Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Luvadaxistat · 2 trials · 1 indication
EBC is a method used to investigate cerebellar-dependent learning. In EBC, a conditioned stimulus, a tone precedes but co-terminates with an unconditioned stimulus, an airpuff to the eyelid. Learning is demonstrated when an eyeblink (the conditioned response) occurs prior to the onset of the unconditioned stimulus. The percentage can range from 0% (no conditioned learning has occurred) to 100% (all responses are conditioned). Results are reported as least squares (LS) means at Day 8, determined using an analysis of variance (ANOVA).
PANSS assesses the positive symptoms, negative symptoms and general psychopathology associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Here, the PANSS NSFS subscale consists of 7 items which assess the negative symptoms with subscale score ranging from 7 to 49, where a higher score indicates greater severity. Baseline was defined as the last observed value before the first dose of study treatment. Results are reported as least squares (LS) mean change from baseline at Week 12, determined using a mixed model for repeated measures (MMRM). A negative change from baseline indicates improvement.
| Arm | Type | Description |
|---|---|---|
| Luvadaxistat 500 mg, then Placebo | EXPERIMENTAL | Participants first received luvadaxistat 500 mg orally once daily (QD) for 8 days during treatment period 1. After a washout of 14 to 21 days, participants then received matching placebo orally QD for 8 days during treatment period 2. |
| Placebo, then Luvadaxistat 500 mg | EXPERIMENTAL | Participants first received matching placebo orally QD for 8 days during treatment period 1. After a washout of 14 to 21 days, participants then received luvadaxistat 500 mg orally QD for 8 days during treatment period 2. |
| Luvadaxistat 50 mg, then Placebo | EXPERIMENTAL | Participants first received luvadaxistat 50 mg orally QD for 8 days during treatment period 1. After a washout of 14 to 21 days, participants then received matching placebo orally QD for 8 days during treatment period 2. |
| Placebo, then Luvadaxistat 50 mg | EXPERIMENTAL | Participants first received matching placebo orally QD for 8 days during treatment period 1. After a washout of 14 to 21 days, participants then received luvadaxistat 50 mg orally QD for 8 days during treatment period 2. |
| Luvadaxistat 50 milligrams (mg) | EXPERIMENTAL | Participants received luvadaxistat 50 mg orally once daily (QD) for 12 weeks (Days 1 to 84). |
| Luvadaxistat 125 mg | EXPERIMENTAL | Participants received luvadaxistat 125 mg orally QD for 12 weeks (Days 1 to 84). |
| Luvadaxistat 500 mg | EXPERIMENTAL | Participants received luvadaxistat 500 mg orally QD for 12 weeks (Days 1 to 84). |
| Placebo | PLACEBO_COMPARATOR | Participants received placebo (matching luvadaxistat) orally QD for 12 weeks (Days 1 to 84). |
| Name | Type | Description |
|---|---|---|
| Luvadaxistat | DRUG | TAK-831 Tablets. |
| Matching Placebo | DRUG | Matching Placebo Tablets. |
| Placebo | DRUG | Luvadaxistat placebo-matching tablets. |
Inclusion Criteria: * Have a body mass index (BMI) greater than or equal to (\>=) 18.5 and less than or equal to (\<=) 40.0 (kilogram per square meter \[kg/m\^2\]) at the Screening Visit. * With a current Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of schi...
Luvadaxistat is an investigational small molecule being developed for the treatment of schizophrenia. It has been studied in adults with schizophrenia, including a trial specifically evaluating its effects on negative symptoms of the disorder. The drug is currently in Phase 2 clinical development.
Luvadaxistat is being developed by Neurocrine Biosciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol NBIX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with schizophrenia.
Luvadaxistat is in Phase 2 clinical development. Two Phase 2 trials have been completed, both involving adult patients with schizophrenia. The drug is investigational and has not been approved by regulatory authorities for commercial use.
Luvadaxistat has been studied in two completed Phase 2 clinical trials. NCT03359785 evaluated multiple oral doses in 31 adults with schizophrenia in the United States. NCT03382639 evaluated three dose levels in 256 adults with negative symptoms of schizophrenia across multiple countries including the United States, Bulgaria, Czechia, Germany, Italy, Poland, Spain, and Ukraine.
Luvadaxistat is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for schizophrenia. Two Phase 2 trials have been completed, but the drug has not yet received regulatory approval for any indication.