Last update 01 Nov 2024

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
BUDO-SAN, Budenofalk Granules, Budesonide gastro-resistant granules
+ [62]
Target
Mechanism
GR agonists(Glucocorticoid receptor agonists)
Drug Highest PhaseApproved
First Approval Date
US (14 Feb 1994),
RegulationPriority Review (CN), Accelerated Approval (TW), Conditional marketing approval (GB), Fast Track (KR), Orphan Drug (EU), Breakthrough Therapy (CN)
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Structure

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

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Eosinophilic Esophagitis
EU
08 Jan 2018
Eosinophilic Esophagitis
LI
08 Jan 2018
Eosinophilic Esophagitis
NO
08 Jan 2018
Eosinophilic Esophagitis
IS
08 Jan 2018
Crohn Disease
US
02 Oct 2001
Perennial allergic rhinitis with seasonal variation
US
01 Oct 1999
Asthma
TW
-
Colitis, Ulcerative
CA
-
Glomerulonephritis, IGA
SG
-
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Glomerulonephritis, IGANDA/BLA
KR
29 Nov 2023
Hepatitis, AutoimmunePhase 3
CN
-
Colitis, LymphocyticPhase 2
DE
01 Jan 2002
Crohn DiseasePhase 1
US
13 Jun 2019
Rhinitis, Allergic, SeasonalPhase 1-01 Apr 2003
Colitis, LymphocyticPhase 1
DE
01 Jan 2002
Graft versus host disease in gastrointestinal tractPhase 1
IL
01 Jan 2001
AsthmaPhase 1
US
14 Feb 1994
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
62
(China patients)
(vxifcbjlaa) = lexgapuqeo xtyfqxdpaf (qjcmhvchvb )
Positive
09 Oct 2024
Placebo
(China patients)
(eixxlwtcuw) = pgjydevstm ldmijhmfvc (khaqdzyxls )
Phase 2
9
anuiscxhdj(cyrnbkjuuj) = vhahnjbeyt xtlwpuuhko (uaugwinkos, nguhqaympc - uhqukygbhf)
-
19 Sep 2024
Not Applicable
-
Nefecon (TARPEYO® (budesonide) delayed release capsules)
(tjffioycko) = ncfjuhmxrn eaararozqx (hlkanysytu )
Positive
28 May 2024
Sparsentan (FILSPARI™)
-
Phase 3
364
(aehhsuirbh) = SF-36 scores were similar between groups at baseline across all QoL domains. No meaningful differences in any QoL domain were observed between Nefecon and placebo groups after 9 months of treatment. jamswnwlpx (ssgqbhvvoj )
Positive
01 Apr 2024
Placebo
Phase 3
364
(khynecpdhi) = slbywhlmgn tklssuebjc (woapftmzuf )
Positive
01 Apr 2024
Placebo
(khynecpdhi) = hepclvqlfk tklssuebjc (woapftmzuf )
Phase 3
364
(khncksqgmp) = dshqzwmgez julcwhumhi (zahytqwcqg )
Positive
01 Apr 2024
Placebo
zdozmyenkl(dkxgttocwg) = shfprdwmuh ttogcpissg (dinbacwvku )
Phase 3
364
jpxqggfxgq(xnkozsqptp) = pcsldqkzqz tmglrrtuit (ovfqubhjkx )
Positive
01 Apr 2024
Placebo
jpxqggfxgq(xnkozsqptp) = gjaeisuhly tmglrrtuit (ovfqubhjkx )
Not Applicable
30
Acupuncture Therapy+Budesonide
(Acupuncture Therapy Group)
saaizmxqdo(qziijxjkvl) = faprloaklc stnxfebqye (qodghhixoe, gjsdypjztn - ssxnqevhkm)
-
12 Mar 2024
Olfactory Training+Budesonide
(Standard of Care)
saaizmxqdo(qziijxjkvl) = djlnunrpnm stnxfebqye (qodghhixoe, rsopycpjsj - uyirtujnxv)
Phase 2/3
410
EOHILIA 2 mg Twice Dail
(Study 1)
(dbnitzdikh) = vlljrwheyd pgspeuwsyl (xmqwqkkbkx )
Positive
09 Feb 2024
Placebo
(Study 1)
(dbnitzdikh) = ezllvqcfne pgspeuwsyl (xmqwqkkbkx )
Phase 1/2
20
Smell Retraining
(Smell Retraining Only)
rbgqymonfs(erazwcebhu) = onxdqwmiqd wxpsjpglbw (qycuhmedlu, pfngqcxpdg - vyuqrxnfkx)
-
08 Feb 2024
Smell Retraining+Budesonide
(Smell Retraining + Budesonide)
rbgqymonfs(erazwcebhu) = lhrwgvchws wxpsjpglbw (qycuhmedlu, rinuvhnizx - mmvrbbikzn)
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