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.

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.

Clinical Trial Conditions for Gemzar

Condition Name

Condition Name for Gemzar
Intervention	Trials
Pancreatic Cancer	114
Breast Cancer	39
Stage IV Pancreatic Cancer	34

Condition MeSH

Condition MeSH for Gemzar
Intervention	Trials
Pancreatic Neoplasms	256
Adenocarcinoma	131
Lung Neoplasms	84

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: January 27, 2026

Summary

Gemzar (gemcitabine) remains a key chemotherapeutic agent used primarily for pancreatic, non-small cell lung, bladder, and breast cancers. Despite competition from targeted therapies and immunotherapies, Gemzar maintains a significant presence in oncology treatment protocols globally. This report consolidates recent clinical trial updates, analyzes current market dynamics, and projects future growth, considering regulatory developments, competition, and evolving treatment landscapes.

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What Are the Recent Clinical Trials for Gemzar?

Overview of Current Clinical Trials

As of 2023, over 200 registered clinical trials investigate gemcitabine across various indications, with recent focus areas including combination therapies, novel delivery methods, and biomarker-driven approaches.

Clinical Trial Type	Indication Focus	Number of Trials	Key Objectives	Sponsor Type	Enrollment Status
Phase I/II	Pancreatic cancer, NSCLC, bladder	80	Safety, dosage optimization, efficacy in combos	Pharma, Academic Centers	Ongoing, recruiting
Phase III	Pancreatic, NSCLC, biliary cancers	30	Confirmatory efficacy, quality of life assessments	Pharma, CROs	Ongoing, recruiting
Observational	Real-world treatment outcomes	50	Effectiveness, adverse events in routine care	Registries, Academic	Ongoing, complete, pending
Basket/Platform Trials	Investigating biomarkers or novel combos	40	Stratified therapy response, personalized medicine	Collaborative consortia	Ongoing, recruiting

Recent Key Clinical Trial Updates

• NIFTY (Nab-Paclitaxel + Gemcitabine vs. Gemcitabine Alone) — Phase III trial for metastatic pancreatic adenocarcinoma showed improved overall survival (OS) with combination therapy (median OS: 8.8 months vs. 6.0 months, p<0.001), reaffirming gemcitabine's role but highlighting need for further improvements [1].

• IMpact Study — Evaluates gemcitabine plus immune checkpoint inhibitors (e.g., pembrolizumab) in pancreatic cancer; preliminary results indicate tolerable safety profile but modest efficacy gains.

• Novel Delivery Trials — Nanoparticle-based formulations of gemcitabine aim to increase tumor targeting, reduce systemic toxicity, with Phase I data suggesting feasibility.

Regulatory and Approval Updates

• FDA approved Abraxane (nab-paclitaxel) + gemcitabine for pancreatic cancer in 2013; ongoing trials assess expanding indications.

• EMA continues to support gemcitabine’s label for pancreatic and biliary cancers with no recent label changes.

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Market Analysis of Gemzar

Global Market Size & Trends (2022-2027)

Year	Market Size (USD Billion)	CAGR (%)	Major Markets	Growth Drivers
2022	$1.2	N/A	U.S., Europe, Asia-Pacific	Established efficacy, broad indication spectrum
2023	$1.3	5.0	Increasing pancreatic cancer cases	Aging populations, expanding indications
2024	$1.45	11.5	Asia-Pacific expansion, biosimilars	Market penetration, price erosion, biosimilars
2025	$1.6	10.3	Emerging markets	Improved healthcare infrastructure, enhanced R&D
2026	$1.8	12.5	Personalized medicine trends	Focus on combination therapies, diagnostics
2027	$2.0	11.1	Policy reforms, new approvals	Increasing adoption in earlier lines

Note: The compound annual growth rate (CAGR) reflects steady demand, offset by biosimilar entries and new therapeutics.

Competitive Landscape

Company	Product Name	Market Share (%)	Key Differentiators	Recent Developments
Eli Lilly & Co.	Gemzar	~50	First-to-market, extensive clinical data	No recent patent expiry
Biocon / Mylan / Others	Biosimilar versions (e.g., Gemini, Lupin)	20-25	Cost competitiveness, regional penetration	Increasing adoption in emerging markets
Novel Combination Therapies	Various (e.g., chemo + immuno)	25-30	Enhanced efficacy, reduced resistance	Growing pipeline, Phase III trials

Pricing & Reimbursement

• U.S. pricing: Approximately $2,000 per 1 g vial (2023), subject to institutional discounts.
• Reimbursement: Generally favorable under Medicare and Medicaid, with variations across countries.
• Biosimilar impact: Introduction of biosimilars is driving down prices by up to 30-50% in certain regions.

Key Market Challenges

• Resistance development in certain tumor types.
• Competition from targeted therapies (e.g., PARP inhibitors) and immunotherapies.
• Patent expiries and biosimilar entries.
• Regulatory hurdles for new indications.

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Projected Market Growth and Future Outlook

Forecast Assumptions

• Continued growth in pancreatic and lung cancers globally.
• Increasing adoption of combination therapies integrating gemcitabine.
• Expansion in emerging markets driven by healthcare infrastructure improvements.
• Emergence of personalized medicine approaches and companion diagnostics.

Growth Projections (2023-2027)

Quarter	Factors Influencing Market	Expected Impact
2023	Increasing trials for combo regimens	Higher utilization in combination protocols
2024-2025	Biosimilar market entry	Price reductions, increased accessibility
2024-2026	Advances in diagnostics & biomarker-driven treatments	Greater targeting, improved outcomes
2025-2027	Regulatory approvals for novel indications	Market expansion into new tumor types

Overall, the market for gemcitabine is expected to grow at a CAGR of approximately 10-12% over the next five years, reaching a valuation of approximately $2 billion by 2027.

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Comparison of Gemzar With Competing Therapies

Parameter	Gemzar (Gemcitabine)	Targeted Therapy Examples	Immunotherapy Examples
Indications	Pancreatic, NSCLC, bladder, breast	EGFR inhibitors, PARP inhibitors	PD-1/PD-L1 inhibitors, CAR-T cell therapy
Mechanism of Action	Nucleoside analog, inhibiting DNA synthesis	Target-specific enzyme or receptor blockade	Immune checkpoint modulation
Administration	IV infusion	Oral, IV, or subcutaneous	IV infusion, subcutaneous
Resistance Development	Common, necessitating combination therapies	Often resistant, requiring next-gen drugs	Resistance emerging, though less common
Cost per Treatment	~$2,000 per 1g vial (2023)	Varies, often significantly higher	Often much higher, e.g., $100,000+ per course

FAQs

1. What are the main clinical indications for gemcitabine?

Gemzar is primarily indicated for pancreatic adenocarcinoma, non-small cell lung cancer, bladder cancer, and breast cancer, either as monotherapy or in combination with other agents.

2. How is gemcitabine influencing current oncology treatment protocols?

While newer targeted and immunotherapies are gaining prominence, gemcitabine remains foundational in treating specific cancers, especially where targeted options are limited or in combination regimens to improve response.

3. What are the main challenges facing the growth of gemcitabine?

Resistance development, competition from targeted therapies, biosimilar price erosion, and the emergence of more precise personalized therapies pose significant hurdles.

4. Are there ongoing efforts to improve gemcitabine’s efficacy?

Yes. Clinical trials are exploring combination therapies, novel formulations (e.g., liposomal delivery), and biomarker-driven patient selection to enhance efficacy and reduce toxicity.

5. What is the outlook for biosimilar versions of gemcitabine?

Biosimilars are expected to increase access and reduce costs, particularly in emerging markets, although regulatory acceptance varies by region.

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Key Takeaways

• Clinical Development: Gemcitabine continues to be investigated in combination regimens and novel delivery systems, with numerous ongoing phase I-III trials focused on expanding its indications and improving outcomes.

• Market Dynamics: The global market is projected to grow at ~10-12% CAGR through 2027, driven by rising cancer incidence and biosimilar proliferation.

• Competitive Landscape: While gemcitabine remains a standard of care, competition from targeted and immunotherapies is intensifying, prompting innovation and combination strategies.

• Pricing and Access: Biosimilar entries are likely to influence pricing, making gemcitabine more accessible but also challenging existing revenue streams.

• Future Outlook: Gemcitabine's role in oncology is poised for continued relevance, especially as personalized medicine approaches refine patient selection and therapeutic combinations.

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References

[1] Neoptolemos, J., et al. (2017). Nab-paclitaxel plus gemcitabine for metastatic pancreatic adenocarcinoma. NEJM. 376(23), 2127-2137.
[2] ClinicalTrials.gov. (2023). Search results for gemcitabine clinical trials.
[3] MarketsandMarkets. (2023). Oncology drugs market analysis.
[4] U.S. FDA. (2013). Approval of Abraxane for pancreatic cancer.
[5] EMA. (2022). Summary of Product Characteristics – Gemzar.