PALETTE- Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Bayesian Basket Trial"

PALETTE is a perpetual adaptive platform to efficiently study sepsis interventions within 'treatable traits' in all-ages patients enabling prompt evaluation of pandemic treatments. Treatable traits, therapeutic targets identified by phenotypes or endotypes (defined by biological mechanism or by treatment response) through validated biomarkers (measurable characteristic reflecting normal or pathogenic processes, or treatment responses), may include multi-omics, cellular, immune, metabolic, endocrine features, or intelligent algorithms. PALETTE Bayesian adaptive design enables parallel investigations of multiple interventions for sepsis, and quick inclusion of pandemic pathogens. PALETTE's new conceptual model will respond to the challenges of standard approaches, i.e. series of sepsis trials, each investigating one or two interventions, expensive, time consuming, and inappropriate in pandemic context.

Start Date01 Apr 2026

Sponsor / Collaborator

Assistance Publique des Hôpitaux de Paris SA

NCT05251727

/ TerminatedPhase 1

Double-blind, Placebo-controlled, Randomized, Dose-escalating, Multi-center, Phase 1 Study to Assess the Safety and Tolerability of ART-123 With Leucovorin/5-fluorouracil/Oxaliplatin and Bevacizumab in Metastatic Colorectal Cancer Patients

To evaluate the safety and tolerability of ART-123 in patients with metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy and bevacizumab

Start Date24 Mar 2022

Sponsor / Collaborator

Veloxis Pharmaceuticals A/S

NCT04492436

/ WithdrawnPhase 2

A Randomized, Double-blind, Placebo-controlled, Multi-national, Multi-center, Parallel-group, Phase 2b Assessing ART-123's Effect on Preventing Sensory Symptoms of OIPN in Unresectable mCRC Subjects Receiving Oxaliplatin-containing Chemo

To evaluate the efficacy and safety of ART-123 on sensory symptoms of oxaliplatin-induced peripheral neuropathy (OIPN) in patients with unresectable metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy

Start Date01 Oct 2021

Sponsor / Collaborator

Veloxis Pharmaceuticals A/S

100 Clinical Results associated with Thrombomodulin Alfa (Genetical Recombination)

100 Translational Medicine associated with Thrombomodulin Alfa (Genetical Recombination)

100 Patents (Medical) associated with Thrombomodulin Alfa (Genetical Recombination)

227

Literatures (Medical) associated with Thrombomodulin Alfa (Genetical Recombination)

01 Sep 2025·THROMBOSIS RESEARCH

The modified Japanese Association for Acute Medicine disseminated intravascular coagulation diagnostic criteria in sepsis is useful for an indicator of initiating treatment for disseminated intravascular coagulation

Article

Author: Yamakawa, Kazuma ; Sasaki, Junichi ; Matsuoka, Tadashi ; Honmma, Koichiro ; Umemura, Yutaka ; Hisamune, Ryo ; Okamoto, Kohji ; Ushio, Noritaka

BACKGROUND:

Disseminated intravascular coagulation (DIC) is a severe complication of sepsis. Recently, the Japanese Association for Acute Medicine (JAAM) DIC criteria were modified into the JAAM-2-DIC criteria. This study aimed to assess the utility of the JAAM-2 DIC criteria as an indicator for initiating treatment for DIC using a large-scale database.

METHODS:

We analyzed data from the Japanese Administrative Claims Database, which covers approximately 18 million patients from 600 hospitals. Adult patients with sepsis, defined by the Sepsis-3 criteria, were included. The relationship between DIC treatment (recombinant thrombomodulin and antithrombin) and survival, and bleeding complications, including the timing of initiation, was evaluated according to the JAAM-2-DIC, ISTH-overt DIC, and sepsis-induced coagulopathy (SIC) criteria.

RESULTS:

Among 1903 patients, 415 (22 %) received DIC treatment. At sepsis diagnosis, 673 (35 %), 174 (9 %), and 699 (37 %) patients met the JAAM-2 DIC, ISTH-overt DIC, and SIC criteria, respectively. DIC treatment was associated with improved survival in patients diagnosed with DIC by any criteria but not in those without DIC. In patients without DIC, DIC treatment increased bleeding complications requiring transfusion, whereas this risk was not elevated in patients with DIC. Only the JAAM-2-DIC criteria showed significant effect modification for both efficacy and safety. Initiating DIC treatment based on JAAM-2-DIC criteria most effectively identified patients with a survival benefit.

CONCLUSION:

The JAAM-2-DIC criteria effectively identify patients with better survival outcomes and a low risk of bleeding among those receiving DIC treatment. These criteria may serve as a useful indicator for starting DIC treatment in this population.

01 Jul 2025·Therapeutic Advances in Gastroenterology

Clinical impact of recombinant thrombomodulin administration on disseminated intravascular coagulation due to severe acute pancreatitis (Recover-AP study)

Article

Author: Matsuno, Jun ; Bessho, Kimi ; Hattori, Nobuhiro ; Ueno, Saori ; Uba, Yuki ; Nishikawa, Hiroki ; Iwatsubo, Taro ; Aboelezz, Ahmad F. ; Sakamoto, Jun ; Nishioka, Nobu ; Okuda, Atsushi ; Nakamura, Junichi ; Ogura, Takeshi ; Hakoda, Akitoshi ; Tomita, Mitsuki

Background::

If severe acute pancreatitis (SAP) is complicated by disseminated intravascular coagulation (DIC) or walled-off necrosis (WON), the mortality rate may increase. Therefore, prevention of the development of WON and treatment of DIC are likely to play important roles in improving survival in SAP. Although recombinant human soluble thrombomodulin (rhTM) might play a useful role in treating DIC, the impact of rhTM on improving survival and resolution of DIC due to SAP is still unclear.

Objective::

This study aimed to evaluate the clinical impact of rhTM in patients with SAP and DIC.

Design::

A single-center retrospective study.

Method::

The patients were divided into two groups: the rhTM group and the non-rhTM group, in which rhTM was not administered. The primary outcome was the DIC resolution rate at 7 days after starting treatment. The mortality rate at 28 days was secondarily evaluated.

Results::

Among 321 SAP patients, 63 patients were complicated with DIC, and they were divided into rhTM ( n = 28) and non-rhTM ( n = 35) groups. The rate of development of WON was significantly higher in the non-rhTM group (51.4%, 18/35) compared with the rhTM group (25.0%, 7/28) ( p = 0.033). The resolution rate of DIC within 7 days was significantly higher in the rhTM group (89.3%, 25/28) compared with the non-rhTM group (60.0%, n = 9/35) ( p = 0.009). The mortality rate within 14 days, which might have been strongly influenced by the presence of DIC, was significantly higher in the non-rhTM group (20.0%, 7/35) compared with the rhTM group (0%, 0/28) ( p = 0.01). According to multivariate analysis, rTM non-administration was an independent factor for failed DIC resolution or developing WON.

Conclusion::

In conclusion, rhTM may play a role not only in improving the resolution rate of DIC and improving the survival rate of SAP, but also in preventing the development of WON.

01 May 2025·INTERNATIONAL JOURNAL OF HEMATOLOGY

Clinical practice guidelines for management of disseminated intravascular coagulation in Japan 2024. Part 3: solid cancers and vascular abnormalities

Review

Author: Ikezoe, Takayuki ; Sakamoto, Yuichiro ; Iba, Toshiaki ; Kushimoto, Shigeki ; Gando, Satoshi ; Mayumi, Toshihiko ; Uchiba, Mitsuhiro ; Koga, Shin ; Kawano, Noriaki ; Yamakawa, Kazuma ; Wada, Hideo ; Matsumoto, Takeshi ; Ito, Takashi ; Nishio, Kenji ; Okamoto, Kohji ; Kawasaki, Kaoru ; Asakura, Hidesaku ; Tamura, Toshihisa ; Hayakawa, Mineji ; Yamada, Shinya ; Seki, Yoshinobu ; Uchiyama, Toshimasa ; Madoiwa, Seiji ; Ishikura, Hiroyasu

This study discusses disseminated intravascular coagulation (DIC) associated with solid cancers and various vascular abnormalities, both of which generally exhibit chronic DIC patterns. Solid cancers are among the most significant underlying diseases that induce DIC. However, the severity, bleeding tendency, and progression of DIC vary considerably depending on the type and stage of the cancer, making generalization difficult. Moreover, during the process of creating these guidelines, it became apparent that despite solid cancers being a major underlying condition for DIC, there is a lack of high-quality research on DIC associated with solid cancers. Nevertheless, we developed recommendations for clinical questions (CQs) regarding the use of heparin and recombinant thrombomodulin. Additionally, statements concerning these five questions were provided. DIC associated with various vascular abnormalities, is characterized by hyperfibrinolytic activity and linked to underlying conditions such as aortic aneurysm, aortic dissection, vasculitis syndromes, and vascular malformations. These conditions must always be considered differential diagnoses when unexplained thrombocytopenia or bleeding tendencies are observed. Although no evidence was found to support the assignment of recommendation levels, three statements were made. However, traumatic vascular abnormalities have not been discussed in this context.

News (Medical) associated with Thrombomodulin Alfa (Genetical Recombination)

02 Jul 2025

·pipelinereview.com

Asahi Kasei Pharma Starts Phase III Study of Promising CIPN Prevention Therapy, ART-123 (Recomodulin™), to Enhance Treatment Options Worldwide

CHELMSFORD, MA, USA & NOVI, MI, USA & DÜSSELDORF, Germany & TOKYO, Japan I July 02, 2025 I Asahi Kasei Pharma has started trial drug administration in a Phase III study of ART-123 in Japan (generic name: thrombomodulin alfa; marketed as Recomodulin™ Injection in Japan) for the prevention of chemotherapy-induced peripheral neuropathy (CIPN) related symptoms. This announcement follows encouraging data from earlier Phase I and II studies performed in Japan on the efficacy of ART-123 in relieving patient symptoms without compromising existing treatment plans. Chemotherapies such as platinum-based drugs, taxanes, and vinca alkaloids are known to induce peripheral neuropathy. This condition, known as CIPN, is characterized by tingling and pain in the hands and feet, which, when severe, can impair day-to-day activities. In some cases, reduced dosage or suspension of chemotherapy may be necessary to alleviate symptoms, leading to a clinical effect on the patient’s prognosis. There are currently no drugs showing clear, established effectiveness for the prevention or treatment of CIPN, leaving patients with limited, often undesirable options. ART-123 is a recombinant human thrombomodulin (rTM) approved in Japan in 2008. Previous Phase I and II studies suggest efficacy and patient tolerability of ART-123 for CIPN by suppressing the activation of protein C and thrombin-activable fibrinolysis inhibitor (TAFI). After consultation with Japan’s Pharmaceuticals and Medical Devices Agency (PDMA) regarding potential clinical development, Asahi Kasei Pharma initiated the Phase III study. The study will assess the efficacy and safety of ART-123 for CIPN in patients diagnosed with colorectal cancer and undergoing chemotherapy including the platinum drug oxaliplatin. “Patients undergoing chemotherapy still have no options for preventive or therapeutic drugs with clearly demonstrated efficacy for CIPN, leaving a significant unmet medical need worldwide,” said Yoshikazu Aoki, President, Asahi Kasei Pharma Corporation. “Limited treatment options for CIPN have made an already difficult situation even harder, leaving many patients and healthcare providers feeling discouraged as they seek ways to manage this challenging condition. We believe ART-123 could offer a new path forward in addressing this challenge and bringing solutions for patients on a global scale.” This is in line with Asahi Kasei’s Medium-Term Management Plan , which targets high growth in the Healthcare sector with pharmaceuticals identified as a ‘First Priority’ area in its strategic positioning. About Asahi Kasei Pharma Asahi Kasei Pharma is a specialty pharmaceutical firm with a global presence focusing on the development of new world-class drugs in the areas of pain management, musculoskeletal disorders, and critical care medicine. Through its mission “to sincerely care for each individual life and solve their unmet medical needs with a wealth of ideas and solid science,” Asahi Kasei Pharma delivers innovative pharmaceutical solutions that improve health and enhance quality of life. For more information, visit: https://www.asahi-kasei.co.jp/pharma/en/ About Asahi Kasei The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber business, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 50,000 employees worldwide, the company contributes to sustainable society by providing solutions to the world’s challenges through its three business sectors of Healthcare, Homes, and Material. For more information, visit www.asahi-kasei.com . Asahi Kasei is also dedicated to sustainability initiatives and is contributing to reaching a carbon neutral society by 2050. To learn more, visit https://www.asahi-kasei.com/sustainability/ . SOURCE: Asahi Kasei

Phase 3Drug ApprovalPhase 1Phase 2

19 May 2021

·www.globenewswire.com

Emerging Drugs for the Chemotherapy Induced Peripheral

Los Angeles, USA , May 19, 2021 (GLOBE NEWSWIRE) -- Emerging Drugs for the Chemotherapy Induced Peripheral Neuropathy Treatment Will Soon Benefit Patients: A Focus on Recent Clinical Trials Chemotherapy-Induced Peripheral Neuropathy Pipeline Report covers a complete clinical trials analysis of 15+ drugs and 15+ companies, which are developing therapies to change the treatment outlook. DelveInsight’s “Chemotherapy Induced Peripheral Neuropathy (CIPN) Pipeline Insight” report provides comprehensive insights about 15+ companies and 15+ pipeline drugs in the Chemotherapy-Induced Peripheral Neuropathy pipeline landscapes. It comprises CIPN pipeline drug profiles, including clinical and non-clinical stage products. It also includes the Chemotherapy Induced Peripheral Neuropathy therapeutics assessment by product type, stage, route of administration, and molecule type and further highlights the inactive CIPN pipeline products. Some of the key takeaways of the Chemotherapy Induced Peripheral Neuropathy Pipeline Report Get an overview of pipeline landscape @ CIPN Clinical Trials Analysis Chemotherapy-Induced Peripheral Neuropathy (CIPN) is a common, dose-dependent adverse effect of many frequently prescribed chemotherapy and biotherapy drugs, including taxanes, platinum-based drugs, vinca alkaloids, thalidomide, bortezomib, and interferon. However, there are currently no approved drugs available to prevent or treat CIPN. Certain chemotherapy drugs are more likely to cause neuropathy. These include platinum drugs, such as oxaliplatin; taxanes, such as docetaxel; vinca alkaloids, such as vincristine; and myeloma treatments, such as bortezomib. Other chemotherapy drugs can also cause neuropathy. Chemotherapy-Induced Peripheral Neuropathy Emerging Drugs PledOx (akacalmangafodipir, SP-04), being developed by Pledpharma (now Egetis Therapeutics AB), is a first in class drug candidate developed for the prevention of nerve damage caused by chemotherapy treatment in colorectal cancer patients. Research and DevelopmentPhase III NCT03654729Phase III (POLAR-M): In October 2018, PledPharma initiated a Phase III, multicenter, double-blind, placebo-controlled study to establish the efficacious dose of PledOx in the prevention of chronic chemotherapy-induced peripheral neuropathy (CIPN) induced by oxaliplatin. This Phase III trial enrolled 291 participants and got completed in August 2020. NCT04034355: Phase III (POLAR-A): In November 2018, PledPharm, in collaboration with Solasia Pharma, initiated a phase III, double-blind, multicenter, placebo-controlled study of PledOx used on top of modified FOLFOX6 (5-FU/FA and Oxaliplatin) to prevent CIPN in the adjuvant treatment of patients with stage III or high-risk stage II colorectal cancer. A total of 301 participants were enrolled in this trial, and this trial was completed in August 2020. ART 123 (recombinant human thrombomodulin alpha, marketed as Recomodulin® in Japan), the company’s lead product candidate, represents a promising new treatment for severe sepsis with coagulopathy. ART-123 is a soluble recombinant human thrombomodulin. ART-123 inhibits the coagulation process by accelerating the activation of protein C by thrombin. The drug is currently in phase 2 of clinical trials for the treatment of Chemotherapy-induced Peripheral Neuropathy Research and DevelopmentPhase IINCT04492436: In July 2021, Asahi Kasei Pharma will initiate a trial titled “A Randomized, Double-blind, Placebo-controlled, Multi-national, Multi-center, Parallel-group, Phase 2b Assessing ART-123's Effect on Preventing Sensory Symptoms of OIPN in Unresectable mCRC Subjects Receiving Oxaliplatin-containing Chemo”. The aim of this study is to compare the efficacy and safety of ART-123 (low and high dose) to placebo on sensory symptoms of oxaliplatin-induced peripheral neuropathy (OIPN) in patients with unresectable metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy. The trial is expected to get completed by July 2024. For further information, refer to the detailed report @ Chemotherapy-Induced Peripheral Neuropathy Pipeline Therapeutics Scope of CIPN Pipeline Drug Insight Key Questions regarding Current Chemotherapy-Induced Peripheral Neuropathy Treatment Landscape and Emerging Therapies Answered in the Pipeline Report Table of Contents Get a customised pipeline report @ Chemotherapy-Induced Peripheral Neuropathy Drugs Pipeline Report Related Reports DelveInsight's CIPN - Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease and a depth understanding of historical and forecasted epidemiology. DelveInsight's Chemotherapy-Induced Peripheral Neuropathy (CIPN) Epidemiology Forecast 2030 report delivers an in-depth understanding of the disease, historical, and forecasted epidemiology. DelveInsight’s ‘Gene Therapy for Ocular Rare Disease -Market Insights, Competitive Landscape and Market Forecast - 2026’ report delivers an in-depth understanding of the disease. Human Immunodeficiency Virus Type 1 (HIV-1) Infection Pipeline Insights, 2021 report by DelveInsight outlays comprehensive insights of present clinical development scenario and growth prospects. DelveInsight’s Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP) Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease. DelveInsight' s IgA Nephropathy (IgAN) - Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease and a depth understanding of historical and forecasted epidemiology. DelveInsight's IgG4-Related Disease- Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed understanding of historical and forecasted epidemiology. About DelveInsightDelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also provides Healthcare Consulting services comprising credible market analysis that will help accelerate the business growth and overcome challenges with a practical approach.

CollaborateSmall molecular drugGene TherapyFirst in Class

100 Deals associated with Thrombomodulin Alfa (Genetical Recombination)

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KEGG	Wiki	ATC	Drug Bank
D06410	-	B01AX	DB05777

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Disseminated Intravascular Coagulation	Japan	Asahi Kasei Corp.	25 Jan 2008

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Peripheral Nervous System Diseases	Phase 3	Japan	Asahi Kasei Pharma Corp.	10 Jun 2020
Idiopathic Pulmonary Fibrosis	Phase 3	Japan	Asahi Kasei Corp.	01 May 2016
Blood Coagulation Disorders	Phase 3	United States	-	29 Oct 2012
Blood Coagulation Disorders	Phase 3	Argentina	-	29 Oct 2012
Blood Coagulation Disorders	Phase 3	Australia	-	29 Oct 2012
Blood Coagulation Disorders	Phase 3	Belgium	-	29 Oct 2012
Blood Coagulation Disorders	Phase 3	Brazil	-	29 Oct 2012
Blood Coagulation Disorders	Phase 3	Bulgaria	-	29 Oct 2012
Blood Coagulation Disorders	Phase 3	Canada	-	29 Oct 2012
Blood Coagulation Disorders	Phase 3	Croatia	-	29 Oct 2012

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02792842 (CTgov)	Phase 2	Stage III Colon Cancer	79	ART-123 (3-day ART) (ART-123 (3-day ART))	vjoqigzrbt = znivqnivmt tadnodrfyv (xvewvugowt, xivxamvlbt - hmhuviuciz) View more	-	04 Apr 2024
				ART-123 (1-day ART) (ART-123 (1-day ART))	vjoqigzrbt = cadlsmzuoz tadnodrfyv (xvewvugowt, aojtrygmht - ficfupdtth) View more
NCT02739165 (Pubmed) Manual	Phase 3	Idiopathic Pulmonary Fibrosis	77	corticosteroid+Thrombomodulin Alfa	cejtvojtxy(cepjxncoge) = kqggrnkvth kbdmvycovp (pqzuhnitxi ) View more	Negative	01 May 2020
				corticosteroid+Placebo	cejtvojtxy(cepjxncoge) = ewbanoeaqp kbdmvycovp (pqzuhnitxi ) View more
NCT01598831 (SCARLET, CTgov)	Phase 3	Sepsis \| Blood Coagulation Disorders	816	ART-123 (ART-123)	korqvyljxh = dezmlcmrtq hteidcobot (iqukuqqdcr, sjnzfursxm - tmahinsrti) View more	-	21 Apr 2020
				Placebo (Placebo)	korqvyljxh = smlsnoxmju hteidcobot (iqukuqqdcr, ddbomnydpl - xjguwlwsvy) View more
NCT01598831 (SCARLET, Pubmed \| J Coll Physicians Surg Pak \| JAMA) Manual	Phase 3	Shock, Septic \| Blood Coagulation Disorders	800	Recombinant Human Soluble Thrombomodulin	trzjfvqtkx(hkfdslvmyc) = afypfqnddp ymyoyajggx (rbzixplrpz ) View more	Negative	28 May 2019
				Placebo	trzjfvqtkx(hkfdslvmyc) = xsluiinsyx ymyoyajggx (rbzixplrpz ) View more

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