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OTSUKA

OTSKF
$38.82B
Large Cap
NASDAQHealthcare๐Ÿ‡บ๐Ÿ‡ธNorth America37.8K employees

Drugs in Pipeline

157

Phase 3 Programs

101

Upcoming Catalysts

10

Next Catalyst

This month

Market Overview

Stock performance and key metrics

OTSKF News
Catalyst Timeline

10 upcoming, 0 past

Drug Pipeline

OPC-61815 injection

Phase 3

Congestive Heart Failure

ASC-01

Phase 3

Major Depressive Disorder

0.3% OPA-15406

Phase 3

Atopic Dermatitis

Lithium

Phase 3

Bipolar Disorder Mania

0.3% OPA-15406 Ointment

Phase 3

Atopic Dermatitis (AD)

OPA-15406

Phase 3

Atopic Dermatitis

OPC-61815

Phase 3

Congestive Heart Failure

CDP870 200mg

Phase 3

Rheumatoid Arthritis

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

Rebamipide 1%

Phase 3

Keratoconjunctivitis Sicca

Centanafadine

Phase 3

Major Depressive Disorder

Tolvaptan Suspension

Phase 3

Autosomal Recessive Polycystic Kidney (ARPKD)

SEP-363856 50mg

Phase 3

Schizophrenia

SEP363856

Phase 3

Schizophrenia

JNT-517

Phase 3

Phenylketonuria (PKU)

Brexpiprazole

Phase 3

Major Depressive Disorder

Ropinirole

Phase 3

Parkinson's Disease

SEP-363856 75mg

Phase 3

Schizophrenia

Meptin swinghaler

Phase 3

Asthma

Aripiprazole depot 300 or 400 mg

Phase 3

Schizophrenia

Aripiprazole (Fixed dose)

Phase 3

Major Depressive Disorder

Quetiapine extended release

Phase 3

Schizophrenia

Aripiprazole

Phase 3

Schizophrenia

Busulfan

Phase 3

Multiple Myeloma

Aripiprazole (BMS-337039)

Phase 3

Dementia, Alzheimer Type

Aripiprazole+ ADT

Phase 3

Major Depressive Disorder

Olanzapine or Quetiapine or Risperidone

Phase 3

Schizophrenia

Tolvaptan (OPC-41061)

Phase 3

Autosomal Recessive Polycystic Kidney Disease (ARPKD)

Antidepressant + Aripiprazole

Phase 3

Major Depressive Disorder

OPC-34712

Phase 3

Schizophrenia

Vadadustat

Phase 3

Anemia

Aripiprazole Low (2 mg/day)

Phase 3

Schizophrenia

Cilostazol

Phase 3

Vasospastic Angina

EB-1020 (Centanafadine) 164.4 mg

Phase 3

Attention Deficit Hyperactivity Disorder (ADHD)

Aripiprazole and aripiprazole once-monthly

Phase 3

Schizophrenia

JNT-517 Tablet

Phase 3

Phenylketonuria (PKU)

AVP-786

Phase 3

Agitation in Patients With Dementia of the Alzheimer's Type

CDP870

Phase 3

Rheumatoid Arthritis

Aripiprazole Oral Solution

Phase 3

Autistic Disorder

Aripiprazole (Abilifyยฎ) IM Depot Injection

Phase 3

Schizophrenia

Hyalein Mini Ophthalmic solution

Phase 3

Dry Eye Syndromes

Aripiprazole IM Depot

Phase 3

Schizophrenia

OPC-41061(Tolvaptan)

Phase 3

Cardiac Edema

Aripiprazole tablet

Phase 3

Schizophrenia

OPC-14597 (Aripiprazole)

Phase 3

Major Depressive Disorder

TEV-48125

Phase 3

Migraine

Aripiprazole depot

Phase 3

Schizophrenia

Procaterol, Salbultamol

Phase 3

Moderate Acute Asthma

Brexpiprazole, OPC-34712

Phase 3

Agitation Associated With

High Dose Melphalan

Phase 3

Myeloma

Delamanid (DLM)

Phase 3

Tuberculosis, MDR

Aripiprazole tablet, 10 mg

Phase 3

Schizophrenia

OPC-12759 Ophthalmic suspension

Phase 3

Dry Eye Syndromes

OPC-41061 ๏ผˆTolvaptan)

Phase 3

Cardiac Edema

OPC-6535

Phase 3

Crohn's Disease

OPC-34712 + ADT

Phase 3

Depressive Disorder

OPC-34712FUM/ Brexpiprazole fumarate

Phase 3

Acute Schizophrenia

Asacolยฎ

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

Sibeprenlimab 400 mg

Phase 3

Immunoglobulin A Nephropathy

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

Latanoprost ophthalmic solution

Phase 3

Glaucoma

OPC-34712 [Brexpiprazole] High Dose

Phase 3

Acute Schizophrenia

Meptinยฎ Swinghaler

Phase 3

Asthma

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

Rebamipide and Omeprazole

Phase 3

Gastric Ulcer

Rebamipide

Phase 3

Keratoconjunctivitis Sicca

OPC-1085EL ophthalmic solution

Phase 3

Glaucoma

Centanafadine XR

Phase 3

Attention-deficit/Hyperactivity Disorder

EB-1020 (Centanafadine) low dose

Phase 3

Attention-Deficit Hyperactivity Disorder(ADHD)

Tolvaptan

Phase 3

Congestive Heart Failure

OPC-1085EL

Phase 3

Open Angle Glaucoma or Ocular Hypertension

Nalmefene hydrochloride

Phase 3

Alcohol Dependence

Misoprostol

Phase 3

Rheumatoid Arthritis

CDP870 400mg

Phase 3

Rheumatoid Arthritis

centanafadine capsule

Phase 3

Attention Deficit/Hyperactivity Disorder

Probucol

Phase 3

Hyperlipidemia

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) 328.8 mg

Phase 3

Attention Deficit Hyperactivity Disorder (ADHD)

EB-1020 (Centanafadine) high dose

Phase 3

Attention-Deficit Hyperactivity Disorder(ADHD)

Delamanid + OBR

Phase 3

Multidrug-resistant Tuberculosis

ADT

Phase 3

Major Depressive Disorder

Centanafadine Hydrochloride

Phase 3

Attention-Deficit/Hyperactivity Disorder

1% OPA-15406

Phase 3

Atopic Dermatitis

Tolvaptan Oral Tablet

Phase 3

Syndrome of Inappropriate Antidiuretic Hormone Secretion

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

IRL757

Phase 2

PARKINSON DISEASE (Disorder)

OCV-501

Phase 2

Acute Myeloid Leukemia

Delamanid + Bedaquiline + OPC-167832 10 mg

Phase 2

Pulmonary TB

Sodium hyaluronate ophthalmic solution

Phase 2

Keratoconjunctival Epithelial Disorder

OPB-31121

Phase 2

Hepatocellular Carcinoma

OPC-64005

Phase 2

Adult Attention Deficit Hyperactivity Disorder

OPC-249

Phase 2

Pain Due to Osteoporosis

IV busulfan

Phase 2

Multiple Myeloma

Optimized Background Regimen (OBR)

Phase 2

Tuberculosis, Pulmonary

OPC-41061 7.5mg

Phase 2

Cirrhosis

13C-uracil

Phase 2

Dyspeptic Subjects

OPC-64005 20 mg , Once-daily

Phase 2

Major Depressive Disorder

Probucol 250mg/day

Phase 2

Diabetic Nephropathy

tetomilast (OPC-6535)

Phase 2

Chronic Obstructive Pulmonary Disease

0.5% OPC-12759

Phase 2

Dry Eye Syndromes

Delamanid

Phase 2

Tuberculosis, Multidrug-Resistant

10 mg OPC-167832

Phase 2

Pulmonary TB

CTN SR

Phase 2

Attention Deficit Disorder With Hyperactivity

Cilostazol, Probucol

Phase 2

Peripheral Artery Disease

IV Decitabine

Phase 2

Myelodysplastic Syndromes

1% OPC-12759 ophthalmic suspension

Phase 2

Dry Eye Syndromes

Calcium (13C)Carbonate

Phase 2

Gastric Acid-related Diseases

Gastric acid inhibitors

Phase 2

Gastroesophageal Reflux Disease

Tolvaptan MR

Phase 2

Autosomal Dominant Polycystic Kidney Disease

Tolvaptan IR

Phase 2

Autosomal Dominant Polycystic Kidney Disease

Sibeprenlimab

Phase 2

IgA Nephropathy

OPC-18

Phase 2

Hepatocellular Carcinoma

OPS-2071 tablet

Phase 2

Bacterial Enteritis

Delamanid Pediatric Formulation (DPF)

Phase 2

Multidrug Resistant Tuberculosis

OPC-67683

Phase 2

Pulmonary Tuberculosis

2% Rebamipide liquid

Phase 2

Head and Neck Cancer

OPS-2071

Phase 2

Irritable Bowel Syndrome of Diarrhea Type (IBS-D)

Vesnarinone

Phase 2

Sarcoma, Kaposi

IV Busulfan, Cyclophosphamide and Etoposide (BuCyE Regimen)

Phase 2

Lymphoma

OPC 131461 10mg group

Phase 2

Cardiac Edema (CHF)

AVP-786-28

Phase 2

Neurobehavioral Disinhibition

Low Dose-VIS649

Phase 2

Immunoglobulin A Nephropathy

Rexulti

Phase 2

Borderline Personality Disorder

120mg of ETC-1002(bempedoic acid)

Phase 2

Hypercholesterolemia

AVP-786 (d6-dextromethorphan hydrobromide and quinidine sulfate combination)

Phase 2

Depressive Disorder, Treatment-Resistant

Ponatinib 30mg OD

Phase 2

Chronic Myeloid Leukemia

OPDC-34712

Phase 2

Attention Deficit Hyperactivity Disorder

OPC-415

Phase 2

Multiple Myeloma (MM)

JNT-517 Suspension

Phase 2

Phenylketonuria

rabbit anti-thymocyte globulin (ATG)

Phase 2

Chronic Myeloproliferative Disorders

Aripiprazole + IEM (Ingestible Event Marker)

Phase 2

Schizophrenia

Busulfan, Fludarabine, Cytoxan

Phase 2

Lymphoma

busulfan, melphalan and fludarabine

Phase 2

Multiple Myeloma

Bedaquiline

Phase 2

Tuberculosis, Multidrug-Resistant

PB

Phase 2

Autosomal Dominant Polycystic Kidney Disease

High-dose chemotherapy

Phase 2

Non-Hodgkin's Lymphoma

Flu/Bu4 conditioning regimen

Phase 2

Hematological Malignancies

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

Phase 2

Schizophrenia

Linezolid 600 mg

Phase 2

Tuberculosis, Multidrug-Resistant

Optimized multidrug background regimen (OBR) for children with MDR-TB

Phase 2

Tuberculosis

Clofarabine/Busulfan x 4

Phase 2

Acute Myeloblastic Leukemia

Source: CatalystAlert database (ClinicalTrials.gov, SEC EDGAR)

Market-Implied Move
Regulatory Approvals

Frequently asked questions

What is in OTSUKA's drug pipeline?โ†’

CatalystAlert tracks 157 drug candidates in OTSUKA's (OTSKF) pipeline across Phase 3, Phase 2. Its lead program is OPC-61815 injection (Phase 3). Each drug's phase, indication and upcoming catalysts are listed on this page.

When is OTSUKA's next FDA catalyst?โ†’

OTSUKA's (OTSKF) next tracked catalyst is a Phase 3 expected October 20, 2026. See the catalyst timeline on this page for the full schedule of PDUFA dates, trial readouts and FDA events.

How do I track OTSKF biotech catalysts?โ†’

Add OTSKF to your CatalystAlert watchlist for alerts ahead of each catalyst, and follow OTSUKA's live catalyst calendar, drug pipeline and clinical-trial timeline on this page โ€” sourced from ClinicalTrials.gov, FDA and SEC filings.

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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