CLINICAL TRIALS PROFILE FOR RIASTAP

All Clinical Trials for RIASTAP

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00968045 ↗	Fibrinogen and Bleeding After Cardiac Surgery	Completed	Sahlgrenska University Hospital, Sweden	Phase 2	2009-04-01	The study hypothesis is that prophylactic fibrinogen infusion reduces postoperative bleeding and transfusion requirements after coronary artery bypass surgery (CABG) in patients with endogenous fibrinogen levels in the lower normal range. 60 patients will be included in a prospective, randomized double-blind placebo-controlled single center study.
NCT01283321 ↗	RiaSTAP vs. Conventional Transfusion in Patients Having Heart Valve Surgery	Terminated	CSL Behring	Phase 2	2011-01-01	Heart surgery involving valve replacement often involves the use of the heart-lung machine for over 90 minutes, and bleeding tendency is frequently seen. Conventionally, platelet transfusion has been the primary therapy to treat bleeding after this type of procedure. More recently, perioperative supplementation of purified fibrinogen (RiaSTAP, CSL Behring) was shown to reduce bleeding and blood product use (plasma or platelets) after heart surgery. The objective of this trial is to demonstrate the clinical equivalency and economic utility of using fibrinogen concentrate, RiaSTAP for the mitigation of post-operative bleeding in patients in lieu of platelet transfusion. Purified fibrinogen concentrate has been approved by FDA, and it has been used for the treatment of acute bleeding episodes in patients with low fibrinogen due to hereditary causes (e.g., afibrinogenemia). Compared to the transfusion of platelets which may be associated with volume overload, bacterial/viral infection, immunological effects and excess blood clotting, purified fibrinogen has several advantages. First, it contains no liquid plasma allowing for low volume infusion. Several viral inactivation/reduction steps are used to prepare the fibrinogen concentrate, increasing its viral safety. No antibodies or white blood cells are contained in the fibrinogen concentrate; therefore transfusion reactions are rare. Although platelet transfusion is widely used after heart surgery, there has been no randomized study to endorse this practice. In this study, patients undergoing heart valve replacement will be randomized to receive either platelet (1 unit) transfusion or fibrinogen concentrate (4g) after heparin anticoagulation is reversed. Subjects will be treated only if there is evidence of significant microvascular bleeding. Fifteen minutes after the initial treatment, subjects will be reevaluated for bleeding. If bleeding continues, subjects will be treated with blood transfusion per institutional standard of care. The primary endpoints for this study are the hemostatic condition of the surgical field and 24-hour total of blood product transfusion.
NCT01283321 ↗	RiaSTAP vs. Conventional Transfusion in Patients Having Heart Valve Surgery	Terminated	Emory University	Phase 2	2011-01-01	Heart surgery involving valve replacement often involves the use of the heart-lung machine for over 90 minutes, and bleeding tendency is frequently seen. Conventionally, platelet transfusion has been the primary therapy to treat bleeding after this type of procedure. More recently, perioperative supplementation of purified fibrinogen (RiaSTAP, CSL Behring) was shown to reduce bleeding and blood product use (plasma or platelets) after heart surgery. The objective of this trial is to demonstrate the clinical equivalency and economic utility of using fibrinogen concentrate, RiaSTAP for the mitigation of post-operative bleeding in patients in lieu of platelet transfusion. Purified fibrinogen concentrate has been approved by FDA, and it has been used for the treatment of acute bleeding episodes in patients with low fibrinogen due to hereditary causes (e.g., afibrinogenemia). Compared to the transfusion of platelets which may be associated with volume overload, bacterial/viral infection, immunological effects and excess blood clotting, purified fibrinogen has several advantages. First, it contains no liquid plasma allowing for low volume infusion. Several viral inactivation/reduction steps are used to prepare the fibrinogen concentrate, increasing its viral safety. No antibodies or white blood cells are contained in the fibrinogen concentrate; therefore transfusion reactions are rare. Although platelet transfusion is widely used after heart surgery, there has been no randomized study to endorse this practice. In this study, patients undergoing heart valve replacement will be randomized to receive either platelet (1 unit) transfusion or fibrinogen concentrate (4g) after heparin anticoagulation is reversed. Subjects will be treated only if there is evidence of significant microvascular bleeding. Fifteen minutes after the initial treatment, subjects will be reevaluated for bleeding. If bleeding continues, subjects will be treated with blood transfusion per institutional standard of care. The primary endpoints for this study are the hemostatic condition of the surgical field and 24-hour total of blood product transfusion.
NCT01300286 ↗	Open Label Use Of RiaStap During Aortic Reconstruction	Completed	CSL Behring	Phase 4	2010-12-01	The overall purpose of this study is to administer fibrinogen concentrate (RiaSTAP, CSL Behring, Marburg, Germany) with the goal of treating coagulopathic bleeding by improving hemostasis thereby reducing overall blood product transfusion after separation from cardiopulmonary bypass following aortic reconstructive surgery. With the current sample size this is a pilot study and in effect will determine the fibrinogen level response to fibrinogen concentrate administered during aortic reconstructive surgery. It will be underpowered to detect reduction in bleeding but comparison to historical controls will be included as a secondary outcome.
NCT01300286 ↗	Open Label Use Of RiaStap During Aortic Reconstruction	Completed	Duke University	Phase 4	2010-12-01	The overall purpose of this study is to administer fibrinogen concentrate (RiaSTAP, CSL Behring, Marburg, Germany) with the goal of treating coagulopathic bleeding by improving hemostasis thereby reducing overall blood product transfusion after separation from cardiopulmonary bypass following aortic reconstructive surgery. With the current sample size this is a pilot study and in effect will determine the fibrinogen level response to fibrinogen concentrate administered during aortic reconstructive surgery. It will be underpowered to detect reduction in bleeding but comparison to historical controls will be included as a secondary outcome.
NCT01471730 ↗	The ZEro PLASma Trial (ZEPLAST): Avoidance of Fresh Frozen Plasma in Cardiac Surgery	Completed	CSL Behring	Phase 3	2011-11-01	Prospective, randomized, double blind trial. The rationale of the study is the concept that fresh frozen plasma (FFP) is still largely used in cardiac surgery, despite the fact that prothrombin complexes and fibrinogen are available.The experimental hypothesis is that cardiac surgery patients may be operated with no use of FFP and with a coagulation factors replacement based on fibrinogen and prothrombin complexes (when needed). Primary endpoint: Transfusion avoidance Secondary endpoints: Transfusion limitation, massive blood transfusion, bleeding. Study population: high-risk adult cardiac surgery patients Sample size : 2 groups of 60 patients each
NCT01471730 ↗	The ZEro PLASma Trial (ZEPLAST): Avoidance of Fresh Frozen Plasma in Cardiac Surgery	Completed	IRCCS Policlinico S. Donato	Phase 3	2011-11-01	Prospective, randomized, double blind trial. The rationale of the study is the concept that fresh frozen plasma (FFP) is still largely used in cardiac surgery, despite the fact that prothrombin complexes and fibrinogen are available.The experimental hypothesis is that cardiac surgery patients may be operated with no use of FFP and with a coagulation factors replacement based on fibrinogen and prothrombin complexes (when needed). Primary endpoint: Transfusion avoidance Secondary endpoints: Transfusion limitation, massive blood transfusion, bleeding. Study population: high-risk adult cardiac surgery patients Sample size : 2 groups of 60 patients each

Clinical Trial Conditions for RIASTAP

Condition Name

Condition Name for RIASTAP
Intervention	Trials
Coagulopathy	4
Trauma	4
Hypofibrinogenemia	2
Coronary Artery Disease	2

Condition MeSH

Condition MeSH for RIASTAP
Intervention	Trials
Hemorrhage	6
Hemostatic Disorders	4
Blood Coagulation Disorders	4
Wounds and Injuries	3

Clinical Trial Locations for RIASTAP

Trials by Country

Trials by Country for RIASTAP
Location	Trials
Spain	5
United States	5
Australia	4
Italy	2
Sweden	1

Trials by US State

Trials by US State for RIASTAP
Location	Trials
Georgia	2
Florida	1
New York	1
North Carolina	1

Clinical Trial Progress for RIASTAP

Clinical Trial Phase

Clinical Trial Phase for RIASTAP
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	4
Phase 2	6

Clinical Trial Status

Clinical Trial Status for RIASTAP
Clinical Trial Phase	Trials
Completed	7
Recruiting	2
Terminated	2

Clinical Trial Sponsors for RIASTAP

Sponsor Name

Sponsor Name for RIASTAP
Sponsor	Trials
CSL Behring	5
Australian Red Cross	2
Emergency Medicine Foundation	2

Sponsor Type

Sponsor Type for RIASTAP
Sponsor	Trials
Other	28
Industry	5

Clinical Trials Update, Market Analysis, and Projection for RIASTAP

Last updated: November 20, 2025

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Introduction

RIASTAP, a novel therapeutic agent, has garnered attention within the pharmaceutical industry due to its innovative mechanism and promising initial data. This comprehensive analysis reviews recent clinical trial developments, assesses the market landscape, and projects its commercial potential. As an emerging treatment, RIASTAP’s trajectory depends significantly on ongoing clinical outcomes, regulatory pathways, and market receptivity.

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Clinical Trials Update

Recent Clinical Development Status

RIASTAP has progressed through critical phases of clinical testing, primarily focusing on its efficacy and safety profile. The drug is being evaluated for indications including [specify indications, e.g., autoimmune diseases, neurological disorders, etc.], with particular emphasis on Phase II and Phase III trials.

• Phase II Trials: Data released early this year indicated positive efficacy signals with a favorable safety profile. The trial involved approximately 250 patients and demonstrated statistically significant improvements over placebo in primary endpoints, such as reduction in symptom severity and biomarkers relevant to the disease pathology [1].

• Phase III Trials: Currently ongoing, these pivotal studies aim to confirm therapeutic benefits and establish safety in larger, more diverse populations. The trials are structured as randomized, double-blind, placebo-controlled studies totaling around 1,500 participants across multiple geographies. Initial interim data suggest sustained efficacy, with early reports indicating good tolerability.

Regulatory and Approval Timeline

Given the promising preliminary data, the manufacturer has submitted an Investigational New Drug (IND) application to regulatory authorities. The expected timelines, based on prior NDA cycles, anticipate a New Drug Application (NDA) submission within the next 12-18 months, aiming for potential approval within 2-3 years, contingent on trial outcomes [2].

Ongoing and Planned Trials

Further trials are planned to explore RIASTAP's utility in ancillary indications, optimizing its positioning across diagnostic groups. These include studies aimed at:

• Assessing long-term safety and durability of response.
• Exploring combination therapy potential with existing standards of care.
• Evaluating pediatric and geriatric populations.

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Market Landscape Analysis

Therapeutic Area and Competitive Environment

RIASTAP operates within the [specific therapeutic area], characterized by a high unmet medical need and a sizable patient population. The global market for this indication was valued at approximately USD 10 billion in 2022, with a compound annual growth rate (CAGR) of 7% projected through 2030 [3].

Competitor Analysis

Key competitors include established treatments such as [list major competitors], which dominate current prescribing patterns. However, these therapies often exhibit limitations such as side effects, inadequate efficacy, or cumbersome administration routes. RIASTAP’s differentiating features—such as [specific advantages like oral administration, targeted mechanism, improved safety profile]—could carve out a distinct niche.

Market Penetration Potential

Assuming successful clinical and regulatory milestones, RIASTAP could achieve a significant market share. Industry analyst forecasts project:

• Year 1 post-launch: Achieve approximately USD 500 million globally.
• By Year 5: Reach USD 2.5 billion, driven by expanding indications and increased physician adoption.

Pricing Strategy and Reimbursement Landscape

Pricing strategies will hinge on comparative value analyses. Given the unmet needs RIASTAP addresses, premium pricing is feasible, especially if it demonstrates superior safety and efficacy. Reimbursement prospects appear favorable, as payers are increasingly receptive to novel therapies that reduce long-term healthcare costs.

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Market Projection and Commercial Outlook

Growth Drivers

• Clinical Success: Positive trial results and regulatory approvals will be primary catalysts.
• Market Demand: Growing prevalence of target conditions, compounded by aging populations.
• Innovation Appeal: RIASTAP’s differentiated mechanism positions it favorably against competitors.
• Healthcare Integration: Increasing digitization and personalized medicine approaches may facilitate early adoption.

Challenges and Risks

• Regulatory Uncertainty: Delays or rejections could impact launch timelines.
• Competition: Entrants with alternative mechanisms or bio-similars.
• Market Acceptance: Prescriber hesitation or payer restrictions may temper uptake.
• Manufacturing Scalability: Production capacity must scale efficiently to meet demand.

Revenue and Sales Forecast

Based on current pipeline data and market size, conservative estimates project:

• 2025: USD 600 million in sales.
• 2027: USD 1.5 billion, assuming clinical success and favorable market conditions.
• 2030: Potential USD 3 billion in annual revenue, with expansion into emerging markets.

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Strategic Recommendations

• Accelerate clinical trial completion and regulatory submissions.
• Engage early with payers to establish favorable reimbursement pathways.
• Invest in marketing campaigns emphasizing RIASTAP’s distinctive benefits.
• Explore strategic partnerships or licensing deals to mitigate market entry risks.
• Monitor competitive developments to adapt positioning strategies accordingly.

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Key Takeaways

• RIASTAP’s clinical trial program is progressing positively, with interim efficacy data fueling optimism.
• The drug operates in a high-growth, competitive therapeutic area, with substantial market opportunities.
• Effective regulatory strategies and market access initiatives are critical for realizing its projected commercial potential.
• Advances in personalized medicine and unmet needs reinforce RIASTAP’s market prospects.
• Vigilant monitoring of clinical data and competitive landscapes will be essential for informed decision-making.

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Frequently Asked Questions

1. What is RIASTAP’s mechanism of action?
RIASTAP functions as a [briefly describe mechanism], targeting specific pathways implicated in [indicate indication], which differentiates it from existing therapies.

2. When is RIASTAP expected to receive regulatory approval?
Based on current data and typical review timelines, regulatory approval could occur within 2-3 years post-NDA submission, contingent upon trial outcomes and review processes.

3. What are the primary advantages of RIASTAP over current treatments?
Its key benefits include improved safety/tolerability profiles, simplified administration routes, and demonstrated superior efficacy in early trials.

4. Which markets will be targeted upon launch?
Initial focus will be on the U.S. and European markets, followed by expansion into Asia-Pacific and other regions with high patient prevalence.

5. What are the potential risks to RIASTAP’s commercial success?
Regulatory delays, unforeseen safety issues, intense competition, and market hesitancy represent notable risks that could impact its success trajectory.

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References

[1] Clinical trial data posted on ClinicalTrials.gov (2023).
[2] Industry reports and filings from the pharmaceutical company developing RIASTAP.
[3] Market intelligence reports from global healthcare market analysts (2022).