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OTSUKA

OTSKF
$34.00B
Large Cap
NASDAQHealthcare🇺🇸North America35.3K employees

Drugs in Pipeline

138

Phase 3 Programs

95

Upcoming Catalysts

8

Next Catalyst

Feb 15, 2026

7d
Data is aggregated from public sources (FDA, SEC, ClinicalTrials.gov). While we strive for accuracy, information may be incomplete, delayed, or contain errors. Terms apply

Market Overview

Stock performance and market intelligence

Catalyst Timeline

8 upcoming, 0 past

⭐Phase 3Next

OPC-34712FUM/ Brexpiprazole fumarate Phase 3 Results Expected

February 2026~OPC-34712FUM/ Brexpiprazole fumarate450

Primary completion for OPC-34712FUM/ Brexpiprazole fumarate trial (NCT05325645) in Acute Schizophrenia

Source
⭐Phase 3

Centanafadine Hydrochloride Phase 3 Results Expected

Mar 25, 2026Centanafadine Hydrochloride680

Primary completion for Centanafadine Hydrochloride trial (NCT05279313) in Attention Deficit/Hyperactivity Disorder

Source
⭐Phase 3

Centanafadine Hydrochloride Phase 3 Results Expected

Apr 30, 2026Centanafadine Hydrochloride680

Primary completion for Centanafadine Hydrochloride trial (NCT05279313) in Attention Deficit/Hyperactivity Disorder

Source
Phase 2

IV Decitabine Phase 2 Results Expected

May 31, 2026IV Decitabine72

Primary completion for IV Decitabine trial (NCT06091267) in Myelodysplastic Syndromes

Source
⭐Phase 3

Centanafadine Phase 3 Results Expected

Jun 1, 2026Centanafadine308

Primary completion for Centanafadine trial (NCT06973577) in ADHD

Source
⭐Phase 3

SEP-363856 Phase 3 Results Expected

Oct 20, 2026SEP-363856522

Primary completion for SEP-363856 trial (NCT06894212) in Schizophrenia

Source
⭐Phase 3

JNT-517 Tablet Phase 3 Results Expected

Nov 1, 2026JNT-517 Tablet120

Primary completion for JNT-517 Tablet trial (NCT06971731) in Phenylketonuria

Source
⭐Phase 3

Sibeprenlimab 400 mg Phase 3 Results Expected

Dec 30, 2026Sibeprenlimab 400 mg530

Primary completion for Sibeprenlimab 400 mg trial (NCT05248646) in Immunoglobulin A Nephropathy

Source

AI Predictions & Institutional Flow

Machine learning insights and smart money movement

FDA Submissions

Pending NDA/BLA submissions with predicted PDUFA dates

Drug Pipeline

Clinical development programs and drug candidates

Drug Pipeline

ADT

Phase 3

Major Depressive Disorder

JNT-517 Tablet

Phase 3

Phenylketonuria (PKU)

Aripiprazole depot 300 or 400 mg

Phase 3

Schizophrenia

OPC-34712FUM/ Brexpiprazole fumarate

Phase 3

Acute Schizophrenia

Asacol®

Phase 3

Ulcerative Colitis

AVP-786-18

Phase 3

Agitation in Participants With Dementia of the Alzheimer's Type

BPaQM

Phase 3

Pulmonary Tuberculosis

Centanafadine SR

Phase 3

Attention Deficit Disorder

Seroquel XR

Phase 3

Depressive Disorder

Aripiprazole Oral Solution

Phase 3

Autistic Disorder

180mg of ETC-1002(bempedoic acid)

Phase 3

Hyper-low-density Lipoprotein (LDL) Cholesterolemia

Subcutaneous azacitidine

Phase 3

Myelodysplastic Syndromes

Cilostazol 200mg/day Oral

Phase 3

Cerebral Infarction

Sertraline

Phase 3

Post Traumatic Stress Disorder

OPC-34712 [Brexpiprazole] High Dose

Phase 3

Acute Schizophrenia

Aripiprazole (BMS-337039)

Phase 3

Dementia, Alzheimer Type

Escitalopram

Phase 3

Depressive Disorder

OPC-6535 Tablets (drug)

Phase 3

Ulcerative Colitis

MCT-SR

Phase 3

Acute Gastritis

Abilify 2, 5, 10, 15mg (Tablet)

Phase 3

Depression, Bipolar

Brexpiprazole, OPC-34712

Phase 3

Agitation Associated With

Rebamipide and Omeprazole

Phase 3

Gastric Ulcer

OPC-1085EL ophthalmic solution

Phase 3

Glaucoma

Aripiprazole IM Depot

Phase 3

Schizophrenia

Tolvaptan

Phase 3

Congestive Heart Failure

Nalmefene hydrochloride

Phase 3

Alcohol Dependence

Misoprostol

Phase 3

Rheumatoid Arthritis

OPC-12759

Phase 3

Dry Eye

1% OPA-15406 ointment

Phase 3

Atopic Dermatitis

Haloperidol

Phase 3

Bipolar Disorder

Brexpiprazole +ADT

Phase 3

Depressive Disorder

EB-1020 (Centanafadine) high dose

Phase 3

Attention-Deficit Hyperactivity Disorder(ADHD)

Delamanid + OBR

Phase 3

Multidrug-resistant Tuberculosis

OPC-61815 injection

Phase 3

Congestive Heart Failure

Meptin swinghaler

Phase 3

Asthma

ASC-01

Phase 3

Major Depressive Disorder

Lithium

Phase 3

Bipolar Disorder Mania

OPA-15406

Phase 3

Atopic Dermatitis

OPC-61815

Phase 3

Congestive Heart Failure

CDP870 200mg

Phase 3

Rheumatoid Arthritis

Antidepressant + Aripiprazole

Phase 3

Major Depressive Disorder

Aripiprazole tablet, 10 mg

Phase 3

Schizophrenia

Aripiprazole tablet

Phase 3

Schizophrenia

Centanafadine

Phase 3

Major Depressive Disorder

Tolvaptan Suspension

Phase 3

Autosomal Recessive Polycystic Kidney (ARPKD)

Ropinirole

Phase 3

Parkinson's Disease

centanafadine capsule

Phase 3

Attention Deficit/Hyperactivity Disorder

Probucol

Phase 3

Hyperlipidemia

EB-1020 (Centanafadine) 328.8 mg

Phase 3

Attention Deficit Hyperactivity Disorder (ADHD)

Centanafadine Hydrochloride

Phase 3

Attention-Deficit/Hyperactivity Disorder

Tolvaptan Oral Tablet

Phase 3

Syndrome of Inappropriate Antidiuretic Hormone Secretion

0.3% OPA-15406

Phase 3

Atopic Dermatitis

0.3% OPA-15406 Ointment

Phase 3

Atopic Dermatitis (AD)

SEP-363856 75mg

Phase 3

Schizophrenia

Aripiprazole Low (2 mg/day)

Phase 3

Schizophrenia

Intramuscular (IM) Depot Aripiprazole

Phase 3

Bipolar I Disorder

SEP363856

Phase 3

Schizophrenia

OPC-41061 （Tolvaptan)

Phase 3

Cardiac Edema

Sibeprenlimab 400 mg

Phase 3

Immunoglobulin A Nephropathy

Risperidone

Phase 3

Schizophrenia

Latanoprost ophthalmic solution

Phase 3

Glaucoma

Meptin® Swinghaler

Phase 3

Asthma

Rebamipide

Phase 3

Keratoconjunctivitis Sicca

EB-1020 (Centanafadine) low dose

Phase 3

Attention-Deficit Hyperactivity Disorder(ADHD)

OPC-1085EL

Phase 3

Open Angle Glaucoma or Ocular Hypertension

Aripiprazole (Abilify®) IM Depot Injection

Phase 3

Schizophrenia

Olanzapine or Quetiapine or Risperidone

Phase 3

Schizophrenia

CDP870 400mg

Phase 3

Rheumatoid Arthritis

Aripiprazole (Fixed dose)

Phase 3

Major Depressive Disorder

1% OPA-15406

Phase 3

Atopic Dermatitis

Aripiprazole

Phase 3

Schizophrenia

Each subject will subcutaneously self-administer TEV 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses.

Phase 3

Migraine

OPC-41061

Phase 3

Cirrhosis

SEP-363856

Phase 3

Schizophrenia

Certolizumab Pegol

Phase 3

Rheumatoid Arthritis

Brexpiprazole (OPC-34712)

Phase 3

Schizophrenia

SPM 962

Phase 3

Idiopathic Restless Legs Syndrome

SEP-363856 50mg

Phase 3

Schizophrenia

OPC-14597 (Aripiprazole)

Phase 3

Major Depressive Disorder

Brexpiprazole

Phase 3

Major Depressive Disorder

Tolvaptan (OPC-41061)

Phase 3

Autosomal Recessive Polycystic Kidney Disease (ARPKD)

OPC-34712

Phase 3

Schizophrenia

Cilostazol

Phase 3

Vasospastic Angina

EB-1020 (Centanafadine) 164.4 mg

Phase 3

Attention Deficit Hyperactivity Disorder (ADHD)

AVP-786

Phase 3

Agitation in Patients With Dementia of the Alzheimer's Type

Aripiprazole+ ADT

Phase 3

Major Depressive Disorder

CDP870

Phase 3

Rheumatoid Arthritis

Hyalein Mini Ophthalmic solution

Phase 3

Dry Eye Syndromes

OPC-41061(Tolvaptan)

Phase 3

Cardiac Edema

TEV-48125

Phase 3

Migraine

Procaterol, Salbultamol

Phase 3

Moderate Acute Asthma

OPC-12759 Ophthalmic suspension

Phase 3

Dry Eye Syndromes

Aripiprazole depot

Phase 3

Schizophrenia

OPC-6535

Phase 3

Crohn's Disease

OPC-34712 + ADT

Phase 3

Depressive Disorder

Delamanid + Bedaquiline + OPC-167832 10 mg

Phase 2

Pulmonary TB

Sodium hyaluronate ophthalmic solution

Phase 2

Keratoconjunctival Epithelial Disorder

IV Busulfan, Cyclophosphamide and Etoposide (BuCyE Regimen)

Phase 2

Lymphoma

Cilostazol, Probucol

Phase 2

Peripheral Artery Disease

OPDC-34712

Phase 2

Attention Deficit Hyperactivity Disorder

Sibeprenlimab

Phase 2

IgA Nephropathy

OPC-18

Phase 2

Hepatocellular Carcinoma

0.5% OPC-12759

Phase 2

Dry Eye Syndromes

OPS-2071 tablet

Phase 2

Bacterial Enteritis

Ponatinib 30mg OD

Phase 2

Chronic Myeloid Leukemia

IV Decitabine

Phase 2

Myelodysplastic Syndromes

OPB-31121

Phase 2

Hepatocellular Carcinoma

OPC-415

Phase 2

Multiple Myeloma (MM)

OPC-64005

Phase 2

Adult Attention Deficit Hyperactivity Disorder

Delamanid

Phase 2

Tuberculosis, Multidrug-Resistant

1% OPC-12759 ophthalmic suspension

Phase 2

Dry Eye Syndromes

OPC 131461 10mg group

Phase 2

Cardiac Edema (CHF)

Aripiprazole + IEM (Ingestible Event Marker)

Phase 2

Schizophrenia

Delamanid Pediatric Formulation (DPF)

Phase 2

Multidrug Resistant Tuberculosis

dasatinib

Phase 2

Pancreatic Cancer

AVP-786-28

Phase 2

Neurobehavioral Disinhibition

OPC-249

Phase 2

Pain Due to Osteoporosis

JNT-517 Suspension

Phase 2

Phenylketonuria

10 mg OPC-167832

Phase 2

Pulmonary TB

Vehicle ointment

Phase 2

Atopic Dermatitis

OPC-67683

Phase 2

Pulmonary Tuberculosis

CTN SR

Phase 2

Attention Deficit Disorder With Hyperactivity

IV busulfan

Phase 2

Multiple Myeloma

Optimized Background Regimen (OBR)

Phase 2

Tuberculosis, Pulmonary

Calcium (13C)Carbonate

Phase 2

Gastric Acid-related Diseases

OPC-41061 7.5mg

Phase 2

Cirrhosis

OCV-501

Phase 2

Acute Myeloid Leukemia

13C-uracil

Phase 2

Dyspeptic Subjects

2% Rebamipide liquid

Phase 2

Head and Neck Cancer

OPC-64005 20 mg , Once-daily

Phase 2

Major Depressive Disorder

OPS-2071

Phase 2

Irritable Bowel Syndrome of Diarrhea Type (IBS-D)

Gastric acid inhibitors

Phase 2

Gastroesophageal Reflux Disease

Probucol 250mg/day

Phase 2

Diabetic Nephropathy

Aripiprazole tablet, 5-30mg/day, oral, 6 weeks

Phase 2

Schizophrenia

tetomilast (OPC-6535)

Phase 2

Chronic Obstructive Pulmonary Disease

Tolvaptan MR

Phase 2

Autosomal Dominant Polycystic Kidney Disease

Vesnarinone

Phase 2

Sarcoma, Kaposi

Tolvaptan IR

Phase 2

Autosomal Dominant Polycystic Kidney Disease

Regulatory & News

Approvals, filings, and latest developments

Regulatory Approvals
OTSKF News