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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.

Psychiatry & Neurology

News releases related to psychiatry & neurology

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
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
Binge-eating disorder
US
Phase II/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
JP, US
Phase III

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

Oncology

News releases related to oncology

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 II

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

Cardiovascular & Renal areas

News releases related to cardiovascular & renal areas

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

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

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 inhibitor
Dosage form: Oral

voclosporin
Lupus nephritis
Europe
Filed

Origin: Aurinia
Features: Calcineurin inhibitor
Dosage form: Oral

Other therapeutic areas

News releases related to other therapeutic areas

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

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

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

aripiprazole long-acting injection
aripiprazole
Schizophrenia
China
Filed

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

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
JP, 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
EB-1020
centanafadine
Binge-eating disorder
US
Phase II/III

Origin: Neurovance
Features: Norepinephrine, dopamine and serotonin reuptake inhibitor
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-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

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

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

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 inhibitor
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

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.

(as of March 31, 2022)

Other Innovation & Science contents

Original Research & Development

Otsuka takes a holistic approach to people's health and well-being through its two core businesses of pharmaceuticals and nutraceuticals. Aiming to find cures for diseases and to maintain and promote people's health, we continue to take the untraveled path in research and development.
Otsuka's Open Innovation

As part of our inquisitive research culture, Otsuka Pharmaceutical also enters into "horizontal collaborations" in which we harmonize with, as equals, bioventures and academic institutions. Aligning our own drug discovery resources with external knowledge and technologies multiplies our collective capacity for pathbreaking innovation.
Partnering / Licensing Activities

Otsuka views partnership as a key strategy for innovation.
Otsuka Group - Pipeline Information