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Upacicalcet: First Approval.

Sheridan M Hoy1

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

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Summary

Upacicalcet is an intravenous calcimimetic approved for treating secondary hyperparathyroidism (SHPT) in dialysis patients. This treatment lowers parathyroid hormone (PTH) by targeting calcium-sensing receptors.

Area of Science:

  • Pharmacology
  • Nephrology
  • Endocrinology

Background:

  • Secondary hyperparathyroidism (SHPT) is a common complication in chronic kidney disease (CKD) patients on hemodialysis.
  • Elevated parathyroid hormone (PTH) levels in SHPT contribute to cardiovascular and bone disease.
  • Current treatments for SHPT have limitations, necessitating novel therapeutic approaches.

Purpose of the Study:

  • To summarize the development milestones of upacicalcet, a novel calcimimetic agent.
  • To highlight the regulatory approval of upacicalcet for SHPT in hemodialysis patients.

Main Methods:

  • Upacicalcet acts as a calcimimetic by modulating calcium-sensing receptors on parathyroid cells.
  • Intravenous administration three times weekly during hemodialysis sessions.

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  • Dose adjustment based on parathyroid hormone (PTH) and serum calcium levels.

    • Main Results:

    • Upacicalcet received its first marketing approval in Japan on June 23, 2021.
    • The drug effectively suppresses excessive PTH secretion.
    • Achieved therapeutic PTH and serum calcium levels within a defined dosage range.

    Conclusions:

    • Upacicalcet represents a significant advancement in managing SHPT for patients undergoing hemodialysis.
    • The intravenous administration offers a convenient dosing schedule within the dialysis procedure.
    • This development provides a new therapeutic option for a prevalent complication of CKD.