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Sulfonylureas
Sulfonylureas is a Small molecule drug developed by Canadian Network for Observational Drug Effect Studies, CNODES. It is currently in Phase 3 development. Also known as: oral hypoglycemic agent, glibenclamide, chlorpropamide, tolbutamide.
Sulfonylureas are a class of small molecule organic compounds used in medicine, specifically in the management of diabetes mellitus type 2. They are used to treat type 2 diabetes mellitus, as indicated by various clinical trials registered on ClinicalTrials.gov.
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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 | Sulfonylureas |
|---|---|
| Also known as | oral hypoglycemic agent, glibenclamide, chlorpropamide, tolbutamide, glibornuride |
| Sponsor | Canadian Network for Observational Drug Effect Studies, CNODES |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- A Pan-European Post-Authorisation Safety Study: Risk of Pancreatic Cancer Among Type 2 Diabetes Patients Who Initiated Exenatide as Compared With Those Who Initiated Other Non-Glucagon-Like Peptide 1 Receptor Agonists Based Glucose Lowering Drugs
- Pharmacokinetic Study of Single-Dose Modified Release Glipizide in Healthy Volunteers (PHASE1)
- Early Add-On Combination of GLP-1 Receptor Agonist and SGLT2 Inhibitor in People With Cardiovascular-Kidney-Metabolic Stage 2-3
- Effect of Dapagliflozin vs Sitagliptin on Liver Fat Accumulation and Body Composition in Patients With Diabetes Mellitus and Liver Transplantation (NA)
- Oral Anti Diabetic Agents in the Hospital (PHASE4)
- A Pragmatic Randomized Trial to Evaluate the Comparative Effectiveness Between Dapagliflozin and Standard of Care in Type 2 Diabetes Patients (PHASE4)
- Real-world Canadian Retrospective Study Evaluating Longitudinal Semaglutide Use on Cardio-Kidney-Metabolic Outcomes
- Spinal Cord Injury Neuroprotection With Glyburide (PHASE1)
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:
- Sulfonylureas CI brief — competitive landscape report
- Sulfonylureas updates RSS · CI watch RSS
- Canadian Network for Observational Drug Effect Studies, CNODES portfolio CI
Frequently asked questions about Sulfonylureas
What is Sulfonylureas?
Who makes Sulfonylureas?
Is Sulfonylureas also known as anything else?
What development phase is Sulfonylureas in?
Related
- Manufacturer: Canadian Network for Observational Drug Effect Studies, CNODES — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: oral hypoglycemic agent, glibenclamide, chlorpropamide, tolbutamide, glibornuride
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing