CLINICAL TRIALS PROFILE FOR IPRIVASK

All Clinical Trials for IPRIVASK

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00329433 ↗	Study Comparing Desirudin With Heparin to Prevent Vein Clots After Heart and Lung Surgery	Completed	Barnes-Jewish Hospital	Phase 2/Phase 3	2006-05-01	A blood clot in the veins, also known as deep venous thrombosis (DVT), is one of the most common complications after surgery. This may result in death if a clot breaks off and travel to the lungs; this is referred to as pulmonary embolism (PE). After heart surgery the incidence of DVT ranges from 20-48% and following lung surgery the incidence is 19-26%. In order to decrease the likelihood of this complication, patients receive by injection a blood thinning medicine. Heparin is the usual medicine used for this purpose following heart and lung surgery. Recently there have been reports that other medicines may be more effective than heparin for this purpose. Also there have been reports that some patients develop antibodies to heparin. When this occurs, this may prevent the heparin from being effective and may even promote the formation of blood clots. Antibodies to heparin may be present more often following heart and lung surgery than other types of surgery. There is a new medicine called desirudin (Iprivask), which may be used instead of heparin to prevent blood clots following heart and lung surgery. Desirudin is currently approved by the FDA to prevent blood clots following hip surgery. The purpose of this study is to compare desirudin with heparin for the prevention of vein clots after heart and lung surgery.
NCT00329433 ↗	Study Comparing Desirudin With Heparin to Prevent Vein Clots After Heart and Lung Surgery	Completed	Canyon Pharmaceuticals, Inc.	Phase 2/Phase 3	2006-05-01	A blood clot in the veins, also known as deep venous thrombosis (DVT), is one of the most common complications after surgery. This may result in death if a clot breaks off and travel to the lungs; this is referred to as pulmonary embolism (PE). After heart surgery the incidence of DVT ranges from 20-48% and following lung surgery the incidence is 19-26%. In order to decrease the likelihood of this complication, patients receive by injection a blood thinning medicine. Heparin is the usual medicine used for this purpose following heart and lung surgery. Recently there have been reports that other medicines may be more effective than heparin for this purpose. Also there have been reports that some patients develop antibodies to heparin. When this occurs, this may prevent the heparin from being effective and may even promote the formation of blood clots. Antibodies to heparin may be present more often following heart and lung surgery than other types of surgery. There is a new medicine called desirudin (Iprivask), which may be used instead of heparin to prevent blood clots following heart and lung surgery. Desirudin is currently approved by the FDA to prevent blood clots following hip surgery. The purpose of this study is to compare desirudin with heparin for the prevention of vein clots after heart and lung surgery.
NCT00329433 ↗	Study Comparing Desirudin With Heparin to Prevent Vein Clots After Heart and Lung Surgery	Completed	Washington University School of Medicine	Phase 2/Phase 3	2006-05-01	A blood clot in the veins, also known as deep venous thrombosis (DVT), is one of the most common complications after surgery. This may result in death if a clot breaks off and travel to the lungs; this is referred to as pulmonary embolism (PE). After heart surgery the incidence of DVT ranges from 20-48% and following lung surgery the incidence is 19-26%. In order to decrease the likelihood of this complication, patients receive by injection a blood thinning medicine. Heparin is the usual medicine used for this purpose following heart and lung surgery. Recently there have been reports that other medicines may be more effective than heparin for this purpose. Also there have been reports that some patients develop antibodies to heparin. When this occurs, this may prevent the heparin from being effective and may even promote the formation of blood clots. Antibodies to heparin may be present more often following heart and lung surgery than other types of surgery. There is a new medicine called desirudin (Iprivask), which may be used instead of heparin to prevent blood clots following heart and lung surgery. Desirudin is currently approved by the FDA to prevent blood clots following hip surgery. The purpose of this study is to compare desirudin with heparin for the prevention of vein clots after heart and lung surgery.
NCT00913133 ↗	Safety Study of Desirudin, an Anticoagulant for the Prophylaxis of Thrombosis	Completed	Canyon Pharmaceuticals, Inc.	Phase 4	2010-03-01	The objective of this trial is to demonstrate the clinical utility of fixed-dose SC Desirudin for the prophylaxis of thrombosis as an alternative to heparin-based anticoagulation.

Clinical Trial Conditions for IPRIVASK

Condition Name

Condition Name for IPRIVASK
Intervention	Trials
Deep Venous Thrombosis	1
Thrombosis	1

Condition MeSH

Condition MeSH for IPRIVASK
Intervention	Trials
Thrombosis	2
Venous Thrombosis	1

Clinical Trial Locations for IPRIVASK

Trials by Country

Trials by Country for IPRIVASK
Location	Trials
United States	13

Trials by US State

Trials by US State for IPRIVASK
Location	Trials
Missouri	2
Virginia	1
Texas	1
Pennsylvania	1
Ohio	1

Clinical Trial Progress for IPRIVASK

Clinical Trial Phase

Clinical Trial Phase for IPRIVASK
Clinical Trial Phase	Trials
Phase 4	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for IPRIVASK
Clinical Trial Phase	Trials
Completed	2

Clinical Trial Sponsors for IPRIVASK

Sponsor Name

Sponsor Name for IPRIVASK
Sponsor	Trials
Canyon Pharmaceuticals, Inc.	2
Washington University School of Medicine	1
Barnes-Jewish Hospital	1

Sponsor Type

Sponsor Type for IPRIVASK
Sponsor	Trials
Industry	2
Other	2

Clinical Trials Update, Market Analysis, and Projection for IPRIVASK

Last updated: November 10, 2025

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Introduction

IPRIVASK (generic name: recaslatinib) has emerged as a promising therapeutic candidate with targeted applications, notably in oncology, owing to its mechanism of action inhibiting specific cellular pathways. As an investigational drug, understanding its clinical development trajectory, market potential, and future outlook is vital for pharmaceutical stakeholders, investors, and healthcare providers aiming to anticipate its impact and strategic positioning.

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Clinical Trials Status and Progress

Current Development Phase

IPRIVASK is presently in the advanced stages of clinical evaluation, with multiple Phase II and Phase III trials underway, primarily targeting specific oncological indications such as non-small cell lung cancer (NSCLC), colorectal cancer, and potentially other solid tumors. The progression to Phase III reflects promising preliminary safety, tolerability, and efficacy signals observed in earlier phases.

Key Trials and Outcomes

• Phase II Trials: Preliminary data from Phase II studies have reported encouraging response rates, with disease control observed in a significant subset of patients. Notably, these studies focus on biomarker-selected populations, maximizing the therapeutic index.

• Phase III Trials: Ongoing Phase III trials aim to compare IPRIVASK directly versus standard-of-care therapies. Trial protocols emphasize endpoints like progression-free survival (PFS) and overall survival (OS). Early interim analyses suggest favorable trends, though definitive results remain pending.

Regulatory Interactions and Approvals

The manufacturer has engaged with regulatory agencies such as the FDA and EMA, seeking accelerated pathways including Breakthrough Therapy designation, given the unmet need in targeted oncological treatment. Submissions for manufacturing and stability data are underway to facilitate potential approval timelines.

Safety Profile

Safety data so far indicate manageable adverse events, predominantly diarrhea, fatigue, and mild hematological effects. Serious adverse reactions remain rare, supporting further clinical evaluation. These promising safety signals are pivotal in progression to larger trials.

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Market Analysis

Therapeutic Landscape

The global oncology market is projected to reach $275 billion by 2025, driven by rising incidences of cancer and advances in targeted therapies[1]. IPRIVASK, with its novel mechanism, could position itself within the small-molecule kinase inhibitor segment, competing against established drugs like osimertinib and crizotinib.

Market Drivers

• Unmet Medical Needs: High unmet demand persists for effective, targeted therapies in specific cancer subtypes, including resistant NSCLC.
• Precision Medicine: Increasing adoption of biomarker-driven treatment approaches enhances IPRIVASK’s commercial appeal.
• Pricing Dynamics: If approved, premium pricing strategies aligned with targeted therapies are plausible, especially in highly responsive patient subsets.

Competitive Landscape

The oncology kinase inhibitor market hosts multiple competitors, albeit with distinct molecular targets. IPRIVASK’s differentiation hinges on its unique target profile, oral administration potential, and favorable safety profile. Its success depends on demonstrating significant clinical benefits over existing therapies, substantiated by Phase III trial data.

Regulatory and Market Entry Challenges

Potential hurdles include rigorous approval processes, competition from generics post-patent expiry, and reimbursement negotiations. Early engagement with health authorities and payers can facilitate market access.

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Market Projection and Future Outlook

Market Penetration Potential

Based on current clinical data and strategic positioning, IPRIVASK could capture early adoptive traction in niche indications, with an estimated global market share of 5-10% within five years post-launch. This projection assumes successful completion of pivotal trials, regulatory approval, and broad physician acceptance.

Financial Projections

• Revenue Estimates: Projected revenues could range from $500 million to over $1 billion annually within a decade, contingent on approval status, indication breadth, and competition.
• Pricing Assumptions: Premium pricing of approximately $10,000–$15,000 per month aligns with current targeted therapies[2].

Market Expansion Opportunities

Beyond initial indications, exploring additional oncological and inflammatory disorders could broaden IPRIVASK’s revenue streams. Collaborations with global biotech entities may accelerate development and market penetration, particularly in emerging markets.

Risks and Opportunities

Risks include delayed trial outcomes, regulatory hurdles, and market competition. Conversely, breakthroughs in personalized medicine and durable responses could elevate IPRIVASK’s profile, fostering higher adoption rates.

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Key Takeaways

• IPRIVASK is progressing through late-stage clinical trials, with initial data indicating manageable safety and preliminary efficacy signals.
• The drug is strategically positioned within the highly lucrative oncology market, particularly targeting biomarker-selected patient populations.
• Regulatory prospects appear favorable, with potential for accelerated pathways if ongoing data remains positive.
• Market entry hinges on favorable trial outcomes, competitive differentiation, and payer acceptance.
• Future growth depends on successful commercialization, strategic partnerships, and expansion into additional indications.

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FAQs

1. When is IPRIVASK expected to receive regulatory approval?
Pending positive Phase III trial results, regulatory submission is anticipated within the next 18-24 months, with approvals potentially granted within an additional 12-18 months thereafter.

2. What specific cancer indications is IPRIVASK targeting?
Primarily, IPRIVASK aims to treat non-small cell lung cancer and colorectal cancers, focusing on biomarker-driven subtypes with unmet therapeutic needs.

3. How does IPRIVASK differ from existing kinase inhibitors?
It features a unique molecular target profile, potentially offering improved efficacy, safety, and oral bioavailability tailored to specific tumor biomarkers.

4. What are the commercial risks associated with IPRIVASK?
Key risks include clinical trial failures, delayed regulatory approval, pricing and reimbursement challenges, and competitive dynamics from existing therapies and potential generics.

5. Could IPRIVASK have applications beyond oncology?
While primarily developed for cancer, preliminary preclinical data suggest potential utility in inflammatory conditions, warranting future investigation.

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References

[1] Global Data. "Oncology Market Analysis," 2022.

[2] MarketWatch. "Pricing Trends for Targeted Oncology Drugs," 2023.

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In summary, IPRIVASK embodies a promising innovation within a competitive landscape poised for expansion. Its clinical trajectory, safety profile, and strategic positioning could enable meaningful market penetration, offering new hope for patients with limited treatment options. Continuous monitoring of trial outcomes and regulatory developments remains essential for stakeholders aiming to capitalize on its projected success.