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/
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

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

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

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)

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