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SEL 212

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Drug Profile

SEL 212

Alternative Names: Nanoecapsulated sirolimus plus pegadricase - Cartesian Therapeutics; NASP - Cartesian Therapeutics; Non-immunogenic uricase; Pegadricase-SVP; Pegsiticase-SVP; SEL-037/SEL-110; SEL-212; SEL-212A; SEL-212B; SVP-Rapamycin/pegsiticase

Latest Information Update: 16 Sep 2025

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At a glance

  • Originator Selecta Biosciences
  • Developer Cartesian Therapeutics
  • Class Antigouts; Enzymes; Oxidoreductases; Polyethylene glycols; Recombinant proteins
  • Mechanism of Action Urate oxidase replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Preregistration Gout

Most Recent Events

  • 10 Sep 2025 US FDA assigns PDUFA action date of 27/06/2026 for SEL 212 for Gout
  • 10 Sep 2025 US FDA accepts BLA for SEL 212 for Gout (Treatment-experienced) for review
  • 02 Jul 2024 Preregistration for Gout (Treatment-experienced) in USA (IV)

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