SEP-363856 reduces symptom severity for acute exacerbation of schizophrenia


Very encouraging, thank you!

  1. How did the PANSS reduction distribute over the subscales, i.e. how effective is it for negative and cognitive symptoms?

  2. It has been granted “Breakthrough Therapy designation” by the FDA in July 2019. When can we expect it to be available in the US if everything runs smoothly?


There is a phase 3 trial scheduled to end late 2022. Then analysis of results and New Drug Application. So maybe possible approval early 2024. My rough guess.
(There is another phase 3 trial scheduled to end March 2022.)


Thank you for answering that question .

1 Like

Regarding question 1: According to, the PANSS reduction on the 3 subscales was: PANSS positive subscale score (-5.5 vs. -3.9; P=0.019; effect size, 0.32), PANSS negative subscale score (-3.1 vs. -1.6; P=0.008; effect size, 0.37), PANSS general psychopathology subscale score (-9.0 vs. -4.7; P<0.001; effect size, 0.51)

1 Like

Current antipsychotic treatments rely on dopamine D2 receptor antagonism for psychosis. However, the therapies are limited in the treatment of negative symptoms and cognitive impairment. SEP-363856 was developed as a new class of psychotropic agents with a non-D2-receptor binding mechanism of action for the treatment of psychosis in schizophrenia. As such, this study evaluated the efficacy and safety of SEP-363856 in patients with an acute exacerbation of schizophrenia. The participants were randomized to receive SEP-363856 or placebo treatment for four weeks. The study determined the patients in the SEP-363856 group had a lower PANSS total score from baseline compared to the placebo group. However, one patient in the treatment group did suffer a serious adverse event of sudden cardiac death.

In the case of treating any genetic disease such as diabetes/high blood pressure:
1- The medication aims to correct the chemical mistakes in order to restore a state of chemical balance,which in turns leads to the disappearance of the existential symptoms
2- The medication does not aim to reduce the severity of the emotional symptoms of the disease,because it does not allow the existential symptoms to be present in any degree,or let them coexist with the patient after taken the medication does
3- The emotional symptoms that be felt by the patient will disappear until they appear again after a period of time has passed
4- with the sz, whatever the kind of medication,the sz condition and its existential symptoms are exist and they are coexist with the person -and this does not apply for the real genetic disease
In other meaning,reduces symptoms severity is related the viral infection not the genetic disease

Any more news on this drug?

What do you want to improve?

Mostly positive symptoms…