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albuterol

Generic: ALBUTEROL·Brand: ACCUNEB, ALBUTEROL, ALBUTEROL SULFATE, PROAIR DIGIHALER, PROAIR HFA, PROAIR RESPICLICK, PROVENTIL, PROVENTIL-HFA, VENTOLIN, VENTOLIN HFA, VENTOLIN ROTACAPS, VOLMAX, VOSPIRE ER

albuterol: developed by 1 company · 4 clinical trials tracked · 1 FDA decision.

albuterol evidence translation

What we can confirm

1 FDA record · 4 tracked trials

What it means

Source-backed records connect albuterol to TEVA; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could albuterol → TEVA affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 1 study sponsors

Related indications

Development Pipeline (1)
CompanyPhase
Teva Pharmaceutical Industries Limited (TEVA)Approved
Clinical Trials (4)

Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and Revefenacin) vs. Short-Acting Bronchodilators (Albuterol and Ipratropium) in Patients Presenting to the Emergency Department With Acute Exacerbation of COPD (ECOPD): A Phase IV, Prospective, Randomized, Blinded, Parallel-group Trial

NCT07721922·Phase 4
Not yet recruiting

Primary endpoint: Difference in Modified Borg Dyspnea Scale scores between groups

InterventionalRandomizedtriple280 targetStarted 2026-09Completion 2028-091 site · United StatesUniversity of Tennessee Graduate School of Medicine

ANCHOR - Assessment of Combination Short-Acting BroNchodilator and Inhaled Corticosteroid Rescue Therapy on Health Outcomes in Routine Care

NCT06422689·Phase 4·AZN
Active, not recruiting

Primary endpoint: Asthma exacerbation

Interventionalopen1,511 enrolledStarted 2024-05Completion 2027-0211 sites · United StatesAstraZeneca

A Randomized, Double-Blind, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate Fixed-Dose Combination on Severe Asthma Exacerbations in Patients With Asthma

NCT06052267·Phase 3·TEVA
Active, not recruiting

Primary endpoint: Time to First Severe Clinical Asthma Exacerbation (CAE) with High Dose (HD) Fp/ABS eMDPI

InterventionalRandomizedquadruple2,772 enrolledStarted 2023-08Completion 2026-1050 sites · United StatesTeva Branded Pharmaceutical Products R&D LLC

CONNected Electronic Inhalers Asthma Control Trial 1 ("CONNECT 1"), a 12-Week Treatment, Multicenter, Open-Label, Randomized, Parallel Group Comparison, Feasibility Study to Evaluate the Effectiveness of the Albuterol eMDPI Digital System, to Optimize Outcomes in Patients at Least 13 Years of Age or Older With Asthma

NCT03890666·Phase 4·TEVA
Completed

Primary endpoint: Percentage of Participants Achieving Meaningful Asthma Improvement at the End of 12-Week Treatment Period

InterventionalRandomizedopen333 enrolledStarted 2020-10Completion 2021-1029 sites · United StatesTeva Branded Pharmaceutical Products R&D, Inc.
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE ProAir Digihaler is a beta 2 -adrenergic agonist indicated for: Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. ( 1.1 ) Prevention of exercise-induced bronchospasm in patients 4 years of age and older. ( 1.2 ) 1.1 Bronchospasm ProAir ® Digihaler ® is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. 1.2 Exercise-(TEVA)FDA ↗
NDA205636Type 3 - New Dosage FormStandardInhalationPowder, Metered

Frequently asked questions

Who is developing albuterol?

albuterol is being developed by Teva Pharmaceutical Industries Limited.

How many clinical trials involve albuterol?

BioSniper tracks 4 clinical trials involving albuterol.

What is albuterol's latest FDA decision?

The most recent tracked FDA decision for albuterol is Approval for 1 INDICATIONS AND USAGE ProAir Digihaler is a beta 2 -adrenergic agonist indicated for: Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. ( 1.1 ) Prevention of exercise-induced bronchospasm in patients 4 years of age and older. ( 1.2 ) 1.1 Bronchospasm ProAir ® Digihaler ® is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. 1.2 Exercise-, dated March 31, 2015.