Last reviewed · How we verify
Oxytropium Bromide (OXITROPIUM)
Oxytropium Bromide (generic name: OXITROPIUM) is a oxitropium drug. It is currently in Phase 3 development for Chronic obstructive lung disease.
Oxytropium works by blocking the action of acetylcholine, a neurotransmitter that causes airway muscles to contract.
Oxytropium bromide is a small molecule medication used to treat conditions such as chronic obstructive pulmonary disease (COPD) and critical illness. It is administered via a metered dose inhaler, powder inhalation capsules, or other formulations like Ventilat, Tiotropium, and Tersigan.
-
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). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| 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 | OXITROPIUM |
|---|---|
| Drug class | oxitropium |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | Phase 3 |
Mechanism of action
Imagine your airways are like a narrow tube. When you breathe, the muscles around the tube relax, allowing air to flow in and out. Oxytropium helps keep these muscles relaxed, making it easier to breathe by blocking the signal that tells them to contract.
Approved indications
- Chronic obstructive lung disease
Common side effects
Key clinical trials
- Effect of Physiotherapy in Hospitalized COPD Patients (NA)
- Transcutaneous Partial Oxygen and Carbon Dioxide Pressures Compared With Blood Gas Values (NA)
- Comparison of Tiotropium Inhalation Capsules and Oxitropium Metered Dose Inhalator (MDI) in Patients With Chronic Obstructive Pulmonary Disease (COPD) (PHASE3)
- Physiotherapy in Acute Exacerbation of Chronic Obstructive Pulmonary Disease (NA)
- Postmarketing Surveillance Study of Anticholinergics - Prescribing Pattern and Therapeutic Long Term Value in Patients Suffering From Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD)
- Post-marketing Surveillance of Ventilat® Metered Dose Inhaler in Chronic Obstructive Bronchitis
- Post-marketing Surveillance of Ventilat® in Long-term Therapy in Chronic Obstructive Pulmonary Disease
- Efficacy and Safety of Ba679BR Powder Inhalation in Patients With Chronic Obstructive Pulmonary Disease (COPD) (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:
- Oxytropium Bromide CI brief — competitive landscape report
- Oxytropium Bromide updates RSS · CI watch RSS
Frequently asked questions about Oxytropium Bromide
What is Oxytropium Bromide?
How does Oxytropium Bromide work?
What is Oxytropium Bromide used for?
What is the generic name of Oxytropium Bromide?
What drug class is Oxytropium Bromide in?
What development phase is Oxytropium Bromide in?
Related
- Drug class: All oxitropium drugs
- Therapeutic area: All drugs in Neuroscience
- Indication: Drugs for Chronic obstructive lung disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing