Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BIIB061 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| BIIB061 | EXPERIMENTAL | Single oral dose of 30 mg BIIB061 of the new formulation |
| Name | Type | Description |
|---|---|---|
| BIIB061 | DRUG | Capsule |
Key Inclusion Criteria: * Males and postmenopausal (defined as no menses for 12 months and confirmed by follicle-stimulating hormone \[FSH\] levels determined at screening to be in the postmenopausal range) or surgically sterile females. * All male subjects must practice effective contraception dur...
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BIIB061 is an investigational small molecule being developed by Biogen for multiple sclerosis. It is in Phase 1 clinical development and has been studied in a single-dose trial in healthy volunteers. It is not an approved treatment for multiple sclerosis or any other condition.
BIIB061 is developed by Biogen Inc., which trades on the Nasdaq under the ticker BIIB. Biogen is the sponsor of the clinical program evaluating the drug in multiple sclerosis.
BIIB061 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The program has enrolled a total of 8 participants across its clinical testing to date.
BIIB061 has been evaluated in one completed Phase 1 trial, NCT02521545, titled Single-Dose Study of a New Formulation of BIIB061. The trial enrolled 8 healthy volunteers in the United States and was conducted in participants aged 20 years and older.
No. BIIB061 is an investigational drug in Phase 1 clinical development and has not been approved by the FDA. Its only completed trial was a single-dose Phase 1 study in healthy volunteers, so it remains an experimental candidate for multiple sclerosis.