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Nebilet
Nebilet is a Small molecule drug developed by Berlin-Chemie Menarini. It is currently in Phase 3 development.
Nebivolol is a small molecule used to treat high blood pressure and heart failure, typically taken by mouth. It is also studied for other conditions such as coronary artery disease, hypertension, frailty, endothelial dysfunction, and obstructive sleep apnea.
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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 | Nebilet |
|---|---|
| Sponsor | Berlin-Chemie Menarini |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Clinical Application of Simcyp-Guided Doses of Antihypertensive Drugs in Cirrhotic Patients (PHASE4)
- Beta-blOckers discoNtinuation in Patients Presenting Heart FaIlure With REcovered Left Ventricular Ejection Fraction (PHASE3)
- Rate Control in Patients With Atrial Fibrillation (NA)
- Nebivolol for the Prevention of Left Ventricular Systolic Dysfunction in Patients With Duchenne Muscular Dystrophy (PHASE3)
- Evaluation of the Cardioprotective Effect of Nebivolol on Trastuzumab-Induced Cardiotoxicity in Breast Cancer Patients (PHASE2)
- N-of-1 for Beta-Blockers in Cardiac Amyloidosis (PHASE4)
- A Preliminary Study for INFORMED (PHASE4)
- Beta-blockers for Prevention of Supraventricular Arrhythmia Following PFO Closure (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:
- Nebilet CI brief — competitive landscape report
- Nebilet updates RSS · CI watch RSS
- Berlin-Chemie Menarini portfolio CI
Frequently asked questions about Nebilet
What is Nebilet?
Who makes Nebilet?
What development phase is Nebilet in?
Related
- Manufacturer: Berlin-Chemie Menarini — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing