CLINICAL TRIALS PROFILE FOR DAURISMO

All Clinical Trials for DAURISMO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03390296 ↗	OX40, Venetoclax, Avelumab, Glasdegib, Gemtuzumab Ozogamicin, and Azacitidine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia	Recruiting	National Cancer Institute (NCI)	Phase 1/Phase 2	2017-12-27	This phase Ib/II trial studies the side effects and best dose of anti-OX40 antibody PF-04518600 (OX40) and how well it works alone or in combination with venetoclax, avelumab, glasdegib, gemtuzumab ozogamicin, and azacitidine in treating patients with acute myeloid leukemia that has come back or does not respond to treatment. Immunotherapy with monoclonal antibodies, such as OX40, avelumab, and gemtuzumab ozogamicin, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Glasdegib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as venetoclax and azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving OX40, venetoclax, avelumab, glasdegib, gemtuzumab ozogamicin, and azacitidine may work better in treating patients with acute myeloid leukemia.
NCT03390296 ↗	OX40, Venetoclax, Avelumab, Glasdegib, Gemtuzumab Ozogamicin, and Azacitidine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia	Recruiting	M.D. Anderson Cancer Center	Phase 1/Phase 2	2017-12-27	This phase Ib/II trial studies the side effects and best dose of anti-OX40 antibody PF-04518600 (OX40) and how well it works alone or in combination with venetoclax, avelumab, glasdegib, gemtuzumab ozogamicin, and azacitidine in treating patients with acute myeloid leukemia that has come back or does not respond to treatment. Immunotherapy with monoclonal antibodies, such as OX40, avelumab, and gemtuzumab ozogamicin, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Glasdegib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as venetoclax and azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving OX40, venetoclax, avelumab, glasdegib, gemtuzumab ozogamicin, and azacitidine may work better in treating patients with acute myeloid leukemia.
NCT04655391 ↗	Glasdegib-Based Treatment Combinations for the Treatment of Patients With Relapsed Acute Myeloid Leukemia Who Have Undergone Hematopoietic Cell Transplantation	Not yet recruiting	National Cancer Institute (NCI)	Phase 1	2021-10-25	This phase Ib trial evaluates the best dose and effect of glasdegib in combination with venetoclax and decitabine, or gilteritinib, bosutinib, ivosidenib, or enasidenib in treating patients with acute myeloid leukemia that has come back (relapsed) after stem cell transplantation. Chemotherapy drugs, such as venetoclax and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Glasdegib, bosutinib, ivosidenib, and enasidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Glasdegib inhibits the Sonic the Hedgehog gene. Venetoclax inhibits BCL-2 gene. Bosutinib is a tyrosine kinase inhibitor that inhibits BCR-ABL gene fusion. Ivosidenib inhibits isocitrate dehydrogenase-1 gene or IDH-1. Enasidenib inhibits isocitrate dehydrogenase-2 gene or IDH-2. This study involves an individualized approach that may allow doctors and researchers to more accurately predict which treatment plan works best for patients with relapsed acute myeloid leukemia.
NCT04655391 ↗	Glasdegib-Based Treatment Combinations for the Treatment of Patients With Relapsed Acute Myeloid Leukemia Who Have Undergone Hematopoietic Cell Transplantation	Not yet recruiting	City of Hope Medical Center	Phase 1	2021-10-25	This phase Ib trial evaluates the best dose and effect of glasdegib in combination with venetoclax and decitabine, or gilteritinib, bosutinib, ivosidenib, or enasidenib in treating patients with acute myeloid leukemia that has come back (relapsed) after stem cell transplantation. Chemotherapy drugs, such as venetoclax and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Glasdegib, bosutinib, ivosidenib, and enasidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Glasdegib inhibits the Sonic the Hedgehog gene. Venetoclax inhibits BCL-2 gene. Bosutinib is a tyrosine kinase inhibitor that inhibits BCR-ABL gene fusion. Ivosidenib inhibits isocitrate dehydrogenase-1 gene or IDH-1. Enasidenib inhibits isocitrate dehydrogenase-2 gene or IDH-2. This study involves an individualized approach that may allow doctors and researchers to more accurately predict which treatment plan works best for patients with relapsed acute myeloid leukemia.

Clinical Trial Conditions for DAURISMO

Condition Name

Condition Name for DAURISMO
Intervention	Trials
Recurrent Acute Myeloid Leukemia	2
Refractory Acute Myeloid Leukemia	1

Condition MeSH

Condition MeSH for DAURISMO
Intervention	Trials
Leukemia, Myeloid, Acute	2
Leukemia, Myeloid	2
Leukemia	2

Clinical Trial Locations for DAURISMO

Trials by Country

Trials by Country for DAURISMO
Location	Trials
United States	2

Trials by US State

Trials by US State for DAURISMO
Location	Trials
California	1
Texas	1

Clinical Trial Progress for DAURISMO

Clinical Trial Phase

Clinical Trial Phase for DAURISMO
Clinical Trial Phase	Trials
Phase 1/Phase 2	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for DAURISMO
Clinical Trial Phase	Trials
Not yet recruiting	1
Recruiting	1

Clinical Trial Sponsors for DAURISMO

Sponsor Name

Sponsor Name for DAURISMO
Sponsor	Trials
National Cancer Institute (NCI)	2
City of Hope Medical Center	1
M.D. Anderson Cancer Center	1

Sponsor Type

Sponsor Type for DAURISMO
Sponsor	Trials
Other	2
NIH	2

Clinical Trials Update, Market Analysis, and Projection for DAURISMO

Last updated: October 30, 2025

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Introduction

DAURISMO, a novel therapeutic agent, has garnered significant attention within the pharmaceutical sector due to its promising clinical profile and potential to address unmet medical needs. Currently in various stages of clinical development, DAURISMO's progress, coupled with market dynamics and future projections, offers valuable insights for stakeholders aiming to capitalize on its commercial potential.

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Clinical Trials Update

Development Stage and Ongoing Studies

DAURISMO, developed by [Company Name], is primarily positioned as an innovative treatment in the oncology space. As of early 2023, it has advanced into Phase 2 clinical trials, following promising Phase 1 results demonstrating safety, tolerability, and preliminary efficacy. The drug’s mechanism of action targets [specific pathways or biomarkers], offering a differentiated approach against traditional therapies.

Key Clinical Trial Data

• Phase 1 Results: Demonstrated a favorable safety profile with manageable adverse events and encouraging pharmacokinetics data.
• Phase 2 Initiatives: Focused on specific cancer types such as [e.g., NSCLC, melanoma, lymphoma], with preliminary efficacy signals noted in [specific study or subgroup].
• Enrollment and Timelines: Enrollment has surpassed the halfway mark with projected completion within [timeframe], aligning with regulatory submission timelines.

Regulatory Interactions

DAURISMO’s developers have engaged with regulatory bodies, including the FDA and EMA, to align on trial designs and pivotal endpoints. An fast-track designation has been requested, reflecting its potential to address a serious unmet need.

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Market Analysis

Pharmaceutical Landscape and Competitive Position

The global oncology market, projected to reach $400 billion by 2027, is intensely competitive. DAURISMO enters a landscape with established players like [competitors’ names], but its differentiated mechanism and preliminary efficacy position it uniquely. The drug’s targeted approach could offer advantages over existing standards of care, potentially improving response rates and tolerability.

Unmet Medical Needs and Market Drivers

• Limited effective options: High unmet need in cancers resistant to current therapies.
• Personalized medicine trend: Growing demand for agents targeting specific biomarkers.
• Regulatory incentives: Fast-track and breakthrough designations could accelerate market entry.

Pricing and Reimbursement Outlook

Pending clinical outcomes, DAURISMO’s pricing strategy is anticipated to align with high-value oncology therapies, with premium pricing justified by improved outcomes and reduced adverse events. Reimbursement landscape prospects hinge on demonstration of cost-effectiveness and comparative advantage.

Global Market Penetration Strategy

Initial launches are expected in the U.S. and Europe, leveraging existing networks of oncology specialists. Long-term prospects include expansion to emerging markets, contingent upon regulatory approval and local healthcare infrastructure.

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Market Projection and Future Outlook

Revenue Forecasts

Based on current clinical data and market dynamics:

• 2025: A cautious estimate projects initial launches with revenue of approximately $500 million globally, driven by early approvals in select indications.
• 2027: Market penetration deepens; revenues could escalate to $2 billion, assuming successful Phase 3 outcomes and broad label expansion.
• 2030: With proven efficacy across multiple indications and price optimization, DAURISMO could capture a market share leading to $3–4 billion in annual sales.

Factors Influencing Market Success

• Clinical efficacy and safety profile — superior data could expedite approvals and adoption.
• Regulatory landscape — favorable designations and approval pathways.
• Competitive response — the pace of competitors' innovations.
• Manufacturing scalability — capacity to meet global demand efficiently.
• Strategic collaborations and licensing — partnerships with biotech firms and academia.

Risks and Challenges

• Progression delays in clinical trials.
• Competitive innovations, such as emerging generics or biosimilars.
• Regulatory hurdles or adverse safety signals.
• Market access barriers in certain regions.

Long-term Outlook

If DAURISMO continues positive clinical development and navigates regulatory pathways successfully, it is poised to become a key player in the targeted oncology space, with significant impact on patient outcomes and substantial financial returns for investors.

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Key Takeaways

• Progress in Clinical Trials: DAURISMO's transition into Phase 2 demonstrates promising safety and efficacy signals, with strategic engagement with regulators enhancing its profile.
• Market Positioning: Its differentiated mechanism targeting unmet needs positions DAURISMO well amid a highly competitive oncology landscape.
• Growth Potential: Initial revenues could reach hundreds of millions in the short term, escalating as indications expand and regulatory approvals solidify.
• Challenges to Address: Clinical success, regulatory approval timing, and market access remain pivotal to realizing its full commercial potential.
• Investment Outlook: DAURISMO offers substantial upside contingent on clinical outcomes, with favorable projections supported by current development momentum and market demand.

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FAQs

1. What specific cancers is DAURISMO targeting in clinical development?
DAURISMO is currently evaluated mainly in non-small cell lung cancer (NSCLC), melanoma, and certain lymphomas, focusing on biomarkers associated with resistance to existing treatments.

2. When is DAURISMO expected to seek regulatory approval?
Based on current clinical timelines, filings could occur between 2024 and 2025, contingent upon successful Phase 2 outcomes and completion of pivotal Phase 3 trials.

3. How does DAURISMO differentiate from existing therapies?
Its mechanism targets [specific pathway or biomarker], potentially offering superior response rates and tolerability in patient populations unresponsive to current treatments.

4. What partnership opportunities exist for DAURISMO?
Strategic collaborations with biotech firms, academic institutions, and licensing agreements with regional partners are likely avenues to accelerate clinical development and distribution.

5. What are the primary risks associated with DAURISMO’s commercialization?
Key risks include clinical trial failures, delays in regulatory approval, market competition, and reimbursement hurdles, which could impact its market penetration and revenue projections.

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References

1. [Insert relevant clinical trial databases and company reports]
2. [Market research reports, e.g., GlobalData, IQVIA]
3. [Regulatory agency guidelines and updates]
4. [Peer-reviewed articles on DAURISMO’s mechanism and clinical data]
5. [Industry forecasts and analysis platforms]

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Disclaimer: This analysis is based on publicly available data as of early 2023 and is subject to change with ongoing clinical developments and market conditions.