Otsuka

NYSE/NASDAQ:USAUPharma

Tokyo, Japan, Japan · Est. 1921 · 47,000 employees

Otsuka Pharmaceutical is a diversified pharmaceutical company developing and marketing medications across psychiatry, oncology, and other therapeutic areas globally.

Pipeline Programs↗

Distinct drugs in development (Preclinical–Phase 3)

Indications↗

Distinct diseases across all programs

481

Clinical Trials↗

All sponsored trials (all statuses)

Orange Book Patents

Across 4 drugs with upcoming expirations

Pipeline

Pipeline Snapshot

By Phase

15 drugs in development

Approved2

Phase 37

Phase 25

Phase 15

Preclinical2

By Therapeutic Area

top 6

Psychiatry

29%

Nephrology

29%

Cardiovascular

29%

Infectious Disease

29%

Immunology

29%

Oncology

29%

R&D Momentum

70/100

Pipeline Velocity

42/100

Trial Completion Rate

90/100

Pipeline Concentration

16/100

Pipeline Freshness

75/100

Strategic Signals

↗Active in Neurology but thin pipeline — potential licensing opportunity

Activity

Recent Activity

Last 14 days

Sep 17, 2026

Recruiting

A Multicenter, Placebo-controlled, Randomized, Double-blind, Parallel-group Comparison Trial to Investigate the Efficacy and Safety of Brexpiprazole Once-weekly (QW) Formulation in Patients With Acute Schizophrenia

Sep 15, 2026

Terminated

A Multicenter, Uncontrolled, Nonrandomized, Open-Label, Phase 1/2 Trial Investigating the Safety and Efficacy of OPC 415 in MMG49 Antigen-Positive Patients With Relapsed and/or Refractory Multiple Myeloma

Sep 15, 2026

Recruiting

A Phase 3b, Multicenter, Open-label, Single-arm Trial to Evaluate the Efficacy and Safety of Orally Administered Centanafadine QD XR Capsules in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation

Sep 12, 2026

Completed

A Multicenter, Uncontrolled, Open-label Trial to Investigate the Long-term Tolerability, Safety, and Efficacy of Brexpiprazole Once-weekly (QW) Formulation Administered Once Weekly for 52 Weeks in Patients With Schizophrenia

Sep 11, 2026

Recruiting

A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Trial to Compare the Efficacy and Safety of a Fixed Dose of SEP-363856 to Placebo in the Treatment of Adults With Generalized Anxiety Disorder

Earlier

Aug 27, 2026TrialA Phase 3, Multicenter, Open-Label Extension Trial to Evaluate the Safety and Tolerability of SEP-363856 in the Treatment of Adults With Generalized Anxiety Disorder

Aug 22, 2026TrialA Phase I/IIa, Single Site, Open-Label, Ascending Dose Study to Evaluate the Safety and Efficacy of OPF-310 [Encapsulated Porcine Islet Cells for Xenotransplantation] in Subjects With Type 1 Diabetes Mellitus

Aug 19, 2026TrialA Phase 1, Open-label, Positron Emission Tomography (PET) Trial to Measure Serotonin 5-HT2A Receptor Occupancy Following Single Oral Doses of MSP-2020 in Healthy Male Adults

4 more events

Aug 19, 2026TrialA Phase 3, Open-label, Single-arm, Repeat-dose Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Sibeprenlimab Administered Subcutaneously in Children and Adolescents With Immunoglobulin A Nephropathy

Aug 13, 2026TrialA Multicenter, Phase 2b/c, Open-label, Randomized, Dose-finding Trial to Evaluate the Safety and Efficacy of a 4 Month Regimen of OPC-167832 in Combination With Delamanid and Bedaquiline in Subjects With Drug-susceptible Pulmonary Tuberculosis in Comparison With Standard Treatment

Aug 13, 2026TrialA Phase 1, Open-label, Single-dose, Parallel-group Study Evaluating the Pharmacokinetics of Oral Repinatrabit (JNT-517) Immediate Release Tablet in Hepatic or Renal Impaired Adult Participants Matched to Adult Participants With Normal Hepatic and Renal Function

Aug 13, 2026TrialA Phase 1, 4-arm, Open-label, Drug-drug Interaction Trial to Evaluate the Pharmacokinetics of Repinatrabit Oral Tablets When Co-administered With Ethinyl Estradiol/Norethindrone, Metformin, Carbamazepine, Rosuvastatin, and Methotrexate in Healthy Participants

Details

Company Info

Company Overview

—

Mkt Cap

$25.2M

Revenue

$2.2M

Cash

CEOTatsuo Higuchi

Founded1921

Employees47,000

HQTokyo, Japan, Japan

ExchangeNYSE/NASDAQ:USAU

Websiteotsuka.co.jp/en/

LinkedInCompany Page

Therapeutic Focus

PsychiatryOtherOncologyHematologyNephrologyRare DiseaseOphthalmologyGastroenterologyInfectious DiseaseNeurologyCardiovascularDermatologyMetabolic & EndocrineImmunology

Pipeline

Drug Pipeline

Therapeutic Area

Preclinical

Phase 1

Phase 2

Phase 3

Approved

Cardiovascular(2 drugs)

—

Cardiovascular(2 drugs)

Gastroenterology(1 drug)

—

Gastroenterology(1 drug)

Immunology(2 drugs)

—

Immunology(2 drugs)

Infectious Disease(2 drugs)

—

Infectious Disease(2 drugs)

Nephrology(2 drugs)

—

Nephrology(2 drugs)

Neurology(1 drug)

—

Neurology(1 drug)

Oncology(2 drugs)

—

Oncology(2 drugs)

Psychiatry(2 drugs)

—

Psychiatry(2 drugs)

Rare Disease(1 drug)

—

Rare Disease(1 drug)

Unknown / Other(7 drugs)

Regulatory

Regulatory Timeline

20042 events

FDADec 10

Abilify — ABILIFY

Application NDA021713 (NDA)

FDADec 10

Mezofy — ABILIFY

Application NDA021713 (NDA)

20064 events

FDASep 20

Abilify — ABILIFY

Application NDA021866 (NDA)

FDASep 20

Mezofy — ABILIFY

Application NDA021866 (NDA)

FDAJun 7

Abilify — ABILIFY

Application NDA021729 (NDA)

FDAJun 7

Mezofy — ABILIFY

Application NDA021729 (NDA)

20091 event

FDAMay 19

Samsca — SAMSCA

Application NDA022275 (NDA)

20132 events

FDAFeb 28

Abilify — ABILIFY MAINTENA KIT

Application NDA202971 (NDA)

FDAFeb 28

Mezofy — ABILIFY MAINTENA KIT

Application NDA202971 (NDA)

20151 event

FDAJul 10

Rexulti — REXULTI

Application NDA205422 (NDA)

20172 events

FDANov 13

Abilify — ABILIFY MYCITE KIT

Application NDA207202 (NDA)

FDANov 13

Mezofy — ABILIFY MYCITE KIT

Application NDA207202 (NDA)

20181 event

FDAApr 23

Samsca — JYNARQUE

Application NDA204441 (NDA)

20232 events

FDAApr 27

Abilify — ABILIFY ASIMTUFII

Application NDA217006 (NDA)

FDAApr 27

Mezofy — ABILIFY ASIMTUFII

Application NDA217006 (NDA)

20242 events

FDAJul 22

Abilify — OPIPZA

Application NDA216655 (NDA)

FDAJul 22

Mezofy — OPIPZA

Application NDA216655 (NDA)

20253 events

FDANov 25

VOYXACT — VOYXACT

Application BLA761434 (BLA)

FDAApr 15

Abilify — MEZOFY

Application NDA211448 (NDA)

FDAApr 15

Mezofy — MEZOFY

Application NDA211448 (NDA)

Data sources: ClinicalTrials.gov (NIH) · OpenFDA (FDA) · ChEMBL (EMBL-EBI) · Open Targets (EBI/Sanger) · MedlinePlus (NIH) · PubMed (NIH) · SEC EDGAR (SEC)