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Sovateltide: First Approval

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Abstract

Sovateltide (Tycamzzi™), a highly selective endothelin-B receptor agonist and synthetic analog of endothelin-1, is being developed by Pharmazz, Inc. as a neural progenitor cell therapeutic agent for the treatment of acute cerebral ischemic stroke (ACIS), hypoxic-ischemic encephalopathy (HIE), spinal cord injuries and Alzheimer's disease. In May 2023, sovateltide was approved in India for the treatment of cerebral ischemic stroke within 24 h of stroke onset. This article summarizes the milestones in the development of sovateltide leading to this first approval for use in patients with ACIS.

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

    Susan J. Keam

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  1. Susan J. Keam
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Correspondence to Susan J. Keam.

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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. Susan J. Keam 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.

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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.

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Keam, S.J. Sovateltide: First Approval. Drugs 83, 1239–1244 (2023). https://doi.org/10.1007/s40265-023-01922-4

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