This study is a single-center, open-label, multiple-dose trial in healthy participants. The primary purpose of this study is to assess the adhesion of TK-254RX. Secondary purposes are to assess the safety of TK-254RX and the residual amount of the patch.

Start Date19 Jan 2026

Sponsor / Collaborator

Teikoku Seiyaku Co. Ltd.

[+4]

NCT06052254

/ RecruitingPhase 2

A Double-Blind, Placebo-Controlled Evaluation of the Dexmedetomidine Transdermal Systems for Agitation Associated With Dementia of the Alzheimer's Type

The primary objective of this study is to evaluate the efficacy of DMTS on frequency and severity of agitation associated with dementia of the Alzheimer's type, compared with placebo.

Start Date16 Sep 2025

Sponsor / Collaborator

Teikoku Pharma USA, Inc.

NCT06866613

/ CompletedPhase 3

Randomized, Controlled, Double-blind, Multi-center Trial to Evaluate the Efficacy and Safety of an Esflurbiprofen Topical System (EFTS) vs. Placebo in the Local Symptomatic and Short-term Treatment of Pain in Ankle Sprains.

This study is a multi-center, double-blind, randomized controlled trial to evaluate the efficacy and safety of EFTS vs. placebo in patients with ankle sprains. The primary objective of this study is to demonstrate that the EFTS is superior in pain reduction compared to a matching placebo in patients with ankle sprains.
The secondary objective is to evaluate tolerability, local tolerability, and adhesion of EFTS vs. placebo.

Start Date31 Mar 2025

Sponsor / Collaborator

Teikoku Seiyaku Co. Ltd.

[+4]

100 Clinical Results associated with Teikoku Seiyaku Co. Ltd.

0 Patents (Medical) associated with Teikoku Seiyaku Co. Ltd.

Literatures (Medical) associated with Teikoku Seiyaku Co. Ltd.

10 Oct 2023·Journal of Alzheimer's disease : JAD

Long-Term Safety, Tolerability, and Efficacy of a Transdermal Donepezil Patch in Patients with Severe Alzheimer’s Disease

Article

Author: Takashi Kikuchi ; Kohei Narita ; Yu Nakamura ; Kenichi Nishiyama ; Rei Kim ; Ichiro Ishikawa ; Hiroshi Aoki

Background: Oral formulations are not suitable for demented patients with dysphagia, those refuse to take tablets, or those with drug compliance problem. However, only oral formulations of donepezil hydrochloride are approved for the treatment of severe Alzheimer’s disease in Japan. Objective: To evaluate the safety, tolerability, and efficacy of long-term application of a 55.0 mg transdermal donepezil patch switched from a 10 mg oral donepezil hydrochloride tablet, for the treatment of patients with severe Alzheimer’s disease. Methods: A 52-week, multicenter, open-label, uncontrolled (phase III) study (jRCT2080224612) was conducted in Japan between April 2019 and August 2021. A 10 mg donepezil hydrochloride tablet was administered once a day for four weeks; a 55.0 mg donepezil patch was then applied once a day for 52 weeks in patients with severe Alzheimer’s disease. Results: Of 64 patients received the patch, 45 completed the 52-week period. The overall discontinuation rate was 29.7% (19/64). Among the 19 patients discontinued, six patients 9.4% (6/64) discontinued due to adverse events. The incidence of adverse events at application sites was 67.2% (43/64), including application site erythema 29.7% (19/64), application site pruritus 25.0% (16/64), and contact dermatitis 20.3% (13/64). Adverse events were mild and did not increase with time, demonstrating a favorable safety profile. Cognitive function, measured using the Mini-Mental State Examination, was maintained for up to 24 weeks. Conclusions: Adverse events were considered manageable in a clinical setting. The long-term application of a 55.0 mg donepezil patch once a day was feasible treatment in patients with severe Alzheimer’s disease.

01 Jan 2020·Arerugi = [Allergy]

[USEFULNESS OF RUPATADINE FOR PRURITUS OF PATIENTS WITH ATOPIC DERMATITIS].

Article

Author: Komorita, Naruyasu ; Hirata, Kazuya ; Tanaka, Ayaka ; Hide, Michihiro ; Kubo, Hajime ; Aoki, Hiroshi ; Suzuki, Takamasa

BACKGROUND:

Histamine H1 receptor antagonists (antihistamines) are recommended as adjunctive therapy for atopic dermatitis (AD). However, their long-term usefulness and the effect of updosing have not been clarified.

PURPOSE:

To analyzed the long-term usefulness and the effect of updosing of rupatadine, a second generation antihistamine, for patients with AD.

METHODS:

Efficacy and safety of rupatadine were evaluated in 66 AD patients, including 50 patients with dose escalation by post hoc analysis of the phase III trial of rupatadine for Japanese patients with pruritus associated with skin diseases.

RESULTS:

The mean score at baseline total pruritus score (TPS) was 4.682. It decreased to 3.885 at 2 weeks, and 2.376 at 52 weeks by rupatadine administration. The change (of one week after baseline TPS) was significant. Baseline TPS of dose escalation groups, either after 2 weeks or after week 4, were higher than those of 10mg maintenance dose cases, but no significant difference was shown in the change from baseline TPS among the groups at 52 weeks. The occurrence of adverse drug reactions and somnolence were observed in 19.7% and 15.2% of the subjects.

CONCLUSION:

These results suggest the long-term usefulness of rupatadine for pruritus in AD.

01 Jun 2019·Journal of dermatological scienceQ2 · MEDICINE

Long-term safety and efficacy of rupatadine in Japanese patients with itching due to chronic spontaneous urticaria, dermatitis, or pruritus: A 12-month, multicenter, open-label clinical trial

Q2 · MEDICINE

Article

Author: Suzuki, Takamasa ; Hide, Michihiro ; Aoki, Hiroshi ; Tanaka, Ayaka

BACKGROUND:

Rupatadine is a novel H1 antihistamine with platelet-activating factor antagonist activity. Its efficacy and safety on pruritic skin diseases have been demonstrated by 10mg/day rupatadine in a two weeks clinical trial.

OBJECTIVE:

To investigate the long-term efficacy and safety of rupatadine in the management of pruritus, and the clinical effect of updosing to 20mg in Japanese adult and adolescent patients.

METHODS:

In this 52-week, multicenter, open-label clinical trial (JapicCTI-152787), 206 patients (132, eczema or dermatitis; 58, pruritus; and 16, chronic spontaneous urticaria) received the study medication. The primary efficacy endpoint was change from baseline in the total pruritus score to Week 2 by treatment with rupatadine 10mg once daily. From Week 3 to Week 52, rupatadine updosing to 20mg was allowed.

RESULTS:

The mean [95% CI] change from baseline to Week 2 in the total pruritus score was -1.241 [-1.450, -1.033] (paired t test, P< 0.001). The therapeutic effect persisted up to Week 52 (paired t test, P< 0.001). Adverse drug reactions (ADRs) were reported at an overall incidence of 18.0% (45 events in 37 patients). No serious or clinically significant ADRs were reported. Somnolence was the most common ADR (14.1%).

CONCLUSIONS:

This clinical trial demonstrated the short- and long-term benefits of rupatadine in the management of patients with chronic spontaneous urticaria, dermatitis, and pruritus. Rupatadine 10 and 20mg doses are effective for the treatment of itch in adults and adolescents, and can be used safely on a long-term basis.

News (Medical) associated with Teikoku Seiyaku Co. Ltd.

22 Dec 2025

·www.pharmaceutical-technology.com

MEDIPOST, Teikoku Seiyaku partner for CARTISTEM commercialisation in Japan

MEDIPOST global business division head and co-CEO Antonio Seung Jin Lee, and Teikoku Seiyaku international business board member and senior managing director Akira Nakagawa. Credit: MEDIPOST/PR Newswire. MEDIPOST has announced a multi-year exclusive partnership with Teikoku Seiyaku to commercialise CARTISTEM, an allogeneic stem cell therapy for moderate to severe knee osteoarthritis, in Japan. The agreement covers the promotion license, sales, and distribution of CARTISTEM. MEDIPOST will supply the drug substance and retain manufacturing rights, while the exclusive rights for the Japanese market will be managed by Teikoku Seiyaku. Under this agreement, MEDIPOST’s Japanese subsidiary receive a short-term regulatory milestone payment of $10m, an upfront payment of $8m, and additional undisclosed sales-based long-term milestone payments. Teikoku Seiyaku intends to use its network of orthopaedic clinics and hospitals to support the adoption and distribution of CARTISTEM among patients with moderate to severe knee osteoarthritis. The company is preparing to expand its medical representative division in advance of regulatory approval, with the aim of addressing unmet medical needs in knee osteoarthritis treatment in Japan. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence CARTISTEM is designed to regenerate cartilage in patients with knee osteoarthritis and holds the potential as a disease-modifying osteoarthritis drug (DMOAD). Since its regulatory approval in South Korea in 2012, CARTISTEM has been used in more than 35,000 patients over 13 years. The therapy is based on allogeneic human umbilical cord blood-derived mesenchymal stem/stromal cells (hUCB-MSC). MEDIPOST’s integrated operations includes cell and gene therapy contract development and manufacturing; research, product and clinical development; and cord blood banking. The company introduced CARTISTEM, the first allogeneic hUCB-MSC therapy product to receive regulatory approval for treating knee osteoarthritis in patients of all ages. Teikoku Seiyaku is focused on transdermal drug delivery and pain management. The company has also signed a basic sales agreement with ReqMed Company for exclusive distribution rights in Japan for a sodium pentosan polysulfate subcutaneous injection, which is in Phase III clinical trials. It intends to grow its orthopaedics team to 100 members and enhance efforts to provide therapies for conditions with significant unmet medical needs. Pharmaceutical Technology Excellence Awards - Nominations Closed Nominations are now closed for the Pharmaceutical Technology Excellence Awards . A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact. Excellence in Action Awarded the 2025 Pharmaceutical Technology Excellence Award for Business Expansion in Integrated Manufacturing , Upperton Pharma Solutions is rapidly expanding its UK GMP and sterile manufacturing footprint. Find out how Upperton’s integrated CDMO model helps pharma companies move from early development to clinical and niche commercial supply with fewer handovers and faster timelines. Discover the Impact

Phase 3License out/in

19 Dec 2025

·www.prnewswire.com

MEDIPOST Announces the Exclusive Commercialization License Agreement with Teikoku Seiyaku for Knee Osteoarthritis Treatment CARTISTEM® in Japan

- South Korean biotech company secures US$8 million in upfront payment for the joint commercialization of the stem cell therapy CARTISTEM® targeting the Japanese knee osteoarthritis market. SEOUL, South Korea, Dec. 19, 2025 /PRNewswire/ -- MEDIPOST Co., Ltd. (KOSDAQ 078160), a fully integrated cell therapy biotechnology company, today announced a multi-year partnership with Japan's Teikoku Seiyaku Co., Ltd. for the commercialization of CARTISTEM®, an innovative treatment for knee osteoarthritis, in the Japanese market. Continue Reading Antonio Seung Jin Lee, Head of MEDIPOST's Global Business Division and Co-CEO of MEDIPOST, Inc. & Akira Nakagawa, Board Member & Senior Managing Director, International Business Under the terms of the agreement, MEDIPOST K.K. (MEDIPOST's wholly-owend Japanese subsidiary) will grant an exclusive sales, distribution and promotion license for CARTISTEM® in Japan to Teikoku Seiyaku Co. Ltd.. Further, MEDIPOST will supply the drug substance (DS) while retaining all manufacturing rights. Additionally, MEDIPOST will receive an upfront payment of US$8 million, along with a US$10 million short-term regulatory-based milestone and undisclosed sales-based long-term milestones. In turn, Teikoku Seiyaku Co. Ltd. will leverage its extensive orthopedic hospital and clinic network to promote and distribute CARTISTEM® in order to accelerate CARTISTEM®'s adoption among patients with moderate to severe knee osteoarthritis. Teikoku Seiyaku Co. Ltd. also plans to expand its medical representative division ahead of CARTISTEM®'s approval and as it seeks to address the significant unmet medical needs in Japan's knee osteoarthritis treatment landscape. About CARTISTEM® CARTISTEM® is an allogeneic stem cell therapy designed to treat moderate to severe knee osteoarthritis. Since receiving regulatory approval in South Korea in 2012, CARTISTEM® has been administered to more than 35,000 patients over the past 13 years. CARTISTEM® demonstrates the ability to regenerate cartilage in knee osteoarthritis patients and holds the potential to be recognized as a disease-modifying osteoarthritis drug (DMOAD). About MEDIPOST Founded in 2000, MEDIPOST is a global stem cell therapy company with integrated capabilities spanning across discovery research with product and clinical development of allogeneic cell therapy pipelines, cord blood banking, and cell and gene therapy contract development and manufacturing (CDMO) business portfolios. MEDIPOST successfully commercialized the world's first regulatory-approved (2012) allogeneic human umbilical cord blood-derived mesenchymal stem/stromal cell (hUCB-MSC) therapy product, CARTISTEM®, for the treatment of knee osteoarthritis patients across all age groups. About Teikoku Seiyaku Founded in 1848, Teikoku Seiyaku is dedicated to its mission "For a World Without Pain." Leveraging its expertise in transdermal drug delivery technology, the company develops, manufactures, and markets pharmaceutical products, including transdermal patches and medical narcotics. For osteoarthritis, Teikoku Seiyaku has entered into a basic sales agreement with ReqMed Company, Ltd. regarding exclusive distribution rights in Japan for a subcutaneous injection containing NaPPS (sodium pentosan polysulfate), which is currently in Phase 3 clinical trials in Japan. Going forward, in orthopedics—one of its priority areas—we will expand its dedicated orthopedic team on the scale of 100 members and further strengthen its efforts to deliver treatments for diseases with high unmet medical needs, including osteoarthritis, to patients. SOURCE MEDIPOST 21% more press release views with Request a Demo

Cell TherapyLicense out/inPhase 3Drug ApprovalGene Therapy

19 Dec 2025

·www.biospace.com

MEDIPOST Announces the Exclusive Commercialization License Agreement with Teikoku Seiyaku for Knee Osteoarthritis Treatment CARTISTEM® in Japan

- South Korean biotech company secures US$8 million in upfront payment for the joint commercialization of the stem cell therapy CARTISTEM ® targeting the Japanese knee osteoarthritis market. SEOUL, South Korea , Dec. 19, 2025 /PRNewswire/ -- MEDIPOST Co., Ltd. (KOSDAQ 078160), a fully integrated cell therapy biotechnology company, today announced a multi-year partnership with Japan's Teikoku Seiyaku Co., Ltd. for the commercialization of CARTISTEM ® , an innovative treatment for knee osteoarthritis, in the Japanese market. Under the terms of the agreement, MEDIPOST K.K. (MEDIPOST's wholly-owend Japanese subsidiary) will grant an exclusive sales, distribution and promotion license for CARTISTEM ® in Japan to Teikoku Seiyaku Co. Ltd.. Further, MEDIPOST will supply the drug substance (DS) while retaining all manufacturing rights. Additionally, MEDIPOST will receive an upfront payment of US$8 million, along with a US$10 million short-term regulatory-based milestone and undisclosed sales-based long-term milestones. In turn, Teikoku Seiyaku Co. Ltd. will leverage its extensive orthopedic hospital and clinic network to promote and distribute CARTISTEM ® in order to accelerate CARTISTEM ® 's adoption among patients with moderate to severe knee osteoarthritis. Teikoku Seiyaku Co. Ltd. also plans to expand its medical representative division ahead of CARTISTEM ® 's approval and as it seeks to address the significant unmet medical needs in Japan's knee osteoarthritis treatment landscape. About CARTISTEM ® CARTISTEM ® is an allogeneic stem cell therapy designed to treat moderate to severe knee osteoarthritis. Since receiving regulatory approval in South Korea in 2012, CARTISTEM ® has been administered to more than 35,000 patients over the past 13 years. CARTISTEM ® demonstrates the ability to regenerate cartilage in knee osteoarthritis patients and holds the potential to be recognized as a disease-modifying osteoarthritis drug (DMOAD). About MEDIPOST Founded in 2000, MEDIPOST is a global stem cell therapy company with integrated capabilities spanning across discovery research with product and clinical development of allogeneic cell therapy pipelines, cord blood banking, and cell and gene therapy contract development and manufacturing (CDMO) business portfolios. MEDIPOST successfully commercialized the world's first regulatory-approved (2012) allogeneic human umbilical cord blood-derived mesenchymal stem/stromal cell (hUCB-MSC) therapy product, CARTISTEM ® , for the treatment of knee osteoarthritis patients across all age groups. About Teikoku Seiyaku Founded in 1848, Teikoku Seiyaku is dedicated to its mission "For a World Without Pain." Leveraging its expertise in transdermal drug delivery technology, the company develops, manufactures, and markets pharmaceutical products, including transdermal patches and medical narcotics. For osteoarthritis, Teikoku Seiyaku has entered into a basic sales agreement with ReqMed Company, Ltd. regarding exclusive distribution rights in Japan for a subcutaneous injection containing NaPPS (sodium pentosan polysulfate), which is currently in Phase 3 clinical trials in Japan. Going forward, in orthopedics—one of its priority areas—we will expand its dedicated orthopedic team on the scale of 100 members and further strengthen its efforts to deliver treatments for diseases with high unmet medical needs, including osteoarthritis, to patients. View original content to download multimedia: SOURCE MEDIPOST

Cell TherapyLicense out/inPhase 3Drug ApprovalGene Therapy

100 Deals associated with Teikoku Seiyaku Co. Ltd.

100 Translational Medicine associated with Teikoku Seiyaku Co. Ltd.

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Pipeline

Pipeline Snapshot as of 20 Mar 2026

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Preclinical

Phase 1

Phase 2

Phase 3

NDA/BLA

Approved

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Diflorasone Diacetate ( GR )	Eczema More	Approved
Indomethacin ( COXs )	Tenosynovitis More	Approved
Rupatadine Fumarate ( H1 receptor x Platelet-activating factor )	Rhinitis, Allergic More	Approved
Amcinonide ( GR )	Eczema More	Approved
Wuji San	Arthralgia More	Approved

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