Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MYL-1501D product using manufacture process V · 1 trial · 1 indication
Change in HbA1c from baseline
| Arm | Type | Description |
|---|---|---|
| MYL-1501D (Process V Product) | ACTIVE_COMPARATOR | MYL-1501D (Process V Product) |
| MYL-1501D (Process VI Product) | ACTIVE_COMPARATOR | MYL-1501D (Process VI Product) |
| Name | Type | Description |
|---|---|---|
| MYL-1501D product using manufacture process V | DRUG | MYL-1501D product using manufacture process V |
| MYL-1501D product using manufacture process VI | DRUG | MYL-1501D product using manufacture process VI |
Inclusion Criteria: 1. Written and signed informed consent needs to be provided by subjects or their legal representatives before starting any protocol-specific procedures. 2. Male and female subjects between the ages of 18 to 65 years, both ages inclusive. 3. Subjects with an established diagnosis...
MYL-1501D is being developed for the treatment of Diabetes Mellitus, Type 1. It is an investigational small molecule product studied in adults 18 years and older. Development is at Phase 3, and the program's single registered trial has been completed.
MYL-1501D is being developed by Viatris Inc., which trades under the ticker VTRS. The company is the sponsor behind the Phase 3 program for this product in Type 1 diabetes.
MYL-1501D is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently listed as active. The product is investigational and has not been approved by the FDA for any indication.
MYL-1501D has been studied in one completed Phase 3 trial, NCT03376789, titled the Mylan Insulin Glargine Study. It enrolled 219 participants with Diabetes Mellitus, Type 1 in the United States, was randomized, double blind, and used an active control.
The completed Phase 3 trial NCT03376789 enrolled 219 participants with Type 1 diabetes in the United States. It was randomized, double blind, and active controlled, and it enrolled adults aged 18 years and older. Healthy volunteers were not eligible for this study.