OTSUKA
OTSKFDrugs in Pipeline
140
Phase 3 Programs
97
Upcoming Catalysts
4
Next Catalyst
Oct 2026
Market Overview
Stock performance and key metrics
5 upcoming, 0 past
Meptin swinghaler
Asthma
AVP-786-18
Agitation in Participants With Dementia of the Alzheimer's Type
BPaQM
Pulmonary Tuberculosis
Centanafadine SR
Attention Deficit Disorder
Seroquel XR
Depressive Disorder
Aripiprazole Oral Solution
Autistic Disorder
180mg of ETC-1002(bempedoic acid)
Hyper-low-density Lipoprotein (LDL) Cholesterolemia
Subcutaneous azacitidine
Myelodysplastic Syndromes
Cilostazol 200mg/day Oral
Cerebral Infarction
Sertraline
Post Traumatic Stress Disorder
OPC-34712 [Brexpiprazole] High Dose
Acute Schizophrenia
Aripiprazole (BMS-337039)
Dementia, Alzheimer Type
Escitalopram
Depressive Disorder
OPC-6535 Tablets (drug)
Ulcerative Colitis
MCT-SR
Acute Gastritis
Abilify 2, 5, 10, 15mg (Tablet)
Depression, Bipolar
Rebamipide and Omeprazole
Gastric Ulcer
OPC-1085EL ophthalmic solution
Glaucoma
Aripiprazole IM Depot
Schizophrenia
Tolvaptan
Congestive Heart Failure
Nalmefene hydrochloride
Alcohol Dependence
Misoprostol
Rheumatoid Arthritis
OPC-12759
Dry Eye
1% OPA-15406 ointment
Atopic Dermatitis
Haloperidol
Bipolar Disorder
Brexpiprazole +ADT
Depressive Disorder
EB-1020 (Centanafadine) high dose
Attention-Deficit Hyperactivity Disorder(ADHD)
Delamanid + OBR
Multidrug-resistant Tuberculosis
OPC-61815 injection
Congestive Heart Failure
ASC-01
Major Depressive Disorder
Lithium
Bipolar Disorder Mania
OPA-15406
Atopic Dermatitis
OPC-61815
Congestive Heart Failure
CDP870 200mg
Rheumatoid Arthritis
Antidepressant + Aripiprazole
Major Depressive Disorder
Aripiprazole tablet, 10 mg
Schizophrenia
Aripiprazole tablet
Schizophrenia
Rebamipide 1%
Keratoconjunctivitis Sicca
Centanafadine
Major Depressive Disorder
Tolvaptan Suspension
Autosomal Recessive Polycystic Kidney (ARPKD)
SEP363856
Schizophrenia
JNT-517
Phenylketonuria (PKU)
Ropinirole
Parkinson's Disease
Brexpiprazole, OPC-34712
Agitation Associated With
JNT-517 Tablet
Phenylketonuria (PKU)
Aripiprazole depot 300 or 400 mg
Schizophrenia
centanafadine capsule
Attention Deficit/Hyperactivity Disorder
Probucol
Hyperlipidemia
EB-1020 (Centanafadine) 328.8 mg
Attention Deficit Hyperactivity Disorder (ADHD)
Centanafadine Hydrochloride
Attention-Deficit/Hyperactivity Disorder
Tolvaptan Oral Tablet
Syndrome of Inappropriate Antidiuretic Hormone Secretion
0.3% OPA-15406
Atopic Dermatitis
0.3% OPA-15406 Ointment
Atopic Dermatitis (AD)
SEP-363856 75mg
Schizophrenia
Aripiprazole Low (2 mg/day)
Schizophrenia
Intramuscular (IM) Depot Aripiprazole
Bipolar I Disorder
OPC-41061 （Tolvaptan)
Cardiac Edema
Sibeprenlimab 400 mg
Immunoglobulin A Nephropathy
Risperidone
Schizophrenia
Latanoprost ophthalmic solution
Glaucoma
Meptin® Swinghaler
Asthma
Rebamipide
Keratoconjunctivitis Sicca
EB-1020 (Centanafadine) low dose
Attention-Deficit Hyperactivity Disorder(ADHD)
OPC-1085EL
Open Angle Glaucoma or Ocular Hypertension
Aripiprazole (Abilify®) IM Depot Injection
Schizophrenia
Olanzapine or Quetiapine or Risperidone
Schizophrenia
CDP870 400mg
Rheumatoid Arthritis
Aripiprazole (Fixed dose)
Major Depressive Disorder
ADT
Major Depressive Disorder
1% OPA-15406
Atopic Dermatitis
Aripiprazole
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.
Migraine
OPC-41061
Cirrhosis
SEP-363856
Schizophrenia
Certolizumab Pegol
Rheumatoid Arthritis
Brexpiprazole (OPC-34712)
Schizophrenia
SPM 962
Idiopathic Restless Legs Syndrome
SEP-363856 50mg
Schizophrenia
OPC-14597 (Aripiprazole)
Major Depressive Disorder
Brexpiprazole
Major Depressive Disorder
Tolvaptan (OPC-41061)
Autosomal Recessive Polycystic Kidney Disease (ARPKD)
OPC-34712
Schizophrenia
Cilostazol
Vasospastic Angina
EB-1020 (Centanafadine) 164.4 mg
Attention Deficit Hyperactivity Disorder (ADHD)
AVP-786
Agitation in Patients With Dementia of the Alzheimer's Type
Aripiprazole+ ADT
Major Depressive Disorder
CDP870
Rheumatoid Arthritis
Hyalein Mini Ophthalmic solution
Dry Eye Syndromes
OPC-41061(Tolvaptan)
Cardiac Edema
TEV-48125
Migraine
Procaterol, Salbultamol
Moderate Acute Asthma
OPC-12759 Ophthalmic suspension
Dry Eye Syndromes
Aripiprazole depot
Schizophrenia
OPC-6535
Crohn's Disease
OPC-34712 + ADT
Depressive Disorder
OPC-34712FUM/ Brexpiprazole fumarate
Acute Schizophrenia
Asacol®
Ulcerative Colitis
OCV-501
Acute Myeloid Leukemia
OPDC-34712
Attention Deficit Hyperactivity Disorder
Low Dose-VIS649
Immunoglobulin A Nephropathy
Delamanid + Bedaquiline + OPC-167832 10 mg
Pulmonary TB
Sodium hyaluronate ophthalmic solution
Keratoconjunctival Epithelial Disorder
Sibeprenlimab
IgA Nephropathy
Cilostazol, Probucol
Peripheral Artery Disease
OPC-18
Hepatocellular Carcinoma
OPS-2071 tablet
Bacterial Enteritis
OPC 131461 10mg group
Cardiac Edema (CHF)
0.5% OPC-12759
Dry Eye Syndromes
Aripiprazole + IEM (Ingestible Event Marker)
Schizophrenia
AVP-786-28
Neurobehavioral Disinhibition
IV Decitabine
Myelodysplastic Syndromes
OPB-31121
Hepatocellular Carcinoma
OPC-415
Multiple Myeloma (MM)
OPC-64005
Adult Attention Deficit Hyperactivity Disorder
Delamanid
Tuberculosis, Multidrug-Resistant
1% OPC-12759 ophthalmic suspension
Dry Eye Syndromes
Delamanid Pediatric Formulation (DPF)
Multidrug Resistant Tuberculosis
dasatinib
Pancreatic Cancer
JNT-517 Suspension
Phenylketonuria
Ponatinib 30mg OD
Chronic Myeloid Leukemia
OPC-249
Pain Due to Osteoporosis
OPC-67683
Pulmonary Tuberculosis
2% Rebamipide liquid
Head and Neck Cancer
10 mg OPC-167832
Pulmonary TB
Calcium (13C)Carbonate
Gastric Acid-related Diseases
OPS-2071
Irritable Bowel Syndrome of Diarrhea Type (IBS-D)
IV busulfan
Multiple Myeloma
Optimized Background Regimen (OBR)
Tuberculosis, Pulmonary
CTN SR
Attention Deficit Disorder With Hyperactivity
OPC-41061 7.5mg
Cirrhosis
Vesnarinone
Sarcoma, Kaposi
13C-uracil
Dyspeptic Subjects
Gastric acid inhibitors
Gastroesophageal Reflux Disease
OPC-64005 20 mg , Once-daily
Major Depressive Disorder
Tolvaptan MR
Autosomal Dominant Polycystic Kidney Disease
IV Busulfan, Cyclophosphamide and Etoposide (BuCyE Regimen)
Lymphoma
Probucol 250mg/day
Diabetic Nephropathy
Aripiprazole tablet, 5-30mg/day, oral, 6 weeks
Schizophrenia
tetomilast (OPC-6535)
Chronic Obstructive Pulmonary Disease
Tolvaptan IR
Autosomal Dominant Polycystic Kidney Disease
| Drug Name | Phase | Indication | Designations | Patent |
|---|---|---|---|---|
Meptin swinghaler | Phase 3 | Asthma | - | - |
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 | - | - |
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 | - | - |
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 | - | - |
Rebamipide 1% | Phase 3 | Keratoconjunctivitis Sicca | - | - |
Centanafadine | Phase 3 | Major Depressive Disorder | - | - |
Tolvaptan Suspension | Phase 3 | Autosomal Recessive Polycystic Kidney (ARPKD) | - | - |
SEP363856 | Phase 3 | Schizophrenia | - | - |
JNT-517 | Phase 3 | Phenylketonuria (PKU) | - | - |
Ropinirole | Phase 3 | Parkinson's Disease | - | - |
Brexpiprazole, OPC-34712 | Phase 3 | Agitation Associated With | - | - |
JNT-517 Tablet | Phase 3 | Phenylketonuria (PKU) | - | - |
Aripiprazole depot 300 or 400 mg | Phase 3 | Schizophrenia | - | - |
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 | - | - |
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 | - | - |
ADT | 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 | - | - |
OPC-34712FUM/ Brexpiprazole fumarate | Phase 3 | Acute Schizophrenia | - | - |
Asacol® | Phase 3 | Ulcerative Colitis | - | - |
OCV-501 | Phase 2 | Acute Myeloid Leukemia | - | - |
OPDC-34712 | Phase 2 | Attention Deficit Hyperactivity Disorder | - | - |
Low Dose-VIS649 | Phase 2 | Immunoglobulin A Nephropathy | - | - |
Delamanid + Bedaquiline + OPC-167832 10 mg | Phase 2 | Pulmonary TB | - | - |
Sodium hyaluronate ophthalmic solution | Phase 2 | Keratoconjunctival Epithelial Disorder | - | - |
Sibeprenlimab | Phase 2 | IgA Nephropathy | - | - |
Cilostazol, Probucol | Phase 2 | Peripheral Artery Disease | - | - |
OPC-18 | Phase 2 | Hepatocellular Carcinoma | - | - |
OPS-2071 tablet | Phase 2 | Bacterial Enteritis | - | - |
OPC 131461 10mg group | Phase 2 | Cardiac Edema (CHF) | - | - |
0.5% OPC-12759 | Phase 2 | Dry Eye Syndromes | - | - |
Aripiprazole + IEM (Ingestible Event Marker) | Phase 2 | Schizophrenia | - | - |
AVP-786-28 | Phase 2 | Neurobehavioral Disinhibition | - | - |
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 | - | - |
Delamanid Pediatric Formulation (DPF) | Phase 2 | Multidrug Resistant Tuberculosis | - | - |
dasatinib | Phase 2 | Pancreatic Cancer | - | - |
JNT-517 Suspension | Phase 2 | Phenylketonuria | - | - |
Ponatinib 30mg OD | Phase 2 | Chronic Myeloid Leukemia | - | - |
OPC-249 | Phase 2 | Pain Due to Osteoporosis | - | - |
OPC-67683 | Phase 2 | Pulmonary Tuberculosis | - | - |
2% Rebamipide liquid | Phase 2 | Head and Neck Cancer | - | - |
10 mg OPC-167832 | Phase 2 | Pulmonary TB | - | - |
Calcium (13C)Carbonate | Phase 2 | Gastric Acid-related Diseases | - | - |
OPS-2071 | Phase 2 | Irritable Bowel Syndrome of Diarrhea Type (IBS-D) | - | - |
IV busulfan | Phase 2 | Multiple Myeloma | - | - |
Optimized Background Regimen (OBR) | Phase 2 | Tuberculosis, Pulmonary | - | - |
CTN SR | Phase 2 | Attention Deficit Disorder With Hyperactivity | - | - |
OPC-41061 7.5mg | Phase 2 | Cirrhosis | - | - |
Vesnarinone | Phase 2 | Sarcoma, Kaposi | - | - |
13C-uracil | Phase 2 | Dyspeptic Subjects | - | - |
Gastric acid inhibitors | Phase 2 | Gastroesophageal Reflux Disease | - | - |
OPC-64005 20 mg , Once-daily | Phase 2 | Major Depressive Disorder | - | - |
Tolvaptan MR | Phase 2 | Autosomal Dominant Polycystic Kidney Disease | - | - |
IV Busulfan, Cyclophosphamide and Etoposide (BuCyE Regimen) | Phase 2 | Lymphoma | - | - |
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 IR | Phase 2 | Autosomal Dominant Polycystic Kidney Disease | - | - |
Full breakdown — the signals behind the verdict
Frequently asked questions
What is in OTSUKA's drug pipeline?→
CatalystAlert tracks 140 drug candidates in OTSUKA's (OTSKF) pipeline across Phase 3, Phase 2. Its lead program is Meptin swinghaler (Phase 3). Each drug's phase, indication and upcoming catalysts are listed on this page.
When is OTSUKA's next FDA catalyst?→
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?→
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 — sourced from ClinicalTrials.gov, FDA and SEC filings.