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

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


Shots:

  • 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

Related News:- TOLREMO Therapeutics’ TT125-802 Secures 2 US FDA’s Fast-Track Designation for NSCLC with EGFR & KRAS-G12C Mutation

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