Brimapitide - Auris Medical/Xigen

Drug Profile

Brimapitide - Auris Medical/Xigen

Alternative Names: AM-111; AM111 peptide; Brimapitide otic gel; D-JNKI-1; XG-102; XG102 peptide

Latest Information Update: 09 May 2018

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At a glance

  • Originator Xigen
  • Developer Auris Medical; ribOvax Biotechnologies; Xigen
  • Class Cardiovascular therapies; Eye disorder therapies; Neuroprotectants; Peptides; Urologics
  • Mechanism of Action Mitogen-activated protein kinase 8 inhibitors
  • Orphan Drug Status

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

    Yes - Sensorineural hearing loss
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Ocular inflammation; Sensorineural hearing loss
  • Preclinical Alzheimer's disease; Interstitial cystitis; Kidney disorders
  • No development reported Eye-Disorders; Stroke
  • Discontinued Ear disorders; Myocardial infarction; Parkinson's disease; Transplant rejection

Most Recent Events

  • 15 Aug 2018 Auris Medical expects the US FDA's feedback regarding the regulatory path for AM 111 during the third quarter of 2018
  • 07 May 2018 Auris Medical intends to request a Type C meeting with US FDA for regulatory discussions related with potential approval in Sensorineural hearing loss
  • 07 May 2018 Auris Medical receives Scientific Advice (Protocol Assistance) from CHMP of EMA for clinical development in Sensorineural hearing loss
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