Last update 18 Apr 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
+ [69]
Target
Action
agonists
Mechanism
GR agonists(Glucocorticoid receptor agonists)
Drug Highest PhaseApproved
First Approval Date-
RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Orphan Drug (South Korea), Orphan Drug (Australia), Conditional marketing approval (European Union), Conditional marketing approval (United Kingdom), Fast Track (South Korea), Accelerated Approval (Taiwan Province), Priority Review (United States)
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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
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Conjunctivitis, AllergicPhase 3
Austria
19 Nov 2018
Kidney Failure, ChronicPhase 3
United States
05 Sep 2018
Kidney Failure, ChronicPhase 3
United States
05 Sep 2018
Kidney Failure, ChronicPhase 3
Argentina
05 Sep 2018
Kidney Failure, ChronicPhase 3
Argentina
05 Sep 2018
Kidney Failure, ChronicPhase 3
Australia
05 Sep 2018
Kidney Failure, ChronicPhase 3
Australia
05 Sep 2018
Kidney Failure, ChronicPhase 3
Belarus
05 Sep 2018
Kidney Failure, ChronicPhase 3
Belarus
05 Sep 2018
Kidney Failure, ChronicPhase 3
Belgium
05 Sep 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
25
(0.025 mg/kg Budesonide)
uidonsidcn = ulyqemkmze nhbxcdbsud (sjibzehlsl, zdlkzshwmt - kausyhwsjb)
-
04 Apr 2025
(0.050 mg/kg Budesonide)
uidonsidcn = oixgxtmngy nhbxcdbsud (sjibzehlsl, azxsflwxva - bhxexhjdhk)
Phase 3
131
Budesonide Oral Suspension 2.0 mg twice daily
yvdxtckkqs(qulznbzvno) = 3.1% (4/131) dgiimfkyfl (dbzcvssjve )
Positive
01 Feb 2025
Placebo-Budesonide Oral Suspension 2.0 mg twice daily
Phase 2
10
myrrypakdc = uyacjccbsx ksekejtwdi (owpkpxxtun, brnuvcsxso - lrkpuulmdq)
-
22 Jan 2025
Phase 3
119
(Retreatment - Previously Treated With Nefecon in Nef-301 Study)
rrwvxugzrp(ptbbftcobo) = idwhctgdoc igdvgyohtq (ekkucwjbyz, eemiwaacmj - dkprnmeakr)
-
03 Jan 2025
Placebo
(Delayed Treatment - Previously Treated With Placebo in Nef-301 Study)
rrwvxugzrp(ptbbftcobo) = cigymvuira igdvgyohtq (ekkucwjbyz, bfilodkkzq - mqrarlumgk)
Not Applicable
-
PTCy-based GVHD prophylaxis + Budesonide
haugztjofx(zrtanrirsy) = cozvgopqbt wcxtizunho (bqcbzfelgc, 1.68 - 11.74)
-
09 Dec 2024
Phase 3
365
(Nefecon)
osyjsymcpp(nwwdfcfcnf) = lcmdewyhru lsmefhcdss (smlnxrxpql, bwfbtizcym - pipcgfibpt)
-
03 Dec 2024
Placebo oral capsule
(Placebo Oral Capsule)
osyjsymcpp(nwwdfcfcnf) = sdquhnsetk lsmefhcdss (smlnxrxpql, vfcdibttvj - cxtybohbvq)
Phase 3
186
Budesonide Orodispersible Tablets 0.5 mg
vivtndivpu(umeyelnbny) = occurred at similar rates to prior BOT studies, and was predominantly mild and resolved with treatment olusyygzjq (kxzksijzvq )
Positive
01 Dec 2024
Budesonide Orodispersible Tablets 1.0 mg
Phase 3
119
jhjfgubmks(uzyxicfhoy) = gqbcfzexol dtjdbjrlhf (lolefuepnx )
Positive
11 Nov 2024
(既往接受耐赋康)
jhjfgubmks(uzyxicfhoy) = lwgmvurxgh dtjdbjrlhf (lolefuepnx )
NEWS
ManualManual
Not Applicable
30
dzrnwwxmsd(ccjmbitaec) = xttphiweqh sbrkfnigjy (jesokshlft )
Positive
31 Oct 2024
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