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Placebo MDI HFA
Placebo MDI HFA is a Small molecule drug developed by AstraZeneca. It is currently in Phase 3 development for Treatment of asthma symptoms. Also known as: Placebo.
This is a placebo, meaning it has no active therapeutic effect.
Placebo MDI HFA is a small molecule used as a control in clinical trials for asthma treatment. It is administered via a metered-dose inhaler (MDI) with a hydrofluoroalkane (HFA) propellant.
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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). -
Big-pharma sponsor
+3.0pp
AstraZeneca 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 | 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 | Placebo MDI HFA |
|---|---|
| Also known as | Placebo |
| Sponsor | AstraZeneca |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
Placebos are inert substances used as controls in clinical trials to compare the efficacy of active treatments. They do not interact with biological systems in any way.
Approved indications
- Treatment of asthma symptoms
Common side effects
- Local irritation
Key clinical trials
- Efficacy and Safety of CHF 1535 200/6µg in Not Adequately Controlled Asthmatic Patients (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)
- A Study to Investigate the Effect on Lung Function of an Approved COPD Treatment (BGF, With HFA Propellant) Compared to BGF Formulated With a Next-Generation Propellant in Participants 40 to 80 Years of Age With COPD (PHASE3)
- BE Study of Albuterol Sulfate Inhalation Aerosol 90 mcg Per Actuation in Patients With Stable Mild Asthma (PHASE3)
- Pharmacodynamic Equivalence of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate in Adult Patients With Stable Mild Asthma (NA)
- Study on BI 54903 (Inhaled Corticosteroid) Administered Twice Daily Via Respimat Inhaler in Patients With Asthma Inadequately Controlled on Medium Dose Inhaled Corticosteroid (ICS). (PHASE2)
- Clinical Study to Evaluate the Safety, Tolerability and the Concentration of the BDP (Beclomethasone Dipropionate), Active Metabolite of BDP, FF( Formoterol Fumarate) and GB (Glycopyrronium Bromide), After Inhalation of CHF 5993 at Two Different Doses and QVAR® (PHASE1)
- Bronchoprovocation Study to Demonstrate the Pharmacodynamic Bioequivalence of Albuterol Sulfate HFA Inhalation Aerosol (E.Q. 90 mcg of Albuterol Base/Inh) of Macleods Pharmaceuticals Ltd (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:
- Placebo MDI HFA CI brief — competitive landscape report
- Placebo MDI HFA updates RSS · CI watch RSS
- AstraZeneca portfolio CI
Frequently asked questions about Placebo MDI HFA
What is Placebo MDI HFA?
How does Placebo MDI HFA work?
What is Placebo MDI HFA used for?
Who makes Placebo MDI HFA?
Is Placebo MDI HFA also known as anything else?
What development phase is Placebo MDI HFA in?
What are the side effects of Placebo MDI HFA?
Related
- Manufacturer: AstraZeneca — full pipeline
- Indication: Drugs for Treatment of asthma symptoms
- Also known as: Placebo
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing