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

Gemzar (gemcitabine) Clinical Trials Update, Market Analysis, and Projection

Last updated: April 24, 2026

What is Gemzar’s current clinical and regulatory status?

Gemzar is the brand name for gemcitabine, an established cytidine nucleoside analog used across multiple tumor types. Because gemcitabine is an off-patent, legacy product, the “clinical trials update” today is dominated by new combination regimens, biomarker-stratified studies, and next-generation schedules or delivery approaches, rather than first-in-class development.

Key ongoing trial patterns (what is being tested)

Across recent years, studies on gemcitabine have concentrated on:

• Combination chemotherapy regimens (gemcitabine plus platinum, gemcitabine plus immunotherapy, gemcitabine plus targeted agents)
• Maintenance and line-of-therapy optimization (timing and sequencing changes)
• Biomarker-led patient selection (tumor markers and resistance pathways guiding inclusion)
• Formulation and schedule refinements (dose, frequency, and supportive regimens)

Clinical implication: Gemcitabine’s core activity remains anchored in standard-of-care settings, while the pipeline value has shifted to incremental efficacy and tolerability gains through combination strategy and patient selection.

What is the market size and current commercial footprint?

Gemzar’s market is driven by:

• Broad historical uptake in solid tumors where gemcitabine is embedded in chemotherapy standards
• Persistent use in pancreatic cancer and biliary tract cancers as foundational regimens
• Continued physician reliance due to predictable administration and established safety management

Market drivers

• Incidence and survival dynamics in pancreatic and biliary malignancies increase long-run chemotherapy demand.
• Guideline inclusion keeps gemcitabine in regimen menus even as immunotherapies expand.
• Generic availability pressures net pricing, but overall volume remains supported by established clinical use.

Commercial constraints

• Patent expiry and generic competition limit branded revenue capture and cap price growth.
• Protocol drift toward immunotherapy-based combinations can change the share of gemcitabine-containing regimens, depending on tumor type and setting.
• Drug supply and reimbursement factors determine access more than novelty.

What does the demand outlook imply for 2025–2035?

A realistic projection for gemcitabine is not “brand growth,” but total gemcitabine utilization across tumor regimens.

Projection framework used

For legacy chemotherapy agents like gemcitabine, forecasts are usually modeled on:

• Epidemiology (treated population growth tied to incidence trends)
• Regimen penetration (share of patients receiving gemcitabine)
• Line-of-therapy depth (how many patients reach later treatment lines)
• Price erosion (net price declines due to generic competition and tendering dynamics)
• Clinical substitution risk (shift away from gemcitabine in specific indications due to new standards)

Directional outlook

• Volume: Expected to remain resilient because gemcitabine is a long-standing backbone for multiple cancers.
• Value: Expected to be structurally constrained by generic pricing pressure.
• Incidence-linked demand: Supports continued utilization, but growth is unlikely to be uniform across all tumor types.
• Regimen evolution: Some share can move between gemcitabine-containing combinations and newer standards, creating variability by indication and geography.

Which indications drive Gemzar/gemcitabine utilization the most?

Gemcitabine demand clusters in solid tumors where it has durable standard-of-care roles:

Primary demand centers

• Pancreatic cancer (major driver of gemcitabine use in chemotherapy history and combination settings)
• Biliary tract cancer (substantial share in chemotherapy frameworks)
• Non-small cell lung cancer (NSCLC) (historical use in specific chemotherapy contexts)
• Ovarian and other solid tumors (more variable and regimen-dependent)

Clinical positioning

Gemzar’s continued presence in guidelines is driven by:

• Established efficacy signals
• Manageable toxicity profile relative to many alternatives
• Depth of real-world experience and predictable administration pathways

What is the competitive landscape versus modern standards?

Substitution pressure

Modern oncology has increased competition from:

• Immunotherapy combinations
• Targeted therapies that can replace chemotherapy in biomarker-defined subgroups
• New chemotherapy backbones in certain settings

Why gemcitabine remains in the mix

• Many regimens still require a chemotherapy partner with a tolerability profile compatible with immunotherapy and targeted agents.
• Gemcitabine has practical clinical use characteristics and has been widely studied in combination formats.

Key takeaways for business planning

• Gemzar is a legacy, high-utility cytotoxic where clinical activity concentrates on combination optimization and patient selection, not fundamental mechanism reinvention.
• Market growth is likely to be volume-led, value-limited due to generic competition and net pricing compression.
• The most stable demand base sits in pancreatic and biliary tract cancers, with substitution risk highest where immunotherapy or targeted regimens most strongly displace chemotherapy.
• Forecasting Gemzar/gemcitabine should be done at the indication regimen share level, not at brand-level assumptions.

---

Key Takeaways

• Gemzar (gemcitabine) remains anchored to durable standards in pancreatic and biliary tract oncology.
• Current “clinical trial momentum” is best interpreted as incremental improvement work through new combinations and selection.
• Market value growth is structurally capped by generic penetration, while utilization should remain supported by incidence-driven demand.
• Projections should be built around regimen share shifts by tumor type and line of therapy, with pricing erosion modeled explicitly.

---

FAQs

1) Is Gemzar still considered a standard-of-care chemotherapy backbone?

Yes. It remains embedded in multi-line chemotherapy frameworks, especially in pancreatic and biliary tract cancers.

2) What kind of trials are most common for gemcitabine today?

Studies most often evaluate combination regimens, schedule optimization, and biomarker or response-guided inclusion.

3) Will Gemzar’s revenue grow faster than total gemcitabine volume?

No. Net value growth is constrained by generic pricing pressure, so utilization growth typically outpaces revenue growth.

4) Where is substitution risk highest for gemcitabine?

Substitution risk is highest in settings where immunotherapy- or targeted-therapy standards most strongly reduce chemotherapy reliance.

5) What should investors and R&D teams focus on for “Gemzar-like” opportunities?

Focus on incremental regimen efficacy and patient selection where gemcitabine still functions as a chemotherapy backbone, plus strategies that reduce toxicity or improve response rates in real-world populations.

---

References

[1] FDA. Drugs@FDA: GEMZAR (gemcitabine) product information. U.S. Food and Drug Administration.
[2] National Cancer Institute. Gemcitabine overview and clinical information (PDQ and drug summaries). U.S. National Institutes of Health.
[3] EMA. EPAR and assessment materials for gemcitabine-containing medicinal products. European Medicines Agency.