Skip to main content
SpringerLink
Log in

Upacicalcet: First Approval

  • AdisInsight Report
  • Published:
Drugs Aims and scope Submit manuscript

Abstract

Upacicalcet (UPASITA®) is an intravenous calcimimetic agent being developed by Sanwa Kagaku Kenkyusho, under license from EA Pharma, for the treatment of secondary hyperparathyroidism (SHPT), a common and early complication of chronic kidney disease, in patients undergoing haemodialysis. By acting directly on parathyroid cell membrane calcium-sensing receptors, upacicalcet suppresses excessive parathyroid hormone (PTH) secretion, thereby lowering blood PTH levels. Upacicalcet received its first approval on 23 June 2021 for the treatment of SHPT in adults undergoing haemodialysis in Japan. It is administered intravenously three times per week into the venous side of the haemodialysis circuit at the time of blood return at the end of the haemodialysis session. The generally recommended starting dose of upacicalcet is 25 µg, with the dose adjusted within a 25–300 µg range based on PTH and serum calcium levels. This article summarizes the milestones in the development of upacicalcet leading to this first approval for the treatment of SHPT in patients undergoing haemodialysis.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Ketteler M, Ambuhl P. Where are we now? Emerging opportunities and challenges in the management of secondary hyperparathyroidism in patients with non-dialysis chronic kidney disease. J Nephrol. 2021. https://doi.org/10.1007/s40620-021-01082-2.

  2. Cunningham J, Locatelli F, Rodriguez M. Secondary hyperparathyroidism: pathogenesis, disease progression, and therapeutic options. Clin J Am Soc Nephrol. 2011;6(4):913–21.

    Article  CAS  Google Scholar 

  3. Rroji M, Spasovski G. Calcimimetics versus parathyroidectomy: what is preferable? Int Urol Nephrol. 2018;50(7):1271–5.

    Article  CAS  Google Scholar 

  4. Komaba H, Ketteler M, Cunningham J, et al. Old and new drugs for the management of bone disorders in CKD. Calcif Tissue Int. 2021;108(4):486–95.

    Article  CAS  Google Scholar 

  5. Kissei Pharmaceutical Co. Ltd. Announcement of Marketing Authorization Approval in Japan and co-promotion agreement of UPASITA® IV injection syringe for the treatment of secondary hyperparathyroidism in dialysis patients [media release]. 23 Jun 2021. https://www.kissei.co.jp.

  6. Sanwa Kagaku Kenkyusho Co Ltd. Sanwa Kagaku Kenkyusho Co Ltd.: company presentation (March 2018). 2018. https://www.een-japan.eu/sites/default/files/PSEU-Japanese_POD/SanwaKagakuKenkyusho/BIO-Europe_Spring_2018_SKK_Company_Presentation.pdf. Accessed 8 Jul 2021.

  7. EA Pharma, Tasly Pharmaceutical Group. Signed license agreement with Chinese Tasly Pharmaceutical Group of AJT 240 for treatment of secondary hyperparathyroidism [media release]. 12 Jun 2018. http://www.eapharma.co.jp.

  8. Sanwa Kagaku Kenkyusho Co Ltd. UPASITA® IV injection syringe for dialysis: Japanese prescribing information. Nagoya: Sanwa Kagaku Kenkyusho Co Ltd; 2021.

    Google Scholar 

  9. EA Pharma. EA Pharma signed a license agreement with JW Pharmaceutical for secondary hyperparathyroidism treatment AJT240 [media release]. 31 Oct 2017. http://www.eapharma.co.jp.

  10. Nishimura G, Yamaguchi Y, Goto M, et al. Upacicalcet, a novel non-peptide calcimimetic for the treatment of secondary hyperparathyroidism, has a low risk of hypocalcemia [abstract no. PO0318]. J Am Soc Nephrol. 2020;31:148.

    Google Scholar 

  11. Akizawa T, Honda D, Taniguchi M, et al. Efficacy and safety of upacicalcet in hemodialysis patients with secondary hyperparathyroidism: a phase 3 study [abstract no. TH-OR20]. J Am Soc Nephrol. 2020;31:6–7.

    Article  Google Scholar 

  12. US National Institutes of Health. ClinicalTrials.gov identifier NCT03801980. 2020. http://clinicaltrials.gov/. Accessed 9 Jul 2021.

  13. US National Institutes of Health. ClinicalTrials.gov identifier NCT03626948. 2020. http://clinicaltrials.gov/. Accessed 9 Jul 2021.

Download references

Author information

Authors and Affiliations

  1. Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand

    Sheridan M. Hoy

Authors
  1. Sheridan M. Hoy
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Sheridan M. Hoy.

Ethics declarations

Funding

The preparation of this review was not supported by any external funding.

Authorship and Conflict of interest

During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. S. M. Hoy is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability

Not applicable.

Additional information

This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.

Supplementary Information

Below is the link to the electronic supplementary material.

Supplementary file1 (PPTX 502 KB)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Hoy, S.M. Upacicalcet: First Approval. Drugs 81, 1593–1596 (2021). https://doi.org/10.1007/s40265-021-01578-y

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40265-021-01578-y

Search

Navigation