Endeavor BioMedicines Receives Orphan Drug Designation from the U.S. Food and Drug Administration and European Commission for Taladegib (ENV-101) for the Treatment of Idiopathic Pulmonary Fibrosis (Businesswire) - Jul 16, 2025 - "Endeavor BioMedicines...announced that both the European Commission (EC) and the U.S. Food and Drug Administration (FDA) have granted Orphan Drug Designation to its investigational therapy, taladegib (ENV-101), for the treatment of idiopathic pulmonary fibrosis (IPF). Endeavor is currently enrolling patients in the Phase 2b WHISTLE-PF (Wound-remodeling Hedgehog-Inhibitor ILD Study Testing Lung Function Endpoints-PF) clinical trial of taladegib in IPF, a chronic, progressive lung disease with limited treatment options. Enrollment in the WHISTLE-PF trial is on track and expected to be completed in 2026."
Enrollment status • Orphan drug • Idiopathic Pulmonary Fibrosis • Interstitial Lung Disease
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