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Tablets

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Comments
Indication: Idiopathic pulmonary fibrosis (IPF) Clinical stage: Phase 2b Modality: Small molecule (first-in-class angiotensin II type 2 receptor agonist) Mechanism / Target: First-in-class direct agonist at angiotensin II type 2 receptor (AT2R); activates AT2R anti-fibrotic and anti-inflammatory signalling in lung tissue; counteracts fibrosis-promoting angiotensin II/AT1R axis; promotes tissue repair through vasodilatory and anti-oxidative pathways Route / form: Oral tablet Differentiation: First-in-class AT2R agonist; entirely novel anti-fibrotic mechanism distinct from pirfenidone (TGF-β pathway) and nintedanib (tyrosine kinase inhibitor); oral once-daily dosing; Phase 2b ASPIRE ongoing;
Manufacturer #39342
Europe-based publicly listed clinical-stage company developing a first-in-class oral Rx small molecule with a novel receptor-agonist mechanism. Lead compound is in global mid-stage development for a serious progressive fibrotic disease and holds multiple regulatory designations.

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