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Tofogliflozin: First Global Approval

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Abstract

Tofogliflozin (Apleway®, Deberza® [Japan]), an orally active small molecule sodium-glucose co-transporter type 2 (SGLT2) inhibitor, has been developed by Chugai Pharmaceutical for the treatment of type 2 diabetes mellitus (T2DM), and a marketing authorization application was filed in Japan in 2013 by licensees Sanofi K.K. and Kowa. Tofogliflozin has received its first global approval for this indication in Japan as either monotherapy or in combination with other antihyperglcaemic agents. This article summarizes the milestones in the development of tofogliflozin leading to this first approval for the treatment of T2DM.

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Disclosure

The preparation of this report was not supported by any external funding. 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. R.M. Poole is a contracted employee of Adis, Springer SBM. J.E. Prossler is a salaried employee of Adis, Springer SBM.

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Authors and Affiliations

  1. Adis R&D Insight, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore, 0754, Auckland, New Zealand

    Jennifer E. Prossler

  2. Adis, Auckland, New Zealand

    Raewyn M. Poole

Authors
  1. Raewyn M. Poole
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  2. Jennifer E. Prossler
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Corresponding author

Correspondence to Jennifer E. Prossler.

Additional information

This profile has been extracted and modified from the Adis R&D Insight drug pipeline database. Adis R&D Insight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch.

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Poole, R.M., Prossler, J.E. Tofogliflozin: First Global Approval. Drugs 74, 939–944 (2014). https://doi.org/10.1007/s40265-014-0229-1

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  • DOI: https://doi.org/10.1007/s40265-014-0229-1

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