NB 1001

Drug Profile

NB 1001

Alternative Names: GLP-1-XTEN; NB1001; XTEN™-GLP-1

Latest Information Update: 21 Nov 2017

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At a glance

  • Originator Amunix
  • Developer Naia Limited
  • Class Antihyperglycaemics
  • Mechanism of Action Glucagon like peptide 1 receptor agonists
  • Orphan Drug Status

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

    Yes - Short bowel syndrome
  • New Molecular Entity Yes

Highest Development Phases

  • Phase I Short bowel syndrome
  • Discontinued Type 2 diabetes mellitus

Most Recent Events

  • 15 Nov 2017 United Kingdom Medicines and Healthcare Products Regulatory Agency (UK MHRA) approves clinical trial authorisation (CTA) for clinical trial in Short bowel syndrome
  • 06 Apr 2017 Naia Rare Diseases intends to launch NB 1001 for Short bowel syndrome in 2019 (Naia Rare Diseases website, April 2017)
  • 30 Nov 2016 Naia limited files an IND application with the US FDA for a phase Ib trial in Short bowel syndrome
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