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Aglicid (TOLBUTAMIDE)
Tolbutamide, also known as Aglicid, is a small molecule sulfonylurea drug that targets the sulfonylurea receptor 1, Kir6.2. Originally developed and currently owned by various generic manufacturers, it was first approved by the FDA in 1961 for the treatment of type 2 diabetes mellitus and diagnostic testing for pancreatic islet cell adenoma. As an off-patent medication, tolbutamide is widely available in generic form from multiple manufacturers. Key safety considerations include its potential to cause hypoglycemia and interactions with other medications. Tolbutamide has a half-life of 7.0 hours and bioavailability of 85%.
At a glance
| Generic name | TOLBUTAMIDE |
|---|---|
| Drug class | Sulfonylurea |
| Target | Sulfonylurea receptor 1, Kir6.2 |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1961 |
Approved indications
- Diabetes mellitus type 2
- Diagnostic Test for Pancreatic Islet Cell Adenoma
Common side effects
Drug interactions
- CYP2C9 Substrates
- fosaprepitant
- levofloxacin
- norfloxacin
- rifampicin
- voriconazole
Key clinical trials
- Glimepiride, Empagliflozin, and Sitagliptin With Metformin for Type 2 Diabetes (PHASE4)
- Pharmacokinetic Study to Characterize Individual Metabolic Profile (PHASE1)
- A Study for Comparison of Canagliflozin Versus Alternative Antihyperglycemic Treatments on Risk of Heart Failure Hospitalization and Amputation for Participants With Type 2 Diabetes Mellitus and the Subpopulation With Established Cardiovascular Disease
- A Trial to Evaluate the Impact of C21 on the Exposure of 4 Substrates in Healthy Volunteers (PHASE1)
- Real-World Evaluation of Omarigliptin for Type 2 Diabetes Meliitus in Bangladesh (PHASE4)
- Study to Evaluate the Effect of Multiple-Dose Ritlecitinib on the Pharmacokinetics (PK) of Tolbutamide (PHASE1)
- Licorice Botanical Dietary Supplements - Metabolism and Safety in Women (PHASE1)
- BTZ-043 - Multiple Ascending Dose (MAD) to Evaluate Safety, Tolerability and Early Bactericidal Activity (EBA) (PHASE1,PHASE2)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Aglicid CI brief — competitive landscape report
- Aglicid updates RSS · CI watch RSS