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.
New Combination	NCT03496662 ↗	BMS-813160 With Nivolumab and Gemcitabine and Nab-paclitaxel in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)	Recruiting	National Institutes of Health (NIH)	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
NCT00003587 ↗	S9806: Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer	Completed	Southwest Oncology Group	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 Long-Term Projection

Last updated: July 27, 2026

Gemzar (gemcitabine; Eli Lilly) is an established oncology chemotherapy with limited near-term “new pipeline” impact because its core asset is mature. Commercial demand continues to be driven by label breadth across solid tumors and ongoing regimen evolution (combinations, sequencing, and line-of-therapy shifts). Clinical activity is concentrated in incremental combinations, biomarker-defined subgroups, and optimization of dosing/schedules rather than platform-changing monotherapy replacement.

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Is Gemzar (gemcitabine) still in clinical trials, and what are the latest readouts by cancer type?

Yes. Gemcitabine remains active in Phase 1 to Phase 3 studies, primarily as a backbone for combination regimens in pancreatic cancer, biliary tract cancers, non-small cell lung cancer, ovarian and urothelial settings, and hematologic combinations (less frequent).

Latest trial activity by indication (what is actually moving)

Across registrational and late-stage portfolios, gemcitabine is most often used to:

• Combine with checkpoint inhibitors (PD-1/PD-L1) and other immuno-oncology agents
• Pair with targeted therapies (EGFR, KRAS-pathway, FGFR, DNA repair targets depending on tumor)
• Explore novel cytotoxic schedules and dose-intensity approaches
• Test triplets in frontline or post-progression settings where gemcitabine’s efficacy and tolerability support escalation

Pancreatic cancer

• Gemcitabine-based regimens remain clinically relevant in locally advanced and metastatic pancreatic cancer where combinations are tuned against disease biology (KRAS-driven subtypes, DDR status, tumor microenvironment markers).
• Trial designs increasingly emphasize immunotherapy combinations and biomarker stratification.

Biliary tract cancer (BTC)

• Gemcitabine plus cisplatin remains a standard reference in BTC, which creates a stable platform for trials adding immunotherapy and targeted agents.
• Late-stage and ongoing studies focus on response durability and subgroup outcomes rather than replacing the backbone.

Urothelial cancer

• Gemcitabine-based chemotherapy regimens continue to be tested in new sequences and combinations, including with antibody-drug conjugates and immunotherapy.

NSCLC

• Gemcitabine has a long record in NSCLC; current trials often position it in combination arms where comparator regimens include immunotherapy and platinum doublets.

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What is the current FDA status of Gemzar, and does it have ongoing label expansion?

Gemzar is an FDA-approved cytotoxic chemotherapy. Its commercial use is anchored by decades of clinical uptake and broad standard-of-care positioning across multiple solid tumors.

Orange Book status and exclusivity

The key business point: gemcitabine is long off patent exclusivity in the United States in the classic sense. Most commercial exposure is generics and authorized distributors rather than monopoly brand protection. Any remaining exclusivity today is typically attributable to:

• Specific formulations/manufacturing (if still protected in certain dosage forms)
• New combination indications only when supported by proprietary sponsor-specific filings
• Filing-path incentives rather than base-drug exclusivity

Because gemcitabine is widely generic, the competitive question is not “will a generic exist” but “what regulatory pathway and what compatibility with treatment standards will preserve market share for remaining brand or distribution advantages.”

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How many patents protect Gemzar (gemcitabine) in the US, and when do key exclusivity windows end?

Gemzar’s patent estate for the drug substance and core manufacturing has largely expired. Current IP, where present, tends to cluster around:

• Process/manufacturing improvements
• Specific solid dosage forms or presentation-specific changes (less often relevant for gemcitabine due to typical injectable formats)
• Narrow method-of-use claims that may be tied to particular combinations or biomarkers

Practical expiration view for market modeling

For projections, model Gemzar as:

• A legacy brand with structurally limited remaining US exclusivity value
• A product whose future pricing and volumes depend more on guideline positioning and competition from generics and biosimilar-adjacent substitution risk in oncology than on monopoly patent cliffs

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What generic entry risks exist for Gemzar, including Paragraph IV challenges?

For gemcitabine, the risk profile is different from newer proprietary oncology agents:

• Generics already exist across most conventional dosing markets.
• Paragraph IV challenges are less informative than ongoing market price erosion, supply dynamics, and tender-driven purchasing.
• The higher “entry” risk is not new competitive entry of gemcitabine, but continued erosion from additional abbreviated entrants, authorized generics, and supply-chain cost compression.

Market forecast should treat competitive intensity as already mature.

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How does Gemzar’s clinical evidence compare with competing gemcitabine regimens and non-gemcitabine standards?

Gemzar’s role is that of a backbone chemotherapy. Its clinical positioning is strongest where guidelines historically include gemcitabine plus partner agents.

Competitive regimen map (decision drivers)

• Pancreatic cancer: gemcitabine-based combinations compete against FOLFIRINOX and modified regimens depending on performance status, age, comorbidity burden, and metastatic burden.
• BTC: gemcitabine plus cisplatin remains a comparator, with combination upgrades determining uptake.
• Urothelial cancer: chemotherapy sequencing vs immunotherapy affects demand for older cytotoxic backbones.

Implication for market projection

Gemzar’s future volume growth is less likely to be driven by monotherapy wins and more likely by:

• Continued guideline inclusion in combination regimens
• Regional practice patterns that favor gemcitabine-based approaches
• Ongoing use in salvage settings where tolerability and established clinical workflow matter

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What is the market size for gemcitabine (Gemzar) by geography, and what share is likely held by the brand vs generics?

Gemcitabine is a mature, widely genericized chemotherapy. The brand’s share depends on:

• Contracting with group purchasing organizations (GPOs) and hospital formularies
• Regional tendering and distributor incentives
• Availability and pricing of generic equivalents

Modeling baseline (structural facts)

For business planning:

• Total category demand is tied to incidence of target cancers and oncology regimen utilization
• Share shifts mostly reflect pricing and procurement rather than clinical trial breakthroughs

Because gemcitabine is an established backbone, category demand is relatively stable, with modest growth possible from:

• Overall cancer treatment expansion
• Shift toward combination chemotherapy use in certain settings
• Higher treatment intensity in some geographies

Declines occur with substitution toward regimens perceived as more effective or more tolerable (trial-driven practice change) in specific indications.

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What revenue projection is realistic for Gemzar over the next 5 to 10 years?

A robust projection must separate:

1. Category trend in gemcitabine-containing regimens
2. Brand share trend under ongoing generic competition
3. Any meaningful clinical or regulatory events that shift standard-of-care utilization

Base-case projection logic (high-level)

• If guidelines continue recommending gemcitabine-based regimens in major indications, category volumes remain steady to slightly growing.
• Brand revenue is typically pressured by generic displacement and tender pricing.
• Net brand revenue over 5 to 10 years is more likely to be flat to declining than to grow meaningfully unless a proprietary formulation/combination achieves differentiation with durable uptake.

Scenario framework to use in forecasting

• Base case: stable category volumes, continued share erosion for brand, modest nominal revenue decline driven by price compression.
• Downside: faster practice shift away from gemcitabine in key settings plus intensifying supply-chain pricing.
• Upside: favorable combination trial readouts that strengthen guideline inclusion for gemcitabine backbones in multiple tumor sites, supporting volume and limiting further brand share loss.

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Which ongoing clinical trials for Gemzar could change standard of care, and what endpoints matter for adoption?

Adoption hinges on endpoints tied to clinical benefit and practice change:

• Overall survival (OS) in late-line or frontline randomized settings
• Progression-free survival (PFS) and response rates (ORR/DoR) where OS is difficult
• Safety and tolerability, especially rate of clinically meaningful toxicities and discontinuation rates
• Biomarker-positive subgroup performance that supports label-like usage patterns

What to watch (decision-relevant signals)

• Confirmed efficacy in biomarker-defined cohorts that match real-world ordering behavior
• Evidence that gemcitabine combination improves durability without unacceptable toxicity
• Predictable administration schedules and manageable adverse event profiles for oncology workflows

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What formulation, dosing, or manufacturing innovations affect Gemzar competitiveness?

For mature injectables, differentiation often comes from:

• Stability and shelf-life improvements
• Manufacturing yield and supply assurance
• Administration convenience factors and supportive care compatibility
• Presentation changes in ways that reduce treatment burden

These can influence contracting outcomes even when clinical efficacy is unchanged.

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What patent litigation affects Gemzar, and are there any active cases involving generic competition?

Gemcitabine is widely generic in the US, so litigation relevance is typically lower than for new biologics and branded small molecules under active monopoly. The market impact is more likely to come from:

• Generic supply and pricing rather than court outcomes
• Regulatory approvals and manufacturing continuity

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Key Takeaways

• Gemzar remains clinically used as a chemotherapy backbone across multiple solid tumors, with ongoing Phase 1-3 studies largely testing combinations and sequencing rather than replacing gemcitabine’s role.
• The commercial structure is mature: gemcitabine is broadly genericized, so brand revenue is constrained more by price competition and contracting than by remaining exclusivity.
• Market growth potential is limited and incremental, driven by overall oncology treatment demand and regimen positioning, while brand share faces continued erosion.
• Forecasting should model category stability and procurement-driven share change as the dominant drivers over the next 5 to 10 years.

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FAQs

1) Is Gemzar still used in pancreatic cancer today compared with FOLFIRINOX-based regimens?
Yes, gemcitabine-based combinations remain used, with selection depending on performance status and patient tolerability profiles and guideline context.

2) Do gemcitabine combination trials focus more on immunotherapy or targeted therapy?
Both, with immunotherapy combinations prominent in many tumor settings and targeted strategies used based on molecular eligibility.

3) How does generic pricing typically impact brand chemotherapy like Gemzar?
Hospital purchasing and tenders usually shift volume to lowest-cost compliant supplies, compressing nominal brand revenue.

4) What endpoints most influence adoption of gemcitabine backbone combinations?
OS where available, otherwise PFS and durable response, plus safety metrics that affect treatment continuation.

5) Are there biosimilar-style substitution dynamics for gemcitabine?
No. Gemcitabine is a small-molecule injectable; competitive pressure comes from generic small-molecule approvals rather than biosimilars.

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References (APA)

1. U.S. Food and Drug Administration. (n.d.). Drug approvals and label information for gemcitabine products. FDA.
2. U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
3. ClinicalTrials.gov. (n.d.). Studies of gemcitabine in combination regimens across solid tumors. National Library of Medicine.