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MNKD-101
- Development stage
- Phase 2
- Lead developer
- Mannkind
- Modality
- Inhalation Devices → Device-based Delivery → Drug Delivery Systems, Small Molecules
- Administration
- Inhalation
01
Overview
MNKD-101 is an investigational inhaled formulation of clofazimine, developed as a clofazimine inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease, particularly infections caused by Mycobacterium avium complex (MAC). Clofazimine is an antibiotic that inhibits mycobacterial growth and binds preferentially to mycobacterial DNA. The inhaled delivery aims to provide high drug concentrations directly in the lungs while minimizing systemic toxicity and side effects associated with oral administration. MNKD-101 has received Orphan Drug, Qualified Infectious Disease Product (QIDP), and Fast Track designations from the FDA for pulmonary NTM infections. It is currently being evaluated in a global Phase 3 clinical trial (ICoN-1) as an add-on to guideline-based therapy in adults with refractory NTM lung disease[1][2][5][7][8].
- Other names
- clofazimine inhalation suspension
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