Wednesday, July 8, 2026

Drug profile · INN

budesonide

budesonide (BUDENOFALK) is a glucocorticoid receptor agonist. Associated with AstraZeneca. Route of administration: rectal. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved NMPA: clinical trials Alimentary tract and metabolism (A07) A07EA06
US status approved
Patents linked 20
Pipeline programs 41
News articles 0
Drug details — budesonide
US status
approved
Class
Alimentary tract and metabolism (A07)
Route
RECTAL
Patents
20
Programs
41
Data quality
0.89

Quick answer

budesonide (BUDENOFALK) is a glucocorticoid receptor agonist. Associated with AstraZeneca. Route of administration: rectal. Current US regulatory status: approved.

Key facts

INN budesonide
Brand BUDENOFALK
Mechanism Glucocorticoid receptor agonist
Target Glucocorticoid receptor
Therapeutic class Alimentary tract and metabolism (A07)
Route RECTAL
Formulation AEROSOL, FOAM
ATC code A07EA06
Originator AstraZeneca

Mechanism of action

Glucocorticoid receptor agonist

Primary target: Glucocorticoid receptor

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
NMPA clinical trials

Pipeline programs

  1. BUL-8/EEA Phase 3 · Dr. Falk Pharma · eosinophilic esophagitis
  2. Budesonide Phase 3 · AstraZeneca · Asthma
  3. Budesonide Phase 3 · Bausch + Lomb · Colitis, Ulcerative
  4. Budesonide and formoterol fumarate dehydrate (BF) SPIROMAX Phase 3 · Teva Pharma · Asthma
  5. Budesonide oral suspension Phase 3 · Takeda · Eosinophilic Esophagitis (EoE)
  6. Budesonide/Formoterol SPIROMAX® Phase 3 · Teva Pharma · Asthma
  7. Budesonide/Formoterol fumarate dihydrate Phase 3 · Teva Pharma · Asthma
  8. Budesonide/formoterol Turbuhaler Phase 3 · AstraZeneca · Asthma

Related & competitor drugs

  1. agalsidase alfa Alimentary tract and metabolism (A16)
  2. alogliptin Alimentary tract and metabolism (A10)
  3. alogliptin benzoate Alimentary tract and metabolism (A10)
  4. aprepitant Alimentary tract and metabolism (A04)
  5. beclomethasone dipropionate Glucocorticoid receptor agonist
  6. betamethasone acetate Glucocorticoid receptor agonist
  1. US 12123012

    Methods and compositions for nucleic acid and protein payload delivery

    Expires Mon Oct 17 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 11970482

    Acetal compounds and therapeutic uses thereof

    Expires Mon Apr 25 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 11773110

    Heterocycle amines and uses thereof

    Expires Mon Sep 28 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 11566041

    Nucleotide prodrug compounds

    Expires Mon Jan 26 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 11413296

    Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract

    Expires Mon Aug 11 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 11278559

    Prodrug compounds and their uses

    Expires Mon Mar 17 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 11197822

    Topical corticosteroids for the treatment of inflammatory diseases of the gastrointestinal tract

    Expires Mon Dec 09 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 11186593

    Heterocycle amines and uses thereof

    Expires Mon Nov 25 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. US 10975388

    Methods and compositions for nucleic acid and protein payload delivery

    Expires Mon Apr 08 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  10. US 10874638

    Methods and compositions for modulating hormone levels

    Expires Mon Dec 24 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  11. US 10604533

    Heterocycle amines and uses thereof

    Expires Mon Mar 26 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  12. US 10449210

    Prodrug compounds and their uses

    Expires Mon Oct 17 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  13. US 10441567

    Methods and compositions for modulating hormone levels

    Expires Mon Oct 10 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  14. US 10150788

    Prodrug compounds and uses thereof

    Expires Mon Dec 06 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  15. US 10030034

    Heterocycle amines and uses thereof

    Expires Mon Jul 19 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  16. US 9994600

    Prodrug compounds and uses therof

    Expires Mon Jun 07 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  17. US 9662312

    Method for treating glomerulosclerosis

    Expires Mon May 25 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  18. US 9326991

    Nucleotide prodrug compounds and use

    Expires Mon Apr 28 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  19. US 9266874

    Heterocycle amines and uses thereof

    Expires Mon Feb 18 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  20. US 9119863

    Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract

    Expires Mon Aug 27 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is budesonide?

budesonide (BUDENOFALK) is a glucocorticoid receptor agonist. Associated with AstraZeneca. Route of administration: rectal. Current US regulatory status: approved.

What is the brand name for budesonide?

BUDENOFALK is a marketed brand name for budesonide. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of budesonide?

budesonide has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.