Last reviewed 2026-04-22 · How we verify

Augmenting: Antidepressant + Aripiprazole

VA Office of Research and Development · Phase 3 active Small molecule

Augmenting: Antidepressant + Aripiprazole is a Atypical antipsychotic (augmentation agent) Small molecule drug developed by VA Office of Research and Development. It is currently in Phase 3 development for Major depressive disorder with inadequate response to antidepressant monotherapy.

Aripiprazole augments antidepressant therapy by acting as a partial agonist at dopamine D2 and serotonin 5-HT1A receptors, enhancing monoaminergic neurotransmission in depression.

Aripiprazole augments antidepressant therapy by acting as a partial agonist at dopamine D2 and serotonin 5-HT1A receptors, enhancing monoaminergic neurotransmission in depression. Used for Major depressive disorder with inadequate response to antidepressant monotherapy.

Likelihood of approval

55.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	Augmenting: Antidepressant + Aripiprazole
Sponsor	VA Office of Research and Development
Drug class	Atypical antipsychotic (augmentation agent)
Target	Dopamine D2 receptor (partial agonist), Serotonin 5-HT1A receptor
Modality	Small molecule
Therapeutic area	Psychiatry / Mental Health
Phase	Phase 3

Mechanism of action

Aripiprazole is added to ongoing antidepressant treatment to improve efficacy in patients with inadequate response to antidepressants alone. As a partial dopamine D2 agonist and serotonin modulator, it complements the mechanism of SSRIs/SNRIs by stabilizing dopaminergic and serotonergic signaling. This combination strategy targets multiple neurotransmitter systems implicated in major depressive disorder.

Approved indications

Major depressive disorder with inadequate response to antidepressant monotherapy

Common side effects

Akathisia
Weight gain
Sedation
Tremor
Nausea

Key clinical trials

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:

Augmenting: Antidepressant + Aripiprazole CI brief — competitive landscape report
Augmenting: Antidepressant + Aripiprazole updates RSS · CI watch RSS
VA Office of Research and Development portfolio CI

Frequently asked questions about Augmenting: Antidepressant + Aripiprazole

What is Augmenting: Antidepressant + Aripiprazole?

Augmenting: Antidepressant + Aripiprazole is a Atypical antipsychotic (augmentation agent) drug developed by VA Office of Research and Development, indicated for Major depressive disorder with inadequate response to antidepressant monotherapy.

How does Augmenting: Antidepressant + Aripiprazole work?

Aripiprazole augments antidepressant therapy by acting as a partial agonist at dopamine D2 and serotonin 5-HT1A receptors, enhancing monoaminergic neurotransmission in depression.

What is Augmenting: Antidepressant + Aripiprazole used for?

Augmenting: Antidepressant + Aripiprazole is indicated for Major depressive disorder with inadequate response to antidepressant monotherapy.

Who makes Augmenting: Antidepressant + Aripiprazole?

Augmenting: Antidepressant + Aripiprazole is developed by VA Office of Research and Development (see full VA Office of Research and Development pipeline at /company/va-office-of-research-and-development).

What drug class is Augmenting: Antidepressant + Aripiprazole in?

Augmenting: Antidepressant + Aripiprazole belongs to the Atypical antipsychotic (augmentation agent) class. See all Atypical antipsychotic (augmentation agent) drugs at /class/atypical-antipsychotic-augmentation-agent.

What development phase is Augmenting: Antidepressant + Aripiprazole in?

Augmenting: Antidepressant + Aripiprazole is in Phase 3.

What are the side effects of Augmenting: Antidepressant + Aripiprazole?

Common side effects of Augmenting: Antidepressant + Aripiprazole include Akathisia, Weight gain, Sedation, Tremor, Nausea.

What does Augmenting: Antidepressant + Aripiprazole target?

Augmenting: Antidepressant + Aripiprazole targets Dopamine D2 receptor (partial agonist), Serotonin 5-HT1A receptor and is a Atypical antipsychotic (augmentation agent).

Drug class: All Atypical antipsychotic (augmentation agent) drugs
Target: All drugs targeting Dopamine D2 receptor (partial agonist), Serotonin 5-HT1A receptor
Manufacturer: VA Office of Research and Development — full pipeline
Therapeutic area: All drugs in Psychiatry / Mental Health
Indication: Drugs for Major depressive disorder with inadequate response to antidepressant monotherapy

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing