Drugs / Risperdal Consta
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | RISPERDAL CONSTA | — | 2007-04-12 – 2009-05-15 | fda.gov ↗ |
| Approved | US (FDA) | RISPERDAL CONSTA | — | 2003-10-29 | fda.gov ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT00132678 | Feb 2005 → Oct 2007 | bipolar disorder | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | Met primary |
| Phase 42 trials · 1 missed | ||||||
| Phase 4 | NCT00299702 | Feb 2006 → Jan 2009 | schizophrenia | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | Missed primary |
| Phase 4 | NCT00313391 | Dec 2005 → Dec 2007 | schizoaffective disorder, schizophrenia | Emory University | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT02411526 Comparator | Feb → Sep 2015 | schizoaffective disorder, schizophrenia | Zogenix, Inc. | Completed | No outcome recorded |
Press releases naming this drug 18 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | RISPERDAL CONSTA | “The purpose of this trial is to evaluate the long-term effectiveness of Risperdal® Consta®, a long-acting injectable antipsychotic medication, versus Abilify®, an oral...” NCT00299702 ↗4“RISPERDAL CONSTA (risperidone long-acting injection) may provide substantial improvement” NCT00132678 ↗ |
| Known as | risperidone | “RISPERDAL CONSTA (risperidone long-acting injection) may provide substantial improvement” NCT00132678 ↗ |
| Route | Intramuscular | “Risperidone LAI i.m. injections (12.5mg, 25 mg, 37.5 mg, or 50 mg) given every 2 weeks” NCT00132678 ↗ |