Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07145918 | A Study to Assess Adverse Events, Change in Disease Activity, and How Oral Emraclidine Moves Through the Body in Adult Participants With Schizophrenia | PHASE2 | RECRUITING | 268 | — | — | Aug 4, 2025 | Feb 1, 2028 | Feb 10, 2026 | 7 | United States |
| NCT05227703 | A Trial of 15 and 30 mg Doses of CVL-231 (Emraclidine) in Participants With Schizophrenia | PHASE2 | COMPLETED | 391 | — | — | Jul 5, 2022 | Sep 11, 2024 | Oct 28, 2025 | 26 | United States, Bulgaria +1 |
| NCT05227690 | A Trial of 10 and 30 mg Doses of CVL-231 (Emraclidine) in Participants With Schizophrenia | PHASE2 | COMPLETED | 385 | — | — | Jun 30, 2022 | Aug 26, 2024 | Sep 17, 2025 | 25 | United States, Bulgaria |
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Cmax of Emraclidine
Tmax of Emraclidine
AUCt of Emraclidine
AUCtau of Emraclidine
MRCmax of Emraclidine
MRAUCtau of Emraclidine
Cmin of Emraclidine
Cavg of Emraclidine
Terminal phase elimination half-life of Emraclidine
λz of Emraclidine
CL/F of Emraclidine
Vz/F of Emraclidine
PTR of Emraclidine
RacCmax of Emraclidine
RacAUCta of Emraclidine
Cmax of Metabolite (CV-0000364)
Tmax of Metabolite (CV-000036)
AUCtau of Metabolite (CV-000036)
AUCt of Metabolite (CV-000036)
MRCmax of Metabolite (CV-000036)
MRAUCtau of Metabolite (CV-000036)
PANSS is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS consists of 3 subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms.
The PANSS measures symptom severity of participants with schizophrenia and contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale with a total minimum score of 30 and a maximum score of 210. Baseline was defined as the last value obtained prior to initiation of investigational medicinal product (IMP). Change from baseline for a given endpoint was defined as the value on a given Study Day (Time Point) minus the Baseline Value. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
| Arm | Type | Description |
|---|---|---|
| Emraclidine Part A | EXPERIMENTAL | Participants will be assigned to received one of multiple ascending doses of oral emraclidine for 14 or up to 21 days, followed by a 30-day safety follow-up period. |
| Placebo-Part A | EXPERIMENTAL | Participants will be assigned to received one of multiple ascending doses of oral placebo for 14 or up to 21 days, followed by a 30-day safety follow-up period. |
| Emraclidine-Part B | EXPERIMENTAL | Participants will receive oral emraclidine for 42 days followed by a 30-day safety follow-up period. |
| Placebo-Part B | EXPERIMENTAL | Participants will receive placebo for 42 days followed by a 30-day safety follow-up period. |
| CVL-231 15 mg, once daily (QD) | EXPERIMENTAL | Oral Dose |
| CVL-231 30 mg, once daily (QD) | EXPERIMENTAL | Oral Dose |
| Placebo, once daily (QD) | PLACEBO_COMPARATOR | Oral Dose |
| Placebo | PLACEBO_COMPARATOR | Participants received placebo tablets orally once daily (QD) through Day 45 of Week 6. |
| Emraclidine 10 mg, once daily (QD) | EXPERIMENTAL | Participants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6. |
| Emraclidine 30 mg, once daily (QD) | EXPERIMENTAL | Participants received emraclidine 30 mg tablets orally once daily (QD) through Day 45 of Week 6. |
| Name | Type | Description |
|---|---|---|
| Emraclidine | DRUG | Oral Tablets |
| Placebo | DRUG | Oral Tablets |
| Emraclidine 15 mg | DRUG | Emraclidine 15 mg, oral (tablet), once per day (QD) for 6 weeks |
| Emraclidine 30 mg | DRUG | Emraclidine 30 mg, oral (tablet), QD for 6 weeks |
| Emraclidine 10 mg | DRUG | Emraclidine 10 mg, oral (tablet), once per day for 6 weeks |
Inclusion Criteria: * BMI within 18 to 40 kg/m2 (inclusive of both values), and body weight \> 50 kg (110 lbs). * (Part A only): Positive and Negative Syndrome Scale (PANSS) total score \< 80 at Screening and at Baseline * (Part B only): Participant experiencing an acute exacerbation of psychotic s...