11:17 AM EDT, 04/29/2024 (MT Newswires) -- MannKind ( MNKD ) said Monday the Food and Drug Administration has approved its investigational new drug application for a phase 3 trial of MNKD-101 (clofazimine inhalation suspension) for the treatment of nontuberculous mycobacterial lung disease.

The trial is expected to start in the US by the end of Q2 and globally in H2 2024, the company said.

"Oral clofazimine has been utilized as a treatment option for patients living with NTM lung disease and we believe that by reducing the dose and administering it directly to the lung we can demonstrate improved dosing, tolerability and safety," said MannKind ( MNKD ) Chief Executive Michael Castagna.

MannKind ( MNKD ) shares were up by more than 2% in recent trading.

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