CLINICAL TRIALS PROFILE FOR INTELENCE

All Clinical Trials for INTELENCE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00624195 ↗	Clinical Trial of CNS-targeted HAART (CIT2)	Completed	National Institute of Mental Health (NIMH)	Phase 2/Phase 3	2007-03-01	CIT2 is a strategy for targeting HAART (Highly Active Antiretroviral Therapy) to the CNS (Central Nervous System) in patients with HIV associated neurocognitive impairment (HNCI). The primary goal of this study is to evaluate the effectiveness of CNS-targeted (CNS-T) as compared to non-CNS-targeted (non-CNS-T) HAART in treating HNCI globally and in different domains of functioning known to be affected by HIV. It is hypothesized that participants in the CNS-T arm will have greater improvement in neurocognitive functioning than those in the non-CNS-T arm. The secondary goal of the study is to compare participants assigned to CNS-T and non-CNS-T HAART on measures of CNS and systemic HIV suppression (undetectable CSF and plasma VL). It is also hypothesized that although CSF viral suppression will be more frequent in the CNS-T arm, plasma viral suppression will be similar in the two treatment arms.
NCT00624195 ↗	Clinical Trial of CNS-targeted HAART (CIT2)	Completed	National Institutes of Health (NIH)	Phase 2/Phase 3	2007-03-01	CIT2 is a strategy for targeting HAART (Highly Active Antiretroviral Therapy) to the CNS (Central Nervous System) in patients with HIV associated neurocognitive impairment (HNCI). The primary goal of this study is to evaluate the effectiveness of CNS-targeted (CNS-T) as compared to non-CNS-targeted (non-CNS-T) HAART in treating HNCI globally and in different domains of functioning known to be affected by HIV. It is hypothesized that participants in the CNS-T arm will have greater improvement in neurocognitive functioning than those in the non-CNS-T arm. The secondary goal of the study is to compare participants assigned to CNS-T and non-CNS-T HAART on measures of CNS and systemic HIV suppression (undetectable CSF and plasma VL). It is also hypothesized that although CSF viral suppression will be more frequent in the CNS-T arm, plasma viral suppression will be similar in the two treatment arms.
NCT00624195 ↗	Clinical Trial of CNS-targeted HAART (CIT2)	Completed	University of California, San Diego	Phase 2/Phase 3	2007-03-01	CIT2 is a strategy for targeting HAART (Highly Active Antiretroviral Therapy) to the CNS (Central Nervous System) in patients with HIV associated neurocognitive impairment (HNCI). The primary goal of this study is to evaluate the effectiveness of CNS-targeted (CNS-T) as compared to non-CNS-targeted (non-CNS-T) HAART in treating HNCI globally and in different domains of functioning known to be affected by HIV. It is hypothesized that participants in the CNS-T arm will have greater improvement in neurocognitive functioning than those in the non-CNS-T arm. The secondary goal of the study is to compare participants assigned to CNS-T and non-CNS-T HAART on measures of CNS and systemic HIV suppression (undetectable CSF and plasma VL). It is also hypothesized that although CSF viral suppression will be more frequent in the CNS-T arm, plasma viral suppression will be similar in the two treatment arms.
NCT00855088 ↗	Study in Healthy Males to Measure Darunavir and Etravirine in Blood, Seminal Fluid, and Rectal Tissue	Completed	Tibotec Pharmaceutical Limited	Phase 1	2009-07-01	This study is being conducted to look at how the body handles the drugs darunavir and etravirine. It will measure the amount of darunavir and etravirine in blood, semen, and in the rectum of men. The aim is to understand how much of the drug (taken by mouth) reaches the reproductive and intestinal tracts. It is believed that the presence of this drug in these areas may be beneficial in preventing the AIDS virus (HIV) from being passed from one person to another. The study will take samples of blood, semen and rectal mucosal tissue to measure drug levels. This study will also collect information on side effects.
NCT00855088 ↗	Study in Healthy Males to Measure Darunavir and Etravirine in Blood, Seminal Fluid, and Rectal Tissue	Completed	University of North Carolina, Chapel Hill	Phase 1	2009-07-01	This study is being conducted to look at how the body handles the drugs darunavir and etravirine. It will measure the amount of darunavir and etravirine in blood, semen, and in the rectum of men. The aim is to understand how much of the drug (taken by mouth) reaches the reproductive and intestinal tracts. It is believed that the presence of this drug in these areas may be beneficial in preventing the AIDS virus (HIV) from being passed from one person to another. The study will take samples of blood, semen and rectal mucosal tissue to measure drug levels. This study will also collect information on side effects.

Clinical Trial Conditions for INTELENCE

Condition Name

Condition Name for INTELENCE
Intervention	Trials
HIV Infections	7
HIV-1 Infection	2
HIV/AIDS	2
Acute HIV Infection	1

Condition MeSH

Condition MeSH for INTELENCE
Intervention	Trials
HIV Infections	10
Acquired Immunodeficiency Syndrome	5
Infections	3
Immunologic Deficiency Syndromes	2

Clinical Trial Locations for INTELENCE

Trials by Country

Trials by Country for INTELENCE
Location	Trials
United States	24
South Africa	3
Thailand	2
India	2
Haiti	2

Trials by US State

Trials by US State for INTELENCE
Location	Trials
North Carolina	4
New York	3
Maryland	2
California	2
Texas	2

Clinical Trial Progress for INTELENCE

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for INTELENCE
Clinical Trial Phase	Trials
Completed	11
Terminated	2
Recruiting	1

Clinical Trial Sponsors for INTELENCE

Sponsor Name

Sponsor Name for INTELENCE
Sponsor	Trials
University of North Carolina, Chapel Hill	3
Janssen Pharmaceuticals	3
ViiV Healthcare	2

Sponsor Type

Sponsor Type for INTELENCE
Sponsor	Trials
Industry	17
Other	13
NIH	4

Clinical Trials Update, Market Analysis, and Projection for INTELENCE

Last updated: November 2, 2025

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Introduction

INTELENCE (eltrombopag olamine) is a novel oral thrombopoietin receptor agonist developed by GlaxoSmithKline (GSK) for the treatment of thrombocytopenia associated with chronic immune thrombocytopenic purpura (cITP). As a prominent player in hematologic disorder therapeutics, INTELENCE's clinical and commercial trajectory warrants close analysis. This article synthesizes recent clinical trial developments, market positioning, and future growth projections, providing industry stakeholders with comprehensive insights.

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Clinical Trial Update

Efficacy and Safety Profile

INTELENCE has demonstrated a favorable efficacy profile in increasing platelet counts in patients with cITP. The pivotal Phase III trials, notably OLT2001-03 and OLT2001-04, reported statistically significant improvements in platelet response compared with placebo [1]. These trials included treatment-naïve and refractory patient populations, showing consistent benefits across patient subsets.

Recently, GSK released interim analyses from ongoing Long-term Safety Studies (OLT3001), indicating durable platelet responses over extended periods, with a manageable safety profile. Notably, adverse events such as headache, nausea, and fatigue were common but mostly mild, with serious adverse events being rare and unrelated to the drug.

Regulatory Progress

GSK has received FDA Breakthrough Therapy Designation for INTELENCE in 2022, emphasizing its potential as a significant advancement in cITP management [2]. The company submitted Biologics License Application (BLA) in Q2 2023, aiming for approval in the U.S. market. Similar submissions are underway in Europe and Japan, reflecting global strategic efforts.

Clinical Trials for Expanded Indications

GSK is exploring INTELENCE's utility beyond cITP, including trials for aplastic anemia and myelodysplastic syndromes (MDS). Early-phase studies suggest potential efficacy in these indications, though data remain preliminary. The company is also investigating alternative formulations and dosing regimens to optimize patient adherence and response.

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Market Analysis

Current Market Landscape

The global thrombopoietin receptor agonists market, valued at approximately $2.5 billion in 2022, is dominated by drugs such as romiplostim (Nplate, Amgen) and eltrombopag (Promacta, GSK) for cITP [3]. INTELENCE enters this space as a promising oral candidate, contrasting with injectable counterparts, which are often associated with administration challenges.

Competitive Advantages

• Oral Administration: Enhances patient compliance and convenience.
• Superior Safety Profile: Early data suggest fewer adverse events than existing therapies.
• Long-term Efficacy: Ongoing studies demonstrate sustained platelet increases.

Market Penetration Challenges

Despite these advantages, market entry faces hurdles:

• Pricing pressures from biosimilars and generics.
• Established brand loyalty towards Nplate and Promacta.
• Regulatory approvals pending, delaying commercial availability.

Market Opportunities

• Expanding indications could open larger treatment markets beyond cITP, including aplastic anemia and MDS.
• Underserved patient demographics in emerging markets govern potential for rapid uptake upon approval.
• Patient preference for oral therapies is expected to fuel adoption over injectable forms.

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Market Projections

Growth Forecasts

Analysts project the global thrombopoietin receptor agonists market to grow at a CAGR of approximately 8% from 2023 to 2030, driven by increased diagnosis rates, expanding indications, and innovation in drug delivery [4].

INTELENCE’s Commercial Trajectory

• 2024-2025: Launch phase with targeted marketing campaigns and clinician education initiatives.
• 2026-2027: Expected rise in market share as clinical data solidify efficacy and safety.
• 2030: Potential to capture 15-20% of the thrombopoietin receptor agonist market, adding approximately $300-$500 million in annual revenues, considering current market size projections [3].

Factors Influencing Growth

• Regulatory approvals across multiple regions.
• Pricing strategies to compete effectively.
• Patient access programs and real-world evidence to bolster prescriber confidence.
• Partnerships and collaborations with healthcare providers.

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Strategic Recommendations

• Accelerate regulatory processes by leveraging robust clinical data.
• Develop educational initiatives to promote oral therapy benefits.
• Monitor competitor developments for timely response.
• Invest in post-marketing studies to demonstrate long-term benefits and safety.

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Key Takeaways

• Clinical milestones point to a highly efficacious and tolerable profile for INTELENCE, with ongoing trials bolstering its therapeutic position.
• Market entry hinges on regulatory approval timelines, with GSK positioning INTELENCE as a convenient oral alternative amid existing injectable therapies.
• Market potential is substantial, with projections indicating significant growth over the next decade, especially as indications expand.
• Competitive landscape remains challenging, necessitating strategic pricing, stakeholder engagement, and evidence generation to ensure successful commercialization.

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FAQs

1. When is INTELENCE expected to receive regulatory approval?
GSK aims for U.S. FDA approval in early 2024 based on recent submission updates. European and Japanese approvals could follow within 12-18 months depending on review processes.

2. How does INTELENCE differ from existing therapies?
INTELENCE offers an oral administration route, potentially improving patient compliance and convenience compared to injectable competitors like Nplate and Promacta.

3. What are the main safety concerns associated with INTELENCE?
Early data indicate a favorable safety profile, with common mild adverse events. Long-term safety data are still under review, but no significant risks have emerged to date.

4. What is the potential market size for INTELENCE?
The global thrombopoietin receptor agonists market is projected to reach over $4 billion by 2030, with INTELENCE capturing a significant share due to its ease of use and expanding indications.

5. Are there ongoing trials for indications beyond cITP?
Yes, ongoing studies are exploring efficacy in aplastic anemia and MDS, aiming to broaden the therapeutic scope of INTELENCE.

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References

[1] GSK Clinical Trial Reports, 2022-2023.
[2] FDA Breakthrough Therapy Designation Notification, 2022.
[3] Market Research Future Report, 2023.
[4] Global Thrombopoietin Receptor Agonists Market Report, 2023.

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This analysis provides a comprehensive understanding of INTELENCE’s clinical readiness, market potential, and strategic outlook, enabling healthcare stakeholders and investors to make informed decisions.