ORTIKOS

Peak

budesonide

NDAORALCAPSULE, DELAYED RELEASE
Approved
Jun 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20

Clinical Trials (5)

NCT05976802Phase 4Not Yet Recruiting

Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Rectal Foam in Pediatric Patients Aged 5 to 17 Years With Active, Mild to Moderate Distal Ulcerative Colitis

Started Jun 2027
100 enrolled
Ulcerative Colitis
NCT07433569Phase 1Recruiting

A Study to Investigate How Budesonide and Formoterol Move Through the Body (Pharmacokinetics) When Delivered With Different Devices in Participants Aged 4 to Less Than 12 Years Old With Asthma

Started Mar 2026
12 enrolled
Asthma
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
NCT06712563N/ARecruiting

Pooled Analysis of Single-arm Studies of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting

Started Apr 2025
2,000 enrolled
Pulmonary Disease, Chronic Obstructive
NCT06723756Phase 1Completed

A Study to Investigate the Exposure of Budesonide, Glycopyrronium, and Formoterol (BGF) Delivered by Hydrofluoroolefin (HFO) Propellant Metered Dose Inhaler (MDI) Compared to a Hydrofluoroalkane (HFA) Propellant MDI in Healthy Adults

Started Jan 2025
105 enrolled
Healthy Participants

Loss of Exclusivity

LOE Date
Sep 9, 2036
128 months away
Patent Expiry
Sep 9, 2036

Patent Records (2)

Patent #ExpiryTypeUse Code
10172802
Sep 9, 2036
U-2554
9707182
Sep 9, 2036
Product
U-2554