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Albuterol MDPI
Albuterol MDPI is a Beta-2 adrenergic agonist (short-acting bronchodilator) Small molecule drug developed by Teva Branded Pharmaceutical Products R&D, Inc.. It is currently in Phase 3 development for Acute bronchospasm and reversible airway obstruction in asthma, Chronic obstructive pulmonary disease (COPD) with reversible airway obstruction. Also known as: ProAir® RespiClick, Albuterol Spiromax®, ProAir® RespiClick, Albuterol Spiromax, Spiromax®.
Albuterol is a beta-2 adrenergic agonist that binds to beta-2 receptors on airway smooth muscle, causing relaxation and bronchodilation.
Albuterol MDPI is a small molecule used to treat conditions such as pulmonary disease, chronic obstructive, and asthma.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Albuterol MDPI |
|---|---|
| Also known as | ProAir® RespiClick, Albuterol Spiromax®, ProAir® RespiClick, Albuterol Spiromax, Spiromax® |
| Sponsor | Teva Branded Pharmaceutical Products R&D, Inc. |
| Drug class | Beta-2 adrenergic agonist (short-acting bronchodilator) |
| Target | Beta-2 adrenergic receptor (ADRB2) |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | Phase 3 |
Mechanism of action
Albuterol activates beta-2 adrenergic receptors on bronchial smooth muscle, triggering a cascade that increases intracellular cAMP and leads to smooth muscle relaxation. This results in rapid airway dilation and improved airflow. The metered-dose powder inhaler (MDPI) formulation delivers the drug directly to the lungs for quick onset of action.
Approved indications
- Acute bronchospasm and reversible airway obstruction in asthma
- Chronic obstructive pulmonary disease (COPD) with reversible airway obstruction
Common side effects
- Tremor
- Headache
- Nervousness
- Palpitations
- Muscle cramps
- Tachycardia
Key clinical trials
- Pharmacokinetic Profile and Safety of Fluticasone Propionate and Albuterol Sulfate in Combination When Compared to Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) in Children Aged 4 to 11 Years Old (PHASE1)
- Efficacy and Safety Comparison of Tiotropium Daily + Salmeterol Daily or Twice Daily Versus Tiotropium Daily in Patients With COPD (PHASE3)
- Study of Fluticasone Propionate MDPI Compared With Fluticasone/Salmeterol MDPI in Adolescent and Adult Patients With Persistent Asthma (PHASE3)
- Efficacy and Safety Study of FP MDPI Compared With FS MDPI in Adolescent and Adult Patients With Persistent Asthma (PHASE3)
- A Chronic-Dose Safety and Efficacy Study of Albuterol Multi-Dose Dry Powder Inhaler in Pediatric Asthmatics (PHASE3)
- Study to Determine the Pharmacokinetics and Tolerability of Fluticasone Propionate MDPI and Fluticasone Propionate/Salmeterol MDPI Compared to High Strength FLOVENT® DISKUS® and ADVAIR® DISKUS® in Patients With Persistent Asthma 12 Years of Age and Older (PHASE1)
- A Dose-ranging Study to Evaluate Albuterol and Hydrofluoroalkane in Subjects Ages 12 and Older With Persistent Asthma (PHASE2)
- Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Albuterol MDPI CI brief — competitive landscape report
- Albuterol MDPI updates RSS · CI watch RSS
- Teva Branded Pharmaceutical Products R&D, Inc. portfolio CI
Frequently asked questions about Albuterol MDPI
What is Albuterol MDPI?
How does Albuterol MDPI work?
What is Albuterol MDPI used for?
Who makes Albuterol MDPI?
Is Albuterol MDPI also known as anything else?
What drug class is Albuterol MDPI in?
What development phase is Albuterol MDPI in?
What are the side effects of Albuterol MDPI?
What does Albuterol MDPI target?
Related
- Drug class: All Beta-2 adrenergic agonist (short-acting bronchodilator) drugs
- Target: All drugs targeting Beta-2 adrenergic receptor (ADRB2)
- Manufacturer: Teva Branded Pharmaceutical Products R&D, Inc. — full pipeline
- Therapeutic area: All drugs in Respiratory
- Indication: Drugs for Acute bronchospasm and reversible airway obstruction in asthma
- Indication: Drugs for Chronic obstructive pulmonary disease (COPD) with reversible airway obstruction
- Also known as: ProAir® RespiClick, Albuterol Spiromax®, ProAir® RespiClick, Albuterol Spiromax, Spiromax®
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing