Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Test product · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Test product |
| 2 | EXPERIMENTAL | Reference product |
| Name | Type | Description |
|---|---|---|
| Test product | DRUG | Dimethyl Fumarate (BG00012) |
| Reference product | DRUG | Dimethyl Fumarate (BG00012) |
Inclusion Criteria: * Must give written and informed consent and any authorizations required by local law. * Males and females 18 - 55 years old inclusive at time of consent. * Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive Exclusion Criteria: * History of malignancy (...
Test product is an investigational small molecule developed by Biogen Inc. It is being studied in a Phase 1 clinical program, with one completed trial in healthy volunteers. No approved indication has been announced, and the therapeutic area is listed as other.
Test product is being developed by Biogen Inc., which trades on the Nasdaq under the ticker BIIB. Biogen is the sponsor of the clinical program for this asset.
Test product is in Phase 1 clinical development. One Phase 1 trial has been completed, and no later-stage trials have been recorded. It is an investigational agent and has not been approved by the FDA.
Test product has been studied in one completed Phase 1 trial, NCT01632449, titled Study in Healthy Volunteers to Establish the Bioequivalence of Two Different Manufacturers. The trial enrolled 80 healthy adult volunteers in the United States and used a controlled, randomized design without double blinding.
No therapeutic indication has been announced for Test product. Its completed Phase 1 trial, NCT01632449, was conducted in healthy volunteers to establish bioequivalence between two different manufacturers, not in patients with a specific disease.