor in Biological Fluids of Cystic Fibrosis Patients
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Voclosporin: First Approval.

Young-A Heo1

  • 1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

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PubMed
Summary

Voclosporin is a new oral immunosuppressant approved for lupus nephritis. It offers a new treatment option for adults with this autoimmune kidney disease, improving therapeutic outcomes.

Area of Science:

  • Pharmacology and Therapeutics
  • Nephrology
  • Immunology

Background:

  • Lupus nephritis is a severe complication of systemic lupus erythematosus, often leading to kidney failure.
  • Current treatments for lupus nephritis involve broad immunosuppression with significant side effects.
  • Voclosporin represents a targeted approach to immunosuppression.

Purpose of the Study:

  • To summarize the key development milestones of voclosporin.
  • To highlight the regulatory approval process for voclosporin in lupus nephritis.
  • To discuss the potential of voclosporin in other indications like COVID-19 in kidney transplant recipients.

Main Methods:

  • Review of pivotal Phase II and III clinical trial data.
  • Analysis of regulatory submission and approval pathway.

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  • Exploration of ongoing research for novel applications.

    • Main Results:

    • Positive efficacy and safety results from Phase II and III trials.
    • First US approval for oral voclosporin in January 2021 for active lupus nephritis.
    • Ongoing investigation for use in kidney transplant recipients with COVID-19.

    Conclusions:

    • Voclosporin is the first oral calcineurin inhibitor approved for lupus nephritis.
    • The approval marks a significant advancement in treating autoimmune kidney disease.
    • Further research may expand voclosporin's therapeutic applications.