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Seebri® Breezhaler®
Seebri® Breezhaler® is a Small molecule drug developed by Sunovion Respiratory Development Inc.. It is currently in Phase 1 development. Also known as: glycopyrronium, glycopyrronium bromide.
Seebri Breezhaler is a treatment for Chronic Obstructive Pulmonary Disease (COPD) and ACOS (Fixed Airflow Obstruction and Elevated Eosinophils). It is administered via the Breezhaler inhaler device.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Seebri® Breezhaler® |
|---|---|
| Also known as | glycopyrronium, glycopyrronium bromide |
| Sponsor | Sunovion Respiratory Development Inc. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Morbid Rates After Spiriva Chronic Obstructive Pulmonary Disease (COPD) Protocol Change
- Study to Compare Relative Bioavailability of 3 Indacaterol/Glycopyrronium Test Products and Reference Product (PHASE1)
- Comparative Study of Error Rates Between ELLIPTA® Dry Powder Inhaler (DPI) and Other DPIs
- Study to Determine the Amount of Glycopyrrolate Absorbed in the Lungs After Taking the Medicine With a eFlow Nebulizer and Seebri® Breezhaler® With and Without Activated Charcoal in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD). (PHASE1)
- A Study to Compare Fluticasone /Formoterol Breath Actuated Inhaler (BAI) and Ultibro in Subjects With Fixed Airflow Obstruction and Elevated Eosinophils (PHASE2, PHASE3)
- Efficacy of NVA237 (50 μg o.d) Using Tiotropium (5μg μg o.d) as Active Control in COPD Patients. (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:
- Seebri® Breezhaler® CI brief — competitive landscape report
- Seebri® Breezhaler® updates RSS · CI watch RSS
- Sunovion Respiratory Development Inc. portfolio CI
Frequently asked questions about Seebri® Breezhaler®
What is Seebri® Breezhaler®?
Who makes Seebri® Breezhaler®?
Is Seebri® Breezhaler® also known as anything else?
What development phase is Seebri® Breezhaler® in?
Related
- Manufacturer: Sunovion Respiratory Development Inc. — full pipeline
- Also known as: glycopyrronium, glycopyrronium bromide
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing