# Inhaled Delivery of Clofazimine - A High Efficiency, Flow Independent, Targeted, Low Cost DPI

> **NIH NIH N44** · VIA THERAPEUTICS, LLC · 2020 · $2,999,221

## Abstract

Inhaled Delivery of Clofazimine (CFZ) – An Important Anti-tuberculosis Drug: Development of improved drug regimens to shorten treatment for multidrug-resistant (MDR) and drug susceptible (DS) tuberculosis (TB) and improve tolerance and safety is an extremely high research priority. Clofazimine is a drug approved decades ago for treatment of leprosy. Animal studies of the drug for TB treatment indicate that it may significantly reduce treatment duration, particularly in combinations including PZA. The effectiveness of the “Bangladesh” regimen provides support that inclusion of CFZ in MDR regimens may shorten treatment from 18 to 9-10 months, at least in populations with a low rate of resistance to other MDR drugs.  However, tolerance to orally administered clofazimine is often limited by skin discoloration and GI adverse events. In addition, CFZ substantially increased the QT interval. Inhaled delivery offers the potential to bypass these barriers while still maintaining effectiveness in the lungs by achieving high drug concentrations in the infected pulmonary tissue with lower systemic exposure, thus allowing increased immediate potency.  The goal is to develop an inexpensive, easy-to-use, inhaled delivery system for clofazimine to be used with combinations of systemic anti-tubercular drugs to improve the treatment of MDR and DS TB.

## Key facts

- **NIH application ID:** 10229327
- **Project number:** 272201800039C-P00001-9999-1
- **Recipient organization:** VIA THERAPEUTICS, LLC
- **Principal Investigator:** JOHN KOLENG
- **Activity code:** N44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $2,999,221
- **Award type:** —
- **Project period:** 2018-08-15 → 2023-08-14

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10229327

## Citation

> US National Institutes of Health, RePORTER application 10229327, Inhaled Delivery of Clofazimine - A High Efficiency, Flow Independent, Targeted, Low Cost DPI (272201800039C-P00001-9999-1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10229327. Licensed CC0.

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