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Placebo Nebuliser solution
Placebo Nebuliser solution is a Small molecule drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Clinical trial control arm (indication under investigation in Phase 3 trial not specified). Also known as: Nebulizer, Atomizer.
A placebo nebuliser solution contains no active pharmaceutical ingredient and produces no direct pharmacological effect.
A placebo nebuliser solution contains no active pharmaceutical ingredient and produces no direct pharmacological effect. Used for Clinical trial control arm (indication under investigation in Phase 3 trial not specified).
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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 Nebuliser solution |
|---|---|
| Also known as | Nebulizer, Atomizer |
| Sponsor | GlaxoSmithKline |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
Placebo formulations are inert preparations used as control comparators in clinical trials to distinguish genuine drug effects from placebo response. In a nebulised form, the placebo solution is inhaled via nebuliser device but delivers no therapeutic agent, allowing researchers to measure baseline disease progression and psychological/expectation-driven improvements in Phase 3 trial populations.
Approved indications
- Clinical trial control arm (indication under investigation in Phase 3 trial not specified)
Common side effects
Key clinical trials
- Traditional Chinese Medicine Ultrasonic Atomization Treatment for Dry Eye Disease (NA)
- Inhaled Treprostinil for Dyspnea and Exercise Intolerance in Mild COPD (PHASE2)
- Safety and Efficacy of JKN2304 Inhalation Solution in Patients With Moderate to Severe COPD (PHASE2)
- Inhaled RB042 in Healthy Adult Volunteers and Healthy Adult Smokers (PHASE1)
- Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis (PHASE3)
- A Phase IIb Study of Glycopyrrolate Inhalation Solution Over 1 Week in Subjects With COPD (PHASE2)
- Inhaling Penehyclidine to Prevent Perioperative Respiratory Adverse Events in Children at Risk Undergoing Sevoflurane Anesthesia (PHASE4)
- Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF) (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 Nebuliser solution CI brief — competitive landscape report
- Placebo Nebuliser solution updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about Placebo Nebuliser solution
What is Placebo Nebuliser solution?
How does Placebo Nebuliser solution work?
What is Placebo Nebuliser solution used for?
Who makes Placebo Nebuliser solution?
Is Placebo Nebuliser solution also known as anything else?
What development phase is Placebo Nebuliser solution in?
Related
- Manufacturer: GlaxoSmithKline — full pipeline
- Indication: Drugs for Clinical trial control arm (indication under investigation in Phase 3 trial not specified)
- Also known as: Nebulizer, Atomizer
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing