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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
Agitation associated with dementia due to Alzheimer's disease *2
JP
Approved

[In-house*1]
Features: Dopamine partial agonist
Dosage form: Oral
*1 Co-development with Lundbeck in US
*2 "excessive motor activity or physically/verbally aggressive behavior due to rapid changes in mood, irritability, and/or outbursts associated with dementia due to Alzheimer's disease."

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

[In-house*1]
Features: Dopamine partial agonist
Dosage form: Oral
*1 Co-development with Lundbeck in US

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

[In-house*1]
Features: Dopamine partial agonist
Dosage form: Once-weekly oral
ClinicalTrials.gov numbers of key clinical study: NCT05325645
*1 Co-development with Lundbeck in US

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

[In-house*1]
Features: Dopamine partial agonist
Dosage form: Depot injection
*1 Co-development with Lundbeck in US

OPC-214870
Epilepsy
US
Phase I

[In-house]
Dosage form: Oral

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

[In-house]
Features: Norepinephrine, dopamine and serotonin reuptake inhibitor
Dosage form: Oral
ClinicalTrials.gov numbers of key clinical study: NCT05257265, NCT05428033

EB-1020
centanafadine
Major depressive disorder
US
Phase II

[In-house]
Features: Norepinephrine, dopamine and serotonin reuptake inhibitor
Dosage form: Oral
ClinicalTrials.gov numbers of key clinical study: NCT05536414

SEP-363856
ulotaront
Schizophrenia
US
Phase III

[License (Sumitomo Pharma)]
Features: TAAR1・5-HT1A agonist
Dosage form: Oral
ClinicalTrials.gov numbers of key clinical study: NCT04072354, NCT04092686

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

[License (Sumitomo Pharma)]
Features: TAAR1・5-HT1A agonist
Dosage form: Oral
ClinicalTrials.gov numbers of key clinical study: NCT04825860, NCT05359081

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

[License (Sumitomo Pharma)]
Features: TAAR1・5-HT1A agonist
Dosage form: Oral
ClinicalTrials.gov numbers of key clinical study: NCT05593029

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

[License (Sumitomo Pharma)]
Features: TAAR1・5-HT1A agonist
Dosage form: Oral
ClinicalTrials.gov numbers of key clinical study: NCT05729373

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, acute lymphoblastic leukemia
China
Approved

[License (Takeda Pharmaceutical)]
Features: BCR-ABL tyrosine kinase inhibitor
Dosage form: Oral

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

[In-house]
Dosage form: Oral

OPB-111077
Hematological cancers
US
Phase I

[In-house]
Dosage form: Oral

OPC-415
Multiple myeloma
JP
Phase I/II

[In-house]
Features: Activated integrin β7-targeted CAR-T cell therapy
Dosage form: Injection
ClinicalTrials.gov numbers of key clinical study: NCT04649073

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, China
Phase III

[In-house]
Features: Anti-APRIL monoclonal antibody
Dosage form: Injection
ClinicalTrials.gov numbers of key clinical study: NCT04287985

ETC-1002
bempedoic acid
Hypercholesterolemia
JP
Phase III

[License (Esperion)]
Features: ATP-citrate lyase inhibitor
Dosage form: Oral
ClinicalTrials.gov numbers of key clinical study: NCT05683340

OPC-131461
Cardiac edema
JP
Phase II

[In-house]
Features: V1a / V2 dual antagonist
Dosage form: Oral
ClinicalTrials.gov numbers of key clinical study: NCT05615363


<Lupkynis>
voclosporin
Lupus nephritis
JP
Approved

[License (Aurinia)]
Features: Calcineurin inhibitor
Dosage form: Oral

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

[In-house]
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

[In-house]
Features: Mycolic acid biosynthesis inhibitor
Dosage form: Oral
ClinicalTrials.gov numbers of key clinical study: NCT01424670

OPC-167832
quabodepistat
Tuberculosis
US
Phase II

[In-house]
Features: DprE1 inhibitor
Dosage form: Oral
ClinicalTrials.gov numbers of key clinical study: NCT05971602

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

[In-house]
Features: PDE4 inhibitor
Dosage form: Ointment
ClinicalTrials.gov numbers of key clinical study: NCT05667623

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

[In-house]
Features: β receptor antagonist / PGF2α analogue
Dosage form: Eye drops
ClinicalTrials.gov numbers of key clinical study: NCT05583474

OPS-2071
Irritable Bowel Syndrome
China
Phase II

[In-house]
Features: DNA gyrase inhibitor
Dosage form: Oral
ClinicalTrials.gov numbers of key clinical study: NCT05923892

JNT-517
Phenylketonuria
US
Phase I/II

[In-house]
Features: SLC6A19 inhibitor
Dosage form: Oral
ClinicalTrials.gov numbers of key clinical study: NCT05781399

VIS171
Autoimmune disease
TBD
Phase I

[In-house]
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
Agitation associated with dementia due to Alzheimer's disease *2
JP
Approved

[In-house*1]
Features: Dopamine partial agonist
Dosage form: Oral
*1 Co-development with Lundbeck in US
*2 "excessive motor activity or physically/verbally aggressive behavior due to rapid changes in mood, irritability, and/or outbursts associated with dementia due to Alzheimer's disease."

AP24534
<ICLUSIG>
ponatinib
Chronic myeloid leukemia, acute lymphoblastic leukemia
China
Approved

[License (Takeda Pharmaceutical)]
Features: BCR-ABL tyrosine kinase inhibitor
Dosage form: Oral


<Lupkynis>
voclosporin
Lupus nephritis
JP
Approved

[License (Aurinia)]
Features: Calcineurin inhibitor
Dosage form: Oral

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

[In-house*1]
Features: Dopamine partial agonist
Dosage form: Oral
*1 Co-development with Lundbeck in US

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

[In-house]
Features: V2 -receptor antagonist
Dosage form: Injection

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

[In-house*1]
Features: Dopamine partial agonist
Dosage form: Once-weekly oral
ClinicalTrials.gov numbers of key clinical study: NCT05325645
*1 Co-development with Lundbeck in US

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

[In-house]
Features: Norepinephrine, dopamine and serotonin reuptake inhibitor
Dosage form: Oral
ClinicalTrials.gov numbers of key clinical study: NCT05257265, NCT05428033

SEP-363856
ulotaront
Schizophrenia
US
Phase III

[License (Sumitomo Pharma)]
Features: TAAR1・5-HT1A agonist
Dosage form: Oral
ClinicalTrials.gov numbers of key clinical study: NCT04072354, NCT04092686

VIS649
sibeprenlimab
IgA nephropathy
JP, US, Europe, China
Phase III

[In-house]
Features: Anti-APRIL monoclonal antibody
Dosage form: Injection
ClinicalTrials.gov numbers of key clinical study: NCT04287985

ETC-1002
bempedoic acid
Hypercholesterolemia
JP
Phase III

[License (Esperion)]
Features: ATP-citrate lyase inhibitor
Dosage form: Oral
ClinicalTrials.gov numbers of key clinical study: NCT05683340

OPC-67683
<Deltyba>
delamanid
Multidrug-resistant tuberculosis
US
Phase III

[In-house]
Features: Mycolic acid biosynthesis inhibitor
Dosage form: Oral
ClinicalTrials.gov numbers of key clinical study: NCT01424670

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

[In-house]
Features: PDE4 inhibitor
Dosage form: Ointment
ClinicalTrials.gov numbers of key clinical study: NCT05667623

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

[In-house]
Features: β receptor antagonist / PGF2α analogue
Dosage form: Eye drops
ClinicalTrials.gov numbers of key clinical study: NCT05583474

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

[License (Sumitomo Pharma)]
Features: TAAR1・5-HT1A agonist
Dosage form: Oral
ClinicalTrials.gov numbers of key clinical study: NCT04825860, NCT05359081

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

[License (Sumitomo Pharma)]
Features: TAAR1・5-HT1A agonist
Dosage form: Oral
ClinicalTrials.gov numbers of key clinical study: NCT05593029

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

[License (Sumitomo Pharma)]
Features: TAAR1・5-HT1A agonist
Dosage form: Oral
ClinicalTrials.gov numbers of key clinical study: NCT05729373

EB-1020
centanafadine
Major depressive disorder
US
Phase II

[In-house]
Features: Norepinephrine, dopamine and serotonin reuptake inhibitor
Dosage form: Oral
ClinicalTrials.gov numbers of key clinical study: NCT05536414

OPC-131461
Cardiac edema
JP
Phase II

[In-house]
Features: V1a / V2 dual antagonist
Dosage form: Oral
ClinicalTrials.gov numbers of key clinical study: NCT05615363

OPC-167832
quabodepistat
Tuberculosis
US
Phase II

[In-house]
Features: DprE1 inhibitor
Dosage form: Oral
ClinicalTrials.gov numbers of key clinical study: NCT05971602

OPS-2071
Irritable Bowel Syndrome
China
Phase II

[In-house]
Features: DNA gyrase inhibitor
Dosage form: Oral
ClinicalTrials.gov numbers of key clinical study: NCT05923892

OPC-415
Multiple myeloma
JP
Phase I/II

[In-house]
Features: Activated integrin β7-targeted CAR-T cell therapy
Dosage form: Injection
ClinicalTrials.gov numbers of key clinical study: NCT04649073

JNT-517
Phenylketonuria
US
Phase I/II

[In-house]
Features: SLC6A19 inhibitor
Dosage form: Oral
ClinicalTrials.gov numbers of key clinical study: NCT05781399

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

[In-house*1]
Features: Dopamine partial agonist
Dosage form: Depot injection
*1 Co-development with Lundbeck in US

OPC-214870
Epilepsy
US
Phase I

[In-house]
Dosage form: Oral

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

[In-house]
Dosage form: Oral

OPB-111077
Hematological cancers
US
Phase I

[In-house]
Dosage form: Oral

VIS171
Autoimmune disease
TBD
Phase I

[In-house]
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 September 30, 2024)

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