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Salbutamol MDI
Salbutamol MDI is a Small molecule drug developed by GlaxoSmithKline. It is currently in Phase 2 development.
Salbutamol MDI is a small molecule that acts as a beta-2 adrenergic receptor agonist. It is used to treat conditions such as asthma and COPD, as well as to assess physiologic performance response in healthy individuals.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
GlaxoSmithKline is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Salbutamol MDI |
|---|---|
| Sponsor | GlaxoSmithKline |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Nebulized or Inhaled Albuterol for Lymphangioleiomyomatosis (PHASE1, PHASE2)
- A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma (PHASE3)
- Effects of Salbutamol in Athletes and Implications for Screening and Sports (NA)
- Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma (PHASE3)
- Study to Investigate Changes in Airway Inflammation, Symptoms, and Rescue Therapy Utilization With AIRSUPRA Compared to Albuterol as Needed in Adults With Mild Asthma (PHASE4)
- A Study to Assess and Compare Safety and Tolerability of 3 Months Treatment With Salbutamol Administered Via MDI Containing Propellant HFA-152a or HFA-134a in Participants ≥ 18 Years of Age With Asthma (PHASE3)
- A Study to Investigate the Effect on Lung Function of BDA Formulated With a Next Generation Propellant Compared With an Approved Asthma Treatment (BDA With HFA Propellant) in Participants With Asthma (PHASE3)
- Anti-Inflammatory Reliever South Africa (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:
- Salbutamol MDI CI brief — competitive landscape report
- Salbutamol MDI updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about Salbutamol MDI
What is Salbutamol MDI?
Who makes Salbutamol MDI?
What development phase is Salbutamol MDI in?
Related
- Manufacturer: GlaxoSmithKline — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing