OTSUKA
OTSKFDrugs in Pipeline
142
Phase 3 Programs
97
Upcoming Catalysts
2
Next Catalyst
Q1 2027
Market Overview
Stock performance and key metrics
4 upcoming, 1 past
Meptin swinghaler
Asthma
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
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
OCV-501
Acute Myeloid Leukemia
AVP-786-28
Neurobehavioral Disinhibition
120mg of ETC-1002(bempedoic acid)
Hypercholesterolemia
Delamanid + Bedaquiline + OPC-167832 10 mg
Pulmonary TB
Sodium hyaluronate ophthalmic solution
Keratoconjunctival Epithelial Disorder
AVP-786 (d6-dextromethorphan hydrobromide and quinidine sulfate combination)
Depressive Disorder, Treatment-Resistant
Ponatinib 30mg OD
Chronic Myeloid Leukemia
Delamanid Pediatric Formulation (DPF)
Multidrug Resistant Tuberculosis
0.5% OPC-12759
Dry Eye Syndromes
IV Decitabine
Myelodysplastic Syndromes
dasatinib
Pancreatic Cancer
1% OPC-12759 ophthalmic suspension
Dry Eye Syndromes
OPDC-34712
Attention Deficit Hyperactivity Disorder
Delamanid
Tuberculosis, Multidrug-Resistant
OPB-31121
Hepatocellular Carcinoma
Low Dose-VIS649
Immunoglobulin A Nephropathy
OPC-64005
Adult Attention Deficit Hyperactivity Disorder
OPC-67683
Pulmonary Tuberculosis
2% Rebamipide liquid
Head and Neck Cancer
OPS-2071
Irritable Bowel Syndrome of Diarrhea Type (IBS-D)
Vesnarinone
Sarcoma, Kaposi
Calcium (13C)Carbonate
Gastric Acid-related Diseases
IV Busulfan, Cyclophosphamide and Etoposide (BuCyE Regimen)
Lymphoma
OPC-249
Pain Due to Osteoporosis
10 mg OPC-167832
Pulmonary TB
Aripiprazole + IEM (Ingestible Event Marker)
Schizophrenia
Gastric acid inhibitors
Gastroesophageal Reflux Disease
CTN SR
Attention Deficit Disorder With Hyperactivity
Tolvaptan MR
Autosomal Dominant Polycystic Kidney Disease
IV busulfan
Multiple Myeloma
Optimized Background Regimen (OBR)
Tuberculosis, Pulmonary
OPC-415
Multiple Myeloma (MM)
OPC-41061 7.5mg
Cirrhosis
Tolvaptan IR
Autosomal Dominant Polycystic Kidney Disease
13C-uracil
Dyspeptic Subjects
OPC 131461 10mg group
Cardiac Edema (CHF)
OPC-64005 20 mg , Once-daily
Major Depressive Disorder
JNT-517 Suspension
Phenylketonuria
Sibeprenlimab
IgA Nephropathy
Probucol 250mg/day
Diabetic Nephropathy
Aripiprazole tablet, 5-30mg/day, oral, 6 weeks
Schizophrenia
tetomilast (OPC-6535)
Chronic Obstructive Pulmonary Disease
OPC-18
Hepatocellular Carcinoma
OPS-2071 tablet
Bacterial Enteritis
Cilostazol, Probucol
Peripheral Artery Disease
| Drug Name | Phase | Indication | Designations | Patent |
|---|---|---|---|---|
Meptin swinghaler | Phase 3 | Asthma | - | - |
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 | - | - |
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 | - | - |
OCV-501 | Phase 2 | Acute Myeloid Leukemia | - | - |
AVP-786-28 | Phase 2 | Neurobehavioral Disinhibition | - | - |
120mg of ETC-1002(bempedoic acid) | Phase 2 | Hypercholesterolemia | - | - |
Delamanid + Bedaquiline + OPC-167832 10 mg | Phase 2 | Pulmonary TB | - | - |
Sodium hyaluronate ophthalmic solution | Phase 2 | Keratoconjunctival Epithelial Disorder | - | - |
AVP-786 (d6-dextromethorphan hydrobromide and quinidine sulfate combination) | Phase 2 | Depressive Disorder, Treatment-Resistant | - | - |
Ponatinib 30mg OD | Phase 2 | Chronic Myeloid Leukemia | - | - |
Delamanid Pediatric Formulation (DPF) | Phase 2 | Multidrug Resistant Tuberculosis | - | - |
0.5% OPC-12759 | Phase 2 | Dry Eye Syndromes | - | - |
IV Decitabine | Phase 2 | Myelodysplastic Syndromes | - | - |
dasatinib | Phase 2 | Pancreatic Cancer | - | - |
1% OPC-12759 ophthalmic suspension | Phase 2 | Dry Eye Syndromes | - | - |
OPDC-34712 | Phase 2 | Attention Deficit Hyperactivity Disorder | - | - |
Delamanid | Phase 2 | Tuberculosis, Multidrug-Resistant | - | - |
OPB-31121 | Phase 2 | Hepatocellular Carcinoma | - | - |
Low Dose-VIS649 | Phase 2 | Immunoglobulin A Nephropathy | - | - |
OPC-64005 | Phase 2 | Adult Attention Deficit Hyperactivity Disorder | - | - |
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 | - | - |
Calcium (13C)Carbonate | Phase 2 | Gastric Acid-related Diseases | - | - |
IV Busulfan, Cyclophosphamide and Etoposide (BuCyE Regimen) | Phase 2 | Lymphoma | - | - |
OPC-249 | Phase 2 | Pain Due to Osteoporosis | - | - |
10 mg OPC-167832 | Phase 2 | Pulmonary TB | - | - |
Aripiprazole + IEM (Ingestible Event Marker) | Phase 2 | Schizophrenia | - | - |
Gastric acid inhibitors | Phase 2 | Gastroesophageal Reflux Disease | - | - |
CTN SR | Phase 2 | Attention Deficit Disorder With Hyperactivity | - | - |
Tolvaptan MR | Phase 2 | Autosomal Dominant Polycystic Kidney Disease | - | - |
IV busulfan | Phase 2 | Multiple Myeloma | - | - |
Optimized Background Regimen (OBR) | Phase 2 | Tuberculosis, Pulmonary | - | - |
OPC-415 | Phase 2 | Multiple Myeloma (MM) | - | - |
OPC-41061 7.5mg | Phase 2 | Cirrhosis | - | - |
Tolvaptan IR | Phase 2 | Autosomal Dominant Polycystic Kidney Disease | - | - |
13C-uracil | Phase 2 | Dyspeptic Subjects | - | - |
OPC 131461 10mg group | Phase 2 | Cardiac Edema (CHF) | - | - |
OPC-64005 20 mg , Once-daily | Phase 2 | Major Depressive Disorder | - | - |
JNT-517 Suspension | Phase 2 | Phenylketonuria | - | - |
Sibeprenlimab | Phase 2 | IgA Nephropathy | - | - |
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 | - | - |
OPC-18 | Phase 2 | Hepatocellular Carcinoma | - | - |
OPS-2071 tablet | Phase 2 | Bacterial Enteritis | - | - |
Cilostazol, Probucol | Phase 2 | Peripheral Artery Disease | - | - |
Full breakdown — the signals behind the verdict
Frequently asked questions
What is in OTSUKA's drug pipeline?→
CatalystAlert tracks 142 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 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.