Vigonvita plans Phase 2 test of VV119 against PANSS in acute schizophrenia
The China-based trial will measure PANSS symptom change at week 6 in 500 patients, entering a schizophrenia field led by muscarinic and TAAR1 mechanisms already in Phase 3.
Executive Summary
- Vigonvita Life Sciences is starting a mid-stage trial testing whether its drug candidate can reduce psychotic symptoms in patients experiencing an acute schizophrenia episode, using a validated symptom-severity scale as the primary measure.
- The study includes both an active antipsychotic comparator and a placebo arm, a design that lets any drug effect be judged against an approved standard rather than against placebo alone.
- The trial enters a schizophrenia pipeline where several mechanistically distinct drugs, including a muscarinic agonist and a TAAR1 agonist, are already in Phase 3, making a differentiated signal important for the program to stand out.
- Vigonvita has completed a large clinical portfolio without a terminated trial, giving the program an operational base even though this specific compound's mechanism is not yet characterized in available records.
The trial
Vigonvita Life Sciences added NCT07703956 to the registry on July 15, 2026, a Phase 2 study evaluating VV119 in adults with acute schizophrenia. The trial has not yet begun recruiting, with a start date of July 31, 2026, and a primary completion date of October 31, 2027. It plans to enroll 500 patients across sites in China. NCT07703956Evaluating Safety and Efficacy of VV119 in Acute Schizophrenia AdultsNCT07703956
The endpoint
The primary endpoint is change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at week 6, a 30-to-210-point clinician-rated measure where a decrease indicates symptom improvement. Enrolled patients must have a baseline PANSS total score between 80 and 120, with at least two positive-symptom items rated moderate or worse, reflecting an acutely symptomatic population rather than a stabilized one. Secondary measures include PANSS positive and negative subscores, response rate defined as a 30% or greater PANSS reduction, and clinician-rated global impression and depression scales, all read at week 6. NCT07703956Evaluating Safety and Efficacy of VV119 in Acute Schizophrenia AdultsNCT07703956
Comparator design
The trial is designed with aripiprazole and placebo as comparators, according to the competitive trial search that flagged this study. That structure lets any VV119 effect be measured against both an approved dopamine-partial-agonist antipsychotic and a placebo reference, rather than against placebo alone.
Where it sits
VV119 is Vigonvita's only other clinical asset besides an ongoing Phase 1 multiple-ascending-dose study, also in schizophrenia patients and healthy volunteers, that remains recruiting with a primary completion date of July 1, 2026. VV119's molecular target is not characterized in available records, so this trial adds a second, larger step for the compound rather than a first human test. NCT07703956Evaluating Safety and Efficacy of VV119 in Acute Schizophrenia AdultsNCT07703956
The competitive field
Schizophrenia drug development is active but mechanistically diverse: Bristol-Myers Squibb's KarXT (a muscarinic receptor agonist), Otsuka Pharmaceutical's ulotaront (a TAAR1 agonist), and Neurocrine Biosciences' NBI-1117568 all carry Phase 3 trials in the same indication family. None of these programs shares VV119's mechanism, since VV119's target is not established in available data, so the comparison rests on indication and phase rather than mechanism class. Against a field where several newer-mechanism entrants have already reached late-stage testing, a PANSS improvement that separates from the active comparator at week 6 would be the result that gives VV119 standing to advance.
Sponsor context
Vigonvita has completed 25 of its prior trials with none terminated, and currently runs eight recruiting studies alongside this one. The registry shows no protocol amendments or timing slips for NCT07703956 since its addition, consistent with a newly initiated study rather than one with an operational history to assess.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.