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Betanis
Betanis is a Small molecule drug developed by Astellas Pharma Inc. It is currently in Phase 2 development. Also known as: YM178, mirabegron, Mirabegron.
Betanis, also known as Mirabegron, is a small molecule medication that acts as a beta-3 adrenergic receptor agonist. It is used to treat conditions such as overactive bladder syndrome, overactive bladder, and nocturnal enuresis in children, among others.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Betanis |
|---|---|
| Also known as | YM178, mirabegron, Mirabegron |
| Sponsor | Astellas Pharma Inc |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- The Physiological Responses and Adaptation of Brown Adipose Tissue to Chronic Treatment With Beta3-Adrenergic Receptor Agonists (PHASE1)
- Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity (PHASE2)
- A Study to Learn How Effective and Safe the Drug 'Mirabegron' is and How Long it Stays in the Body of Children Aged 6 Months to Less Than 3 Years of Age With Neurogenic Detrusor Overactivity (PHASE3)
- TReating Incontinence for Underlying Mental and Physical Health (PHASE4)
- Double j Stent Related Symptoms (EARLY_PHASE1)
- Efficacy of Mirabegron for Treatment of Non-monosymptomatic Nocturnal Enuresis in Children (PHASE3)
- Mirabegron in Patients With Age-Related Macular Degeneration
- The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics (PHASE4)
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:
- Betanis CI brief — competitive landscape report
- Betanis updates RSS · CI watch RSS
- Astellas Pharma Inc portfolio CI
Frequently asked questions about Betanis
What is Betanis?
Who makes Betanis?
Is Betanis also known as anything else?
What development phase is Betanis in?
Related
- Manufacturer: Astellas Pharma Inc — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: YM178, mirabegron, Mirabegron
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing