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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

465

Active:9
Completed:288

Trial Phases

5 Phases

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

Drug Approvals

14

NMPA:14

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 (432 trials with phase data)• Click on a phase to view related trials

Phase 3
150 (34.7%)
Phase 2
111 (25.7%)
Phase 1
83 (19.2%)
Not Applicable
55 (12.7%)
Phase 4
21 (4.9%)
phase_2_3
10 (2.3%)
phase_1_2
2 (0.5%)

LUPKYNIS Drug-use Results Survey

Recruiting
Conditions
Lupus Nephritis
First Posted Date
2025-07-08
Last Posted Date
2025-07-10
Lead Sponsor
Otsuka Pharmaceutical Co., Ltd.
Target Recruit Count
400
Registration Number
NCT07053891
Locations
🇯🇵

Pharmacovigilance Department, Osaka, Japan

Evaluation of the Efficacy and Safety of EB-1020 in Adult ADHD Patients

Phase 2
Recruiting
Conditions
Attention Deficit Hyperactivity Disorder (ADHD)
Interventions
Drug: EB-1020 (Centanafadine) 164.4 mg
Drug: EB-1020 (Centanafadine) 328.8 mg
Drug: Placebo
First Posted Date
2025-04-16
Last Posted Date
2025-04-16
Lead Sponsor
Otsuka Pharmaceutical Co., Ltd.
Target Recruit Count
630
Registration Number
NCT06931080
Locations
🇯🇵

Maynds Tower Mental Clinic, Tokyo, Japan

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

Phase 3
Recruiting
Conditions
Attention Deficit Hyperactivity Disorder (ADHD)
Interventions
Drug: EB-1020 (Centanafadine) 164.4 mg
Drug: EB-1020 (Centanafadine) 328.8 mg
First Posted Date
2025-04-15
Last Posted Date
2025-04-15
Lead Sponsor
Otsuka Pharmaceutical Co., Ltd.
Target Recruit Count
180
Registration Number
NCT06926829
Locations
🇯🇵

Maynds Tower Mental Clinic, Tokyo, Japan

REXULTI Drug General Use-results Survey (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)

Recruiting
Conditions
Alzheimer Disease
First Posted Date
2025-03-14
Last Posted Date
2025-07-02
Lead Sponsor
Otsuka Pharmaceutical Co., Ltd.
Target Recruit Count
200
Registration Number
NCT06875986
Locations
🇯🇵

Pharmacovigilance Department, Osaka, Japan

Food Effect Study of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia

Phase 1
Completed
Conditions
Schizophrenia
Interventions
First Posted Date
2023-09-13
Last Posted Date
2025-04-17
Lead Sponsor
Otsuka Pharmaceutical Co., Ltd.
Target Recruit Count
59
Registration Number
NCT06036108
Locations
🇯🇵

Rainbow & Sea Hospital, Saga-shi, 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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