Clinical trials
Follow clinical development from study design and recruitment through results.
- Trial phase
- Status
- Readouts
Drug intelligence / Profile preview
MNKD-101
- Development stage
- Discontinued
- Lead developer
- Mannkind
- Modality
- Small Molecules, Inhalation Devices → Device-based Delivery → Drug Delivery Systems
- 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
Beyond the preview
Go deeper on MNKD-101.
Explore the evidence, development activity, and competitive landscape with Gosset’s full data platform.
Indications & development
Explore development by indication, patient population, and geography.
- Indications
- Development status
- Countries
Licensing & deals
Trace asset ownership, licensing agreements, and commercial partnerships.
- Partners
- Deal terms
- Milestones
Patents & exclusivity
Explore the patent landscape and regulatory exclusivity around an asset.
- Patents
- Expiration dates
- Exclusivity
Competitive landscape
Compare development programs by target, modality, and indication.
- Competing assets
- Targets
- Development stage
Research & analysis
Connect source evidence and development news to your research questions.
- Publications
- News
- Analysis
Bring the full picture into focus.
See how Gosset can support your research on MNKD-101.