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Glenmark Initiates Phase IIb Human Trials Globally for its Novel Molecule 'Revamilast'
Date:8/10/2011

MUMBAI, August 10, 2011 /PRNewswire/ --


  • Revamilast is a PDE4 inhibitor, under development for Asthma, Rheumatoid Arthritis and other inflammatory disorders
  • The molecule successfully completed pre-clinical trials and Phase I studies
    • Phase I studies on healthy volunteers were carried out mainly in the UK
  • Glenmark has initiated global  Phase IIb studies for both indications in Europe and Asia
  • Huge unmet medical need as globally they are over 300 million Asthma patients and over 20 million Rheumatoid Arthritis patients

Glenmark Pharmaceuticals today announced that its Novel Chemical Entity "Revamilast" (GRC 4039) has initiated Phase IIb human dose range finding trials globally. Revamilast is an orally active, potent and selective inhibitor of phosphodiesterase 4 (PDE 4) that is currently being developed by Glenmark for the treatment of chronic inflammatory disorders such as  Asthma, Rheumatoid Arthritis (RA) and other inflammatory diseases. The Phase IIb studies that will be carried out will help establish the efficacy and safety of the molecule and will also provide dose range finding data for Revamilast.

Dr. Steffen Stuerzebecher, President & Chief Medical Officer, Glenmark Pharmaceuticals Ltd said "The clinical trials and the animal studies data for Revamilast are promising for both indications i.e. Asthma and Rheumatoid Arthritis. There is a huge unmet need for both these chronic medical conditions globally. For Glenmark, this is a significant development as we have built on more than a decade of experience in the PDE 4 space to progress an exciting molecule to Phase II human trials."

In Phase I studies carried out mainly in the United Kingdom, nearly 150 healthy volunteers have been dosed and no Serious Adverse Events have been noted. The pharmacodynamic evaluation in healthy hum
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SOURCE Glenmark Pharmaceuticals Ltd.
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