Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication MYXREDLIN is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. MYXREDLIN is a short-acting human insulin indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus ( 1 ). FDA label
insulin human · 1 trial · 2 indications
| Name | Type | Description |
|---|---|---|
| insulin human | DRUG | - |
| insulin lispro | DRUG | - |
| insulin aspart | DRUG | - |
Inclusion Criteria: * Pediatric patients with Type 1 diabetes for at least one year * HbA1c less than 12% * Willing to administer at least 3 injections per day * Willing to perform self monitored blood glucose (SMBG) at least 4 times per day, includes subject and/or parent/guardian, as necessary
Insulin human is used to treat diabetes, including type 1 diabetes mellitus. It is a metabolic therapy developed by Novo Nordisk A/S under the ticker NVO. A Phase 3 trial studied it in a pediatric population aged 6 years and older with diabetes.
Insulin human targets INSR, the insulin receptor, and acts as an agonist at that receptor. By activating INSR, it supports glucose uptake and the metabolic control that people with diabetes require. INSR agonism is the mechanism underlying its use in diabetes.
Insulin human is developed by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk is the sponsor behind the clinical program for this diabetes therapy.
Insulin human is in Phase 3 clinical development for diabetes. It is an investigational therapy and is not described as approved. The Phase 3 trial in its program has completed, and no trials are currently listed as active.
Insulin human has been studied in the Phase 3 trial NCT00071448, titled Insulin Aspart vs. Insulin Lispro vs. Regular Insulin in Paediatric Population. That trial enrolled 378 participants with diabetes and type 1 diabetes mellitus in the United States, was randomized, and has completed.
Yes, insulin human is classified as a small molecule therapeutic in the metabolic area. It is an INSR agonist being developed by Novo Nordisk A/S for diabetes, and it has been evaluated in a completed Phase 3 trial.