OTSUKA
OTSKFDrugs in Pipeline
132
Phase 3 Programs
86
Upcoming Catalysts
4
Next Catalyst
Q1 2027
Market Overview
Stock performance and key metrics
6 upcoming, 1 past
Brexpiprazole, OPC-34712
Agitation Associated With
OPC-34712 + ADT
Depressive Disorder
OPC-34712FUM/ Brexpiprazole fumarate
Acute Schizophrenia
Asacol®
Ulcerative Colitis
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
180mg of ETC-1002(bempedoic acid)
Hyper-low-density Lipoprotein (LDL) Cholesterolemia
Subcutaneous azacitidine
Myelodysplastic Syndromes
Cilostazol 200mg/day Oral
Cerebral Infarction
OPC-34712 [Brexpiprazole] High Dose
Acute Schizophrenia
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
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
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
Meptin swinghaler
Asthma
Aripiprazole (Fixed dose)
Major Depressive Disorder
Quetiapine extended release
Schizophrenia
Aripiprazole
Schizophrenia
Aripiprazole (BMS-337039)
Dementia, Alzheimer Type
Aripiprazole+ ADT
Major Depressive Disorder
Olanzapine or Quetiapine or Risperidone
Schizophrenia
Antidepressant + Aripiprazole
Major Depressive Disorder
JNT-517 Tablet
Phenylketonuria (PKU)
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
OPC-41061 （Tolvaptan)
Cardiac Edema
Sibeprenlimab 400 mg
Immunoglobulin A Nephropathy
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
CDP870 400mg
Rheumatoid Arthritis
ADT
Major Depressive Disorder
1% OPA-15406
Atopic Dermatitis
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
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
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
OPC-6535
Crohn's Disease
OCV-501
Acute Myeloid Leukemia
Gastric acid inhibitors
Gastroesophageal Reflux Disease
Delamanid + Bedaquiline + OPC-167832 10 mg
Pulmonary TB
Sodium hyaluronate ophthalmic solution
Keratoconjunctival Epithelial Disorder
Tolvaptan MR
Autosomal Dominant Polycystic Kidney Disease
AVP-786-28
Neurobehavioral Disinhibition
Tolvaptan IR
Autosomal Dominant Polycystic Kidney Disease
OPDC-34712
Attention Deficit Hyperactivity Disorder
rabbit anti-thymocyte globulin (ATG)
Chronic Myeloproliferative Disorders
10 mg OPC-167832
Pulmonary TB
Sibeprenlimab
IgA Nephropathy
CTN SR
Attention Deficit Disorder With Hyperactivity
OPB-31121
Hepatocellular Carcinoma
OPC-64005
Adult Attention Deficit Hyperactivity Disorder
OPC-18
Hepatocellular Carcinoma
OPS-2071 tablet
Bacterial Enteritis
Busulfan
Multiple Myeloma
Low Dose-VIS649
Immunoglobulin A Nephropathy
Rexulti
Borderline Personality Disorder
OPC-249
Pain Due to Osteoporosis
120mg of ETC-1002(bempedoic acid)
Hypercholesterolemia
Delamanid Pediatric Formulation (DPF)
Multidrug Resistant Tuberculosis
AVP-786 (d6-dextromethorphan hydrobromide and quinidine sulfate combination)
Depressive Disorder, Treatment-Resistant
IV busulfan
Multiple Myeloma
Optimized Background Regimen (OBR)
Tuberculosis, Pulmonary
OPC-41061 7.5mg
Cirrhosis
Cilostazol, Probucol
Peripheral Artery Disease
13C-uracil
Dyspeptic Subjects
Ponatinib 30mg OD
Chronic Myeloid Leukemia
OPC-64005 20 mg , Once-daily
Major Depressive Disorder
OPC-67683
Pulmonary Tuberculosis
Probucol 250mg/day
Diabetic Nephropathy
tetomilast (OPC-6535)
Chronic Obstructive Pulmonary Disease
2% Rebamipide liquid
Head and Neck Cancer
IV Decitabine
Myelodysplastic Syndromes
OPS-2071
Irritable Bowel Syndrome of Diarrhea Type (IBS-D)
1% OPC-12759 ophthalmic suspension
Dry Eye Syndromes
Vesnarinone
Sarcoma, Kaposi
IV Busulfan, Cyclophosphamide and Etoposide (BuCyE Regimen)
Lymphoma
OPC-415
Multiple Myeloma (MM)
0.5% OPC-12759
Dry Eye Syndromes
Aripiprazole + IEM (Ingestible Event Marker)
Schizophrenia
OPC 131461 10mg group
Cardiac Edema (CHF)
Calcium (13C)Carbonate
Gastric Acid-related Diseases
JNT-517 Suspension
Phenylketonuria
Delamanid
Tuberculosis, Multidrug-Resistant
| Drug Name | Phase | Indication | Designations | Patent |
|---|---|---|---|---|
Brexpiprazole, OPC-34712 | Phase 3 | Agitation Associated With | - | - |
OPC-34712 + ADT | Phase 3 | Depressive Disorder | - | - |
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 | - | - |
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 | - | - |
OPC-34712 [Brexpiprazole] High Dose | Phase 3 | Acute Schizophrenia | - | - |
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 | - | - |
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 | - | - |
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 | - | - |
Meptin swinghaler | Phase 3 | Asthma | - | - |
Aripiprazole (Fixed dose) | Phase 3 | Major Depressive Disorder | - | - |
Quetiapine extended release | Phase 3 | Schizophrenia | - | - |
Aripiprazole | Phase 3 | Schizophrenia | - | - |
Aripiprazole (BMS-337039) | Phase 3 | Dementia, Alzheimer Type | - | - |
Aripiprazole+ ADT | Phase 3 | Major Depressive Disorder | - | - |
Olanzapine or Quetiapine or Risperidone | Phase 3 | Schizophrenia | - | - |
Antidepressant + Aripiprazole | Phase 3 | Major Depressive Disorder | - | - |
JNT-517 Tablet | Phase 3 | Phenylketonuria (PKU) | - | - |
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 | - | - |
OPC-41061 （Tolvaptan) | Phase 3 | Cardiac Edema | - | - |
Sibeprenlimab 400 mg | Phase 3 | Immunoglobulin A Nephropathy | - | - |
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 | - | - |
CDP870 400mg | Phase 3 | Rheumatoid Arthritis | - | - |
ADT | Phase 3 | Major Depressive Disorder | - | - |
1% OPA-15406 | Phase 3 | Atopic Dermatitis | - | - |
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 | - | - |
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 | - | - |
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 | - | - |
OPC-6535 | Phase 3 | Crohn's Disease | - | - |
OCV-501 | Phase 2 | Acute Myeloid Leukemia | - | - |
Gastric acid inhibitors | Phase 2 | Gastroesophageal Reflux Disease | - | - |
Delamanid + Bedaquiline + OPC-167832 10 mg | Phase 2 | Pulmonary TB | - | - |
Sodium hyaluronate ophthalmic solution | Phase 2 | Keratoconjunctival Epithelial Disorder | - | - |
Tolvaptan MR | Phase 2 | Autosomal Dominant Polycystic Kidney Disease | - | - |
AVP-786-28 | Phase 2 | Neurobehavioral Disinhibition | - | - |
Tolvaptan IR | Phase 2 | Autosomal Dominant Polycystic Kidney Disease | - | - |
OPDC-34712 | Phase 2 | Attention Deficit Hyperactivity Disorder | - | - |
rabbit anti-thymocyte globulin (ATG) | Phase 2 | Chronic Myeloproliferative Disorders | - | - |
10 mg OPC-167832 | Phase 2 | Pulmonary TB | - | - |
Sibeprenlimab | Phase 2 | IgA Nephropathy | - | - |
CTN SR | Phase 2 | Attention Deficit Disorder With Hyperactivity | - | - |
OPB-31121 | Phase 2 | Hepatocellular Carcinoma | - | - |
OPC-64005 | Phase 2 | Adult Attention Deficit Hyperactivity Disorder | - | - |
OPC-18 | Phase 2 | Hepatocellular Carcinoma | - | - |
OPS-2071 tablet | Phase 2 | Bacterial Enteritis | - | - |
Busulfan | Phase 2 | Multiple Myeloma | - | - |
Low Dose-VIS649 | Phase 2 | Immunoglobulin A Nephropathy | - | - |
Rexulti | Phase 2 | Borderline Personality Disorder | - | - |
OPC-249 | Phase 2 | Pain Due to Osteoporosis | - | - |
120mg of ETC-1002(bempedoic acid) | Phase 2 | Hypercholesterolemia | - | - |
Delamanid Pediatric Formulation (DPF) | Phase 2 | Multidrug Resistant Tuberculosis | - | - |
AVP-786 (d6-dextromethorphan hydrobromide and quinidine sulfate combination) | Phase 2 | Depressive Disorder, Treatment-Resistant | - | - |
IV busulfan | Phase 2 | Multiple Myeloma | - | - |
Optimized Background Regimen (OBR) | Phase 2 | Tuberculosis, Pulmonary | - | - |
OPC-41061 7.5mg | Phase 2 | Cirrhosis | - | - |
Cilostazol, Probucol | Phase 2 | Peripheral Artery Disease | - | - |
13C-uracil | Phase 2 | Dyspeptic Subjects | - | - |
Ponatinib 30mg OD | Phase 2 | Chronic Myeloid Leukemia | - | - |
OPC-64005 20 mg , Once-daily | Phase 2 | Major Depressive Disorder | - | - |
OPC-67683 | Phase 2 | Pulmonary Tuberculosis | - | - |
Probucol 250mg/day | Phase 2 | Diabetic Nephropathy | - | - |
tetomilast (OPC-6535) | Phase 2 | Chronic Obstructive Pulmonary Disease | - | - |
2% Rebamipide liquid | Phase 2 | Head and Neck Cancer | - | - |
IV Decitabine | Phase 2 | Myelodysplastic Syndromes | - | - |
OPS-2071 | Phase 2 | Irritable Bowel Syndrome of Diarrhea Type (IBS-D) | - | - |
1% OPC-12759 ophthalmic suspension | Phase 2 | Dry Eye Syndromes | - | - |
Vesnarinone | Phase 2 | Sarcoma, Kaposi | - | - |
IV Busulfan, Cyclophosphamide and Etoposide (BuCyE Regimen) | Phase 2 | Lymphoma | - | - |
OPC-415 | Phase 2 | Multiple Myeloma (MM) | - | - |
0.5% OPC-12759 | Phase 2 | Dry Eye Syndromes | - | - |
Aripiprazole + IEM (Ingestible Event Marker) | Phase 2 | Schizophrenia | - | - |
OPC 131461 10mg group | Phase 2 | Cardiac Edema (CHF) | - | - |
Calcium (13C)Carbonate | Phase 2 | Gastric Acid-related Diseases | - | - |
JNT-517 Suspension | Phase 2 | Phenylketonuria | - | - |
Delamanid | Phase 2 | Tuberculosis, Multidrug-Resistant | - | - |
Full breakdown — the signals behind the verdict
Frequently asked questions
What is in OTSUKA's drug pipeline?→
CatalystAlert tracks 132 drug candidates in OTSUKA's (OTSKF) pipeline across Phase 3, Phase 2. Its lead program is Brexpiprazole, OPC-34712 (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 2 expected March 13, 2027. 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.