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Placebo ACCUHALER/DISKUS
Placebo ACCUHALER/DISKUS is a Small molecule drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Control arm in Phase 3 clinical trials (therapeutic area unknown).
Placebo contains no active pharmaceutical ingredient and produces no direct pharmacological effect.
Placebo contains no active pharmaceutical ingredient and produces no direct pharmacological effect. Used for Control arm in Phase 3 clinical trials (therapeutic area unknown).
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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
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 | 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 ACCUHALER/DISKUS |
|---|---|
| Sponsor | GlaxoSmithKline |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
Placebo is an inert formulation used as a control in clinical trials to establish baseline efficacy and safety profiles of investigational drugs. The ACCUHALER/DISKUS delivery systems are dry powder inhalers designed for pulmonary drug administration, but when containing placebo, they deliver no active therapeutic agent. Any observed effects are attributable to the placebo response or natural disease progression.
Approved indications
- Control arm in Phase 3 clinical trials (therapeutic area unknown)
Common side effects
Key clinical trials
- Crossover Study Comparing Fluticasone Furoate (FF)/Vilanterol (VI) Once Daily Versus Fluticasone Propionate (FP) Twice Daily in Subjects With Asthma and Exercise-Induced Bronchoconstriction (EIB) (PHASE4)
- An Efficacy and Safety Study of Fluticasone Furoate/Vilanterol 100/25 Microgram (mcg) Inhalation Powder, Fluticasone Propionate/Salmeterol 250/50 mcg Inhalation Powder, and Fluticasone Propionate 250 mcg Inhalation Powder in Adults and Adolescents With Persistent Asthma (PHASE3)
- A Study to Assess the Efficacy of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD) (PHASE3)
- A Study to Compare the Efficacy and Safety of Umeclidinium/Vilanterol and Fluticasone Propionate/Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD) (PHASE3)
- A Study to Compare the Efficacy and Safety of Umeclidinium/Vilanterol With Fluticasone Propionate/Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD) (PHASE3)
- Dose Ranging Study Evaluating the Efficacy and Safety of GSK2190915 Administered Once Daily (PHASE2)
- A Study to Evaluate the Efficacy and Safety of Umeclidinium Bromide/Vilanterol Compared With Fluticasone Propionate/Salmeterol Over 12 Weeks in Subjects With Chronic Obstructive Pulmonary Disease (COPD) (PHASE3)
- Study of Inhaler Device Attributes Investigating Critical and Overall Errors, Ease of Use, and Preference Between a Number of Inhaler Devices (PHASE4)
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 ACCUHALER/DISKUS CI brief — competitive landscape report
- Placebo ACCUHALER/DISKUS updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about Placebo ACCUHALER/DISKUS
What is Placebo ACCUHALER/DISKUS?
How does Placebo ACCUHALER/DISKUS work?
What is Placebo ACCUHALER/DISKUS used for?
Who makes Placebo ACCUHALER/DISKUS?
What development phase is Placebo ACCUHALER/DISKUS in?
Related
- Manufacturer: GlaxoSmithKline — full pipeline
- Indication: Drugs for Control arm in Phase 3 clinical trials (therapeutic area unknown)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing