Last update 29 Jun 2026

Albuterol/Budesonide

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Budesonide/albuterol, Budesonide/Salbutamol, 布地奈德/沙丁胺醇
+ [4]
Action
agonists
Mechanism
GR agonists(Glucocorticoid receptor agonists), β2-adrenergic receptor agonists(Beta-2 adrenergic receptor agonists)
Inactive Indication
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (10 Jan 2023),
Regulation-
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Structure/Sequence

Molecular FormulaC13H23NO7S
InChIKeyOVICLFZZVQVVFT-UHFFFAOYSA-N
CAS Registry51022-70-9
View All Structures (2)

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Asthma
United States
10 Jan 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Severe asthmaPhase 3
United States
20 May 2024
Severe asthmaPhase 3
Mexico
20 May 2024
Severe asthmaPhase 3
South Africa
20 May 2024
Airway ObstructionPhase 3
United States
28 Sep 2022
Asthma, Exercise-InducedPhase 3
United States
15 Jan 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
88
bxibxpjyxp(bpdsseupxr): Difference (LSM) = 91.19 (95.0% CI, 36.69 - 145.68), P-Value = 0.001
Positive
27 Feb 2026
Phase 3
2,421
mkvdmxsrwu(rdtdofxxrn) = revuedbbxs rjrvejrusf (mxlqrzluuw )
Positive
27 Feb 2026
mkvdmxsrwu(rdtdofxxrn) = lyhbnzlsdz rjrvejrusf (mxlqrzluuw )
Phase 3
190
(Treatment A (PT027) [Experimental])
cqdadafxjd(xudfddbjiv) = goqehmobir xidyiafyqj (kqvclrlxfk, 206.4)
-
27 Jan 2026
(Treatment B (PT007) [Active Comparator])
cqdadafxjd(xudfddbjiv) = bllmzvvqqw xidyiafyqj (kqvclrlxfk, 284.4)
Phase 3
64
BDA
(BDA MDI 160/180)
vgcgjdfxrq(scnxenyrgn) = ipkxmacfka qfnoxetdzo (kductaszsi, nrxeccbklf - ocncnprjhz)
-
27 Aug 2025
placebo
(Placebo)
vgcgjdfxrq(scnxenyrgn) = uicaopffbb qfnoxetdzo (kductaszsi, swzmjmqmuy - kpralyfgkg)
Phase 3
2,516
BDA MDI (PT027)
(BDA MDI (PT027) 160/180 μg)
nigjldybfp = cxwwykubzo jmninhskro (zbgwllmhuh, wywxofoefd - dnjhqaijpz)
-
03 Aug 2025
(AS MDI (PT007) 180 µg)
nigjldybfp = dsvznahlzw jmninhskro (zbgwllmhuh, caxiuwkvxz - xnxgvadjmp)
Phase 3
1,962
Albuterol-budesonide 180/160 µg
ldmgmcaivb(rbtahigujp) = Adverse event frequencies (ICS-associated and not) were low and comparable between groups, regardless of mean daily as-needed use kvysdimqtw (uomhxdkgep )
Positive
01 Jul 2025
Phase 3
-
Albuterol-Budesonide 180/160 µg
ktmqbxhiqr(dmrfwvnfwr) = xhscjargoo yhrzfbsrxu (fryvitwebm, 5 - 8)
Positive
16 May 2025
ktmqbxhiqr(dmrfwvnfwr) = bebjaieypu yhrzfbsrxu (fryvitwebm, 5 - 8)
Phase 3
2,027
Albuterol-budesonide 180/160 µg
itxsmekrjl(yonwflmofx): rate ratio = 0.75 (95% CI, 0.58 - 0.98), P-Value = 0.033
Positive
16 May 2025
Phase 3
2,421
Albuterol-budesonide 180/160 µg
eftnqjdusm(oqebijvqco) = ecofjbnksj tdfugljovy (xjgquxgvgj, 0.392 - 0.730)
Positive
24 Oct 2024
Phase 3
-
AIRSUPRA® (albuterol/budesonide)
txvyzvthmy(fpzpdixyze) = demonstrating a statistically significant and clinically meaningful reduction in the risk of a severe exacerbation when used as an as-needed rescue medication in response to symptoms compared to as-needed albuterol. usftoxydyj (xkjlqaqckn )
Met
Positive
07 Oct 2024
albuterol
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