Asthma
According to EmphyCorp's pipeline, inhaled sodium pyruvate has completed phase II trials in the US for the treatment of asthma, and pivotal phase III trials had been planned for 2014. However, as of January 2016, phase III trials had not yet begun.
EmphyCorp initiated a randomised, double-blind, placebo-controlled phase I/II trial in January 2006 to assess the safety and efficacy of inhaled sodium pyruvate in patients with moderate asthma (NCT00262652). The trial was to enrol approximately 55 patients in the US. However, the company reported in June 2011 that trial had been terminated due to a lack of efficacy [3] .
Chronic obstructive pulmonary disease (COPD)
According to EmphyCorp's pipeline, inhaled sodium pyruvate has completed phase II trials in the US for the treatment of COPD, and pivotal phase III trials had been planned for 2014. However, as of January 2016, phase III trials had not yet begun.
EmphyCorp initiated a randomised, double-blind, placebo-controlled phase II trial in September 2004 to investigate the long-term efficacy and safety of inhaled sodium pyruvate in patients with COPD (NCT00262613). The 6-week trial enrolled approximately 60 patients in the US, and was completed in May 2006 [4] .
COVID-2019 infections
In March 2020, EmphyCorp reported that in 10 human clinical trials, the sodium pyruvate inhalation curbed nasal inflammation and enhanced all lung functions along with an increase in synthesis of nasal nitric oxide. The company believe that nitric oxide has anti-viral effect which has potential to reduce the rate and spread of the COVID-2019 among healthy individuals [1] [5] .
Cystic fibrosis
As per EmphyCorp's pipeline, inhaled sodium pyruvate has completed phase II trials in the US for the treatment of cystic fibrosis in December 2013.
In March 2006, EmphyCorp initiated a single-arm phase I trial to assess the safety and efficacy of inhaled sodium pyruvate in patients with cystic fibrosis (NCT00308243). The trial enrolled approximately 15 patients in the US, and was completed in March 2007 [6] .
EmphyCorp's inhaled sodium pyruvate product was granted orphan drug designation by the US FDA in 2005 for the treatment of cystic fibrosis.
Interstitial lung disease
EmphyCorp's inhaled sodium pyruvate product was granted orphan drug designation by the US FDA in 2005 for the treatment of interstitial lung disease.
As per FDA guidelines, EmphyCorp completed phase III clinical trial for NDA marketing application for the treatment of pulmonary fibrosis in August 2019 [7] .
China development
Clinical trials of inhaled sodium pyruvate in unspecified lung indications were initiated in China in 2013.
