Thrombomodulin Alfa

Overview

Thrombomodulin Alfa is a novel, recombinant and soluble thrombomodulin (ART-123). It is a human protein with both thrombin inhibiting and protein C stimulating activities, for the potential treatment of thromboembolism and blood clotting disorders, such as disseminated intravascular thromboembolism.

Indication

Investigated for use/treatment in blood preservative, blood (blood forming organ disorders, unspecified), sepsis and septicemia, and thrombosis.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Assess Safety and Tolerability of ART-123 + FOLFOX + Bevacizumab in Metastatic Colorectal Cancer Patients	2022/02/23	NCT05251727	Phase 1	Terminated	Veloxis Pharmaceuticals
A Trial Measuring ART-123 Ability to Prevent Sensory Neuropathy in Unresectable mCRC Subjects w/Oxaliplatin-based Chemo	2020/07/30	NCT04492436	Phase 2	Withdrawn	Veloxis Pharmaceuticals
The Safety And Efficacy of ART-123 in Subjects With Sepsis and Coagulopathy	2018/05/07	NCT03517501	Phase 3	Withdrawn	Asahi Kasei Pharma America Corporation
Clinical Study of ART-123 for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis	2016/04/15	NCT02739165	Phase 3	Completed	Asahi Kasei Pharma Corporation
Clinical Pharmacokinetics Study of ART-123 in Disseminated Intravascular Coagulation (DIC) Subjects With Renal Impairment	2012/10/11	NCT01704001	Phase 4	Completed	Asahi Kasei Pharma Corporation
Phase 3 Safety and Efficacy Study of ART-123 in Subjects With Severe Sepsis and Coagulopathy	2012/05/15	NCT01598831	Phase 3	Completed	Asahi Kasei Pharma America Corporation
Safety and Efficacy of ART-123 in Subjects With Sepsis and Disseminated Intravascular Coagulation	2007/06/18	NCT00487656	Phase 2	Completed	Artisan Pharma, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

Asahi Kasei Pharma Initiates Phase III Trial of ART-123 for Chemotherapy-Induced Peripheral Neuropathy Prevention

a month ago

Asahi Kasei Pharma has begun patient dosing in a Phase III study of ART-123 (thrombomodulin alfa) for preventing chemotherapy-induced peripheral neuropathy (CIPN) in Japan.

Cancer Pain Market Poised for Transformation with Novel Non-Opioid Therapies by 2034

2 months ago

The cancer pain therapeutics market is expected to experience significant growth by 2034, driven by increasing cancer incidence and the anticipated launch of breakthrough non-opioid therapies.

World Sepsis Day Highlights Critical Need for Better Trial Design and Targeted Therapeutics

a year ago

• Sepsis claims 11 million lives globally each year, with over 7,000 facilities participating in World Sepsis Day to raise awareness and promote medical education. • Current sepsis treatments focus on antibiotics and supportive care, but there remains a critical lack of drugs targeting underlying pathophysiological processes. • Recent Phase III trial failures, including AM Pharma's reCAP and Asahi Kasei's thrombomodulin alfa, highlight the need for improved trial design and AI-driven patient stratification.

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