NDAORALCAPSULE, DELAYED RELEASE
Approved
Jun 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
ORTIKOS (budesonide) by PharmaIN is corticosteroid hormone receptor agonists [moa]. Approved for asthma. First approved in 2019.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ORTIKOS (budesonide) is an oral delayed-release corticosteroid approved in 2019 for a broad range of respiratory, allergic, gastrointestinal, and renal inflammatory conditions. It works as a corticosteroid hormone receptor agonist to reduce inflammation across multiple organ systems. The product targets patients with chronic inflammatory diseases including asthma, COPD, ulcerative colitis, eosinophilic esophagitis, and IgA nephropathy.
$0.213MPart D
Peak10.3 years to LOEEarly-stage peak commercial phase with modest Part D penetration suggests growing adoption; brand team size likely lean relative to established franchises.
Mechanism of Action
Corticosteroid Hormone Receptor Agonists
Indications (1)
Clinical Trials (20)
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
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
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
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
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
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.