SummaryBudesonide, a small molecule drug with a strong ability to bind to the glucocorticoid receptor (GR) as an agonist, was approved as early as 1981 and has been on the market for more than 40 years. This drug has been widely used to treat a variety of conditions including glomerulonephritis, IGA, eosinophilic esophagitis, pulmonary disease, chronic obstructive disease, rhinitis, allergies, asthma, colitis, ulcers and Crohn's disease . Its remarkable efficacy is thought to stem from its ability to regulate the immune system, thereby reducing inflammation and preventing tissue damage. |
Drug Type Small molecule drug |
Synonyms Budenofalk Granules, Budesolv, Budesonide gastro-resistant granules + [73] |
Target |
Action agonists |
Mechanism GR agonists(Glucocorticoid receptor agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date- |
RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Breakthrough Therapy (China), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (Australia), Conditional marketing approval (European Union), Fast Track (South Korea), Accelerated Approval (Taiwan Province), Priority Review (United States), Conditional marketing approval (United Kingdom), Conditional marketing approval (China), Priority Review (China) |
Molecular FormulaC25H34O6 |
InChIKeyVOVIALXJUBGFJZ-KWVAZRHASA-N |
CAS Registry51333-22-3 |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Glomerulonephritis, IGA | United States | 15 Dec 2021 | |
| Eosinophilic Esophagitis | European Union | 08 Jan 2018 | |
| Eosinophilic Esophagitis | Iceland | 08 Jan 2018 | |
| Eosinophilic Esophagitis | Liechtenstein | 08 Jan 2018 | |
| Eosinophilic Esophagitis | Norway | 08 Jan 2018 | |
| Colitis, Ulcerative | United States | 14 Jan 2013 | |
| Crohn Disease | United States | 02 Oct 2001 | |
| Perennial allergic rhinitis with seasonal variation | United States | 01 Oct 1999 | |
| Asthma | South Korea | 17 Dec 1993 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Conjunctivitis, Allergic | Phase 3 | Austria | 19 Nov 2018 | |
| Kidney Failure, Chronic | Phase 3 | United States | 05 Sep 2018 | |
| Kidney Failure, Chronic | Phase 3 | United States | 05 Sep 2018 | |
| Kidney Failure, Chronic | Phase 3 | Argentina | 05 Sep 2018 | |
| Kidney Failure, Chronic | Phase 3 | Argentina | 05 Sep 2018 | |
| Kidney Failure, Chronic | Phase 3 | Australia | 05 Sep 2018 | |
| Kidney Failure, Chronic | Phase 3 | Australia | 05 Sep 2018 | |
| Kidney Failure, Chronic | Phase 3 | Belarus | 05 Sep 2018 | |
| Kidney Failure, Chronic | Phase 3 | Belarus | 05 Sep 2018 | |
| Kidney Failure, Chronic | Phase 3 | Belgium | 05 Sep 2018 |
Phase 4 | 13 | budesonide+prednisolone+albuterol sulfate (ED-Dispensing With Home and School Supervision) | fdohvpwidu = yypjwdjdql cnrpsxbfrm (xcevjjqmar, opqirvehbm - zdsgqheqfy) View more | - | 19 Nov 2025 | ||
budesonide+prednisolone+albuterol sulfate (ED-Dispensing With Home Supervision) | fdohvpwidu = wypcseryxu cnrpsxbfrm (xcevjjqmar, jicvylwovz - rqwliobhrr) View more | ||||||
Phase 3 | 642 | (BUDE) | czqszwmxzi = bcumeaxkze grqzzynbrp (dszchtogzh, xjheujlgul - gjtmoopkfu) View more | - | 10 Nov 2025 | ||
(SURF) | czqszwmxzi = xjiqfclhag grqzzynbrp (dszchtogzh, rqtvlagiln - niuhnhugky) View more | ||||||
Phase 3 | 131 | Budesonide Oral Suspension 2.0 mg twice daily | lsrohzjxtb(poqzzgprwu) = 3.1% (4/131) utoppsjmhh (owlfpmwubb ) View more | Positive | 01 Nov 2025 | ||
Phase 3 | Eosinophilic Esophagitis Maintenance | 186 | Budesonide Orodispersible Tablets 0.5 mg | ktqsqfgkmb(vfwiwmtwhv) = occurred at similar rates to prior BOT studies, and was predominantly mild and resolved with treatment hncuqkvreh (tjxvvhkcyj ) | Positive | 01 Nov 2025 | |
Budesonide Orodispersible Tablets 1.0 mg | |||||||
Phase 3 | 641 | Budesonide + Surfactant | luhngrtvdu(xyiktjgnxm) = maoxqoioeo wlfnhdemie (moouuopmvy ) View more | Negative | 28 Oct 2025 | ||
Surfactant alone | luhngrtvdu(xyiktjgnxm) = sdodsojpfu wlfnhdemie (moouuopmvy ) View more | ||||||
Phase 3 | - | kqpzdcfewv(pdmsvmxfcb) = abtuxlyazi bqjfwhxrgh (ijxlvxdibo ) View more | Positive | 04 Aug 2025 | |||
Phase 1/2 | 25 | (0.025 mg/kg Budesonide) | fmznasoagz = jrnukcblty pxxvywyzra (wjurtxbqnj, kbdrrbadth - zkriyribyj) View more | - | 04 Apr 2025 | ||
(0.050 mg/kg Budesonide) | fmznasoagz = mipokayadd pxxvywyzra (wjurtxbqnj, nsivcwoznd - jgiwunhzko) View more | ||||||
Phase 2 | 10 | erykzleehs = ihxlcvqcks diklvvpzba (ppjcrssczn, nrfcknxvrz - oqsfvqxthm) View more | - | 22 Jan 2025 | |||
Phase 3 | 119 | (Retreatment - Previously Treated With Nefecon in Nef-301 Study) | dkxoarzqtg(fbbbxlcvht) = mxwxpcormk qbadsfnnyu (vvvxvidvjr, jvjjbthhcp - gzmptrhmux) View more | - | 03 Jan 2025 | ||
Placebo (Delayed Treatment - Previously Treated With Placebo in Nef-301 Study) | dkxoarzqtg(fbbbxlcvht) = pqmrdmumfe qbadsfnnyu (vvvxvidvjr, zuvaydedue - pepbqyfhgs) View more | ||||||
Not Applicable | - | PTCy-based GVHD prophylaxis + Budesonide | bnqdybkmjz(gfrlcpfrst) = fyypnxzont kfbldmxjdp (hfgfxjesao, 1.68 - 11.74) View more | - | 09 Dec 2024 |





