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Pulmovant and Roivant’s Mosliciguat Receives MHLW’s Orphan Drug Designation for Pulmonary Hypertension Associated with Interstitial Lung Disease

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  • Japan’s MHLW has granted ODD to mosliciguat for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD)
  • Mosliciguat (dry powder inhaler) is being evaluated in an ongoing global P-II (PHocus) trial against PBO among ~120 PH-ILD adults, with trial design to be presented at ERS Congress 2025
  • Mosliciguat is an sGC activator that works independently of heme & nitric oxide to promote vasodilation, reverse vascular remodeling & reduce inflammation as well as apoptosis, which showed reduced pulmonary vascular resistance by up to 38% in the P-Ib (ATMOS) study

Ref: Pulmovant| Image: Pulmovant & Roivant | Press Release

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