Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication RISPERDAL is an atypical antipsychotic indicated for: Treatment of schizophrenia ( 1.1 ) As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2 ) Treatment of irritability associated with autistic disorder ( 1.3 ) 1.1 Schizophrenia RISPERDAL (risperidone) is indicated for the treatment of schizophrenia. FDA label
Also known as Risperdal®, TV-46000
Risperidone · 4 trials · 2 indications
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. The safety analysis set included all participants who received at least 1 dose of TV46000 in TV-46000-CNS-30072 study or in TV46000-CNS-30078 study.
Relapse was defined as 1 or more of the following items: • Clinical Global Impression-Improvement (CGI-I) of ≥5, and - an increase of any of the 4 Positive and Negative Syndrome Scale (PANSS) items: conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content, to a score of \>4 with an absolute increase of ≥2 on specific item since randomization, or - an increase in any of the 4 individual PANSS items to a score of \>4 and an absolute increase of ≥4 on combined score of 4 items since randomization; • hospitalization due to worsening of psychotic symptoms; • Clinical Global Impression-Severity of Suicidality (CGI-SS) of 4 (severely suicidal) or 5 (attempted suicide) on Part 1 and/or 6 (much worse) or 7 (very much worse) on Part 2; • violent behavior resulting in clinically significant self-injury, injury to another person, or property damage. Data is presented as distribution of relapsing participants (number of participants with impending relapse).
| Arm | Type | Description |
|---|---|---|
| TV-46000 q1m | EXPERIMENTAL | Participants will receive a subcutaneous (SC) injection of TV-46000 at baseline and every 4 weeks (q4w) thereafter for up to 56 weeks. The maximal dose administered to adult participants is comparable to an oral risperidone dose of 5 mg/day, and the maximal dose administered to adolescents is comparable to 4 mg/day. |
| TV-46000 q2m | EXPERIMENTAL | Participants will receive an SC injection of TV-46000 at baseline and every 8 weeks (q8w) thereafter, and a placebo SC injection 4 weeks after baseline and q8w thereafter for up to 56 weeks. The maximal dose administered to adult participants is comparable to an oral risperidone dose of 5 mg/day, and the maximal dose administered to adolescents is comparable to 4 mg/day. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive an SC injection of placebo matching to TV-46000 at baseline and every 4 weeks (q4w) thereafter. Participants will continue treatment until they experience a relapse event; meet 1 or more of the study discontinuation or withdrawal criteria; or remain relapse-free during the double-blind phase until the study is terminated. |
| 1 | EXPERIMENTAL | Risperidone 1 mg Tablet |
| 2 | ACTIVE_COMPARATOR | Risperdal® 1 mg Tablet |
| Name | Type | Description |
|---|---|---|
| TV-46000 | DRUG | TV-46000 will be administered per dose and schedule specified in the arm description. |
| Placebo | DRUG | Placebo matching to TV-46000 will be administered per schedule specified in the arm description. |
| Risperidone | DRUG | 1 mg Tablet |
Inclusion Criteria: Participants Rolling Over from the Pivotal Efficacy Study TV46000-CNS-30072: * The participant must have participated in the pivotal efficacy study (Study TV46000-CNS-30072) without experiencing relapse events and without important protocol deviations. * If the participant was ...
Risperidone is a small molecule drug developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. It is currently in Phase 1 clinical development. The specific medical conditions it is being studied for have not been disclosed, and its therapeutic area is classified as other.
Risperidone targets HTR2A, HTR2C, and DRD2. It acts as an antagonist at these receptors, meaning it blocks their activity. HTR2A and HTR2C are serotonin receptors, while DRD2 is a dopamine receptor. This target profile is consistent with its classification as a small molecule.
Risperidone is being developed by Teva Pharmaceutical Industries Limited, a company whose shares trade under the ticker symbol TEVA. Teva is responsible for the clinical development of this asset.
Risperidone is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for any indication based on the available information. Two Phase 1 trials have been completed, and no active trials are currently listed.
Risperidone has been studied in two completed Phase 1 trials. NCT00830349 evaluated a 1 mg tablet in healthy subjects under fasting conditions, enrolling 30 participants in Canada. NCT00829894 tested a 1 mg tablet under fed conditions, enrolling 24 healthy participants, also in Canada. Both trials are completed.