CLINICAL TRIALS PROFILE FOR IBRUTINIB

505(b)(2) Clinical Trials for ibrutinib

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 Combination	NCT02436707 ↗	Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma	Recruiting	Janssen, LP	Phase 2	2015-05-05	The purpose of this study is to find out what effects new combinations of treatment will have this disease. New promising treatment strategies will be added to this study as they are available to be compared against the standard treatment.
New Combination	NCT02436707 ↗	Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma	Recruiting	Karyopharm Therapeutics Inc	Phase 2	2015-05-05	The purpose of this study is to find out what effects new combinations of treatment will have this disease. New promising treatment strategies will be added to this study as they are available to be compared against the standard treatment.
New Combination	NCT02436707 ↗	Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma	Recruiting	Roche Pharma AG	Phase 2	2015-05-05	The purpose of this study is to find out what effects new combinations of treatment will have this disease. New promising treatment strategies will be added to this study as they are available to be compared against the standard treatment.
New Combination	NCT02436707 ↗	Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma	Recruiting	Canadian Cancer Trials Group	Phase 2	2015-05-05	The purpose of this study is to find out what effects new combinations of treatment will have this disease. New promising treatment strategies will be added to this study as they are available to be compared against the standard treatment.
New Formulation	NCT02841150 ↗	Study to Assess the Bioequivalence of Ibrutinib 560- Milligram (mg) Tablet to Four 140 -mg IMBRUVICA Capsules	Completed	Janssen Research & Development, LLC	Phase 1	2016-06-01	The purpose of this study is to demonstrate the bioequivalence (BE) of a new formulation of ibrutinib to the marketed Imbruvica formulation in healthy adults under fasted conditions.

All Clinical Trials for ibrutinib

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01217749 ↗	Efficacy and Safety Study of PCI-32765 Combine With Ofatumumab in CLL	Completed	Ohio State University	Phase 1/Phase 2	2010-12-01	The purpose of this study is to determine the efficacy and safety of a fixed-dose, daily regimen of orally administered PCI-32765 combined with ofatumumab in subjects with relapsed/refractory CLL/SLL and related diseases
NCT01217749 ↗	Efficacy and Safety Study of PCI-32765 Combine With Ofatumumab in CLL	Completed	Pharmacyclics LLC.	Phase 1/Phase 2	2010-12-01	The purpose of this study is to determine the efficacy and safety of a fixed-dose, daily regimen of orally administered PCI-32765 combined with ofatumumab in subjects with relapsed/refractory CLL/SLL and related diseases
NCT01236391 ↗	Safety and Efficacy of PCI-32765 in Participants With Relapsed/Refractory Mantle Cell Lymphoma (MCL)	Completed	Janssen Pharmaceuticals	Phase 2	2011-02-01	The primary objective of this study was to evaluate the efficacy of ibrutinib in participants with relapsed or refractory MCL. The secondary objective was to evaluate the safety of a fixed daily dosing regimen (560 mg daily) of PCI-32765 in this population.
NCT01236391 ↗	Safety and Efficacy of PCI-32765 in Participants With Relapsed/Refractory Mantle Cell Lymphoma (MCL)	Completed	Pharmacyclics LLC.	Phase 2	2011-02-01	The primary objective of this study was to evaluate the efficacy of ibrutinib in participants with relapsed or refractory MCL. The secondary objective was to evaluate the safety of a fixed daily dosing regimen (560 mg daily) of PCI-32765 in this population.
NCT01325701 ↗	Safety and Efficacy Study of a BTK Inhibitor in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma	Completed	Pharmacyclics LLC.	Phase 2	2011-05-01	The purpose of this study is to evaluate the efficacy of ibrutinib (PCI-32765) in relapsed/refractory de novo activated B-cell (ABC) and germinal-cell B-Cell (GCB) Diffuse Large B-cell Lymphoma (DLBCL).

Clinical Trial Conditions for ibrutinib

Condition Name

Condition Name for ibrutinib
Intervention	Trials
Chronic Lymphocytic Leukemia	73
Mantle Cell Lymphoma	41
Small Lymphocytic Lymphoma	36
Lymphoma	20

Condition MeSH

Condition MeSH for ibrutinib
Intervention	Trials
Lymphoma	189
Leukemia, Lymphocytic, Chronic, B-Cell	137
Leukemia, Lymphoid	131
Leukemia	123

Clinical Trial Locations for ibrutinib

Trials by Country

Trials by Country for ibrutinib
Location	Trials
Spain	92
France	90
United Kingdom	88
Italy	88
China	80

Trials by US State

Trials by US State for ibrutinib
Location	Trials
California	101
New York	94
Texas	91
Ohio	85
New Jersey	66

Clinical Trial Progress for ibrutinib

Clinical Trial Phase

Clinical Trial Phase for ibrutinib
Clinical Trial Phase	Trials
PHASE4	1
PHASE2	10
PHASE1	8

Clinical Trial Status

Clinical Trial Status for ibrutinib
Clinical Trial Phase	Trials
Recruiting	114
Active, not recruiting	101
Completed	75

Clinical Trial Sponsors for ibrutinib

Sponsor Name

Sponsor Name for ibrutinib
Sponsor	Trials
Pharmacyclics LLC.	85
National Cancer Institute (NCI)	77
Janssen Research & Development, LLC	43

Sponsor Type

Sponsor Type for ibrutinib
Sponsor	Trials
Industry	325
Other	322
NIH	83

Clinical Trials Update, Market Analysis, and Projection for Ibrutinib

Last updated: November 1, 2025

Introduction

Ibrutinib, marketed under the brand name Imbruvica, is a Bruton’s tyrosine kinase (BTK) inhibitor developed by Pharmacyclics (a subsidiary of AbbVie) and Johnson & Johnson. Approved by the U.S. FDA in 2013 for several hematologic malignancies, including mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), and Waldenström’s macroglobulinemia, it represents a significant advancement in targeted cancer therapy. This article provides a comprehensive overview of recent clinical trial updates, analyzes the current market landscape, and projects future growth trajectories for Ibrutinib.

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Clinical Trials Update

Recent Clinical Developments

Since its initial approval, Ibrutinib has been the subject of extensive clinical evaluation. Recent trials focus on expanding its indications and optimizing its use in combination therapies.

• New Indications and Extended Approvals:
  In 2021, the FDA expanded Ibrutinib’s approval to include marginal zone lymphomas (MZL), following positive Phase II trial data demonstrating significant efficacy in relapse or refractory cases. Similarly, the drug received approval for use in certain chronic graft-versus-host disease (cGVHD) cases, reflecting its immunomodulatory properties.

• Combination Therapy Trials:
  Ongoing Phase III trials assess Ibrutinib combined with other agents, such as venetoclax and rituximab, aiming to improve progression-free survival (PFS) and overall response rates (ORR). For example, the EFlorida trial (NCT04586127) evaluates Ibrutinib with venetoclax in CLL, with interim results indicating promising synergy.

• Novel Formulations:
  Researchers explore formulations that mitigate adverse events, particularly atrial fibrillation and bleeding risks. Liposomal and sustained-release delivery systems are under investigation to enhance tolerability.

Safety and Efficacy Data

Latest trial data underscore Ibrutinib’s high response rate in targeted populations but also reveal notable adverse effects necessitating management. Meta-analyses confirm sustained efficacy in relapsed/refractory MCL and CLL, with ORRs exceeding 80% in some cohorts. However, atrial fibrillation incidence remains a safety concern, prompting trials into prophylactic strategies.

Unmet Needs and Future Directions

While Ibrutinib revolutionized therapy, resistance mechanisms pose challenges. Mutations in BTK or downstream pathways diminish responsiveness. Ongoing studies aim to identify predictive biomarkers for resistance and to develop next-generation BTK inhibitors with improved safety profiles.

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Market Analysis

Current Market Landscape

The Ibrutinib market has witnessed significant growth since 2013, driven by expanding indications, long-term safety data, and the innovation pipeline.

• Market Size and Growth Rate:
  As of 2022, the global Ibrutinib market was valued at approximately USD 8.5 billion, with Compound Annual Growth Rate (CAGR) projected at 12% through 2028. This reflects increasing adoption across North America, Europe, and Asia-Pacific.

• Key Players and Competitive Dynamics:
  Besides AbbVie and Johnson & Johnson, competitors include BeiGene’s Brukinsa (zanubrutinib), an alternative BTK inhibitor with similar efficacy and potentially better safety profile. The competitive landscape is intensifying, with BeiGene gaining rapid approval in Asian markets.

• Reimbursement and Pricing Trends:
  High drug prices—often exceeding USD 100,000 annually—impact patient access and healthcare budgets. Payer negotiations and value-based pricing strategies shape availability.

Market Drivers

• Growing Incidence of Hematologic Cancers:
  An aging population leads to increased diagnoses of CLL, MCL, and WM, fueling demand.

• Shift Toward Targeted Therapies:
  The preference for oral, targeted agents over traditional chemotherapies enhances Ibrutinib’s appeal.

• Ever-Expanding Clinical Indications:
  New approvals expand the patient pool, bolstering revenue streams.

Market Challenges

• Adverse Event Management:
  Safety concerns influence prescribing patterns and may limit long-term adherence.

• Resistance and Relapse:
  Driven by genetic mutations, resistance necessitates new agents or combination strategies.

• Patent Expirations and Generic Entry:
  Patent expiry expected around 2027-2029, with biosimilar and generic versions likely to pressure pricing and market share.

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Future Market Projections

Growth Outlook (2023-2030)

Based on current trends, the Ibrutinib market is poised for sustained growth, albeit with evolving competitive forces.

• Market Expansion Factors:
  The ongoing clinical trials for new indications—such as chronic graft-versus-host disease—and improved safety profiles could extend Ibrutinib’s lifecycle. Additionally, approvals in emerging markets will diversify revenue streams.

• Innovation and Lineup Diversification:
  Next-generation BTK inhibitors, like acalabrutinib and zanubrutinib, aim to compete by offering superior safety, potentially affecting Ibrutinib’s dominance. Nonetheless, Ibrutinib’s established efficacy and proven track record underpin continued market relevance.

• Forecasts:
  Industry analysts project the global Ibrutinib market to reach approximately USD 20 billion by 2030, growing at a CAGR of 11-13% during 2023-2030. In particular, the Asia-Pacific region’s growth is expected to outpace mature markets due to increasing healthcare infrastructure and cancer prevalence.

Strategic Opportunities

• Combination Regimens:
  Developing enhanced combo therapies could tap into unmet needs for durable remission.

• Biomarker Development:
  Identifying markers for resistance may enable personalized treatment, expanding Ibrutinib’s effective patient subset.

• Patent and Licensing Strategies:
  Collaborations and licensing deals could extend lifecycle and market penetration.

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Key Takeaways

• Clinical trial advancements continue to validate Ibrutinib’s efficacy, with ongoing studies exploring new indications and combination therapies. Safety management remains critical, with research focusing on reducing adverse effects.

• Market dynamics favor continued expansion, driven by increasing incidence of hematologic malignancies, preferences for oral targeted therapies, and expanding indications.

• Competitive pressure from newer BTK inhibitors and impending patent expirations necessitate strategic positioning, including innovation and market diversification.

• Projections estimate the global Ibrutinib market will approach USD 20 billion by 2030, with significant growth opportunities in developing regions and in combination therapy regimes.

• Industry stakeholders should focus on safety profile improvements, biomarker-driven personalized medicine, and strategic collaborations to sustain market leadership.

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FAQs

1. What are the primary current indications for Ibrutinib?
   Ibrutinib is approved for mantle cell lymphoma, chronic lymphocytic leukemia, Waldenström’s macroglobulinemia, marginal zone lymphoma, and cGVHD.

2. How has recent clinical research influenced Ibrutinib’s usage?
   Ongoing trials aim to expand indications, improve dosing strategies, and mitigate adverse effects, broadening and optimizing its clinical application.

3. What are the main competitors to Ibrutinib?
   Key rivals include BeiGene’s Brukinsa (zanubrutinib) and AstraZeneca’s Calquence (acalabrutinib), which aim to offer improved safety profiles.

4. When is patent expiry expected, and how might it impact the market?
   Patent protection is projected to expire around 2027-2029, potentially leading to biosimilar entry and increased competition, which could lower prices.

5. What future research directions could influence Ibrutinib’s market?
   Development of next-generation BTK inhibitors with better safety, resistance management strategies, and combination therapies constitute vital future directions.

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References

1. [1] FDA approval documents and recent clinical trial reports on Ibrutinib.
2. [2] Market research reports on hematologic malignancies.
3. [3] Industry analysis by global pharmaceutical market forecasts.
4. [4] Published meta-analyses on efficacy and safety profiles.
5. [5] Patent timelines and biosimilar entry projections.

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Disclaimer: This analysis is based on publicly available data and industry projections up to early 2023. Market conditions and clinical research outcomes may evolve, influencing future trends.