Clinical Trial Information

What are clinical trials?

Drugs are essential for preventing and treating diseases. Before a “drug” can become available to many patients, a “drug candidate” discovered through research must be evaluated for efficacy and side effects (safety) to gain approval as a “drug” from the government (Ministry of Health, Labour and Welfare).
The first step involves evaluating the efficacy, safety and other attributes of drug candidates using animal models and other methods. Then, we assess the efficacy and side effects in detail through cooperation with healthy subjects and patients who meet specific criteria. This study is called a clinical trial. Clinical trials are a necessary part of developing a new drug.

For more information about clinical trials, please visit the following links　(Japanese Site):

What is a clinical trial? | Learn about clinical trials
For more information, visit the Website of the Japan Pharmaceutical Manufacturers Association

Let’s learn about drugs and clinical trials
Watch the video on the website of the Japan Pharmaceutical Manufacturers Association

What are Clinical Trials? (for the public)
For more information, visit the website of the Ministry of Health, Labour and Welfare

For more information about clinical trials, please visit the following links　(Japanese Site):

What is a clinical trial? | Learn about clinical trials
For more information, visit the Website of the Japan Pharmaceutical Manufacturers Association

Let’s learn about drugs and clinical trials
Watch the video on the website of the Japan Pharmaceutical Manufacturers Association

What are Clinical Trials? (for the public)
For more information, visit the website of the Ministry of Health, Labour and Welfare

Our policy regarding the disclosure of clinical trial information

Taisho Pharmaceutical is committed to increasing our transparency regarding clinical trial information.
We recognize that properly disclosing outlines of our clinical trials in a timely manner, in accordance with national laws, regulations and guidelines on the disclosure of clinical trial information by pharmaceutical companies, will contribute to the advancement of science and medicine, improve people’s health and aid in the progress of pharmaceutical development.

Disclosure of clinical trial information

Taisho registers and discloses outlines of clinical trials on publicly accessible registry websites. These clinical trial registry websites provide the public and medical staff with adequate information. Registered information includes protocols, target diseases, enrollment status, results, and more.

Click the following links to view the clinical trial registry websites.

System for submitting and disclosing clinical research (jRCT, Japan Registry of Clinical Trials)

ClinicalTrials.gov (Database of clinical trials in the United States)

Click the following links to view the clinical trial registry websites.

System for submitting and disclosing clinical research (jRCT, Japan Registry of Clinical Trials)

ClinicalTrials.gov (Database of clinical trials in the United States)

Disclosure of clinical trial results

Taisho will appropriately publish the medical important results of clinical trials at conferences and journals, . When a paper is published, it is registered with publicity accessible clinical trial registry websites. A summary of the clinical trial results based on the clinical study report is also registered on the Japan Registry of Clinical Trials.

【Terms of Use】

　This webpage is based on data available from publicity accessible clinical trial registry sites and provides information about clinical trials to those who search it..

　The purpose of this website is to enhance Taisho transparency regarding its clinical trials (to disclose information). It is not intended to advertise or promote our product.

　This webpage does not recommend the use of any drug for purposes other than its indicated uses or for unapproved used. Physicians should always refer to the latest package insert before prescribing drugs, rather than relying on the information provided here.

　The clinical significance of the information related to the results of clinical trials for each patient should be determined by a physician experienced in treating the disease or by a relevant healthcare professional. If you have questions about specific symptoms, please consult a physician or a relevant healthcare professional.

　Taisho strives to provide the most up to date information about all the clinical trials listed here. However, the information may not be current depending on the last up date of the website. The results of clinical trials shared here reflect the knowledge obtained as of its completion date. This website do not provide information about the most recent assessments of the drug’s safety or efficacy.

Be sure to understand and agree to our “Term of Uses” before viewing this webpage.

　This webpage is based on data available from publicity accessible clinical trial registry sites and provides information about clinical trials to those who search it..

　The purpose of this website is to enhance Taisho transparency regarding its clinical trials (to disclose information). It is not intended to advertise or promote our product.

Be sure to understand and agree to our “Term of Uses” before viewing this webpage.

List of the Taisho clinical trials

(As of October 1, 2026)

For details, see the jRCT or ClinicalTrials.gov.
●: Patient enrollment trial

Type 2 diabetes in children

	Titles	Phase	Status	Clinical trial ID for the registered clinical trial website		Lay Summary (Japanese)
	Titles	Phase	Status	jRCT	ClinicalTrials.gov	Lay Summary (Japanese)
●	A Phase 3 Randomized, Double-blind,Placebo- controlled/Long-term Study of TS-071 in Paediatric Patients withType 2 Diabetes Mellitu	Phase 3	Completed	jRCT2031200244	－	Link
●	Clinical Pharmacology Study of TS-071 in Paediatric Patients with Type 2 Diabetes Mellitus	Phase 1	Completed	jRCT2080223964	－	－

	Titles	Phase	Status	Clinical trial ID for the registered clinical trial website		Lay Summary (Japanese)
	Titles	Phase	Status	jRCT	ClinicalTrials.gov	Lay Summary (Japanese)
●	A Phase 3 Randomized, Double-blind,Placebo- controlled/Long-term Study of TS-071 in Paediatric Patients withType 2 Diabetes Mellitu	Phase 3	Completed	jRCT2031200244	－	Link
●	Clinical Pharmacology Study of TS-071 in Paediatric Patients with Type 2 Diabetes Mellitus	Phase 1	Completed	jRCT2080223964	－	－

Hyperphosphatemia

	Titles	Phase	Status	Clinical trial ID for the registered clinical trial website		Lay Summary (Japanese)
	Titles	Phase	Status	jRCT	ClinicalTrials.gov	Lay Summary (Japanese)
●	An open-label, single-arm clinical study of TS-172 in hyperphosphatemia patientson hemodialysis	Phase 3	Recruiting	jRCT2031260054	NCT07548840	ー
●	An open-label, single-arm clinical study of TS-172 in hyperphosphatemia patients on peritoneal dialysis	Phase 3	Recruiting	jRCT2031260053	NCT07548853	ー
●	A Phase 3, Randomized, Placebo-controlled, Double-blind Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis	Phase 3	Completed	jRCT2031240567	NCT06745531	ー
●	A phase 3 long-term study of TS-172 in hyperphosphatemia patients on hemodialysis with phosphate binders	Phase 3	Recruiting	jRCT2031250523	NCT07285304	ー
●	A phase 3, randomized, placebo-controlled, double-blind, phosphate binder-combination study of TS-172 in hyperphosphatemia patients on hemodialysis	Phase 3	Recruiting	jRCT2031250548	NCT07285291	ー
●	A Phase 2, Randomized, Placebo-controlled, Double-blind, Phosphate Binder-combination Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis	Phase 2	Completed	jRCT2031240568	NCT06745518	ー
	An open-label pharmacokinetic study of TS-172 in patients with hepatic impairment	Phase 1	Recruiting	jRCT2031250445	NCT07231029	ー
	A pharmacodynamic study of TS-172 in healthy adult male subjects	Phase 1	Completed	jRCT2071250044	NCT07084961	ー
	A QT/QTc evaluation study of TS-172 in healthy adult subjects	Phase 1	Completed	jRCT2071240113	NCT06837155	ー
	A drug-drug interaction study with TS-172 in healthy adult male subjects	Phase 1	Completed	jRCT2071240112	NCT06837142	ー
	An open-label pharmacokinetic study of TS-172 in patients on hemodialysis	Phase 1	Completed	jRCT2031240681	NCT06849778	ー
●	A Phase 2, Randomized, Placebo-controlled, Double-blind, Dose-finding Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis	Phase 2	Completed	jRCT2031220587	NCT05699239	ー
	A Phase 1 Mass Balance Study of TS-172 in Healthy Adult Subjects	Phase 1	Completed	jRCT2031240318	NCT06596356	ー
	A Phase 1, Single-Center, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending and Multiple Dose of TS-172 in Healthy Adult Subjects	Phase 1	Completed	jRCT2071210043	NCT04979572	ー

	Titles	Phase	Status	Clinical trial ID for the registered clinical trial website		Lay Summary (Japanese)
	Titles	Phase	Status	jRCT	ClinicalTrials.gov	Lay Summary (Japanese)
●	An open-label, single-arm clinical study of TS-172 in hyperphosphatemia patientson hemodialysis	Phase 3	Recruiting	jRCT2031260054	NCT07548840	ー
●	An open-label, single-arm clinical study of TS-172 in hyperphosphatemia patients on peritoneal dialysis	Phase 3	Recruiting	jRCT2031260053	NCT07548853	ー
●	A Phase 3, Randomized, Placebo-controlled, Double-blind Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis	Phase 3	Completed	jRCT2031240567	NCT06745531	ー
●	A phase 3 long-term study of TS-172 in hyperphosphatemia patients on hemodialysis with phosphate binders	Phase 3	Recruiting	jRCT2031250523	NCT07285304	ー
●	A phase 3, randomized, placebo-controlled, double-blind, phosphate binder-combination study of TS-172 in hyperphosphatemia patients on hemodialysis	Phase 3	Recruiting	jRCT2031250548	NCT07285291	ー
●	A Phase 2, Randomized, Placebo-controlled, Double-blind, Phosphate Binder-combination Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis	Phase 2	Completed	jRCT2031240568	NCT06745518	ー
	An open-label pharmacokinetic study of TS-172 in patients with hepatic impairment	Phase 1	Recruiting	jRCT2031250445	NCT07231029	ー
	A pharmacodynamic study of TS-172 in healthy adult male subjects	Phase 1	Completed	jRCT2071250044	NCT07084961	ー
	A QT/QTc evaluation study of TS-172 in healthy adult subjects	Phase 1	Completed	jRCT2071240113	NCT06837155	ー
	A drug-drug interaction study with TS-172 in healthy adult male subjects	Phase 1	Completed	jRCT2071240112	NCT06837142	ー
	An open-label pharmacokinetic study of TS-172 in patients on hemodialysis	Phase 1	Completed	jRCT2031240681	NCT06849778	ー
●	A Phase 2, Randomized, Placebo-controlled, Double-blind, Dose-finding Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis	Phase 2	Completed	jRCT2031220587	NCT05699239	ー
	A Phase 1 Mass Balance Study of TS-172 in Healthy Adult Subjects	Phase 1	Completed	jRCT2031240318	NCT06596356	ー
	A Phase 1, Single-Center, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending and Multiple Dose of TS-172 in Healthy Adult Subjects	Phase 1	Completed	jRCT2071210043	NCT04979572	ー

Insomnia

	Titles	Phase	Status	Clinical trial ID for the registered clinical trial website		Lay Summary (Japanese)
	Titles	Phase	Status	jRCT	ClinicalTrials.gov	Lay Summary (Japanese)
●	A Multi-center, Open-label Long-Term Study of TS-142 in Patients With Insomnia Disorder	Phase 3	Completed	jRCT2031220208	NCT05461352	ー
●	A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 3 Study of TS-142 in Patients With Insomnia Disorder.	Phase 3	Completed	jRCT2031220209	NCT05453136	Link
●	Late Phase II Study of TS-142 in Patients With Insomnia	Phase 2	Completed	jRCT2080225269	NCT04469023	ー
	A Study to Investigate the Next-day Residual Effects of TS-142 in Healthy Elderly Subjects	Phase 1	Completed	jRCT2071230009	NCT05819710	ー
	A Study to Assess the Food Effect ofTS-142 in Healthy Subjects	Phase 1	Completed	jRCT2071220103	NCT05707897	ー
	An Open-label Pharmacokinetic Study of TS-142 in Patients With Hepatic Impairment	Phase 1	Completed	jRCT2031220463	NCT05624944	ー
	A Study to Evaluate the Effects on QT/QTc Interval of TS-142 in Healthy Adult Subjects	Phase 1	Completed	jRCT2071210018	NCT04873323	ー
	A Study to Evaluate the Respiratory Safety of TS-142 in Patients With Obstructive Sleep Apnea Hypopnea.	Phase 1	Completed	jRCT2031200373	NCT04746105	ー
	A Driving Performance Evaluation Study of TS-142 Using a Driving Simulator in Non-elderly and Elderly Healthy Subjects	Phase 1	Completed	jRCT2071200075	NCT04696952	ー
	Mass Balance Recovery, Pharmacokinetics, Metabolite Identificationand Profiling of 14C-labeled TS-142 in Healthy Adult Subjects.	Phase 1	Completed	jRCT2031210027	NCT04814771	ー
	Drug-drug Interaction Study With TS-142 in Healthy Adult Subjects (Concomitant Administration of Itraconazole)	Phase 1	Completed	jRCT2071200036	NCT04557163	ー

	Titles	Phase	Status	Clinical trial ID for the registered clinical trial website		Lay Summary (Japanese)
	Titles	Phase	Status	jRCT	ClinicalTrials.gov	Lay Summary (Japanese)
●	A Multi-center, Open-label Long-Term Study of TS-142 in Patients With Insomnia Disorder	Phase 3	Completed	jRCT2031220208	NCT05461352	ー
●	A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 3 Study of TS-142 in Patients With Insomnia Disorder.	Phase 3	Completed	jRCT2031220209	NCT05453136	Link
●	Late Phase II Study of TS-142 in Patients With Insomnia	Phase 2	Completed	jRCT2080225269	NCT04469023	ー
	A Study to Investigate the Next-day Residual Effects of TS-142 in Healthy Elderly Subjects	Phase 1	Completed	jRCT2071230009	NCT05819710	ー
	A Study to Assess the Food Effect ofTS-142 in Healthy Subjects	Phase 1	Completed	jRCT2071220103	NCT05707897	ー
	An Open-label Pharmacokinetic Study of TS-142 in Patients With Hepatic Impairment	Phase 1	Completed	jRCT2031220463	NCT05624944	ー
	A Study to Evaluate the Effects on QT/QTc Interval of TS-142 in Healthy Adult Subjects	Phase 1	Completed	jRCT2071210018	NCT04873323	ー
	A Study to Evaluate the Respiratory Safety of TS-142 in Patients With Obstructive Sleep Apnea Hypopnea.	Phase 1	Completed	jRCT2031200373	NCT04746105	ー
	A Driving Performance Evaluation Study of TS-142 Using a Driving Simulator in Non-elderly and Elderly Healthy Subjects	Phase 1	Completed	jRCT2071200075	NCT04696952	ー
	Mass Balance Recovery, Pharmacokinetics, Metabolite Identificationand Profiling of 14C-labeled TS-142 in Healthy Adult Subjects.	Phase 1	Completed	jRCT2031210027	NCT04814771	ー
	Drug-drug Interaction Study With TS-142 in Healthy Adult Subjects (Concomitant Administration of Itraconazole)	Phase 1	Completed	jRCT2071200036	NCT04557163	ー

Rheumatoid arthritis

	Titles	Phase	Status	Clinical trial ID for the registered clinical trial website		Lay Summary (Japanese)
	Titles	Phase	Status	jRCT	ClinicalTrials.gov	Lay Summary (Japanese)
●	An Extension Study of TS-152 in Subjects with Rheumatoid Arthritis	Phase 3	Completed	jRCT2080224848	NCT04077567	－
●	A Phase III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Without Methotrexate (MTX) Therapy	Phase 3	Completed	jRCT2080223973	－	－
●	A Phase II/III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to Methotrexate (MTX) Therapy	Phase 2 /Phase 3	Completed	jRCT2080223971	－	－

	Titles	Phase	Status	Clinical trial ID for the registered clinical trial website		Lay Summary (Japanese)
	Titles	Phase	Status	jRCT	ClinicalTrials.gov	Lay Summary (Japanese)
●	An Extension Study of TS-152 in Subjects with Rheumatoid Arthritis	Phase 3	Completed	jRCT2080224848	NCT04077567	－
●	A Phase III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Without Methotrexate (MTX) Therapy	Phase 3	Completed	jRCT2080223973	－	－
●	A Phase II/III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to Methotrexate (MTX) Therapy	Phase 2 /Phase 3	Completed	jRCT2080223971	－	－

【Contact】

Use the email address below to submit questions about clinical trial information.

shu_chiken@taisho.co.jp

Use the email address below to submit questions about clinical trial information.

shu_chiken@taisho.co.jp