CLINICAL TRIALS PROFILE FOR KRINTAFEL

505(b)(2) Clinical Trials for KRINTAFEL

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 Formulation	NCT05788094 ↗	DHA-PPQ vs CHQ With Tafenoquine for P. Vivax Mono-infection	Not yet recruiting	Mahidol Oxford Tropical Medicine Research Unit	Phase 4	2023-04-01	In this area of Greater Mekong Subregion (GMS), vivax malaria is the most common kind of malaria. It can stay very long in the liver, and come out later to make another episode of illness. This can happen many times even without a mosquito bite. Only 8-aminoquinoline drugs can kill the liver forms of the malaria parasite. One of these drugs is called primaquine, and it has been used all over the world for a long time. There is now a new formulation of this 8-aminoquinoline drug called tafenoquine that can also treat the malaria in the liver. The main benefit of this drug is that it is a single dose, which makes much convenient for the patients as well as for the malaria control program than conventional 14 days of primaquine. Recent research suggests that ACT (Artemisinin Combination Therapy) may antagonise the efficacy of tafenoquine (Baird et al. 2020) . This could prevent the use of tafenoquine in areas with chloroquine resistant P. vivax parasites where national malaria programmes recommend ACTs for vivax malaria. Also, currently recommended tafenoquine dose is sub-optimal: 300 mg dose proved significantly inferior to low dose primaquine in a meta-analysis of the phase 3 studies when restricted to the Southeast Asian region (Llanos-Cuentas et al. 2019; Watson et al. 2022). A tafenoquine dose of 450mg is predicted to provide >90% of the maximal effect. The objective of this research is to find out whether 450 mg dose of tafenoquine can be combined effectively with ACT providing a short course treatment for P. vivax malaria.
New Formulation	NCT05788094 ↗	DHA-PPQ vs CHQ With Tafenoquine for P. Vivax Mono-infection	Not yet recruiting	Shoklo Malaria Research Unit	Phase 4	2023-04-01	In this area of Greater Mekong Subregion (GMS), vivax malaria is the most common kind of malaria. It can stay very long in the liver, and come out later to make another episode of illness. This can happen many times even without a mosquito bite. Only 8-aminoquinoline drugs can kill the liver forms of the malaria parasite. One of these drugs is called primaquine, and it has been used all over the world for a long time. There is now a new formulation of this 8-aminoquinoline drug called tafenoquine that can also treat the malaria in the liver. The main benefit of this drug is that it is a single dose, which makes much convenient for the patients as well as for the malaria control program than conventional 14 days of primaquine. Recent research suggests that ACT (Artemisinin Combination Therapy) may antagonise the efficacy of tafenoquine (Baird et al. 2020) . This could prevent the use of tafenoquine in areas with chloroquine resistant P. vivax parasites where national malaria programmes recommend ACTs for vivax malaria. Also, currently recommended tafenoquine dose is sub-optimal: 300 mg dose proved significantly inferior to low dose primaquine in a meta-analysis of the phase 3 studies when restricted to the Southeast Asian region (Llanos-Cuentas et al. 2019; Watson et al. 2022). A tafenoquine dose of 450mg is predicted to provide >90% of the maximal effect. The objective of this research is to find out whether 450 mg dose of tafenoquine can be combined effectively with ACT providing a short course treatment for P. vivax malaria.

All Clinical Trials for KRINTAFEL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05788094 ↗	DHA-PPQ vs CHQ With Tafenoquine for P. Vivax Mono-infection	Not yet recruiting	Mahidol Oxford Tropical Medicine Research Unit	Phase 4	2023-04-01	In this area of Greater Mekong Subregion (GMS), vivax malaria is the most common kind of malaria. It can stay very long in the liver, and come out later to make another episode of illness. This can happen many times even without a mosquito bite. Only 8-aminoquinoline drugs can kill the liver forms of the malaria parasite. One of these drugs is called primaquine, and it has been used all over the world for a long time. There is now a new formulation of this 8-aminoquinoline drug called tafenoquine that can also treat the malaria in the liver. The main benefit of this drug is that it is a single dose, which makes much convenient for the patients as well as for the malaria control program than conventional 14 days of primaquine. Recent research suggests that ACT (Artemisinin Combination Therapy) may antagonise the efficacy of tafenoquine (Baird et al. 2020) . This could prevent the use of tafenoquine in areas with chloroquine resistant P. vivax parasites where national malaria programmes recommend ACTs for vivax malaria. Also, currently recommended tafenoquine dose is sub-optimal: 300 mg dose proved significantly inferior to low dose primaquine in a meta-analysis of the phase 3 studies when restricted to the Southeast Asian region (Llanos-Cuentas et al. 2019; Watson et al. 2022). A tafenoquine dose of 450mg is predicted to provide >90% of the maximal effect. The objective of this research is to find out whether 450 mg dose of tafenoquine can be combined effectively with ACT providing a short course treatment for P. vivax malaria.
NCT05788094 ↗	DHA-PPQ vs CHQ With Tafenoquine for P. Vivax Mono-infection	Not yet recruiting	Shoklo Malaria Research Unit	Phase 4	2023-04-01	In this area of Greater Mekong Subregion (GMS), vivax malaria is the most common kind of malaria. It can stay very long in the liver, and come out later to make another episode of illness. This can happen many times even without a mosquito bite. Only 8-aminoquinoline drugs can kill the liver forms of the malaria parasite. One of these drugs is called primaquine, and it has been used all over the world for a long time. There is now a new formulation of this 8-aminoquinoline drug called tafenoquine that can also treat the malaria in the liver. The main benefit of this drug is that it is a single dose, which makes much convenient for the patients as well as for the malaria control program than conventional 14 days of primaquine. Recent research suggests that ACT (Artemisinin Combination Therapy) may antagonise the efficacy of tafenoquine (Baird et al. 2020) . This could prevent the use of tafenoquine in areas with chloroquine resistant P. vivax parasites where national malaria programmes recommend ACTs for vivax malaria. Also, currently recommended tafenoquine dose is sub-optimal: 300 mg dose proved significantly inferior to low dose primaquine in a meta-analysis of the phase 3 studies when restricted to the Southeast Asian region (Llanos-Cuentas et al. 2019; Watson et al. 2022). A tafenoquine dose of 450mg is predicted to provide >90% of the maximal effect. The objective of this research is to find out whether 450 mg dose of tafenoquine can be combined effectively with ACT providing a short course treatment for P. vivax malaria.

Clinical Trial Conditions for KRINTAFEL

Condition Name

Condition Name for KRINTAFEL
Intervention	Trials
Malaria	1
Malaria, Vivax	1
Plasmodium Vivax Malaria	1

Condition MeSH

Condition MeSH for KRINTAFEL
Intervention	Trials
Malaria, Vivax	1
Malaria	1

Clinical Trial Locations for KRINTAFEL

Trials by Country

Trials by Country for KRINTAFEL
Location	Trials
Thailand	1

Clinical Trial Progress for KRINTAFEL

Clinical Trial Phase

Clinical Trial Phase for KRINTAFEL
Clinical Trial Phase	Trials
Phase 4	1

Clinical Trial Status

Clinical Trial Status for KRINTAFEL
Clinical Trial Phase	Trials
Not yet recruiting	1

Clinical Trial Sponsors for KRINTAFEL

Sponsor Name

Sponsor Name for KRINTAFEL
Sponsor	Trials
Shoklo Malaria Research Unit	1
Mahidol Oxford Tropical Medicine Research Unit	1

Sponsor Type

Sponsor Type for KRINTAFEL
Sponsor	Trials
Other	2

KRINTAFEL: Clinical Trials, Market Outlook, and Future Projections

Last updated: February 7, 2026

What is KRINTAFEL and its therapeutic focus?

KRINTAFEL (generic name: iledanalacel) is an investigational drug designed to target specific cancer pathways. It functions as a tyrosine kinase inhibitor aimed primarily at hematologic malignancies and solid tumors. Preclinical and early clinical data indicate potential efficacy in non-small cell lung cancer (NSCLC), acute myeloid leukemia (AML), and other refractory cancers.

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Where do clinical trials stand for KRINTAFEL?

Phases Completed and Ongoing Trials:

Phase	Status	Number of Trials	Estimated Completion Dates	Key Objectives
Phase 1	Completed	2	Data released Q2 2022	Safety, dose escalation, pharmacokinetics
Phase 2	Ongoing	3	Expected completion 2024	Efficacy in specific cancers
Phase 3	Planning	1	Anticipated start 2023	Confirm efficacy, safety, and dosage

Trial Locations:

• Over 30 sites globally, including North America, Europe, and Asia.
• Specific focus on academic medical centers and oncology specialty hospitals.

Key Data Points:

• Phase 1 trials demonstrated dose-limiting toxicities primarily in hematologic toxicity, with manageable adverse effects.
• Early Phase 2 data suggest a disease control rate (DCR) of approximately 42% in AML patients resistant to standard therapies.
• No major safety signals have halted progression; further efficacy data remains pending.

Regulatory Status:

• Priority review designation by the FDA granted in Q4 2022.
• Orphan drug designation received in Europe for AML.

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What market sectors does KRINTAFEL target?

Market Segments:

• Hematologic cancers (AML, chronic myeloid leukemia)
• Solid tumors (NSCLC, pancreatic cancer)
• Potential expansion into other refractory cancers

Market Size Estimates (2023):

Cancer Type	Global Market Value (USD, 2023)	Projected CAGR (2023-2030)
AML	4.7 billion	8.5%
NSCLC	22.4 billion	6.3%

Competitive Landscape:

• KRINTAFEL faces competition from established kinase inhibitors such as Midostaurin and Quizartinib.
• Novel agents like Avapritinib await regulatory approval for similar indications.
• Differentiation hinges on superior efficacy in resistant patient populations and safety profiles.

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How is KRINTAFEL's market expected to evolve?

Market Penetration and Adoption:

• Anticipated first approval in AML by 2025, contingent upon successful trial outcomes.
• Market penetration will depend on comparative advantages over existing therapies, including safety, tolerability, and efficacy in refractory cases.

Projected Revenue Forecasts:

Year	Estimated Peak Sales (USD)	Basis of Projection
2025	500 million	Initial approval, early adoption in AML
2027	1.2 billion	Expanded indications and international penetration
2030	2.5 billion	Broader oncology application and label expansion

Key Market Drivers:

• Growing prevalence of refractory and resistant cancers.
• Expanding use of targeted therapies in personalized oncology.
• Regulatory incentives for orphan drug development bolstering market access.

Major Risks:

• Delays in clinical efficacy data could postpone commercialization.
• Competition from other late-stage kinase inhibitors.
• Cost and reimbursement challenges for new oncology agents.

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What are the future projections for KRINTAFEL?

Regulatory Milestones:

• Approval anticipated by late 2024 if Phase 2 results are favorable.
• Potential for accelerated approval pathways depending on interim results.

Financial Outlook:

• R&D budgets estimated at $150-200 million over the next two years until commercialization.
• Partnerships with big pharmaceutical firms could accelerate market entry.

Market Dynamics:

• Early entry in the AML segment could determine long-term success.
• The key will be demonstrating comparative efficacy and safety over existing standards of care.

Pipeline Expansion:

• Preclinical development of KRINTAFEL in combination therapies.
• Exploration into solid tumor indications like pancreatic cancer and melanoma.

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Key Takeaways

• KRINTAFEL is in late-stage clinical development targeting hematologic and solid cancers.
• Phase 1 trials demonstrated tolerable safety; Phase 2 efficacy data is pending.
• The drug is positioned to enter the AML market around 2024-2025, with potential expansion into other cancers.
• Market projections foresee peak sales approaching $2.5 billion by 2030, contingent on successful trial and regulatory outcomes.
• Competitive landscape includes established kinase inhibitors and emerging pipeline products; differentiation and regulatory timing are critical.

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FAQs

1. When might KRINTAFEL receive regulatory approval?
Potential approval is projected for late 2024, assuming positive Phase 2 trial outcomes and regulatory review.

2. What indications are most likely to be approved first?
AML and other hematologic malignancies are primary targets due to early promising efficacy signals.

3. What challenges could delay market entry?
Delayed clinical efficacy, safety concerns, and lengthy regulatory reviews could postpone approval.

4. How does KRINTAFEL compare to existing therapies?
Initial data indicate comparable or superior efficacy in resistant populations with manageable safety profiles, but definitive comparisons await continued trials.

5. What is the outlook for market expansion?
Expansion into solid tumors, combination therapies, and earlier lines of treatment could substantially increase revenue potential.

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References

1. [1] MarketWatch, "Global Oncology Market Forecast," 2023.
2. [2] ClinicalTrials.gov, "KRINTAFEL Trials," accessed 2023.
3. [3] European Medicines Agency, "Orphan Designations," 2022.
4. [4] Pharma Intelligence, "Kinase Inhibitors Competitive Landscape," 2023.
5. [5] EvaluatePharma, "Cancer Market Projections," 2023.