Pipeline

Otsuka Pharmaceutical collaborates actively with leading-edge academia and venture companies, in addition to using conventional drug discovery methods.
This open sharing of ideas enables us to develop unique compounds.

Code / <Brand name>
Generic name
Indication
Country / Region
Development status
(Phase I, II, III, Filed / Approved)
OPC-34712
<REXULTI / RXULTI>
brexpiprazole
Major depressive disorder
JP, Europe
Phase III

Origin: Otsuka Pharmaceutical
Features: Dopamine partial agonist
Dosage form: Oral

OPC-34712
<REXULTI / RXULTI>
brexpiprazole
Schizophrenia
China
Phase III

Origin: Otsuka Pharmaceutical
Features: Dopamine partial agonist
Dosage form: Oral

OPC-34712
<REXULTI / RXULTI>
brexpiprazole
Agitation associated with dementia of the Alzheimer's type
JP, US, Europe
Phase III

Origin: Otsuka Pharmaceutical
Features: Dopamine partial agonist
Dosage form: Oral

OPC-34712
<REXULTI / RXULTI>
brexpiprazole
Posttraumatic stress disorder
US
Phase III

Origin: Otsuka Pharmaceutical
Features: Dopamine partial agonist
Dosage form: Oral

OPC-34712
<REXULTI / RXULTI>
brexpiprazole
Borderline personality disorder
US
Phase II

Origin: Otsuka Pharmaceutical
Features: Dopamine partial agonist
Dosage form: Oral

OPC-34712
<REXULTI / RXULTI>
brexpiprazole
Schizophrenia
US
Phase I
Origin: Otsuka Pharmaceutical
Features: Dopamine partial agonist
Dosage form: Depot injection
aripiprazole long-acting injection
aripiprazole
Schizophrenia
China
Filed

Origin: Otsuka Pharmaceutical
Features: Dopamine partial agonist
Dosage form: Depot injection

OPC-64005
Major depressive disorder
JP
Phase II

Origin: Otsuka Pharmaceutical
Features: Serotonin, norepinephrine and dopamine reuptake inhibitor
Dosage form: Oral

OPC-214870
Epilepsy
US
Phase I

Origin: Otsuka Pharmaceutical
Dosage form: Oral

AVP-786
deuterium-modified dextromethorphan, quinidine
Agitation associated with dementia of the Alzheimer's type
US, Europe
Phase III

Origin: Avanir
Features: NMDA receptor antagonist / Serotonin and norepinephrine reuptake inhibitor / Sigma-1 receptor agonist
Dosage form: Oral

AVP-786
deuterium-modified dextromethorphan, quinidine
Negative symptoms of schizophrenia
US
Phase II/III
Origin: Avanir
Features: NMDA receptor antagonist / Serotonin and norepinephrine reuptake inhibitor / Sigma-1 receptor agonist
Dosage form: Oral
AVP-786
deuterium-modified dextromethorphan, quinidine
Traumatic brain injury
US
Phase II
Origin: Avanir
Features: NMDA receptor antagonist / Serotonin and norepinephrine reuptake inhibitor / Sigma-1 receptor agonist
Dosage form: Oral
AVP-786
deuterium-modified dextromethorphan, quinidine
Intermittent explosive disorder
US
Phase II
Origin: Avanir
Features: NMDA receptor antagonist / Serotonin and norepinephrine reuptake inhibitor / Sigma-1 receptor agonist
Dosage form: Oral
EB-1020
centanafadine
Attention-deficit hyperactivity disorder
US
Phase III

Origin: Neurovance
Features: Norepinephrine, dopamine and serotonin reuptake inhibitor
Dosage form: Oral

EB-1020
centanafadine
Smoking Cessation
US
Phase II

Origin: Neurovance
Features: Norepinephrine, dopamine and serotonin reuptake inhibitor
Dosage form: Oral

SEP-363856
ulotaront
Schizophrenia
US
Phase III

Origin: Sunovion / PsychoGenics*
Features: TAAR1 / 5-HT1A agonist
Dosage form: Oral
*Sunovion discovered ulotaront (SEP-363856) in collaboration with PsychoGenics.

SEP-363856
ulotaront
Schizophrenia
JP, China
Phase II/III

Origin: Sunovion / PsychoGenics*
Features: TAAR1 / 5-HT1A agonist
Dosage form: Oral
*Sunovion discovered ulotaront (SEP-363856) in collaboration with PsychoGenics.

SEP-4199
Bipolar I depression
US
Phase III

Origin: Sunovion
Features: 5-HT7 / D2 antagonist
Dosage form: Oral

SEP-4199
Bipolar I depression
JP
Phase II

Origin: Sunovion
Features: 5-HT7 / D2 antagonist
Dosage form: Oral

Code / <Brand name>
Generic name
Indication
Country / Region
Development status
(Phase I, II, III, Filed / Approved)
ASTX727
<INQOVI>
decitabine, cedazuridine
Myelodysplastic syndromes
JP
Phase I

Origin: Astex
Features: DNA methyltransferase inhibitor
Dosage form: Oral

ASTX727
<INQOVI>
decitabine, cedazuridine
Acute myeloid leukemia
Europe
Phase III

Origin: Astex
Features: DNA methyltransferase inhibitor
Dosage form: Oral

ASTX727
<INQOVI>
decitabine, cedazuridine
Acute myeloid leukemia
US
Phase I

Origin: Astex
Features: DNA methyltransferase inhibitor
Dosage form: Oral

ASTX660
tolinapant
Solid tumors, Lymphomas
US
Phase II

Origin: Astex
Features: IAP inhibitor
Dosage form: Oral

ASTX660
tolinapant
T-cell lymphoma
JP
Phase I

Origin: Astex
Features: IAP inhibitor
Dosage form: Oral

ASTX660 + ASTX727
tolinapant +
decitabine, cedazuridine
Acute myeloid leukemia
US
Phase I

Origin: Astex
Dosage form: Oral

ASTX029
Solid tumors
US
Phase I/II

Origin: Astex
Features: ERK1/2 inhibitor
Dosage form: Oral

ASTX295
Solid tumors
US
Phase I/II

Origin: Astex
Features: MDM2 inhibitor
Dosage form: Oral

ASTX030
azacitidine, cedazuridine
Myelodysplastic syndromes
JP, US
Phase I

Origin: Astex
Dosage form: Oral

AP24534
<ICLUSIG>
ponatinib
Chronic myeloid leukemia, Philadelphia chromosome-positive acute lymphoblastic leukemia
China
Phase II

Origin: Takeda Pharmaceutical
Features: BCR-ABL tyrosine kinase inhibitor
Dosage form: Oral

OPB-111077
Diffuse large B-cell lymphoma
JP
Phase I

Origin: Otsuka Pharmaceutical
Dosage form: Oral

OPB-111077
Hematological cancers
US
Phase I

Origin: Otsuka Pharmaceutical
Dosage form: Oral

OPB-171775
Solid tumors
JP
Phase I

Origin: Otsuka Pharmaceutical
Dosage form: Oral

OPC-415
Multiple myeloma
JP
Phase I/II

Origin: Osaka University
Features: Activated integrin β7-targeted CAR-T cell therapy
Dosage form: Injection

TBI-1301
mipetresgene autoleucel
Synovial sarcoma
JP
Phase I/II

Origin: Takara Bio
Features: NY-ESO-1 siTCR™ gene therapies
Dosage form: Injection

Code / <Brand name>
Generic name
Indication
Country / Region
Development status
(Phase I, II, III, Filed / Approved)
OPC-61815
tolvaptan sodium phosphate
Cardiac edema
JP
Filed

Origin: Otsuka Pharmaceutical
Features: V2 -receptor antagonist
Dosage form: Injection

AKB-6548
vadadustat
Anemia associated with chronic kidney disease
US
Filed

Origin: Akebia
Features: HIF-prolyl hydroxylase inhibitor
Dosage form: Oral

AKB-6548
vadadustat
Anemia associated with chronic kidney disease
Europe
Filed

Origin: Akebia
Features: HIF-prolyl hydroxylase inhibitor
Dosage form: Oral

VIS649
sibeprenlimab
IgA nephropathy
JP, US, Europe
Phase II

Origin: Visterra
Features: Anti-APRIL monoclonal antibody
Dosage form: Injection

ETC-1002
bempedoic acid
Hypercholesterolemia
JP
Phase II

Origin: Esperion
Features: ATP-citrate lyase
Dosage form: Oral

voclosporin
Lupus nephritis
Europe
Filed

Origin: Aurinia
Features: Calcineurin inhibitor
Dosage form: Oral

Code / <Brand name>
Generic name
Indication
Country / Region
Development status
(Phase I, II, III, Filed / Approved)
OPC-67683
<Deltyba>
delamanid
Multidrug-resistant tuberculosis
US
Phase III
Origin: Otsuka Pharmaceutical
Features: Mycolic acid biosynthesis inhibitor
Dosage form: Oral
OPC-167832
Tuberculosis
US
Phase I/II

Origin: Otsuka Pharmaceutical
Features: DPrE1 inhibitor
Dosage form: Oral

OPA-15406
difamilast
Atopic dermatitis
JP
Approved

Origin: Otsuka Pharmaceutical
Features: PDE4 inhibitor
Dosage form: Ointment

Code / <Brand name>
Generic name
Indication
Country / Region
Development status
(Phase I, II, III, Filed / Approved)
OPA-15406
difamilast
Atopic dermatitis
JP
Approved

Origin: Otsuka Pharmaceutical
Features: PDE4 inhibitor
Dosage form: Ointment

aripiprazole long-acting injection
aripiprazole
Schizophrenia
China
Filed

Origin: Otsuka Pharmaceutical
Features: Dopamine partial agonist
Dosage form: Depot injection

OPC-61815
tolvaptan sodium phosphate
Cardiac edema
JP
Filed

Origin: Otsuka Pharmaceutical
Features: V2 -receptor antagonist
Dosage form: Injection

AKB-6548
vadadustat
Anemia associated with chronic kidney disease
US
Filed

Origin: Akebia
Features: HIF-prolyl hydroxylase inhibitor
Dosage form: Oral

AKB-6548
vadadustat
Anemia associated with chronic kidney disease
Europe
Filed

Origin: Akebia
Features: HIF-prolyl hydroxylase inhibitor
Dosage form: Oral

voclosporin
Lupus nephritis
Europe
Filed

Origin: Aurinia
Features: Calcineurin inhibitor
Dosage form: Oral

OPC-34712
<REXULTI / RXULTI>
brexpiprazole
Major depressive disorder
JP, Europe
Phase III

Origin: Otsuka Pharmaceutical
Features: Dopamine partial agonist
Dosage form: Oral

OPC-34712
<REXULTI / RXULTI>
brexpiprazole
Schizophrenia
China
Phase III

Origin: Otsuka Pharmaceutical
Features: Dopamine partial agonist
Dosage form: Oral

OPC-34712
<REXULTI / RXULTI>
brexpiprazole
Agitation associated with dementia of the Alzheimer's type
JP, US, Europe
Phase III

Origin: Otsuka Pharmaceutical
Features: Dopamine partial agonist
Dosage form: Oral

OPC-34712
<REXULTI / RXULTI>
brexpiprazole
Posttraumatic stress disorder
US
Phase III

Origin: Otsuka Pharmaceutical
Features: Dopamine partial agonist
Dosage form: Oral

AVP-786
deuterium-modified dextromethorphan, quinidine
Agitation associated with dementia of the Alzheimer's type
US, Europe
Phase III

Origin: Avanir
Features: NMDA receptor antagonist / Serotonin and norepinephrine reuptake inhibitor / Sigma-1 receptor agonist
Dosage form: Oral

EB-1020
centanafadine
Attention-deficit hyperactivity disorder
US
Phase III

Origin: Neurovance
Features: Norepinephrine, dopamine and serotonin reuptake inhibitor
Dosage form: Oral

SEP-363856
ulotaront
Schizophrenia
US
Phase III

Origin: Sunovion / PsychoGenics*
Features: TAAR1 / 5-HT1A agonist
Dosage form: Oral
*Sunovion discovered ulotaront (SEP-363856) in collaboration with PsychoGenics.

SEP-4199
Bipolar I depression
US
Phase III

Origin: Sunovion
Features: 5-HT7 / D2 antagonist
Dosage form: Oral

ASTX727
<INQOVI>
decitabine, cedazuridine
Acute myeloid leukemia
Europe
Phase III

Origin: Astex
Features: DNA methyltransferase inhibitor
Dosage form: Oral

OPC-67683
<Deltyba>
delamanid
Multidrug-resistant tuberculosis
US
Phase III
Origin: Otsuka Pharmaceutical
Features: Mycolic acid biosynthesis inhibitor
Dosage form: Oral
AVP-786
deuterium-modified dextromethorphan, quinidine
Negative symptoms of schizophrenia
US
Phase II/III
Origin: Avanir
Features: NMDA receptor antagonist / Serotonin and norepinephrine reuptake inhibitor / Sigma-1 receptor agonist
Dosage form: Oral
SEP-363856
ulotaront
Schizophrenia
JP, China
Phase II/III

Origin: Sunovion / PsychoGenics*
Features: TAAR1 / 5-HT1A agonist
Dosage form: Oral
*Sunovion discovered ulotaront (SEP-363856) in collaboration with PsychoGenics.

OPC-34712
<REXULTI / RXULTI>
brexpiprazole
Borderline personality disorder
US
Phase II

Origin: Otsuka Pharmaceutical
Features: Dopamine partial agonist
Dosage form: Oral

OPC-64005
Major depressive disorder
JP
Phase II

Origin: Otsuka Pharmaceutical
Features: Serotonin, norepinephrine and dopamine reuptake inhibitor
Dosage form: Oral

AVP-786
deuterium-modified dextromethorphan, quinidine
Traumatic brain injury
US
Phase II
Origin: Avanir
Features: NMDA receptor antagonist / Serotonin and norepinephrine reuptake inhibitor / Sigma-1 receptor agonist
Dosage form: Oral
AVP-786
deuterium-modified dextromethorphan, quinidine
Intermittent explosive disorder
US
Phase II
Origin: Avanir
Features: NMDA receptor antagonist / Serotonin and norepinephrine reuptake inhibitor / Sigma-1 receptor agonist
Dosage form: Oral
EB-1020
centanafadine
Smoking Cessation
US
Phase II

Origin: Neurovance
Features: Norepinephrine, dopamine and serotonin reuptake inhibitor
Dosage form: Oral

SEP-4199
Bipolar I depression
JP
Phase II

Origin: Sunovion
Features: 5-HT7 / D2 antagonist
Dosage form: Oral

ASTX660
tolinapant
Solid tumors, Lymphomas
US
Phase II

Origin: Astex
Features: IAP inhibitor
Dosage form: Oral

AP24534
<ICLUSIG>
ponatinib
Chronic myeloid leukemia, Philadelphia chromosome-positive acute lymphoblastic leukemia
China
Phase II

Origin: Takeda Pharmaceutical
Features: BCR-ABL tyrosine kinase inhibitor
Dosage form: Oral

VIS649
sibeprenlimab
IgA nephropathy
JP, US, Europe
Phase II

Origin: Visterra
Features: Anti-APRIL monoclonal antibody
Dosage form: Injection

ETC-1002
bempedoic acid
Hypercholesterolemia
JP
Phase II

Origin: Esperion
Features: ATP-citrate lyase
Dosage form: Oral

ASTX029
Solid tumors
US
Phase I/II

Origin: Astex
Features: ERK1/2 inhibitor
Dosage form: Oral

ASTX295
Solid tumors
US
Phase I/II

Origin: Astex
Features: MDM2 inhibitor
Dosage form: Oral

OPC-415
Multiple myeloma
JP
Phase I/II

Origin: Osaka University
Features: Activated integrin β7-targeted CAR-T cell therapy
Dosage form: Injection

TBI-1301
mipetresgene autoleucel
Synovial sarcoma
JP
Phase I/II

Origin: Takara Bio
Features: NY-ESO-1 siTCR™ gene therapies
Dosage form: Injection

OPC-167832
Tuberculosis
US
Phase I/II

Origin: Otsuka Pharmaceutical
Features: DPrE1 inhibitor
Dosage form: Oral

OPC-34712
<REXULTI / RXULTI>
brexpiprazole
Schizophrenia
US
Phase I
Origin: Otsuka Pharmaceutical
Features: Dopamine partial agonist
Dosage form: Depot injection
OPC-214870
Epilepsy
US
Phase I

Origin: Otsuka Pharmaceutical
Dosage form: Oral

ASTX727
<INQOVI>
decitabine, cedazuridine
Myelodysplastic syndromes
JP
Phase I

Origin: Astex
Features: DNA methyltransferase inhibitor
Dosage form: Oral

ASTX727
<INQOVI>
decitabine, cedazuridine
Acute myeloid leukemia
US
Phase I

Origin: Astex
Features: DNA methyltransferase inhibitor
Dosage form: Oral

ASTX660
tolinapant
T-cell lymphoma
JP
Phase I

Origin: Astex
Features: IAP inhibitor
Dosage form: Oral

ASTX660 + ASTX727
tolinapant +
decitabine, cedazuridine
Acute myeloid leukemia
US
Phase I

Origin: Astex
Dosage form: Oral

ASTX030
azacitidine, cedazuridine
Myelodysplastic syndromes
JP, US
Phase I

Origin: Astex
Dosage form: Oral

OPB-111077
Diffuse large B-cell lymphoma
JP
Phase I

Origin: Otsuka Pharmaceutical
Dosage form: Oral

OPB-111077
Hematological cancers
US
Phase I

Origin: Otsuka Pharmaceutical
Dosage form: Oral

OPB-171775
Solid tumors
JP
Phase I

Origin: Otsuka Pharmaceutical
Dosage form: Oral

  • Note: In general, Otsuka discloses clinical trial projects that are in Phase II or later stage of development, however, only clinical trial projects in Phase I conducted with patients are disclosed.

(Update pipeline information based on FY2021 3Q financial results)

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