Last reviewed 2026-05-31 · How we verify

Aripiprazole+ ADT

Otsuka Pharmaceutical Development & Commercialization, Inc. · Phase 3 active Small molecule Under review Quality 0/100

Aripiprazole+ ADT is a Atypical antipsychotic combined with androgen deprivation therapy Small molecule drug developed by Otsuka Pharmaceutical Development & Commercialization, Inc.. It is currently in Phase 3 development for Psychiatric symptoms in patients receiving androgen deprivation therapy for prostate cancer or related conditions. Also known as: Abilify.

Aripiprazole is a dopamine D2/D3 receptor partial agonist combined with an androgen deprivation therapy (ADT) agent to treat psychiatric symptoms in patients undergoing hormone therapy.

Aripiprazole is a partial agonist of the dopamine D2 receptor, classified as a small molecule. Aripiprazole is being studied as an adjunct to antidepressant therapy (ADT) for the treatment of Major Depressive Disorder.

Likelihood of approval

61.3% 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).
Oncology Phase 3 boost +3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.

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	Aripiprazole+ ADT
Also known as	Abilify
Sponsor	Otsuka Pharmaceutical Development & Commercialization, Inc.
Drug class	Atypical antipsychotic combined with androgen deprivation therapy
Target	Dopamine D2/D3 receptors (aripiprazole component); androgen receptor (ADT component)
Modality	Small molecule
Therapeutic area	Psychiatry / Oncology
Phase	Phase 3

Mechanism of action

Aripiprazole acts as a partial agonist at dopamine D2 and D3 receptors, stabilizing dopaminergic neurotransmission and reducing psychotic symptoms. The combination with ADT addresses both the psychiatric manifestations and hormonal aspects of the condition being treated, likely targeting patients with prostate cancer or related conditions who experience treatment-related psychiatric side effects.

Approved indications

Psychiatric symptoms in patients receiving androgen deprivation therapy for prostate cancer or related conditions

Common side effects

Akathisia
Headache
Nausea
Insomnia
Weight gain

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:

Aripiprazole+ ADT CI brief — competitive landscape report
Aripiprazole+ ADT updates RSS · CI watch RSS
Otsuka Pharmaceutical Development & Commercialization, Inc. portfolio CI

Frequently asked questions about Aripiprazole+ ADT

What is Aripiprazole+ ADT?

Aripiprazole+ ADT is a Atypical antipsychotic combined with androgen deprivation therapy drug developed by Otsuka Pharmaceutical Development & Commercialization, Inc., indicated for Psychiatric symptoms in patients receiving androgen deprivation therapy for prostate cancer or related conditions.

How does Aripiprazole+ ADT work?

Aripiprazole is a dopamine D2/D3 receptor partial agonist combined with an androgen deprivation therapy (ADT) agent to treat psychiatric symptoms in patients undergoing hormone therapy.

What is Aripiprazole+ ADT used for?

Aripiprazole+ ADT is indicated for Psychiatric symptoms in patients receiving androgen deprivation therapy for prostate cancer or related conditions.

Who makes Aripiprazole+ ADT?

Aripiprazole+ ADT is developed by Otsuka Pharmaceutical Development & Commercialization, Inc. (see full Otsuka Pharmaceutical Development & Commercialization, Inc. pipeline at /company/otsuka-pharmaceutical-development-commercialization-inc).

Is Aripiprazole+ ADT also known as anything else?

Aripiprazole+ ADT is also known as Abilify.

What drug class is Aripiprazole+ ADT in?

Aripiprazole+ ADT belongs to the Atypical antipsychotic combined with androgen deprivation therapy class. See all Atypical antipsychotic combined with androgen deprivation therapy drugs at /class/atypical-antipsychotic-combined-with-androgen-deprivation-therapy.

What development phase is Aripiprazole+ ADT in?

Aripiprazole+ ADT is in Phase 3.

What are the side effects of Aripiprazole+ ADT?

Common side effects of Aripiprazole+ ADT include Akathisia, Headache, Nausea, Insomnia, Weight gain.

What does Aripiprazole+ ADT target?

Aripiprazole+ ADT targets Dopamine D2/D3 receptors (aripiprazole component); androgen receptor (ADT component) and is a Atypical antipsychotic combined with androgen deprivation therapy.

Drug class: All Atypical antipsychotic combined with androgen deprivation therapy drugs
Target: All drugs targeting Dopamine D2/D3 receptors (aripiprazole component); androgen receptor (ADT component)
Manufacturer: Otsuka Pharmaceutical Development & Commercialization, Inc. — full pipeline
Therapeutic area: All drugs in Psychiatry / Oncology
Indication: Drugs for Psychiatric symptoms in patients receiving androgen deprivation therapy for prostate cancer or related conditions
Also known as: Abilify

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