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
(Phase I, II, III, Filed / Approved)
OPC-34712 FUM
<REXULTI / RXULTI>
[In-house*1]
Features: Dopamine partial agonist
Dosage form: Once-weekly oral
IDs of key clinical study: NCT05325645
*1 Co-development with Lundbeck in US
OPC-34712 FUM
<REXULTI / RXULTI>
[In-house*1]
Features: Dopamine partial agonist
Dosage form: Depot injection
*1 Co-development with Lundbeck in US
[In-house]
Dosage form: Oral
[In-house]
Features: Norepinephrine, dopamine and serotonin reuptake inhibitor
Dosage form: Oral
IDs of key clinical study: NCT05257265, NCT05428033
[In-house]
Features: Norepinephrine, dopamine and serotonin reuptake inhibitor
Dosage form: Oral
IDs of key clinical study: jRCT2071250001, NCT06931080
[License (Sumitomo Pharma)]
Features: TAAR1・5-HT1A agonist
Dosage form: Oral
IDs of key clinical study: NCT06894212
[License (Sumitomo Pharma)]
Features: TAAR1・5-HT1A agonist
Dosage form: Oral
IDs of key clinical study: NCT05593029
[License (Sumitomo Pharma)]
Features: TAAR1・5-HT1A agonist
Dosage form: Oral
IDs of key clinical study: NCT05729373
[License (Sumitomo Pharma)]
Dosage form: Oral
[License (Ionis)]
Features: Antisense oligonucleotide
Dosage form: Injection
IDs of key clinical study: NCT04768972*2
*2 Clinical trials are being conducted by the licensor, Ionis Pharmaceuticals.
Cardiovascular & Renal areas
(Phase I, II, III, Filed / Approved)
<NEXLETOL>
[License (Esperion)]
Features: ATP-citrate lyase inhibitor
Dosage form: Oral
<Samtasu>
[In-house]
Features: V2 -receptor antagonist
Dosage form: Injection
Autoimmunology
(Phase I, II, III, Filed / Approved)
[In-house]
Features: Anti-APRIL monoclonal antibody
Dosage form: Injection
[In-house]
Features: Anti-APRIL monoclonal antibody
Dosage form: Injection
IDs of key clinical study: NCT04287985
[In-house]
Features: Anti-APRIL monoclonal antibody
Dosage form: Injection
IDs of key clinical study: NCT06928142
[In-house]
Features: Modified interleukin-2 molecule designed to specifically activate and amplify regulatory T lymphocytes
Dosage form: Injection
[License (Cantargia)]
Features: Anti-IL-1RAP monoclonal antibody
Dosage form: Injection
Other therapeutic areas
(Phase I, II, III, Filed / Approved)
<Deltyba>
[In-house]
Features: Mycolic acid biosynthesis inhibitor
Dosage form: Oral
IDs of key clinical study: NCT01424670
[In-house]
Features: DprE1 inhibitor
Dosage form: Oral
IDs of key clinical study: NCT05971602
<Moizerto>
[In-house]
Features: PDE4 inhibitor
Dosage form: Ointment
<Mikeluna>
[In-house]
Features: β receptor antagonist / PGF2α analogue
Dosage form: Eye drops
IDs of key clinical study: NCT05583474
[In-house]
Features: DNA gyrase inhibitor
Dosage form: Oral
IDs of key clinical study: NCT05923892
[In-house]
Features: SLC6A19 inhibitor
Dosage form: Oral
IDs of key clinical study: NCT05781399
[License (Ionis)]
Features: Prekallikrein production inhibitor
Dosage form: Injection
(Phase I, II, III, Filed / Approved)
<NEXLETOL>
[License (Esperion)]
Features: ATP-citrate lyase inhibitor
Dosage form: Oral
<Samtasu>
[In-house]
Features: V2 -receptor antagonist
Dosage form: Injection
[In-house]
Features: Anti-APRIL monoclonal antibody
Dosage form: Injection
<Moizerto>
[In-house]
Features: PDE4 inhibitor
Dosage form: Ointment
[License (Ionis)]
Features: Prekallikrein production inhibitor
Dosage form: Injection
OPC-34712 FUM
<REXULTI / RXULTI>
[In-house*1]
Features: Dopamine partial agonist
Dosage form: Once-weekly oral
IDs of key clinical study: NCT05325645
*1 Co-development with Lundbeck in US
[In-house]
Features: Norepinephrine, dopamine and serotonin reuptake inhibitor
Dosage form: Oral
IDs of key clinical study: NCT05257265, NCT05428033
[License (Sumitomo Pharma)]
Features: TAAR1・5-HT1A agonist
Dosage form: Oral
IDs of key clinical study: NCT06894212
[In-house]
Features: Anti-APRIL monoclonal antibody
Dosage form: Injection
IDs of key clinical study: NCT04287985
<Deltyba>
[In-house]
Features: Mycolic acid biosynthesis inhibitor
Dosage form: Oral
IDs of key clinical study: NCT01424670
<Mikeluna>
[In-house]
Features: β receptor antagonist / PGF2α analogue
Dosage form: Eye drops
IDs of key clinical study: NCT05583474
[In-house]
Features: Norepinephrine, dopamine and serotonin reuptake inhibitor
Dosage form: Oral
IDs of key clinical study: jRCT2071250001, NCT06931080
[License (Sumitomo Pharma)]
Features: TAAR1・5-HT1A agonist
Dosage form: Oral
IDs of key clinical study: NCT05593029
[License (Sumitomo Pharma)]
Features: TAAR1・5-HT1A agonist
Dosage form: Oral
IDs of key clinical study: NCT05729373
[License (Ionis)]
Features: Antisense oligonucleotide
Dosage form: Injection
IDs of key clinical study: NCT04768972*2
*2 Clinical trials are being conducted by the licensor, Ionis Pharmaceuticals.
[In-house]
Features: Anti-APRIL monoclonal antibody
Dosage form: Injection
IDs of key clinical study: NCT06928142
[In-house]
Features: DprE1 inhibitor
Dosage form: Oral
IDs of key clinical study: NCT05971602
[In-house]
Features: DNA gyrase inhibitor
Dosage form: Oral
IDs of key clinical study: NCT05923892
[In-house]
Features: SLC6A19 inhibitor
Dosage form: Oral
IDs of key clinical study: NCT05781399
OPC-34712 FUM
<REXULTI / RXULTI>
[In-house*1]
Features: Dopamine partial agonist
Dosage form: Depot injection
*1 Co-development with Lundbeck in US
[In-house]
Dosage form: Oral
[License (Sumitomo Pharma)]
Dosage form: Oral
[In-house]
Features: Modified interleukin-2 molecule designed to specifically activate and amplify regulatory T lymphocytes
Dosage form: Injection
[License (Cantargia)]
Features: Anti-IL-1RAP monoclonal antibody
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 Sep. 30, 2025)


