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A Multicenter, International, Open-label, Safety Study of ND0612, a Solution of Levodopa/Carbidopa Delivered Via a Pump System as a Continuous Subcutaneous Infusion in Subjects With Advanced Parkinson's Disease

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Trial Profile

A Multicenter, International, Open-label, Safety Study of ND0612, a Solution of Levodopa/Carbidopa Delivered Via a Pump System as a Continuous Subcutaneous Infusion in Subjects With Advanced Parkinson's Disease

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 04 Jun 2025

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At a glance

  • Drugs Levodopa/carbidopa (Primary) ; Levodopa
  • Indications Parkinson's disease
  • Focus Adverse reactions
  • Acronyms BeyoND
  • Sponsors NeuroDerm

Most Recent Events

  • 29 May 2025 According to a Mitsubishi Pharma Corporation media release, FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date in the third quarter of FY2025.
  • 28 May 2025 According to a Mitsubishi Tanabe Pharma Corporation Media Release, announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) resubmission for investigational ND0612.The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date in the fourth quarter of 2025.
  • 31 Mar 2025 According to a Mitsubishi Tanabe Pharma Corporation Media Release, company announced that data from this trial will be shared at the 2025 International Conference on Alzheimer's and Parkinsons Diseases and related neurological disorders (AD/PD), taking place April 1-5 in Vienna, Austria.

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