Drug Profile

Nintedanib inhalation - Avalyn Pharmaceuticals

Alternative Names: Aerosolized nintedanib - Avalyn Pharma; AP 02 DP; AP-02; AP02-DP-Inhaled Nintedanib–dry powder; AP02-Inhaled Nintedanib

Latest Information Update: 23 Sep 2026

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At a glance

Originator Avalyn Pharma
Class Acetamides; Alcohols; Anilides; Aniline compounds; Antifibrotics; Antineoplastics; Benzene derivatives; Esters; Eye disorder therapies; Imines; Indoles; Piperazines; Skin disorder therapies; Small molecules
Mechanism of Action Fms-like tyrosine kinase 3 inhibitors; Lymphocyte specific protein tyrosine kinase p56(lck) inhibitors; Lyn protein-tyrosine kinase inhibitors; Platelet-derived growth factor alpha receptor antagonists; Platelet-derived growth factor beta receptor antagonists; Src-family kinase inhibitors; Type 1 fibroblast growth factor receptor antagonists; Type 3 fibroblast growth factor receptor antagonists; Type-2 fibroblast growth factor receptor antagonists; Vascular endothelial growth factor receptor-1 antagonists; Vascular endothelial growth factor receptor-2 antagonists; Vascular endothelial growth factor receptor-3 antagonists

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

No
New Molecular Entity No

21 Sep 2026 Pharmacokinetics and adverse events data from two phase I trials in Idiopathic pulmonary fibrosis released by Avalyn Pharmaceuticals
28 Jun 2026 No recent reports of development identified for phase-I development in Interstitial lung diseases in Australia (Inhalation, Liquid)
20 Apr 2026 Phase-II clinical trials in Idiopathic pulmonary fibrosis in Australia (Inhalation) (NCT07194382)

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