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Cariprazine capsule
Cariprazine capsule is a Small molecule drug developed by Gedeon Richter Plc.. It is currently in Phase 1 development.
Cariprazine is a small molecule that modulates the dopamine D3 receptor, classified as a modulator. It is used to treat conditions such as schizophrenia, bipolar disorder, depression, mania, and bipolar I disorder, as studied in clinical trials.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Cariprazine capsule |
|---|---|
| Sponsor | Gedeon Richter Plc. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Headache
- Akathisia
- Insomnia
- Restlessness
- Nausea
- Weight increased
- HEADACHE
- AKATHISIA
- Anxiety
- Extrapyramidal disorder
- INSOMNIA
- Dyspepsia
Key clinical trials
- A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder. (PHASE3)
- Observational Study of Oral Cariprazine Capsules to Assess Change in Disease Activity in Adult Participants With Bipolar I Disorder
- Open-Label, Flexible-dose Study to Evaluate the Long-Term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Participants With Schizophrenia, Bipolar I Disorder, or Autism Spectrum Disorder (PHASE3)
- Study to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Schizophrenia (PHASE3)
- Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia (PHASE3)
- Bioequivalence Assessment Between Two Cariprazine Hard Capsule Formulations (PHASE1)
- Study of Cariprazine Oral Capsules or Solution to Assess Adverse Events and Change in Irritability Due to Autism Spectrum Disorder (ASD) in Participants Aged 5-17 Years With ASD (PHASE3)
- A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features (PHASE3)
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:
- Cariprazine capsule CI brief — competitive landscape report
- Cariprazine capsule updates RSS · CI watch RSS
- Gedeon Richter Plc. portfolio CI
Frequently asked questions about Cariprazine capsule
What is Cariprazine capsule?
Who makes Cariprazine capsule?
What development phase is Cariprazine capsule in?
What are the side effects of Cariprazine capsule?
Related
- Manufacturer: Gedeon Richter Plc. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing