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
Oncology
Cardiovascular & Renal areas
Other therapeutic areas

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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

Filed

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

Filed

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

OPC-34712/
OPC-34712 FUM
<REXULTI / RXULTI>

brexpiprazole

Posttraumatic stress disorder

Phase III

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

OPC-34712/
OPC-34712 FUM
<REXULTI / RXULTI>

brexpiprazole

Schizophrenia

Phase I

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

OPC-34712/
OPC-34712 FUM
<REXULTI / RXULTI>

brexpiprazole

Schizophrenia

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

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

Phase III

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

EB-1020

centanafadine

Major depressive disorder

Phase II

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

SEP-363856

ulotaront

Schizophrenia

Phase III

Origin: former Sunovion / PsychoGenics^*
Features: TAAR1・5-HT_1A 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-HT_1A agonist
Dosage form: Oral
*Sunovion discovered ulotaront (SEP-363856) in collaboration with PsychoGenics.

SEP-363856

ulotaront

Major depressive disorder

Phase II/III

Origin: former Sunovion / PsychoGenics^*
Features: TAAR1・5-HT_1A 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-HT_1A 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)

ASTX727
<INQOVI / INAQOVI>

decitabine, cedazuridine

Myelodysplastic syndromes

Phase I

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

ASTX727
<INQOVI / INAQOVI>

decitabine, cedazuridine

Acute myeloid leukemia

Europe

Approved

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

ASTX727
<INQOVI / INAQOVI>

decitabine, cedazuridine

Acute myeloid leukemia

Phase II

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

ASTX660

tolinapant

T-cell lymphoma

Phase I

Origin: Astex
Features: IAP inhibitor
Dosage form: Oral

ASTX660 + ASTX727

tolinapant +
decitabine, cedazuridine

T-cell lymphoma

Phase I

Origin: Astex
Dosage form: Oral

ASTX029

Solid tumors

Phase I/II

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

ASTX295

Solid tumors

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

Filed

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

OPB-111077

Diffuse large B-cell lymphoma

Phase I

Origin: Otsuka Pharmaceutical
Dosage form: Oral

OPB-111077

Hematological cancers

Phase I

Origin: Otsuka Pharmaceutical
Dosage form: Oral

OPC-415

Multiple myeloma

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

Phase III

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

OPC-131461

Cardiac edema

Phase II

Origin: Otsuka Pharmaceutical
Features: V_1a / V₂ dual antagonist
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

Phase III

Origin: Otsuka Pharmaceutical
Features: Mycolic acid biosynthesis inhibitor
Dosage form: Oral

OPC-167832

quabodepistat

Tuberculosis

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)

ASTX727
<INQOVI / INAQOVI>

decitabine, cedazuridine

Acute myeloid leukemia

Europe

Approved

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

OPC-34712/
OPC-34712 FUM
<REXULTI / RXULTI>

brexpiprazole

Major depressive disorder

Filed

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

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

OPC-34712/
OPC-34712 FUM
<REXULTI / RXULTI>

brexpiprazole

Posttraumatic stress disorder

Phase III

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

OPC-34712/
OPC-34712 FUM
<REXULTI / RXULTI>

brexpiprazole

Schizophrenia

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

Phase III

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

SEP-363856

ulotaront

Schizophrenia

Phase III

Origin: former Sunovion / PsychoGenics^*
Features: TAAR1・5-HT_1A 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

Phase III

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

OPC-67683
<Deltyba>

delamanid

Multidrug-resistant tuberculosis

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-HT_1A agonist
Dosage form: Oral
*Sunovion discovered ulotaront (SEP-363856) in collaboration with PsychoGenics.

SEP-363856

ulotaront

Major depressive disorder

Phase II/III

Origin: former Sunovion / PsychoGenics^*
Features: TAAR1・5-HT_1A 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-HT_1A agonist
Dosage form: Oral
*Sunovion discovered ulotaront (SEP-363856) in collaboration with PsychoGenics.

EB-1020

centanafadine

Major depressive disorder

Phase II

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

ASTX727
<INQOVI / INAQOVI>

decitabine, cedazuridine

Acute myeloid leukemia

Phase II

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

OPC-131461

Cardiac edema

Phase II

Origin: Otsuka Pharmaceutical
Features: V_1a / V₂ dual antagonist
Dosage form: Oral

OPC-167832

quabodepistat

Tuberculosis

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

ASTX029

Solid tumors

Phase I/II

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

ASTX295

Solid tumors

Phase I/II

Origin: Astex
Features: MDM2 inhibitor
Dosage form: Oral

OPC-415

Multiple myeloma

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

Phase I

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

OPC-214870

Epilepsy

Phase I

Origin: Otsuka Pharmaceutical
Dosage form: Oral

ASTX727
<INQOVI / INAQOVI>

decitabine, cedazuridine

Myelodysplastic syndromes

Phase I

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

ASTX660

tolinapant

T-cell lymphoma

Phase I

Origin: Astex
Features: IAP inhibitor
Dosage form: Oral

ASTX660 + ASTX727

tolinapant +
decitabine, cedazuridine

T-cell lymphoma

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

Phase I

Origin: Otsuka Pharmaceutical
Dosage form: Oral

OPB-111077

Hematological cancers

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 October 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