Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ALK3831 · 1 trial · 1 indication
This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme. Minimum scores (best outcome) equals 30 (total scale); maximum scores (worst outcome) equals 210 (total scale). Change is calculated between the baseline visit and Week 4.
| Arm | Type | Description |
|---|---|---|
| ALKS 3831 | EXPERIMENTAL | Administered as a coated bilayer tablet |
| Olanzapine | ACTIVE_COMPARATOR | Administered as a coated bilayer tablet |
| Placebo | PLACEBO_COMPARATOR | Administered as a coated bilayer tablet |
| Name | Type | Description |
|---|---|---|
| ALK3831 | DRUG | Daily dosing |
| Olanzapine | DRUG | Daily dosing |
| Placebo | DRUG | Daily dosing |
Inclusion Criteria: * Has a body mass index (BMI) of 18.0 - 40.0 kg/m\^2 * Meets criteria for the diagnosis of schizophrenia * Resides in a stable living situation when not hospitalized * Is willing and able to provide government-issued identification * Additional criteria may apply Exclusion Crit...
ALK3831 is an investigational small molecule being developed for the treatment of schizophrenia. It is intended for adults with acute exacerbation of schizophrenia, as studied in a Phase 3 clinical trial. The drug is not yet approved and remains in clinical development.
ALK3831 is being developed by Alkermes plc, a biopharmaceutical company traded on the NASDAQ under the ticker ALKS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with schizophrenia.
ALK3831 is in Phase 3 clinical development for schizophrenia. A Phase 3 study, the ENLIGHTEN-1 trial, has been completed. The drug is investigational and has not been approved by regulatory authorities.
ALK3831 has been studied in one completed Phase 3 trial, NCT02634346, known as the ENLIGHTEN-1 study. This randomized, double-blind, placebo-controlled trial enrolled 403 adults with acute exacerbation of schizophrenia across the United States, Bulgaria, Serbia, and Ukraine.
ALK3831 is not FDA approved. It is an investigational drug currently in clinical development for schizophrenia. The completed Phase 3 trial, ENLIGHTEN-1, provides data for regulatory review, but approval status has not been established.