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Risperdal Consta (drug)
Risperdal Consta (drug) is a Atypical antipsychotic Small molecule drug developed by University of Illinois at Chicago. It is currently in Phase 3 development for Schizophrenia, Bipolar disorder.
Risperdal Consta is a long-acting injectable formulation of risperidone, a second-generation antipsychotic that primarily works by blocking dopamine and serotonin receptors in the brain.
Risperdal Consta is a small molecule serotonin 2a (5-HT2a) receptor antagonist used to treat various mental disorders, including schizophrenia. It is administered as a 1 mg tablet, which is bioequivalent to Risperidone 1 mg tablets.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Risperdal Consta (drug) |
|---|---|
| Sponsor | University of Illinois at Chicago |
| Drug class | Atypical antipsychotic |
| Target | D2 receptor, 5-HT2A receptor |
| Modality | Small molecule |
| Therapeutic area | Psychiatry |
| Phase | Phase 3 |
Mechanism of action
Risperidone, the active ingredient in Risperdal Consta, is a potent antagonist of dopamine D2 and serotonin 5-HT2A receptors. This blockade is thought to contribute to its therapeutic effects in treating schizophrenia and bipolar disorder. Additionally, risperidone has affinity for other receptors, including alpha-1 adrenergic and histamine H1 receptors.
Approved indications
- Schizophrenia
- Bipolar disorder
Common side effects
- Weight gain
- Dyslipidemia
- Hyperprolactinemia
- Somnolence
- Headache
- Dizziness
Key clinical trials
- Elucidating the Relevance of the Psychedelic Experience to Psilocybin's Anti-Anhedonic Effects (PHASE1)
- Subjective Experience Following Psilocybin (PHASE2)
- CLOZAPINE Response in Biotype-1 (PHASE4)
- National Pregnancy Registry for Psychiatric Medications
- "Extended" (Alternate Day) Antipsychotic Dosing (PHASE4)
- Impact of Aripiprazole Once Monthly Medications on Changes in Brain Structure and Metabolism (PHASE4)
- Neuroprotective Effects of Risperdal on Brain and Cognition in 22q11 Deletion Syndrome (NA)
- A Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Risperdal Consta (drug) CI brief — competitive landscape report
- Risperdal Consta (drug) updates RSS · CI watch RSS
- University of Illinois at Chicago portfolio CI
Frequently asked questions about Risperdal Consta (drug)
What is Risperdal Consta (drug)?
How does Risperdal Consta (drug) work?
What is Risperdal Consta (drug) used for?
Who makes Risperdal Consta (drug)?
What drug class is Risperdal Consta (drug) in?
What development phase is Risperdal Consta (drug) in?
What are the side effects of Risperdal Consta (drug)?
What does Risperdal Consta (drug) target?
Related
- Drug class: All Atypical antipsychotic drugs
- Target: All drugs targeting D2 receptor, 5-HT2A receptor
- Manufacturer: University of Illinois at Chicago — full pipeline
- Therapeutic area: All drugs in Psychiatry
- Indication: Drugs for Schizophrenia
- Indication: Drugs for Bipolar disorder
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing