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Placebo inhalation solution QD
Placebo inhalation solution QD is a Small molecule drug developed by Mylan Pharma UK Ltd.. It is currently in Phase 3 development.
Placebo has no active pharmacological mechanism and produces therapeutic effects solely through the placebo effect.
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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 | Placebo inhalation solution QD |
|---|---|
| Sponsor | Mylan Pharma UK Ltd. |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
Placebo is an inert substance used as a control in clinical trials. Any observed clinical benefit derives from patient expectation, the therapeutic context, and psychobiological mechanisms rather than direct drug action. In Phase 3 trials, placebo serves as the comparator to establish the efficacy of the investigational active agent.
Approved indications
Common side effects
Key clinical trials
- Safety and Efficacy of JKN2304 Inhalation Solution in Patients With Moderate to Severe COPD (PHASE2)
- DBM-1152A Inhalation Solution in Healthy Volunteers (PHASE1)
- Safety, Tolerability and Efficacy of MP-376 Given for 28 Days to Cystic Fibrosis (CF) Patients (PHASE2)
- Revefenacin in Chinese Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease(COPD) (PHASE3)
- Safety, Tolerability, & Pharmacokinetics Study of Single & Multiple Inhaled Doses of Imatinib Inhalation Solution (PHASE1)
- A 7-Day Cross-over Study of QD (Once Daily) and BID (Twice Daily) TD-4208 in Chronic Obstructive Pulmonary Disease (COPD) (PHASE2)
- A Study to Evaluate the Effect of AZD8154 Administered Via Nebulizer Once Daily in Subjects With Mild Allergic Asthma Challenged With an Inhaled Allergen (PHASE2)
- Efficacy and Safety Study of RAGWITEK™ (MK-3641) in Children With Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (MK-3641-008) (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 inhalation solution QD CI brief — competitive landscape report
- Placebo inhalation solution QD updates RSS · CI watch RSS
- Mylan Pharma UK Ltd. portfolio CI
Frequently asked questions about Placebo inhalation solution QD
What is Placebo inhalation solution QD?
How does Placebo inhalation solution QD work?
Who makes Placebo inhalation solution QD?
What development phase is Placebo inhalation solution QD in?
Related
- Manufacturer: Mylan Pharma UK Ltd. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing