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Labetolol
Labetolol is a Small molecule drug developed by Zagazig University. It is currently in Phase 1 development. Also known as: (Trandate™,).
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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 | Labetolol |
|---|---|
| Also known as | (Trandate™,) |
| Sponsor | Zagazig University |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Safest Choice of Antihypertensive Regimen for Postpartum Hypertension (PHASE3)
- Hypotensive Anesthesia for Orthognathic Surgery (PHASE4)
- Preeclampsia Postpartum Antihypertensive Treatment (PHASE3)
- Dexmedetomidine vs Labetalol for Airway Stress in Hypertensive Craniotomy Patients (PHASE4)
- Effect of Labetalol, Atenolol, and Nifedipine on Maternal Hemodynamics Measured by ICG in Early Pregnancy
- Intravenous Labetalol vs Phentolamine for the Management of Severe Preeclampsia. (NA)
- Labetalol or Nifedipine for Control of Postpartum Hypertension: A Randomized Controlled Trial (PHASE4)
- Postpartum Management of Gestational Hypertensive Disorders Using Furosemide (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:
- Labetolol CI brief — competitive landscape report
- Labetolol updates RSS · CI watch RSS
- Zagazig University portfolio CI
Frequently asked questions about Labetolol
What is Labetolol?
Who makes Labetolol?
Is Labetolol also known as anything else?
What development phase is Labetolol in?
Related
- Manufacturer: Zagazig University — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: (Trandate™,)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing