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A Phase I/II Study to Assess the Safety, Tolerability and Efficacy of NouvNeu001 Injection for Mid- to Late-stage Parkinson's Disease

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Trial Profile

A Phase I/II Study to Assess the Safety, Tolerability and Efficacy of NouvNeu001 Injection for Mid- to Late-stage Parkinson's Disease

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 04 Mar 2026

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At a glance

  • Drugs NouvNeu 001 (Primary)
  • Indications Parkinson's disease
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors iRegene Therapeutics

Most Recent Events

  • 04 Mar 2026 According to iRegene Therapeutics media release, the first patient dosed in U.S., parallel Phase II trials continue in both the U.S. and China.
  • 19 Jan 2026 According to iRegene Therapeutics media release, company announced that NouvNeu001 has been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA) for the treatment of Parkinsons disease (PD).
  • 13 Oct 2025 Results published in the Media Release

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