FORMOTEROL FUMARATE

Post-LOE

formoterol fumarate dihydrate

ANDAINHALATIONSOLUTION
Approved
Feb 2025
Lifecycle
Post-LOE
Competitive Pressure
30/100
Clinical Trials
20

Mechanism of Action

long-acting, beta 2 -adrenergic receptor agonist (beta 2 -agonist). Inhaled formoterol fumarate acts locally in the lung as a bronchodilator. In vitro studies have shown that formoterol has more than 200-fold greater agonist activity at beta 2 -receptors than at beta 1 -receptors. Although beta 2…

Clinical Trials (5)

NCT07073950Phase 4Recruiting

A Study to Investigate the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) Compared With Placebo MDI on Heart and Lung Function in Participants With Chronic Obstructive Pulmonary Disease (COPD) and Hyperinflation

Started Nov 2025
56 enrolled
Chronic Obstructive Pulmonary DiseaseHyperinflation
NCT06283966Phase 3Recruiting

A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease

Started Feb 2024
5,000 enrolled
COPD (Chronic Obstructive Pulmonary Disease)
NCT06067828Phase 3Completed

A Study to Evaluate the Effect of Budesonide, Glycopyrronium, Formoterol Fumarate (BGF) Metered Dose Inhaler (MDI), Budesonide and Formoterol Fumarate (BFF) MDI and Placebo MDI on Exercise Parameters in Participants With Chronic Obstructive Pulmonary Disease (COPD).

Started Oct 2023
171 enrolled
Chronic Obstructive Pulmonary Disease
NCT05755906Phase 3Completed

A 12-week Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose Inhaler in Participants With Inadequately Controlled Asthma (LITHOS)

Started Feb 2023
374 enrolled
Asthma
NCT05573464Phase 3Completed

A Study to Assess the Safety of Budesonide/Glycopyrronium/Formoterol Fumarate With a Next-Generation Propellant in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Started Sep 2022
559 enrolled
Chronic Obstructive Pulmonary Disease (COPD)