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Berotec
Berotec is a Small molecule drug developed by Taiwan Otsuka Pharm. Co., Ltd. It is currently in Phase 3 development.
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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 | Berotec |
|---|---|
| Sponsor | Taiwan Otsuka Pharm. Co., Ltd |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Functional Strength Training and Neuromuscular Electrical Stimulation in Severe Acute Exacerbations of COPD (NA)
- Continuous Versus Intermittent Nebulization Therapy in Acute Asthma Exacerbation at Emergency Department (NA)
- Prehospital Non-invasive Ventilation for Acute Exacerbation of Chronic Obstructive Pulmonary Disease (NA)
- Bronchodilators on the Exercise Capacity of Bronchiectasis Patients (NA)
- Beta 2 Adrenergic Stimulation vs Cold Exposure to Activate Human Brown Adipose Tissue (EARLY_PHASE1)
- Individualized Dosing Schedule of Inhaled Bronchodilator for Endotracheally Intubated COPD Patients (NA)
- Aerosol Therapy in Obese COPD Patients. (NA)
- Different Positive Pressure Strategies in COPD Patients. (NA)
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:
- Berotec CI brief — competitive landscape report
- Berotec updates RSS · CI watch RSS
- Taiwan Otsuka Pharm. Co., Ltd portfolio CI
Frequently asked questions about Berotec
What is Berotec?
Who makes Berotec?
What development phase is Berotec in?
Related
- Manufacturer: Taiwan Otsuka Pharm. Co., Ltd — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing