BUDESONIDE

Post-LOE

budesonide

Cipla

ANDAINHALATIONSUSPENSION1 Generic Approved

Approved

Nov 2017

Lifecycle

Post-LOE

Competitive Pressure

45/100

Clinical Trials

Data completeness

4/8 — Partial

BUDESONIDE (budesonide) by Cipla is corticosteroid hormone receptor agonists [moa]. Approved for corticosteroid [epc]. First approved in 2017.

Drug data last refreshed 20h ago

Mechanism of Action

Corticosteroid Hormone Receptor Agonists

Pharmacologic Class:

Corticosteroid

Indications

Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.

Clinical Trials (20)

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

Worked on BUDESONIDE at Cipla? Share your interview experience or compensation data (+7 days Pro)

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.