AstraZeneca Plc (LON:AZN), a global, science-led biopharmaceutical company, announced on Monday the grant by the US Food and Drug Administration (FDA) of Orphan Drug Designation (ODD) for saracatinib, a potential new medicine for the treatment of idiopathic pulmonary fibrosis (IPF), a type of lung disease that results in scarring (fibrosis) of the lungs.
Reportedly, Saracatinib is an inhibitor of src kinase, which regulates broad cell functions, including cell growth and cell differentiation. Saracatinib has completed phase I development.
The FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.
According to the company, saracatinib is a small molecule, highly-potent and selective inhibitor of src tyrosine kinase. This potential new medicine was discovered by AstraZeneca and has previously been in clinical development in oncology. Phase II trials for saracatinib in IPF have not yet commenced.
AstraZeneca focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in the three therapy areas of Oncology, Cardiovascular, Renal & Metabolism and Respiratory.
Avacta reports encouraging early efficacy signals for AVA6000 in salivary gland cancer at ASCO 2026
Circio and AaviGen partner to develop next-generation gene therapies for heart disease
Eli Lilly reports positive Phase 1b results for VERVE-102
Bayer's KERENDIA receives FDA priority review for type 1 diabetes and kidney disease treatment
Artivion completes acquisition of Endospan following FDA approval of NEXUS Aortic Arch System
AstraZeneca wins US approval for Baxfendy as first aldosterone synthase inhibitor for hypertension
GSK's Arexvy gains expanded approval in Japan for at-risk adults aged 18-49
Tenaya Therapeutics reports interim RIDGE-1 data showing reduced arrhythmia burden with TN-401
AnaCardio reports Phase 1b/2a data showing cardiac function gains with AC01
Veradermics reports positive Phase 2/3 results for oral VDPHL01 in pattern hair loss treatment