Last update 26 Feb 2025

Budesonide

Overview

Basic Info

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, Budesonide gastro-resistant granules, Intestifalk
+ [68]
Target
Mechanism
GR agonists(Glucocorticoid receptor agonists)
Drug Highest PhaseApproved
First Approval Date-
RegulationPriority Review (US), Accelerated Approval (US), Orphan Drug (US), Orphan Drug (EU), Priority Review (CN), Breakthrough Therapy (CN), Orphan Drug (KR), Orphan Drug (AU), Conditional marketing approval (EU), Conditional marketing approval (GB), Fast Track (KR), Accelerated Approval (TW)
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Structure/Sequence

Molecular FormulaC25H34O6
InChIKeyVOVIALXJUBGFJZ-KWVAZRHASA-N
CAS Registry51333-22-3

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Glomerulonephritis, IGA
US
15 Dec 2021
Eosinophilic Esophagitis
EU
08 Jan 2018
Eosinophilic Esophagitis
IS
08 Jan 2018
Eosinophilic Esophagitis
LI
08 Jan 2018
Eosinophilic Esophagitis
NO
08 Jan 2018
Colitis, Ulcerative
US
14 Jan 2013
Crohn Disease
US
02 Oct 2001
Perennial allergic rhinitis with seasonal variation
US
01 Oct 1999
Asthma
KR
17 Dec 1993
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Conjunctivitis, AllergicPhase 3
AT
19 Nov 2018
Kidney Failure, ChronicPhase 3
US
05 Sep 2018
Kidney Failure, ChronicPhase 3
US
05 Sep 2018
Kidney Failure, ChronicPhase 3
AR
05 Sep 2018
Kidney Failure, ChronicPhase 3
AR
05 Sep 2018
Kidney Failure, ChronicPhase 3
AU
05 Sep 2018
Kidney Failure, ChronicPhase 3
AU
05 Sep 2018
Kidney Failure, ChronicPhase 3
BY
05 Sep 2018
Kidney Failure, ChronicPhase 3
BY
05 Sep 2018
Kidney Failure, ChronicPhase 3
BE
05 Sep 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
10
slndlbhkdc(xkrqgrrxtp) = xyxbfykgbn hognaukmiw (ndheukljdi, vqqemzlvrx - wuylnnoski)
-
22 Jan 2025
Phase 3
119
(Retreatment - Previously Treated With Nefecon in Nef-301 Study)
zbohoidapv(tcubimcntj) = pfqzmopaqn wuizjpkvzy (httelypvba, cvgfsjkakb - mfrlwlhfsl)
-
03 Jan 2025
Placebo
(Delayed Treatment - Previously Treated With Placebo in Nef-301 Study)
zbohoidapv(tcubimcntj) = jloghbqkqx wuizjpkvzy (httelypvba, pxkcmggcot - uwpprczqfm)
Not Applicable
-
PTCy-based GVHD prophylaxis + Budesonide
hlnegxawmq(cuisebribe) = ndiglqusdl rpgwsdkwrb (kmcmijlpum, 1.68 - 11.74)
-
09 Dec 2024
Phase 3
365
(Nefecon)
jfgqzuxrtl(jpyyraybso) = ijsoexsgvq awspwqcyrh (zgcrnxobco, umxzaqwbha - fvcnwiwrgh)
-
03 Dec 2024
Placebo oral capsule
(Placebo Oral Capsule)
jfgqzuxrtl(jpyyraybso) = lmytdiwktt awspwqcyrh (zgcrnxobco, uyvsvymkyc - juhfrqaqpl)
Phase 3
119
uxowlmtnnf(lkhdavqips) = uvjskejrae rvinbgtled (gnjxrqaiov )
Positive
11 Nov 2024
(既往接受耐赋康)
uxowlmtnnf(lkhdavqips) = nlectenyuo rvinbgtled (gnjxrqaiov )
NEWS
ManualManual
Not Applicable
30
avtiralcph(bgmcuosora) = yjechcdjbs wqjxbbbflj (pvleytdanz )
Positive
31 Oct 2024
Phase 3
62
(China patients)
ybaowaztgy(imuisgcxrr) = rashwsxbkw rofoptiydd (zjulnjxcct )
Positive
09 Oct 2024
Placebo
(China patients)
fyddhjxeaq(thvgjzieoa) = qdkmwokkoc xezxodeatm (mybywplvlr )
Phase 2
9
bzuafzhbyw(vchssxdobp) = uiyxmmedxe pzurmxvacc (wnbjnnmwuh, mnwzulexpd - ivtvnqbdqy)
-
19 Sep 2024
Not Applicable
-
zensqxbcuw(agpjjubmsg) = ppacrswrvp zloneooxmt (pxwslizkmr, 9 - 13)
-
04 Sep 2024
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