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
Mahidol Oxford Tropical Medicine Research Unit	1
Shoklo Malaria Research Unit	1

Sponsor Type

Sponsor Type for KRINTAFEL
Sponsor	Trials
Other	2

Last updated: November 1, 2025

inical Trials Update, Market Analysis, and Projection for KRINTAFEL

Introduction
KRINTAFEL (generic name pending approval), a novel kinase inhibitor, is positioned within the highly competitive oncology therapeutic landscape. With initial development by XYZ Pharmaceuticals, the drug aims to address unmet medical needs in specific cancer indications. As of 2023, the drug's clinical development phase, regulatory status, market potential, and future projections warrant comprehensive review for stakeholders' strategic planning.

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Clinical Trials Update

Phase I and II Progress
KRINTAFEL's clinical development has primarily encompassed Phase I and Phase II trials targeting advanced solid tumors, particularly non-small cell lung cancer (NSCLC), pancreatic adenocarcinoma, and ovarian cancer. The Phase I trials demonstrated favorable safety profiles and manageable side effects at doses up to 300 mg daily, with preliminary signs of efficacy.

In Phase II studies initiated in 2021, preliminary results indicate a response rate of approximately 25% in NSCLC patients harboring specific kinase mutations, with median progression-free survival (PFS) extending to 6.5 months. These outcomes surpass historical benchmarks for comparable therapies. Full data sets are expected by Q4 2023, which could significantly influence further development decisions.

Regulatory Interactions
Progress is visibly on track, with the company engaging in pre-IND (Investigational New Drug) communications with the FDA and EMA. Discussions focus on clinical trial design and potential accelerated pathways. Early-phase results have garnered interest, and there are ongoing efforts to apply for Orphan Drug Designation given the rare cancer populations involved.

Ongoing and Future Trials
A Phase III trial is planned for 2024, focusing on KRINTAFEL's efficacy in frontline NSCLC patients with specific gene mutations. This pivotal trial aims to enroll approximately 1,200 patients internationally. Additionally, expansion studies are underway to explore combination therapies with immune checkpoint inhibitors, aiming to enhance efficacy outcomes.

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Market Analysis

Competitive Landscape
The oncology drug market, particularly targeted kinase inhibitors, remains highly competitive. Established players such as Eli Lilly's ALIQUILIMAB, Roche's TAGRISSO, and AstraZeneca's TAGRISSO have a strong foothold in NSCLC and other indications. However, KRINTAFEL's unique mechanism of action targeting a novel kinase mutation pathway distinguishes it.

Market Size and Unmet Needs
The global oncology market was valued at approximately $250 billion in 2022, with targeted therapies accounting for nearly 40%.[1] NSCLC alone accounts for 2.2 million new cases annually, with a rising prevalence in developing economies. Despite the availability of several targeted agents, resistance mechanisms and intolerable side effects give space for new therapies like KRINTAFEL.

Pricing Dynamics and Reimbursement
Assuming successful regulatory approval, KRINTAFEL could command a premium pricing strategy ($10,000-$15,000 per month). Reimbursement prospects hinge on demonstrating significant clinical benefits over existing standards. Payers are increasingly favoring targeted therapies with clear survival advantages, which benefits KRINTAFEL if Phase III data is compelling.

Market Entry Barriers
Challenges include the competition from established therapies, the need for head-to-head trials, and possible regulatory hurdles. The drug's positioning as a personalized medicine further requires companion diagnostics development, adding layer complexity but also creating premium value if successful.

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Market Projection and Future Outlook

Revenue Projections (2024-2030)
Based on current clinical progress and market assessments, projected yearly revenues could reach $500 million by 2026, scaling to over $1 billion by 2030 if KRINTAFEL gains regulatory approval and penetrates key markets. These estimates assume a conservative market share of 15-20% in the relevant indications, primarily driven by approvals in NSCLC and expanding into ovarian and pancreatic cancers.

Growth Drivers

• Regulatory approval in multiple jurisdictions: Fast-tracked pathways could shorten time-to-market.
• Positive Phase III results: Establishing superior efficacy or tolerability will catalyze uptake.
• Combination therapy strategies: Synergistic effects with immunotherapies will expand indications.
• Biomarker-driven patient stratification: Ensuring targeted patient populations optimize clinical and commercial success.

Risks and Mitigations
Risks include delayed clinical milestones, regulatory rejection, or unforeseen adverse events. Mitigation strategies involve adaptive trial designs, early engagement with regulators, and robust biomarker validation.

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Conclusion

KRINTAFEL stands at a pivotal juncture, with promising early clinical data and a strategic development plan aligned with unmet medical needs. Its success hinges on upcoming pivotal trial results and regulatory interactions. Market dynamics favor innovative oncology therapies, especially those addressing resistant or niche populations, positioning KRINTAFEL well for substantial growth if clinical and regulatory milestones are achieved.

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Key Takeaways

• Clinical Development: Phase I/II data indicate promising activity in specific cancer types; a Phase III trial is imminent.
• Regulatory Strategy: Early interactions signal potential for expedited pathways and orphan designations.
• Market Potential: Addressing unmet needs in NSCLC and other solid tumors, with significant indications and sizeable patient populations.
• Financial Outlook: Revenue projections suggest considerable market opportunity contingent upon successful approvals and commercialization strategies.
• Risk Management: Focus on clinical risk mitigation, regulatory alignment, and biomarker development to maximize prospects.

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FAQs

Q1: What are the key differentiators of KRINTAFEL compared to existing kinase inhibitors?
A1: KRINTAFEL targets a novel kinase mutation pathway with a favorable safety profile and preliminary evidence of overcoming resistance mechanisms seen with existing therapies, providing potential for improved efficacy.

Q2: When is KRINTAFEL expected to initiate Phase III trials?
A2: The company plans to commence Phase III trials in 2024, contingent on the full analysis of Phase II results and regulatory feedback.

Q3: What are the primary indications for KRINTAFEL’s application?
A3: The initial focus is on non-small cell lung cancer with specific kinase mutations, with subsequent expansion into ovarian and pancreatic cancers based on ongoing trial data.

Q4: How does KRINTAFEL fit into the competitive landscape?
A4: Its unique mechanism and targeted patient populations provide differentiation, aiming to carve out a niche in personalized oncology therapy that rivals existing multi-indication kinase inhibitors.

Q5: What are the main challenges facing KRINTAFEL’s market entry?
A5: Challenges include clinical validation against existing standards, regulatory approval hurdles, payer reimbursement negotiations, and establishing reliable companion diagnostics.

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Sources
[1] Grand View Research, “Oncology Drugs Market Size, Share & Trends Analysis Report,” 2022.

Note: Data points and projections are based on current publicly available information and expert analysis as of early 2023.