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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/
OPC-34712 FUM
<REXULTI / RXULTI>
brexpiprazole
Major depressive disorder
JP
Approved

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

OPC-34712/
OPC-34712 FUM
<REXULTI / RXULTI>
brexpiprazole
Schizophrenia
China
Filed

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

OPC-34712OPC-34712/
OPC-34712 FUM
<REXULTI / RXULTI>
brexpiprazole
Agitation associated with dementia of the Alzheimer's type
JP
Filed

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

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

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

OPC-34712/
OPC-34712 FUM
<REXULTI / RXULTI>
brexpiprazole
Schizophrenia
US
Phase I

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

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

Origin: Otsuka Pharmaceutical
Features: Dopamine partial agonist
Dosage form: Once-weekly oral

aripiprazole 2-month long-acting injection
<ABILIFY ASIMTUFII>
aripiprazole
Schizophrenia
Europe
Filed

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

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

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
Major depressive disorder
US
Phase II

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

SEP-363856
ulotaront
Schizophrenia
US
Phase III

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

SEP-363856
ulotaront
Major depressive disorder
US
Phase II/III

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

SEP-363856
ulotaront
Generalized anxiety disorder
JP, US
Phase II/III

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

Oncology

News releases related to oncology

Code / <Brand name>
Generic name
Indication
Country / Region
Development status
(Phase I, II, III, Filed / Approved)
AP24534
<ICLUSIG>
ponatinib
Chronic myeloid leukemia, Philadelphia chromosome-positive acute lymphoblastic leukemia
China
Filed

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

OPC-415
Multiple myeloma
JP
Phase I/II

Origin: Osaka University
Features: Activated integrin β7-targeted CAR-T cell therapy
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)
VIS649
sibeprenlimab
IgA nephropathy
JP, US, Europe
Phase III

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

ETC-1002
bempedoic acid
Hypercholesterolemia
JP
Phase III

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

OPC-131461
Cardiac edema
JP
Phase II

Origin: Otsuka Pharmaceutical
Features: V1a / V2 dual antagonist
Dosage form: Oral

voclosporin
Lupus nephritis
JP
Filed

Origin: Aurinia
Features: Calcineurin inhibitor
Dosage form: Oral

OPC-61815
<Samtasu>
tolvaptan sodium phosphate
Cardiac edema
China
Filed

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

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
quabodepistat
Tuberculosis
US
Phase II

Origin: Otsuka Pharmaceutical
Features: DprE1 inhibitor
Dosage form: Oral

OPA-15406
<Moizerto>
difamilast
Atopic dermatitis
China
Phase III

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

OPC-1085EL
<Mikeluna>
carteolol, latanoprost
Glaucoma, ocular hypertension
China
Phase III

Origin: Otsuka Pharmaceutical
Features: β receptor antagonist / PGF2α analogue
Dosage form: Eye drops

OPS-2071
Irritable Bowel Syndrome
China
Phase II

Origin: Otsuka Pharmaceutical
Features: DNA gyrase inhibitor
Dosage form: Oral

VIS171
Autoimmune disease
TBD
Phase I

Origin: Visterra
Features: Modified interleukin-2 molecule designed to specifically activate and amplify regulatory T lymphocytes
Dosage form: Injection

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

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

OPC-34712/
OPC-34712 FUM
<REXULTI / RXULTI>
brexpiprazole
Schizophrenia
China
Filed

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

OPC-34712OPC-34712/
OPC-34712 FUM
<REXULTI / RXULTI>
brexpiprazole
Agitation associated with dementia of the Alzheimer's type
JP
Filed

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

aripiprazole 2-month long-acting injection
<ABILIFY ASIMTUFII>
aripiprazole
Schizophrenia
Europe
Filed

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

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

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

voclosporin
Lupus nephritis
JP
Filed

Origin: Aurinia
Features: Calcineurin inhibitor
Dosage form: Oral

OPC-61815
<Samtasu>
tolvaptan sodium phosphate
Cardiac edema
China
Filed

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

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

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

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

Origin: Otsuka Pharmaceutical
Features: Dopamine partial agonist
Dosage form: Once-weekly 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: former Sunovion / PsychoGenics*
Features: TAAR1・5-HT1A agonist
Dosage form: Oral
*Sunovion discovered ulotaront (SEP-363856) in collaboration with PsychoGenics.

VIS649
sibeprenlimab
IgA nephropathy
JP, US, Europe
Phase III

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

ETC-1002
bempedoic acid
Hypercholesterolemia
JP
Phase III

Origin: Esperion
Features: ATP-citrate lyase 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
OPA-15406
<Moizerto>
difamilast
Atopic dermatitis
China
Phase III

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

OPC-1085EL
<Mikeluna>
carteolol, latanoprost
Glaucoma, ocular hypertension
China
Phase III

Origin: Otsuka Pharmaceutical
Features: β receptor antagonist / PGF2α analogue
Dosage form: Eye drops

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

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

SEP-363856
ulotaront
Major depressive disorder
US
Phase II/III

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

SEP-363856
ulotaront
Generalized anxiety disorder
JP, US
Phase II/III

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

EB-1020
centanafadine
Major depressive disorder
US
Phase II

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

OPC-131461
Cardiac edema
JP
Phase II

Origin: Otsuka Pharmaceutical
Features: V1a / V2 dual antagonist
Dosage form: Oral

OPC-167832
quabodepistat
Tuberculosis
US
Phase II

Origin: Otsuka Pharmaceutical
Features: DprE1 inhibitor
Dosage form: Oral

OPS-2071
Irritable Bowel Syndrome
China
Phase II

Origin: Otsuka Pharmaceutical
Features: DNA gyrase 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

OPC-34712/
OPC-34712 FUM
<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

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

VIS171
Autoimmune disease
TBD
Phase I

Origin: Visterra
Features: Modified interleukin-2 molecule designed to specifically activate and amplify regulatory T lymphocytes
Dosage form: Injection

  • 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 December 31, 2023)

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