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SUMITOMO PHARMA CO LTD

SUMITOMO PHARMA CO LTD logo
🇯🇵Japan
Ownership
Public, Subsidiary
Established
1984-01-01
Employees
5K
Market Cap
$1.8B
Website
http://www.sumitomo-pharma.co.jp

Clinical Trials

50

Active:9
Completed:28

Trial Phases

4 Phases

Phase 1:16
Phase 2:1
Phase 3:11
+1 more phases

Drug Approvals

17

NMPA:17

Drug Approvals

Meropenem for Injection

Product Name
美平
Approval Number
国药准字HJ20140703
Approval Date
Dec 26, 2023
NMPA

Meropenem for Injection

Product Name
美平
Approval Number
国药准字HJ20140702
Approval Date
Dec 26, 2023
NMPA

Mosapride Citrate Tablets

Product Name
加斯清
Approval Number
国药准字HJ20140637
Approval Date
Sep 1, 2023
NMPA

Mosapride Citrate Tablets

Product Name
加斯清
Approval Number
国药准字HJ20140636
Approval Date
Sep 1, 2023
NMPA

Arotinolol Hydrochloride Tablets

Product Name
阿尔马尔
Approval Number
国药准字HJ20140677
Approval Date
Jun 7, 2023
NMPA

Arotinolol Hydrochloride Tablets

Product Name
阿尔马尔
Approval Number
国药准字HJ20140676
Approval Date
Jun 7, 2023
NMPA

Tandospirone Citrate Tablets

Product Name
希德
Approval Number
国药准字HJ20181227
Approval Date
Mar 20, 2023
NMPA

Tandospirone Citrate Tablets

Product Name
希德
Approval Number
国药准字HJ20181228
Approval Date
Mar 20, 2023
NMPA

Blonanserin Tablets

Product Name
洛珊
Approval Number
国药准字HJ20170287
Approval Date
Sep 18, 2021
NMPA

Meropenem for Injection

Product Name
美平
Approval Number
国药准字J20140169
Approval Date
Aug 14, 2019
NMPA
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Clinical Trials

Distribution across different clinical trial phases (30 trials with phase data)• Click on a phase to view related trials

Phase 1
16 (53.3%)
Phase 3
11 (36.7%)
Not Applicable
1 (3.3%)
Phase 2
1 (3.3%)
phase_2_3
1 (3.3%)

First-in-human Phase 1 Study to Assess the Safety, Tolerability, and Immunogenicity of the Adjuvanted Universal Influenza Vaccine “fH1/DSP-0546LP” in Healthy Adults

Phase 1
Active, not recruiting
Conditions
Influenza
Interventions
Biological: fH1 2 ug
Biological: fH1 8 ug
Biological: Placebo
Biological: DSP-0546LP 5 ug
Biological: DSP-0546LP 10 ug
Biological: DSP-0546LP 2.5 ug
First Posted Date
2024-05-03
Last Posted Date
2024-11-29
Lead Sponsor
Sumitomo Pharma Co. Ltd.
Target Recruit Count
144
Registration Number
2023-504378-39-00
Locations
🇧🇪

Universitair Ziekenhuis Gent, Gent, Belgium

A Pharmacodynamics and Safety Study of DSP-9632P in Patients With Levodopa-Induced Dyskinesia in Parkinson's Disease

Phase 1
Completed
Conditions
Parkinson's Disease
Levodopa-induced Dyskinesia
Interventions
Drug: DSP-9632P 27.5 mg
Drug: Placebo
Drug: DSP-9632P 82.5 mg
Drug: DSP-9632P 55.0 mg
First Posted Date
2022-06-28
Last Posted Date
2023-08-09
Lead Sponsor
Sumitomo Pharma Co., Ltd.
Target Recruit Count
7
Registration Number
NCT05435729
Locations
🇯🇵

Nippon Medical School Hospital, Bunkyo, Tokyo, Japan

A Clinical Trial to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan

Phase 3
Terminated
Conditions
Schizophrenia
Interventions
First Posted Date
2022-05-03
Last Posted Date
2025-03-19
Lead Sponsor
Sumitomo Pharma Co., Ltd.
Target Recruit Count
68
Registration Number
NCT05359081
Locations
🇯🇵

Hotei Hospital, Konan-shi, Aichi, Japan

🇯🇵

Heart Care Clinic Omachi, Akita-shi, Akita, Japan

🇯🇵

Seinan Hospital, Hachinohe-shi, Aomori, Japan

and more 48 locations

A Clinical Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic People With Schizophrenia, Followed by an Open-label Extension Phase

Phase 2
Terminated
Conditions
Schizophrenia
Interventions
First Posted Date
2021-04-01
Last Posted Date
2024-03-15
Lead Sponsor
Sumitomo Pharma Co., Ltd.
Target Recruit Count
83
Registration Number
NCT04825860
Locations
🇨🇳

Beijing Anding Hospital Capital Medical University, Beijing, Beijing, China

🇨🇳

Peking University Sixth Hospital, Beijing, Beijing, China

🇨🇳

The Affiliated Brain Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China

and more 51 locations

Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Japanese Male and Female Subjects With Schizophrenia

Phase 1
Completed
Conditions
Schizophrenia
Interventions
Drug: Placebo
First Posted Date
2020-03-30
Last Posted Date
2022-04-12
Lead Sponsor
Sumitomo Pharma Co., Ltd.
Target Recruit Count
13
Registration Number
NCT04325737
Locations
🇯🇵

Shiranui Hospital, Omuta-shi, Fukuoka-Ken, Japan

🇯🇵

Nishiurakai Keihan Hospital, Osaka-Fu, Moriguchi-shi, Japan

🇯🇵

Mental Support SOYOKAZE Hospital, Ueda-shi, Nagano-Ken, Japan

and more 5 locations
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News

Poxel Enters Reorganization Proceedings as Clinical-Stage Biotech Faces Financial Restructuring

Poxel SA, a clinical-stage biopharmaceutical company developing treatments for metabolic diseases, has entered judicial reorganization proceedings following a court hearing on August 5, 2025.

Knight Therapeutics Acquires Sumitomo's Canadian Portfolio Including MYFEMBREE and ORGOVYX for C$25.4 Million

Knight Therapeutics has entered into exclusive licensing agreements with Sumitomo Pharma to commercialize MYFEMBREE, ORGOVYX, and vibegron in Canada for an upfront payment of C$25.4 million.

Poxel's PXL065 Shows Promise in Preclinical Hypertrophic Cardiomyopathy Study, Data to be Presented at ESC 2025

Poxel's PXL065, a deuterium-stabilized R-enantiomer of pioglitazone, demonstrated significant benefits in preventing pathological myocardial remodeling in a mouse model of hypertrophic cardiomyopathy.

Schizophrenia Clinical Trial Pipeline Boasts 60+ Drugs Under Development

• The schizophrenia treatment landscape is expanding with over 60 drugs in active development, driven by increased R&D and innovative therapies. • Key players like Sumitomo Pharma, Boehringer Ingelheim, and Reviva Pharmaceuticals are advancing novel antipsychotics and personalized medicine approaches. • Recent progress includes positive Phase III trial results for brilaroxazine and LY03020's IND approval in China, signaling potential new treatment options. • COBENFY, a first-in-class muscarinic agonist, received FDA approval, marking a significant advancement in schizophrenia treatment after 35 years.

FDA Accepts Sumitomo Pharma's sNDA for Vibegron in Men with OAB and BPH

The FDA has accepted Sumitomo Pharma's sNDA for vibegron (GEMTESA) to treat OAB symptoms in men receiving BPH pharmacological therapy.

Imeglimin's Impact on Glycemic Control and Erythrocytes in Type 2 Diabetes: INFINITY Study

The INFINITY study investigates imeglimin's effects on glycemic control markers and erythrocytes in type 2 diabetes patients over six months.

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