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Antidepressant + Aripiprazole
Antidepressant + Aripiprazole is a Antidepressant + atypical antipsychotic combination Small molecule drug developed by Bristol-Myers Squibb. It is currently in Phase 3 development for Major depressive disorder, treatment-resistant or inadequate response to antidepressant monotherapy. Also known as: Abilify.
This combination enhances serotonergic and noradrenergic neurotransmission via antidepressant action while aripiprazole provides dopaminergic stabilization and augmentation of antidepressant efficacy.
Aripiprazole is a partial agonist of the dopamine D2 receptor, classified as a small molecule. It is used in combination with an antidepressant to treat conditions such as Major Depressive Disorder, Depressive Disorder, Psychotic Disorder, Bipolar I Disorder, and Depression.
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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). -
Big-pharma sponsor
+3.0pp
Bristol-Myers Squibb is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | Antidepressant + Aripiprazole |
|---|---|
| Also known as | Abilify |
| Sponsor | Bristol-Myers Squibb |
| Drug class | Antidepressant + atypical antipsychotic combination |
| Target | Serotonin/norepinephrine reuptake transporters (antidepressant component); dopamine D2 receptor partial agonist (aripiprazole) |
| Modality | Small molecule |
| Therapeutic area | Psychiatry/Mental Health |
| Phase | Phase 3 |
Mechanism of action
The antidepressant component (specific agent not specified) increases monoamine availability in the central nervous system, typically through reuptake inhibition. Aripiprazole, an atypical antipsychotic with partial dopamine D2 agonist activity, is used as an augmentation strategy to enhance antidepressant response and may address residual symptoms in treatment-resistant depression. This combination leverages both serotonergic and dopaminergic pathways.
Approved indications
- Major depressive disorder, treatment-resistant or inadequate response to antidepressant monotherapy
Common side effects
- Akathisia
- Weight gain
- Sedation
- Nausea
- Tremor
- Restlessness
Key clinical trials
- Τhe Combination of Pharmacotherapy With RECOVERYTRSGR and RECOVERYTRSBDGR. (PHASE4)
- Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD) (PHASE1, PHASE2)
- Neurobiological Mechanisms of Pathological Rumination and Effects of Aripiprazole (NA)
- Treating Negative Affect in Low Back Pain Patients (PHASE2, PHASE3)
- Sequential Multiple Assignment Randomized Trial for Bipolar Depression (PHASE4)
- National Pregnancy Registry for Psychiatric Medications
- Maternal And Infant Antipsychotic Study
- Comparison of Esketamine Nasal Spray vs.Aripiprazole in Treat.Resistant Major Depressive Disorder in Elderly Patients (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:
- Antidepressant + Aripiprazole CI brief — competitive landscape report
- Antidepressant + Aripiprazole updates RSS · CI watch RSS
- Bristol-Myers Squibb portfolio CI
Frequently asked questions about Antidepressant + Aripiprazole
What is Antidepressant + Aripiprazole?
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Is Antidepressant + Aripiprazole also known as anything else?
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What does Antidepressant + Aripiprazole target?
Related
- Drug class: All Antidepressant + atypical antipsychotic combination drugs
- Target: All drugs targeting Serotonin/norepinephrine reuptake transporters (antidepressant component); dopamine D2 receptor partial agonist (aripiprazole)
- Manufacturer: Bristol-Myers Squibb — full pipeline
- Therapeutic area: All drugs in Psychiatry/Mental Health
- Indication: Drugs for Major depressive disorder, treatment-resistant or inadequate response to antidepressant monotherapy
- Also known as: Abilify
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing