Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Montbretin A · 1 trial · 1 indication
The MTD is defined as the minimum dose that results in a dose limiting toxicity in the form of gastro-intestinal adverse events (relevant flatulence and/or diarrhea as determined by the Gastrointestinal Symptom Rating Scale) in 33% of the test subjects.
| Arm | Type | Description |
|---|---|---|
| Intervention | EXPERIMENTAL | In this study, participants will receive increasing dosages of the Study Treatment (Montbretin A, MbA) at each treatment visit. The Study Treatment will be taken with a standardized meal (a meal that has specified quantities of carbohydrates, fats and proteins). At each visit, participants will receive one dose (in pill form) of MbA. As long as they are not experiencing any side effects, this dose will be gradually increased at each study visit (starting from 10 mg, 25 mg, 50 mg, 100 mg, 200 mg, to 300 mg MbA). |
| Name | Type | Description |
|---|---|---|
| Montbretin A | DIETARY_SUPPLEMENT | The investigational product is 95% pure montbretin A (MbA), a glycosylated acyl-flavonol isolated from the corms (bulbs) of the Crocosmia plant through hot water extraction. It is a potent and specific inhibitor of human pancreatic amylase (HPA). |
Inclusion Criteria: * Male or female, age ≤ 65 years; ≥19 years; * Have diagnosed type-2 diabetes mellitus with HbA1C between 6.5% to 11% that is currently managed by diet and no other medications or healthy volunteers defined as not having diagnosis of type-2 diabetes mellitus. * Have routine and ...
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Montbretin A is an investigational drug being developed for the treatment of Type 2 Diabetes. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being studied in a clinical trial that includes healthy volunteers and individuals with Type 2 Diabetes.
Montbretin A is being developed by Smith & Nephew SNATS, Inc., a company traded on the New York Stock Exchange under the ticker symbol SNN. The company is conducting a Phase 1 clinical trial of Montbretin A for Type 2 Diabetes.
Montbretin A is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 1 trial is recruiting participants in Canada and is designed to evaluate the drug in healthy volunteers and patients with Type 2 Diabetes.
Montbretin A is being studied in a Phase 1 clinical trial registered as NCT05826054, titled "Montbretin Clinical Trial in Healthy Volunteers and Type 2 Diabetics." The trial is recruiting 50 participants in Canada, including healthy volunteers and individuals with Type 2 Diabetes, and is currently in the recruiting stage.
Montbretin A is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials for Type 2 Diabetes. The drug is still in the early stages of clinical development and has not yet demonstrated safety and efficacy sufficient for regulatory approval.