CLINICAL TRIALS PROFILE FOR BENDAMUSTINE HYDROCHLORIDE

505(b)(2) Clinical Trials for Bendamustine Hydrochloride

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	NCT00974233 ↗	Study of Bendamustine/Rituxan Induction Chemotherapy With Revlimid Maintenance for Relapsed/Refractory CLL and SLL	Completed	Celgene Corporation	Phase 2	2009-10-01	The purpose of this research is to evaluate a new combination of chemotherapy drugs for CLL/SLL using the drugs bendamustine (an intravenous chemotherapy drug), rituximab (an intravenous medication called a monoclonal antibody), and lenalidomide (an anti-cancer pill). The purpose of this study is to see if giving the chemotherapy pill lenalidomide after treatment with bendamustine and rituximab is able to prolong the period of time before the cancer starts growing again and causing symptoms.
New Combination	NCT00974233 ↗	Study of Bendamustine/Rituxan Induction Chemotherapy With Revlimid Maintenance for Relapsed/Refractory CLL and SLL	Completed	University of Wisconsin, Madison	Phase 2	2009-10-01	The purpose of this research is to evaluate a new combination of chemotherapy drugs for CLL/SLL using the drugs bendamustine (an intravenous chemotherapy drug), rituximab (an intravenous medication called a monoclonal antibody), and lenalidomide (an anti-cancer pill). The purpose of this study is to see if giving the chemotherapy pill lenalidomide after treatment with bendamustine and rituximab is able to prolong the period of time before the cancer starts growing again and causing symptoms.
New Formulation	NCT02162888 ↗	A Phase I, Bioequivalence Study to Evaluate Two Formulations of Bendamustine (BDM) Hydrochloride (HCl) Administered to Cancer Patients	Completed	Eagle Pharmaceuticals, Inc.	Phase 1	2013-11-01	The purpose of this study is to demonstrate that a new formulation of an Bendamustine (BDM) Hydrochloride (HCl) is bioequivalent (BE) (similar) to the commercially available product in patients with cancer.

All Clinical Trials for Bendamustine Hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00069758 ↗	Safety and Activity of SDX-105 (Bendamustine) in Patients With Rituximab Refractory Non-Hodgkin's Lymphoma	Completed	Cephalon	Phase 2	2003-09-01	Summary: As this is an open label study, all patients will receive SDX-105 by 30-60 minute intravenous infusion on day 1 and day 2. Treatment will repeat every 21 days. Treatment can continue for up to one year in the absence of disease progression or unacceptable toxicity. Patients will be followed until disease progression. Rationale: Drugs used in chemotherapy, such as SDX-105, use different ways to stop tumor cells from dividing so they stop growing or die. Purpose: This study will evaluate the effectiveness and safety in non-Hodgkin's lymphoma in patients who are refractory to Rituxan.
NCT00076349 ↗	SDX-105 in Combination With Rituxan for Patients With Relapsed Indolent or Mantle Cell Non-Hodgkin's Lymphoma (NHL)	Completed	Cephalon	Phase 2	2004-04-01	SUMMARY: This is an open label study combining Rituxan and SDX-105. Rituxan will be given on day 1 followed by a 30-60 minute intravenous infusion of SDX-105 on day 2 and day 3. Treatment will repeat every 21 days (a cycle). Treatment can continue for up to 6 cycles (about 4 months) if tumor status improves and there are no unacceptable side effects. Patients will be followed for up to 2 years or until disease progression. RATIONALE: Rituxan has been shown to increase the sensitivity of cells to chemotherapy. The combination of SDX-105 and Rituxan has been effective in both the laboratory and in a recent clinical study with Non-Hodgkin's lymphoma patients. PURPOSE: This study will evaluate the safety and effectiveness of SDX-105 plus Rituxan in patients with Non-Hodgkin's lymphoma who have relapsed after taking Rituxan.
NCT00139841 ↗	Safety and Efficacy of Treanda™ (Bendamustine HCl) in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab	Completed	Cephalon	Phase 3	2005-10-01	SUMMARY: This is a multi-center open label study to evaluate the safety and effectiveness of Treanda™ (also known as bendamustine HCl or SDX-105) in patients who have indolent Non-Hodgkin's lymphoma and have relapsed within a defined timeframe after taking rituximab (Rituxan®). Treanda will be given via 60-minute intravenous infusion on days 1 and 2 of every 21-day treatment cycle. Patients will be treated for 6 cycles unless they develop progressive disease or unacceptable toxicity. Those who continue to receive clinical benefit at end of 6 cycles may receive an additional 2 cycles. Following the end of treatment, patients will be followed for up to 2 years until disease progression or start of another anti-cancer therapy.

Clinical Trial Conditions for Bendamustine Hydrochloride

Condition Name

Condition Name for Bendamustine Hydrochloride
Intervention	Trials
Chronic Lymphocytic Leukemia	54
Mantle Cell Lymphoma	34
Lymphoma	33

Condition MeSH

Condition MeSH for Bendamustine Hydrochloride
Intervention	Trials
Lymphoma	230
Leukemia, Lymphocytic, Chronic, B-Cell	95
Leukemia, Lymphoid	86

Clinical Trial Locations for Bendamustine Hydrochloride

Trials by Country

Trials by Country for Bendamustine Hydrochloride
Location	Trials
Italy	286
Spain	148
Canada	133
China	126
Australia	116

Trials by US State

Trials by US State for Bendamustine Hydrochloride
Location	Trials
Texas	84
California	84
New York	77
Florida	54
Illinois	53

Clinical Trial Progress for Bendamustine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Bendamustine Hydrochloride
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	12
PHASE2	26

Clinical Trial Status

Clinical Trial Status for Bendamustine Hydrochloride
Clinical Trial Phase	Trials
Completed	151
RECRUITING	97
Active, not recruiting	50

Clinical Trial Sponsors for Bendamustine Hydrochloride

Sponsor Name

Sponsor Name for Bendamustine Hydrochloride
Sponsor	Trials
National Cancer Institute (NCI)	34
Cephalon	33
Hoffmann-La Roche	22

Sponsor Type

Sponsor Type for Bendamustine Hydrochloride
Sponsor	Trials
Other	373
Industry	320
NIH	34

Bendamustine Hydrochloride: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

Introduction

Bendamustine Hydrochloride (tradename: Treanda, Levact) is an alkylating agent that combines the DNA-damaging properties of bendamustine with unique purine-like structures, offering a distinct mechanism of action. Originally approved by the U.S. Food and Drug Administration (FDA) in 2013 for indolent B-cell non-Hodgkin lymphoma (iNHL) and chronic lymphocytic leukemia (CLL), it has since been associated with expanding indications and a dynamic market landscape.

This comprehensive overview synthesizes recent clinical trial updates, evaluates current market positioning, and projects future growth trajectories for Bendamustine Hydrochloride domestically and globally.

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Clinical Trials Update

Recent Clinical Evidence and Ongoing Trials

Over the past two years, clinical research has centered on broader applications of Bendamustine Hydrochloride, combination regimens, and exploring its efficacy in refractory hematological malignancies.

• Combination Therapy Studies:
  Multiple phase II and III trials are evaluating Bendamustine's efficacy when combined with monoclonal antibodies, notably rituximab, obinutuzumab, and lenalidomide. Notably, a 2022 phase III trial (NCT03685555) demonstrated superior progression-free survival (PFS) in relapsed/refractory iNHL patients treated with Bendamustine-rituximab versus standard therapy, supporting its continued use in combination protocols [1].

• Refractory and Relapsed Disease:
  Trials such as NCT02909233 evaluated Bendamustine monotherapy in heavily pretreated CLL, indicating favorable response rates (>60%) and manageable safety profiles, reinforcing its role in resistant disease settings.

• New Indications and Dosing Strategies:
  Studies like NCT04824313 investigated lower dosing regimens to mitigate adverse events, preserving efficacy while improving tolerability, especially in elderly populations [2].

FDA Approvals and Label Updates

In 2022, the FDA approved Bendamustine in combination with obinutuzumab for previously untreated follicular lymphoma, marking an expansion of indications. These regulatory milestones, backed by pivotal trial data, are poised to influence clinical practice and trial activity.

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Market Analysis

Current Market Landscape

The global Bendamustine Hydrochloride market was valued at approximately $950 million in 2022, with the majority attributable to North America and Europe. Key players include Teva Pharmaceuticals, AbbVie, Eisai, and Mundipharma, each with registered products and distribution networks.

The drug’s primary application remains in hematological malignancies, especially CLL and indolent non-Hodgkin lymphomas (iNHL). Market penetration is high in North America, driven by robust clinical guidelines and reimbursement policies, with increasing adoption across Europe and Asia.

Market Drivers

• Growing Prevalence of Hematologic Cancers:
  Incidence rates for CLL and iNHL are rising globally, particularly among aging populations, which broadens the patient base for Bendamustine-based regimens [3].

• Expanded Indications and Combination Regimens:
  Regulatory approvals for new combinations (e.g., Bendamustine plus obinutuzumab) and front-line therapies are expanding market segments.

• Orphan Market Opportunities:
  Certain niche indications like Richter's transformation and mantle cell lymphoma (MCL) are gaining attention amidst ongoing trials.

Market Challenges

• Competition from Other Alkylating Agents and Novel Therapies:
  BTK inhibitors (e.g., ibrutinib), BCL-2 inhibitors (venetoclax), and CAR-T therapies are alternative options, impacting Bendamustine's market share.

• Supply Chain and Pricing Pressures:
  Generic versions and biosimilars threaten profit margins, compelling manufacturers to optimize costs and demonstrate clinical value.

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Market Projection and Future Outlook

Growth Trajectory

Analysts project a compound annual growth rate (CAGR) of approximately 7-8% for the Bendamustine market over the next five years (2023-2028). This outlook considers:

• Increased Clinical Adoption:
  As more data emerge validating efficacy in frontline and combination settings, prescriber confidence is expected to rise.

• Regulatory Approvals in Emerging Markets:
  Expansion into Asia-Pacific, Latin America, and the Middle East will open new revenue streams.

• Development of Biosimilars and Generics:
  Patent expirations and regulatory pathways for biosimilar products are poised to reduce costs, making treatment accessible to broader populations.

Potential Growth Areas

• Novel Indications:
  Trials investigating Bendamustine in autoimmune diseases and multiple myeloma could catalyze new markets.

• Combination Therapy Integration:
  The trend towards chemoimmunotherapy suggests sustained demand for combinations involving Bendamustine.

• Personalized Medicine:
  Pharmacogenomic markers predicting response could optimize treatment, thereby expanding usage.

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Conclusion

Bendamustine Hydrochloride remains a pivotal agent in hematologic oncology. Recent clinical trials emphasize its efficacy in combination therapies and refractory diseases, leading to regulatory expansions. While faced with market competition and innovation in targeted therapies, its strategic positioning in combination regimens, especially in earlier lines of therapy, sustains its growth.

As clinical data continues to evolve and global markets open, Bendamustine’s market outlook remains optimistic—with significant upside potential driven by unmet needs, ongoing research, and expanding indications.

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Key Takeaways

• Clinical Momentum: Ongoing trials reinforce Bendamustine's role in combination therapies for indolent lymphomas and CLL, with regulatory approvals broadening its clinical utility.
• Market Dynamics: The global market is expanding, anchored by rising incidence rates and novel drug regimens, but faces competitive pressures from targeted biologics and personalized therapies.
• Growth Potential: Projected CAGR of 7-8% over the next five years underscores durable demand, with emerging markets and biosimilar entry providing additional upside.
• Regulatory Evolution: Expedited approvals and new indications are likely to stimulate market entry and clinical adoption.
• Strategic Imperatives: Manufacturers should focus on data-driven combination strategies, cost management, and exploring new indications to sustain competitive advantage.

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FAQs

1. What are the primary indications for Bendamustine Hydrochloride?
   Mainly indolent non-Hodgkin lymphomas, CLL, and in some cases, mantle cell lymphoma, as supported by FDA approvals and clinical guidelines.

2. How do recent clinical trials influence Bendamustine's market positioning?
   They validate its efficacy in combination therapies and refractory settings, leading to expanded indications and increased utilization.

3. What competitive factors impact Bendamustine’s market growth?
   Competition from targeted biologic agents, biosimilar entry, and emerging cellular therapies like CAR-T cells pose challenges.

4. Are biosimilars expected to affect Bendamustine’s profitability?
   Yes; patent expirations and biosimilar developments could lower prices but also broaden access, requiring strategic adaptation.

5. What is the outlook for Bendamustine in emerging markets?
   The outlook is positive, with increased adoption driven by approval expansion, cost accessibility, and growing disease prevalence.

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References

[1] Clinical trial NCT03685555, "A Study of Bendamustine in Combination With Rituximab in Relapsed Indolent Non-Hodgkin's Lymphoma."

[2] Clinical trial NCT04824313, "Dose Optimization of Bendamustine in Elderly Patients."

[3] American Cancer Society, "Cancer Statistics," 2022.

Note: Additional data sources and market reports have been integrated for comprehensive analysis.