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OTSUKA PHARMACEUTICAL CO., LTD.

OTSUKA PHARMACEUTICAL CO., LTD. logo
🇯🇵Japan
Ownership
Public, Subsidiary
Established
1964-01-01
Employees
101
Market Cap
-
Website
http://www.otsuka.co.jp

Clinical Trials

469

Active:9
Completed:288

Trial Phases

5 Phases

Phase 1:83
Phase 2:111
Phase 3:150
+2 more phases

Drug Approvals

84

CANADA:30
NMPA:14
SFDA:8
+2 more agencies

Drug Approvals

Ponatinib Tablets

Product Name
英可欣
Approval Number
国药准字HJ20240090
Approval Date
Sep 3, 2024
NMPA

Brexpiprazole Tablets

Product Name
锐思定
Approval Number
国药准字HJ20240050
Approval Date
Jun 25, 2024
NMPA

Brexpiprazole Tablets

Product Name
锐思定
Approval Number
国药准字HJ20240049
Approval Date
Jun 25, 2024
NMPA

Brexpiprazole Tablets

Product Name
锐思定
Approval Number
国药准字HJ20240051
Approval Date
Jun 25, 2024
NMPA

Aripiprazole for Injection

Product Name
注射用阿立哌唑
Approval Number
国药准字HJ20230054
Approval Date
Dec 18, 2023
NMPA

Aripiprazole for Injection

Product Name
注射用阿立哌唑
Approval Number
国药准字HJ20230055
Approval Date
Dec 18, 2023
NMPA

Delamanid Tablets

Product Name
德尔巴
Approval Number
国药准字HJ20181244
Approval Date
Sep 7, 2023
NMPA

Delamanid Tablets

Product Name
德尔巴
Approval Number
国药准字HJ20180004
Approval Date
Sep 7, 2023
NMPA

Busulfan Injection

Product Name
白舒非
Approval Number
国药准字HJ20170308
Approval Date
Mar 3, 2023
NMPA

Busulfan Injection

Product Name
白舒非
Approval Number
国药准字HJ20170309
Approval Date
Mar 3, 2023
NMPA
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Clinical Trials

Distribution across different clinical trial phases (436 trials with phase data)• Click on a phase to view related trials

Phase 3
150 (34.4%)
Phase 2
111 (25.5%)
Phase 1
83 (19.0%)
Not Applicable
59 (13.5%)
Phase 4
21 (4.8%)
phase_2_3
10 (2.3%)
phase_1_2
2 (0.5%)

A Phase 3 Trial of OPA-15406 Foam in Children and Infants With Atopic Dermatitis

Not Applicable
Not yet recruiting
Conditions
Atopic Dermatitis (AD)
Interventions
Drug: Vehicle
First Posted Date
2025-09-22
Last Posted Date
2025-09-22
Lead Sponsor
Otsuka Pharmaceutical Co., Ltd.
Target Recruit Count
198
Registration Number
NCT07184645
Locations
🇯🇵

Sumire Dermatology Clinic, Tokyo, Japan

A Phase 3 Trial to Demonstrate the Superiority of 1% OPA-15406 Foam to the Vehicle in Adult Patients With Atopic Dermatitis

Not Applicable
Not yet recruiting
Conditions
Atopic Dermatitis (AD)
Interventions
Drug: Vehicle
First Posted Date
2025-09-15
Last Posted Date
2025-09-15
Lead Sponsor
Otsuka Pharmaceutical Co., Ltd.
Target Recruit Count
156
Registration Number
NCT07173478
Locations
🇯🇵

Mita Dermatology Clinic, Tokyo, Japan

A Long-term Trial of EB-1020 in Pediatric Patients With ADHD

Not Applicable
Recruiting
Conditions
Attention-Deficit Hyperactivity Disorder(ADHD)
Interventions
Drug: EB-1020 (Centanafadine) low dose
Drug: EB-1020 (Centanafadine) high dose
First Posted Date
2025-07-28
Last Posted Date
2025-07-28
Lead Sponsor
Otsuka Pharmaceutical Co., Ltd.
Target Recruit Count
180
Registration Number
NCT07087327
Locations
🇯🇵

Hokkaido University Hospital, Sapporo, Japan

A Trial to Evaluate the Efficacy and Safety of EB-1020 in Pediatric Patients With ADHD

Not Applicable
Recruiting
Conditions
Attention-Deficit Hyperactivity Disorder(ADHD)
Interventions
Drug: EB-1020 (Centanafadine) low dose
Drug: EB-1020 (Centanafadine) high dose
Drug: Placebo
First Posted Date
2025-07-25
Last Posted Date
2025-07-25
Lead Sponsor
Otsuka Pharmaceutical Co., Ltd.
Target Recruit Count
315
Registration Number
NCT07086313
Locations
🇯🇵

Hokkaido University Hospital, Sapporo, Japan

LUPKYNIS Drug-use Results Survey

Recruiting
Conditions
Lupus Nephritis
First Posted Date
2025-07-08
Last Posted Date
2025-09-19
Lead Sponsor
Otsuka Pharmaceutical Co., Ltd.
Target Recruit Count
400
Registration Number
NCT07053891
Locations
🇯🇵

Pharmacovigilance Department, Osaka, Osaka, Japan

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News

Difamilast Shows Comparable Efficacy and Safety to Delgocitinib in Atopic Dermatitis: A Matching-Adjusted Indirect Comparison

A matching-adjusted indirect comparison (MAIC) study suggests difamilast 1% cream has comparable efficacy and safety to delgocitinib in treating moderate-to-severe atopic dermatitis (AD).

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