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Last Updated: May 16, 2025

CLINICAL TRIALS PROFILE FOR CYKLOKAPRON


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505(b)(2) Clinical Trials for Cyklokapron

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Dosage NCT05075200 ↗ Tranexamic Acid Dosing for Major Joint Replacement Surgery Not yet recruiting Sunnybrook Health Sciences Centre Phase 2 2021-10-01 Over 1.7 million hip and knee replacements are performed every year worldwide. These surgeries are associated with high blood loss and transfusion rates. In older patients, the high blood loss can result in postoperative anemia. Anemia is a condition where there is a lack of healthy red blood cells to carry oxygen around the body. This means, the patient may need a blood transfusion. This can result in different immune responses such as lung injury, fluid overload, and sepsis. The purpose of this study is to find an optimal dose of tranexamic acid (TXA) to be given during a hip or knee replacement surgery. TXA is one of the drugs given during surgery because it lowers the amount of bleeding and the risk of a blood transfusion. Individuals who are chosen to participate in the study will be split into two separate groups. After anesthesia is administered, study participant will be given the hospitals standard dose of TXA which is 20mg/kg. However, in patients with kidney problems and lower kidney functions, the dose will be lowered because TXA is filtered out of the body through the kidneys. Throughout the surgery and after it, patients will have about 30-50mL (3-5 tablespoons) of blood samples drawn at specific time points. This will be done through IV line which will stay in place during the surgery and post operation to minimize the amount of needle puncturing's. This study will help to development a new dosing guideline for TXA in patients who are undergoing joint replacement surgery.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Cyklokapron

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00111215 ↗ Treatment and Management of Women With Bleeding Disorders Completed Centers for Disease Control and Prevention N/A 2001-01-01 The purpose of the study is to determine whether oral contraceptives, desmopressin acetate, and/or tranexamic acid are effective in the treatment of women with menorrhagia who are diagnosed with a bleeding disorder.
NCT00904709 ↗ The Assessment of Tranexamic Acid in Women With Menorrhagia Who Have Bleeding Disorders Completed Canadian Hemophilia Society Phase 4 2009-10-19 Many women have heavy periods and this can be associated with low blood, tiredness and inability to carry out normal activities. Approximately 10-30% of these women will have an underlying bleeding disorder. There is a drug called tranexamic acid which is commonly used and is effective in reducing menstrual flow. However, up to 1/3 of women have side effects and they are more common at higher doses. In the medical literature, there are different dosing schedules and there is one commonly recommended in Canada. Women with underlying bleeding disorders may require higher doses of this medication compared to those who do not. In this study, the investigators want to find the lowest effective dose of tranexamic acid for girls and women with heavy periods who have bleeding disorders and the investigators think this will be lower then the usual recommended dose. If the investigators' results support this, it may contribute to changing how the investigators presently prescribe this medication and may provide a better option for women with heavy periods in particular those with bleeding disorders. The investigators have just started a Women with Bleeding Disorders Clinic and hope that this project will lead to better care for the patients and more research in the future.
NCT00904709 ↗ The Assessment of Tranexamic Acid in Women With Menorrhagia Who Have Bleeding Disorders Completed K. Sue Robinson Phase 4 2009-10-19 Many women have heavy periods and this can be associated with low blood, tiredness and inability to carry out normal activities. Approximately 10-30% of these women will have an underlying bleeding disorder. There is a drug called tranexamic acid which is commonly used and is effective in reducing menstrual flow. However, up to 1/3 of women have side effects and they are more common at higher doses. In the medical literature, there are different dosing schedules and there is one commonly recommended in Canada. Women with underlying bleeding disorders may require higher doses of this medication compared to those who do not. In this study, the investigators want to find the lowest effective dose of tranexamic acid for girls and women with heavy periods who have bleeding disorders and the investigators think this will be lower then the usual recommended dose. If the investigators' results support this, it may contribute to changing how the investigators presently prescribe this medication and may provide a better option for women with heavy periods in particular those with bleeding disorders. The investigators have just started a Women with Bleeding Disorders Clinic and hope that this project will lead to better care for the patients and more research in the future.
NCT00904709 ↗ The Assessment of Tranexamic Acid in Women With Menorrhagia Who Have Bleeding Disorders Completed Nova Scotia Health Authority Phase 4 2009-10-19 Many women have heavy periods and this can be associated with low blood, tiredness and inability to carry out normal activities. Approximately 10-30% of these women will have an underlying bleeding disorder. There is a drug called tranexamic acid which is commonly used and is effective in reducing menstrual flow. However, up to 1/3 of women have side effects and they are more common at higher doses. In the medical literature, there are different dosing schedules and there is one commonly recommended in Canada. Women with underlying bleeding disorders may require higher doses of this medication compared to those who do not. In this study, the investigators want to find the lowest effective dose of tranexamic acid for girls and women with heavy periods who have bleeding disorders and the investigators think this will be lower then the usual recommended dose. If the investigators' results support this, it may contribute to changing how the investigators presently prescribe this medication and may provide a better option for women with heavy periods in particular those with bleeding disorders. The investigators have just started a Women with Bleeding Disorders Clinic and hope that this project will lead to better care for the patients and more research in the future.
NCT00985920 ↗ Topical Tranexamic Acid for Total Knee Arthroplasty Completed The Physicians' Services Incorporated Foundation Phase 4 2007-09-01 Total knee arthroplasty (TKA), the definitive treatment of osteoarthritis, is often associated with excessive postoperative bleeding due to increased fibrinolysis. Hence, the objective of the proposed study is to determine the role of topical application of tranexamic acid (TA), an anti-fibrinolytic agent, into the knee joint just before closure during TKA to reduce perioperative bleeding. The investigators' hypothesis is that in patients undergoing unilateral primary TKA, intraoperative application of 1.5 g or 3.0g topical TA into the knee joint before closure reduces perioperative bleeding as depicted by a decrement in the maximal drop in hemoglobin concentration following surgery. This proposal describes a randomized, double-blinded, placebo-controlled clinical trial with three arms. The primary outcome is the extent of the postoperative reduction in hemoglobin levels. Secondary outcomes will include transfusion requirements, hospital stay, joint functionality, quality of life and safety of using topical TA. Topical application of TA is a novel intraoperative approach that has not been used or studied in TKA. However if it is effective, it will directly reduce postoperative intra-articular bleeding without subsequent systemic absorption and thromboembolism. In addition, the reduction in microvascular intra-articular bleeding will lead to less pain and infection rates as well as improved surgical functional outcomes.
NCT00985920 ↗ Topical Tranexamic Acid for Total Knee Arthroplasty Completed University Health Network, Toronto Phase 4 2007-09-01 Total knee arthroplasty (TKA), the definitive treatment of osteoarthritis, is often associated with excessive postoperative bleeding due to increased fibrinolysis. Hence, the objective of the proposed study is to determine the role of topical application of tranexamic acid (TA), an anti-fibrinolytic agent, into the knee joint just before closure during TKA to reduce perioperative bleeding. The investigators' hypothesis is that in patients undergoing unilateral primary TKA, intraoperative application of 1.5 g or 3.0g topical TA into the knee joint before closure reduces perioperative bleeding as depicted by a decrement in the maximal drop in hemoglobin concentration following surgery. This proposal describes a randomized, double-blinded, placebo-controlled clinical trial with three arms. The primary outcome is the extent of the postoperative reduction in hemoglobin levels. Secondary outcomes will include transfusion requirements, hospital stay, joint functionality, quality of life and safety of using topical TA. Topical application of TA is a novel intraoperative approach that has not been used or studied in TKA. However if it is effective, it will directly reduce postoperative intra-articular bleeding without subsequent systemic absorption and thromboembolism. In addition, the reduction in microvascular intra-articular bleeding will lead to less pain and infection rates as well as improved surgical functional outcomes.
NCT01005147 ↗ Effect of Tranexamic Acid in Upper Gastrointestinal Bleeding Withdrawn University of Oklahoma N/A 2009-11-01 The investigators hypothesize that addition of Tranexamic acid, an antifibrinolytic agent, to conventional therapy will lead to an improved outcome characterized by lower transfusion requirements.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cyklokapron

Condition Name

Condition Name for Cyklokapron
Intervention Trials
Surgical Blood Loss 3
Hip Fractures 3
Osteoarthritis 3
Blood Loss 3
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Condition MeSH

Condition MeSH for Cyklokapron
Intervention Trials
Hemorrhage 19
Hematoma 6
Fractures, Bone 6
Blood Loss, Surgical 5
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Clinical Trial Locations for Cyklokapron

Trials by Country

Trials by Country for Cyklokapron
Location Trials
United States 41
Canada 20
Australia 8
Netherlands 2
China 2
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Trials by US State

Trials by US State for Cyklokapron
Location Trials
Minnesota 4
Texas 4
Ohio 4
California 3
New York 2
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Clinical Trial Progress for Cyklokapron

Clinical Trial Phase

Clinical Trial Phase for Cyklokapron
Clinical Trial Phase Trials
Phase 4 18
Phase 3 15
Phase 2/Phase 3 5
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Clinical Trial Status

Clinical Trial Status for Cyklokapron
Clinical Trial Phase Trials
Completed 23
Recruiting 17
Unknown status 4
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Clinical Trial Sponsors for Cyklokapron

Sponsor Name

Sponsor Name for Cyklokapron
Sponsor Trials
Population Health Research Institute 4
Sunnybrook Health Sciences Centre 3
University Health Network, Toronto 3
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Sponsor Type

Sponsor Type for Cyklokapron
Sponsor Trials
Other 97
U.S. Fed 5
Industry 4
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CYKLOKAPRON (Tranexamic Acid): Clinical Trials, Market Analysis, and Projections

Introduction

CYKLOKAPRON, known generically as tranexamic acid, is an antifibrinolytic agent widely used to manage and prevent excessive bleeding in various medical conditions. This article provides an update on recent clinical trials, market analysis, and projections for this crucial medication.

Clinical Trials Update

Prophylactic Use in Hematologic Malignancy

A recent placebo-controlled, randomized clinical trial investigated the efficacy of tranexamic acid in patients with hematologic malignancy. The trial involved 330 patients who received either 1300 mg of tranexamic acid orally or 1000 mg intravenously, compared to a placebo group. The results showed no statistically significant difference in the incidence of World Health Organization (WHO) grade ≥2 bleeding, platelet transfusions, or thrombotic events between the tranexamic acid and placebo groups[1].

Use in Liver Resection

Another multicenter randomized clinical trial assessed the effect of tranexamic acid on the need for blood transfusion in patients undergoing liver resection. The study, which included 1384 patients, found that the use of tranexamic acid did not significantly reduce the need for red blood cell transfusions or intraoperative blood loss compared to the placebo group. However, it noted a higher incidence of complications in the tranexamic acid group[4].

Dental Procedures in Hemophilia

Tranexamic acid is also used to reduce the risk of hemorrhage during and following tooth extraction in patients with hemophilia. A new formulation of tranexamic acid injection, approved under the 505(b)(2) regulatory pathway, has been introduced for this indication. This ready-to-use formulation relies on the established efficacy and safety of the existing product, Cyklokapron[3].

Market Analysis

Market Size and Growth

The global tranexamic acid market has been experiencing significant growth, driven by its increasing recognition in managing bleeding disorders and its application in various surgical procedures. As of 2023, the market size was valued at USD 81.85 million and is projected to reach USD 128.50 million by 2031, growing at a CAGR of 5.80%[2].

Key Drivers

Several factors are driving the growth of the tranexamic acid market:

  • Increasing Recognition: Tranexamic acid has been shown to reduce mortality in trauma patients and is widely used in emergency medicine, solidifying its critical role in traumatic bleeding[2].
  • Innovative Formulations: The introduction of topical formulations, such as tranexamic acid sprays, has expanded its usability and application across various medical fields. For example, the launch of a topical hemostatic spray in India has been approved for emergency use, enhancing patient outcomes[2].
  • Healthcare Infrastructure: Growing investments in healthcare infrastructure, particularly in emerging markets like India and Brazil, are increasing access to essential medications, including tranexamic acid[2].

Market Segmentation

The tranexamic acid market is highly fragmented, with numerous players such as Pfizer, Wockhardt Ltd., FDC Limited, and others. The market is segmented by application, with key uses including surgical procedures, trauma care, and management of bleeding disorders like hemophilia[5].

Market Projections

Regional Growth

The Asia-Pacific region is expected to experience significant growth from 2024 to 2031, driven by advancements in the biopharmaceutical sector, strong government support, and initiatives to enhance healthcare access and affordability[2].

Emerging Trends

The market is witnessing a trend towards the development of innovative formulations that enhance the usability and application of tranexamic acid. Topical formulations and ready-to-use injectable formulations are expected to drive market expansion by providing easier and more effective solutions for bleeding management[2].

Safety and Efficacy

Safety Endpoints

Clinical trials have closely monitored safety endpoints, including the incidence of serious adverse events, thrombotic events, and deaths due to serious bleeding. While some trials have noted higher complication rates with tranexamic acid, the overall safety profile remains favorable, especially when used appropriately[1][4].

Efficacy in Different Settings

Tranexamic acid has been proven effective in reducing mortality in trauma patients and is a critical intervention in surgical procedures. However, its efficacy can vary depending on the specific clinical setting, as seen in the mixed results from the liver resection trial[2][4].

Key Takeaways

  • Clinical Trials: Recent trials have shown mixed results, with no significant reduction in bleeding or transfusion needs in some settings, but established efficacy in others.
  • Market Growth: The global tranexamic acid market is projected to grow significantly, driven by innovative formulations and increasing healthcare infrastructure.
  • Regional Focus: The Asia-Pacific region is expected to be a key growth area due to advancements in healthcare and government support.
  • Safety and Efficacy: Tranexamic acid remains a safe and effective medication, though its efficacy can vary by clinical setting.

FAQs

What is the primary use of CYKLOKAPRON (tranexamic acid)?

CYKLOKAPRON is primarily used to manage and prevent excessive bleeding in conditions such as hemophilia, trauma, and during surgical procedures.

What are the recent clinical trial findings on tranexamic acid?

Recent trials have shown mixed results, with no significant reduction in bleeding or transfusion needs in patients with hematologic malignancy or undergoing liver resection, but established efficacy in other settings like trauma care.

How is the tranexamic acid market projected to grow?

The global tranexamic acid market is projected to grow from USD 81.85 million in 2023 to USD 128.50 million by 2031, with a CAGR of 5.80%.

What are the key drivers of the tranexamic acid market growth?

Key drivers include increasing recognition of its efficacy, innovative formulations, and growing investments in healthcare infrastructure, particularly in emerging markets.

Are there any new formulations of tranexamic acid?

Yes, new formulations such as topical hemostatic sprays and ready-to-use injectable formulations have been introduced, enhancing its usability and application across various medical fields.

Sources

  1. Prophylactic tranexamic acid in patients with hematologic malignancy: a placebo-controlled, randomized clinical trial - Blood, 2022.
  2. Global Tranexamic Acid Market Size, Outlook Report & Forecast By 2031 - Data Bridge Market Research.
  3. Center for Drug Evaluation and Research - FDA, 2019.
  4. Tranexamic Acid in Patients Undergoing Liver Resection - JAMA, 2024.
  5. Tranexamic Acid Market Size & Share | Global Industry Report, 2025 - Grand View Research.
Last updated: 2025-01-01

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