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Nomlabofusp - Larimar Therapeutics

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Drug Profile

Nomlabofusp - Larimar Therapeutics

Alternative Names: CTI 1601; Tat-frataxin; TAT-FXN

Latest Information Update: 09 Oct 2025

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At a glance

  • Originator Indiana University; Wake Forest University School of Medicine
  • Developer Larimar Therapeutics
  • Class Recombinant fusion proteins
  • Mechanism of Action Frataxin protein replacements
  • Orphan Drug Status

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

    Yes - Friedreich's ataxia
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Friedreich's ataxia

Most Recent Events

  • 29 Sep 2025 Updated efficacy and adverse events data from the phase II OLE trial in Friedreich's ataxia released by Larimar Therapeutics
  • 14 Aug 2025 Larimar Therapeutics plans a confirmatory phase III trial for Friedreich's ataxia in USA, the European Union, the United Kingdom, Canada and Australia (SC) by the end of year 2025
  • 23 Jun 2025 Larimar Therapeutics receives US FDA Recommendations on safety database, and Other details of BLA submission for Friedreich’s ataxia

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