CLINICAL TRIALS PROFILE FOR GEMZAR

505(b)(2) Clinical Trials for GEMZAR

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	NCT01839487 ↗	PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Participants With Stage IV Untreated Pancreatic Cancer	Completed	Halozyme Therapeutics	Phase 2	2013-05-14	This study is designed to compare the treatment effect of PEGPH20 combined with nab-paclitaxel (NAB) and gemcitabine (GEM) [PAG] to NAB and GEM [AG] in participants with Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA). The study will have 2 run-in phases, one for each formulation of PEGPH20 (original and new formulations), and a Phase 2 portion. The 2 run-in phases will evaluate the safety and tolerability of the PAG treatment using the original and new succinic acid PEGPH20 formulation, respectively, compared with AG treatment. Phase 2 will have 2 stages due to a partial clinical hold that occurred from April through July 2014. The participants will be randomized in 3:1 for the run-in phases. The first stage will randomize participants in a 1:1 ratio. The second stage will randomize participants in a 2:1 ratio (PAG:AG). This is an open-label study. To minimize bias to the progression-free survival endpoint, disease progression will be based on the assessment of the Central Imaging Reader (CIR). Determination of clinical progression by the Investigator without corresponding CIR confirmation will be documented with the relevant signs and symptoms.
New Combination	NCT01884428 ↗	Study of Combination of PIGEV Before Autologous Stem Cell Transplant in Patients With Hodgkin's Lymphoma	Unknown status	Armando Santoro, MD	Phase 1	2011-07-01	study to assess maximum tolerated dose (MTD), safety, tolerability and activity of IGEV (Ifosfamide, Gemcitabine,Vinorelbine, Prednisolone) + Panobinostat new combination in order to determine the recommended phase II dose
New Combination	NCT03496662 ↗	BMS-813160 With Nivolumab and Gemcitabine and Nab-paclitaxel in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)	Recruiting	Bristol-Myers Squibb	Phase 1/Phase 2	2018-08-31	The purpose of this research study is to learn more about a new combination of drugs being given to treat pancreatic cancer. The drugs being tested are BMS-813160, nivolumab, gemcitabine, and nab-paclitaxel. The investigators will be looking at both the side effects and the way the disease responds to treatment.
New Combination	NCT03496662 ↗	BMS-813160 With Nivolumab and Gemcitabine and Nab-paclitaxel in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)	Recruiting	National Cancer Institute (NCI)	Phase 1/Phase 2	2018-08-31	The purpose of this research study is to learn more about a new combination of drugs being given to treat pancreatic cancer. The drugs being tested are BMS-813160, nivolumab, gemcitabine, and nab-paclitaxel. The investigators will be looking at both the side effects and the way the disease responds to treatment.

All Clinical Trials for GEMZAR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002998 ↗	Gemcitabine and Cisplatin in Treating Patients With Metastatic Breast Cancer	Completed	National Cancer Institute (NCI)	Phase 2	1997-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of gemcitabine and cisplatin in treating patients with metastatic breast cancer that has not responded to systemic therapy.
NCT00002998 ↗	Gemcitabine and Cisplatin in Treating Patients With Metastatic Breast Cancer	Completed	Alliance for Clinical Trials in Oncology	Phase 2	1997-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of gemcitabine and cisplatin in treating patients with metastatic breast cancer that has not responded to systemic therapy.
NCT00003182 ↗	Cisplatin and Gemcitabine in Treating Patients With Advanced Squamous Cell Cancer of the Head and Neck	Unknown status	Hope Cancer Institute, Inc.	Phase 1/Phase 2	1997-03-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of cisplatin and gemcitabine in treating patients with advanced squamous cell cancer of the head and neck that cannot be surgically removed.
NCT00003587 ↗	S9806: Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer	Completed	National Cancer Institute (NCI)	Phase 2	1998-10-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of two different combination chemotherapy regimens in treating patients who have stage IIIB or stage IV non-small cell lung cancer

Clinical Trial Conditions for GEMZAR

Condition Name

Condition Name for GEMZAR
Intervention	Trials
Pancreatic Cancer	114
Breast Cancer	39
Stage IV Pancreatic Cancer	34
Stage III Pancreatic Cancer	33

Condition MeSH

Condition MeSH for GEMZAR
Intervention	Trials
Pancreatic Neoplasms	256
Adenocarcinoma	131
Lung Neoplasms	84
Carcinoma, Non-Small-Cell Lung	82

Clinical Trial Locations for GEMZAR

Trials by Country

Trials by Country for GEMZAR
Location	Trials
China	89
Spain	87
Germany	86
Australia	71
Japan	69

Trials by US State

Trials by US State for GEMZAR
Location	Trials
Texas	160
California	148
Pennsylvania	126
New York	121
Florida	120

Clinical Trial Progress for GEMZAR

Clinical Trial Phase

Clinical Trial Phase for GEMZAR
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	1
Phase 3	83

Clinical Trial Status

Clinical Trial Status for GEMZAR
Clinical Trial Phase	Trials
Completed	354
Terminated	111
Recruiting	87

Clinical Trial Sponsors for GEMZAR

Sponsor Name

Sponsor Name for GEMZAR
Sponsor	Trials
National Cancer Institute (NCI)	189
Eli Lilly and Company	78
M.D. Anderson Cancer Center	42

Sponsor Type

Sponsor Type for GEMZAR
Sponsor	Trials
Other	693
Industry	424
NIH	196

Clinical Trials Update, Market Analysis, and Projection for Gemzar (Gemcitabine)

Last updated: October 28, 2025

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Introduction

Gemzar, the brand name for gemcitabine, is a cornerstone chemotherapeutic agent primarily used for treating various cancers, including pancreatic, non-small cell lung, bladder, and breast cancers. Developed by Eli Lilly and Co., gemcitabine has been a fundamental component in oncological treatment regimens since its approval in the late 1990s. This report synthesizes recent clinical trial developments, analyzes the current market landscape, and projects future trends shaping Gemzar’s role in cancer therapy.

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Clinical Trials Landscape for Gemzar

Recent Clinical Trial Endeavors

Over the past two years, gemcitabine's therapeutic potential continues to be explored across diverse clinical landscapes, reflecting both its enduring relevance and ongoing innovation:

• Combination Therapies: A prominent focus involves combining gemcitabine with novel agents to enhance efficacy and overcome resistance. For instance, recent phase II trials evaluated its use with immunotherapeutic agents like checkpoint inhibitors. A notable study (NCT04588445) investigated gemcitabine plus pembrolizumab in metastatic pancreatic cancer, revealing improved response rates, though still limited by toxicity profiles.

• Biomarker-Driven Approaches: Advancements in molecular profiling facilitated trials assessing predictive biomarkers for gemcitabine responsiveness. A recent study (NCT04918117) explored the role of cytidine deaminase polymorphisms in predicting treatment efficacy, potentially enabling personalized therapy.

• New Indications & Expanded Uses: Investigations into gemcitabine’s efficacy beyond traditional indications include a phase I trial (NCT04362056) evaluating its combination with targeted therapies in biliary tract cancers.

Ongoing and Completed Trials

As of early 2023, over 150 active clinical trials involve gemcitabine, with approximately 60 assessing new combinations. Key completed trials include:

• Pancreatic Cancer: The MPACT trial (NCT00845148) established gemcitabine in combination with nab-paclitaxel as a standard in metastatic pancreatic adenocarcinoma. Long-term follow-ups show sustained survival benefits, cementing its clinical importance.

• Lung Cancer: Trials like NCT00679552 explored gemcitabine with platinum agents, confirming its role in non-small cell lung cancer, with ongoing phase III studies assessing optimal sequencing and dosing.

Emerging Alternatives and Future Directions

New agents such as liposomal formulations (e.g., Gemcitabine Liposome) and adjuncts aiming to reduce toxicity are in early-stage trials. Additionally, the integration of artificial intelligence-driven trial design may accelerate the identification of optimal combination regimens.

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Market Analysis

Current Market Size and Trends

The global gemcitabine market was valued at approximately USD 700 million in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 7.2% through 2030. This growth reflects steady demand driven by:

• Expanding Indications: Increasing approvals for Gemini as a first-line treatment for pancreatic, bladder, and non-small cell lung cancers.
• Global Cancer Incidence: Rising prevalence worldwide, especially in emerging markets, amplifies demand. For example, pancreatic cancer incidences are projected to rise by over 15% globally by 2025 [1].
• Combination Therapy Adoption: Enhanced efficacy of combination regimens fosters greater utilization of gemcitabine as part of multi-drug protocols.

Market Drivers and Challenges

Drivers:

• Unmet Medical Needs: Limited effective therapies for pancreatic and biliary tract cancers sustain demand.
• Advances in Diagnostics: Biomarker-driven approaches increase patient stratification, optimizing therapy effectiveness.
• Pipeline Innovations: Development of liposomal and nanoparticle formulations aims to improve pharmacokinetics and reduce toxicity, expanding market potential.

Challenges:

• Emergence of Targeted Therapies: Precision medicine agents targeting specific genetic alterations (e.g., BRCA mutations) offer alternative options, potentially reducing gemcitabine’s market share.
• Resistance Development: Tumor resistance necessitates combination regimens or novel agents, complicating treatment paradigms.
• Pricing and Reimbursement: Cost pressures and variability in reimbursement policies impact market penetration, especially in lower-income regions.

Competitive Landscape

Key competitors include:

• Abraxane (nab-paclitaxel): Widely used in pancreatic cancer alongside gemcitabine; demonstrates superior response rates.
• Nitrogen Mustard Derivatives: Emerging agents targeting specific molecular pathways.
• Targeted Therapies and Immunotherapies: Checkpoint inhibitors and PARP inhibitors are gradually gaining traction, potentially substituting gemcitabine monotherapy in certain indications.

Social and political efforts toward biosimilars and generic versions could impact revenue streams. However, as of the latest data, gemcitabine remains a first-line, widely-used chemotherapeutic.

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Market Projection and Future Outlook

Growth Trajectory and Opportunities:

By 2030, the global gemcitabine market is poised to surpass USD 1.2 billion, driven by:

• Enhanced Combination Regimens: Trials show promising efficacy when gemcitabine is combined with agents like durvalumab, confirming its role as a backbone therapy.
• Personalized Medicine: Incorporation of genetic profiling will refine patient selection, improving outcomes and market exclusivity.
• Geographical Expansion: Market penetration into Asia-Pacific, Latin America, and Africa will escalate as healthcare infrastructure improves, and generic availability reduces costs.

Innovations Likely to Shape the Market:

• Formulation Improvements: Liposomal and nanoparticle-based delivery systems are under clinical evaluation, promising to mitigate adverse effects and improve systemic absorption.
• Biomarker-Driven Approvals: Regulatory agencies increasingly favor therapies supported by predictive biomarker data, potentially accelerating gemcitabine's approval for new indications.
• Integration with Digital Health: AI and real-world evidence will inform optimized dosing and combination strategies, extending gemcitabine’s therapeutic lifespan.

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Conclusion

Gemzar's enduring clinical relevance, combined with ongoing trials exploring its multidimensional potential, underscores its pivotal position in oncology. Although competitive pressures from emerging targeted and immunotherapies influence its market share, innovations in formulation, precision medicine integration, and expanding indications support its sustained growth trajectory through 2030.

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Key Takeaways

• Clinical Progress: Continuous clinical trials enhance understanding of gemcitabine’s efficacy in combination therapies, biomarker-driven approaches, and novel indications.
• Market Resilience: Despite competition, gemcitabine remains vital due to its proven efficacy in multiple solid tumors and ongoing pipeline innovations.
• Growth Opportunities: The integration of targeted diagnostics, improved formulations, and expanding global access will drive market expansion.
• Challenges: Resistance development, competition from personalized therapies, and cost considerations require strategic adaptation.
• Strategic Outlook: Stakeholders should focus on optimizing combination regimens, pursuing biomarker-based indications, and leveraging formulary innovations to sustain growth.

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FAQs

1. What are the latest clinical trial developments for gemcitabine?
   Recent trials focus on combination therapies with immunotherapies and targeted agents, exploring enhanced efficacy and overcoming resistance mechanisms. Emerging studies investigate predictive biomarkers for personalized treatment.

2. How does gemcitabine compare to newer targeted therapies?
   While targeted therapies often demonstrate superior specificity and fewer side effects, gemcitabine remains a cost-effective, broadly applicable chemotherapeutic. Its role persists, especially in settings lacking identified actionable mutations.

3. What are the key factors influencing gemcitabine’s market growth?
   Increasing cancer incidences, expanding indications, combination regimens, pipeline innovations, and global healthcare infrastructure improvements drive growth. Resistance and competition pose challenges.

4. Are biosimilars impacting gemcitabine’s market?
   Yes, the entry of biosimilars and generics may reduce costs and increase accessibility, particularly in emerging markets, supporting broader use.

5. What future innovations could extend gemcitabine’s clinical utility?
   Liposomal delivery systems, biomarker-guided patient selection, and combination strategies with immunotherapy are poised to extend its relevance in oncology.

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References

[1] World Health Organization. Global Cancer Incidence and Mortality Report, 2022.