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A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Nintedanib Inhalation Powder (MNKD-201) in Healthy Volunteers

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Trial Profile

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Nintedanib Inhalation Powder (MNKD-201) in Healthy Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 05 Aug 2026

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At a glance

  • Drugs Nintedanib (Primary)
  • Indications Idiopathic pulmonary fibrosis
  • Focus Adverse reactions; First in man
  • Sponsors MannKind Corporation

Most Recent Events

  • 29 Jul 2026 According to a MannKind Corporation media release, "Across Phase 1a and Phase 1b studies, participants have received more than 700 inhalations of nintedanib DPI, including nearly 450 inhalations administered to people living with IPF.a total of 48 individuals have received nintedanib DPI, 18 of whom were patients with IPF, providing the largest reported clinical dataset with an inhaled nintedanib therapy in patients with IPF to date.
  • 04 Nov 2024 Status changed from recruiting to completed, according to a MannKind Corporation media release.
  • 04 Nov 2024 Results presented in the MannKind Corporation Media Release.

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