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Aripiprazole (Titrated dose)
Aripiprazole (Titrated dose) is a Atypical antipsychotic Small molecule drug developed by Otsuka Pharmaceutical Co., Ltd.. It is currently in Phase 3 development for Schizophrenia, Bipolar I disorder (acute manic or mixed episodes), Major depressive disorder (adjunctive treatment). Also known as: Aripiprazole.
Aripiprazole is a partial agonist at dopamine D2 and serotonin 5-HT1A receptors that modulates dopaminergic and serotonergic neurotransmission in the brain.
Aripiprazole is a small molecule partial agonist of the dopamine D2 receptor, classified as a partial agonist. It is used to treat conditions such as Major Depressive Disorder, Schizophrenia, and Schizoaffective Disorder, among others, and is typically titrated to an effective dose.
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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 | Aripiprazole (Titrated dose) |
|---|---|
| Also known as | Aripiprazole |
| Sponsor | Otsuka Pharmaceutical Co., Ltd. |
| Drug class | Atypical antipsychotic |
| Target | Dopamine D2 receptor (partial agonist), 5-HT1A receptor (partial agonist) |
| Modality | Small molecule |
| Therapeutic area | Psychiatry/Neurology |
| Phase | Phase 3 |
Mechanism of action
Aripiprazole acts as a partial agonist at dopamine D2 receptors, meaning it can both activate and inhibit dopamine signaling depending on baseline dopamine levels, providing a stabilizing effect on dopaminergic neurotransmission. It also has partial agonist activity at 5-HT1A receptors and antagonist activity at 5-HT2A receptors, contributing to its antipsychotic and mood-stabilizing effects. This unique pharmacological profile distinguishes it from typical antipsychotics and may result in a favorable side effect profile.
Approved indications
- Schizophrenia
- Bipolar I disorder (acute manic or mixed episodes)
- Major depressive disorder (adjunctive treatment)
- Autism spectrum disorder (irritability)
Common side effects
- Akathisia
- Headache
- Anxiety
- Insomnia
- Nausea
- Weight gain
- Tremor
- Sedation
Key clinical trials
- Neurobiological Mechanisms of Pathological Rumination and Effects of Aripiprazole (NA)
- Maternal And Infant Antipsychotic Study
- Biomarkers to Enhance Early Schizophrenia Treatment (PHASE4)
- Trial to Evaluate the Short-term Safety & Efficacy of Brexpiprazole Monotherapy in the Treatment of Adolescents With Schizophrenia (PHASE3)
- A Study of Safety and Tolerability in Subjects With Schizophrenia (PHASE1)
- To Assess the Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD) (PHASE3)
- Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD) (PHASE3)
- Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD) (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:
- Aripiprazole (Titrated dose) CI brief — competitive landscape report
- Aripiprazole (Titrated dose) updates RSS · CI watch RSS
- Otsuka Pharmaceutical Co., Ltd. portfolio CI
Frequently asked questions about Aripiprazole (Titrated dose)
What is Aripiprazole (Titrated dose)?
How does Aripiprazole (Titrated dose) work?
What is Aripiprazole (Titrated dose) used for?
Who makes Aripiprazole (Titrated dose)?
Is Aripiprazole (Titrated dose) also known as anything else?
What drug class is Aripiprazole (Titrated dose) in?
What development phase is Aripiprazole (Titrated dose) in?
What are the side effects of Aripiprazole (Titrated dose)?
What does Aripiprazole (Titrated dose) target?
Related
- Drug class: All Atypical antipsychotic drugs
- Target: All drugs targeting Dopamine D2 receptor (partial agonist), 5-HT1A receptor (partial agonist)
- Manufacturer: Otsuka Pharmaceutical Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Psychiatry/Neurology
- Indication: Drugs for Schizophrenia
- Indication: Drugs for Bipolar I disorder (acute manic or mixed episodes)
- Indication: Drugs for Major depressive disorder (adjunctive treatment)
- Also known as: Aripiprazole
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing