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Daonil
Daonil is a Small molecule drug developed by Genuine Research Center, Egypt. It is currently in Phase 1 development. Also known as: Glibenclamide.
Daonil, also known as glibenclamide or glyburide, is a small molecule medication that blocks the Sulfonylurea receptor 1, Kir6.2, and is used to treat type 2 diabetes. It is typically taken by mouth in combination with diet and exercise, and may be used with other antidiabetic medications.
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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 | Daonil |
|---|---|
| Also known as | Glibenclamide |
| Sponsor | Genuine Research Center, Egypt |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Diabetes Management for Primary Healthcare Centers. (NA)
- Spinal Cord Injury Neuroprotection With Glyburide (PHASE1)
- Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study
- Efficacy and Safety Study of Sulfonylureas in Neonatal Diabetes Mellitus (PHASE2)
- Oral Glibenclamide in Preterm Infants With Hyperglycaemia (GALOP) (PHASE2)
- OER Glibenclamide for Neuropathic Pain in Multiple Sclerosis (PHASE1)
- Glibentek in Patients With Neonatal Diabetes Secondary to Mutations in K+-ATP Channels (PHASE3)
- Multicenter Randomized Trial of Non-inferiority Between Glyburide and Insulin for the Treatment of Gestational Diabetes (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:
- Daonil CI brief — competitive landscape report
- Daonil updates RSS · CI watch RSS
- Genuine Research Center, Egypt portfolio CI
Frequently asked questions about Daonil
What is Daonil?
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Related
- Manufacturer: Genuine Research Center, Egypt — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Glibenclamide
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing