CLINICAL TRIALS PROFILE FOR PEMETREXED DISODIUM

All Clinical Trials for pemetrexed disodium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003706 ↗	LY231514 in Treating Patients With Locally Advanced or Metastatic Solid Tumors and Varying Degrees of Kidney Function	Completed	Lily Research Laboratories	Phase 1	1998-04-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemotherapy drugs may have different effects in patients with different degrees of kidney function. PURPOSE: Phase I trial to study the effectiveness of LY231514 in treating patients who have locally advanced or metastatic solid tumors and varying degrees of kidney function.
NCT00003706 ↗	LY231514 in Treating Patients With Locally Advanced or Metastatic Solid Tumors and Varying Degrees of Kidney Function	Completed	National Cancer Institute (NCI)	Phase 1	1998-04-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemotherapy drugs may have different effects in patients with different degrees of kidney function. PURPOSE: Phase I trial to study the effectiveness of LY231514 in treating patients who have locally advanced or metastatic solid tumors and varying degrees of kidney function.
NCT00003706 ↗	LY231514 in Treating Patients With Locally Advanced or Metastatic Solid Tumors and Varying Degrees of Kidney Function	Completed	The University of Texas Health Science Center at San Antonio	Phase 1	1998-04-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemotherapy drugs may have different effects in patients with different degrees of kidney function. PURPOSE: Phase I trial to study the effectiveness of LY231514 in treating patients who have locally advanced or metastatic solid tumors and varying degrees of kidney function.
NCT00003711 ↗	Combination Chemotherapy in Treating Patients With Metastatic Solid Tumors	Completed	San Antonio Cancer Institute	Phase 1	1997-09-01	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 trial to study the effectiveness of combination chemotherapy with pemetrexed disodium and irinotecan in treating patients who have metastatic solid tumors.

Clinical Trial Conditions for pemetrexed disodium

Condition Name

Condition Name for pemetrexed disodium
Intervention	Trials
Lung Cancer	29
Stage IV Non-Small Cell Lung Cancer	14
Unspecified Adult Solid Tumor, Protocol Specific	9
Stage IIIA Non-small Cell Lung Cancer	9

Condition MeSH

Condition MeSH for pemetrexed disodium
Intervention	Trials
Lung Neoplasms	69
Carcinoma, Non-Small-Cell Lung	60
Mesothelioma	12
Carcinoma	11

Clinical Trial Locations for pemetrexed disodium

Trials by Country

Trials by Country for pemetrexed disodium
Location	Trials
United States	975
China	34
Canada	15
United Kingdom	9
Spain	7

Trials by US State

Trials by US State for pemetrexed disodium
Location	Trials
Ohio	40
Illinois	37
California	35
Michigan	35
North Carolina	34

Clinical Trial Progress for pemetrexed disodium

Clinical Trial Phase

Clinical Trial Phase for pemetrexed disodium
Clinical Trial Phase	Trials
PHASE2	2
PHASE1	1
Phase 4	1

Clinical Trial Status

Clinical Trial Status for pemetrexed disodium
Clinical Trial Phase	Trials
Completed	57
Terminated	19
Recruiting	13

Clinical Trial Sponsors for pemetrexed disodium

Sponsor Name

Sponsor Name for pemetrexed disodium
Sponsor	Trials
National Cancer Institute (NCI)	80
Alliance for Clinical Trials in Oncology	12
Eli Lilly and Company	10

Sponsor Type

Sponsor Type for pemetrexed disodium
Sponsor	Trials
Other	112
NIH	80
Industry	21

Pemetrexed Disodium: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: February 19, 2026

What Is the Current Status of Clinical Trials for Pemetrexed Disodium?

Pemetrexed disodium (brand name Alimta) is an antifolate chemotherapy agent primarily approved for malignant pleural mesothelioma and non-small cell lung cancer (NSCLC).

As of 2023, ongoing clinical trials focus on expanding its indications, optimizing dosing regimens, and evaluating combination therapies. Data from ClinicalTrials.gov shows approximately 20 active studies:

Trial Phase	Number of Trials	Focus Areas
Phase 1	3	Safety, pharmacokinetics, combination with immunotherapy
Phase 2	10	Efficacy in other solid tumors, biomarker-driven studies
Phase 3	7	Confirmatory studies for new indications or combinations

Key ongoing studies include:

• Evaluating pemetrexed with pembrolizumab in lung cancer (NCT03685210)
• Testing in mesothelioma resistant to first-line therapy (NCT04219772)
• Combination with novel targeted agents in ovarian and gastric cancers (NCT04952237 and NCT05112433)

Most trials aim to expand the drug’s applicability to other cancers, improve tolerability, or enhance efficacy through combinations.

How Has the Market for Pemetrexed Disodium Evolved?

Pemetrexed disodium enjoys a dominant position in NSCLC treatment due to its approval since 2004 and subsequent standard-of-care designation. The global market reached approximately USD 1.5 billion in 2022, driven by:

• Increased incidence of lung cancer, especially among aging populations
• Expanded indications, including mesothelioma
• Adoption of combination regimens with platinum agents and immune checkpoint inhibitors

The key markets include:

Region	Market Size (2022, USD billion)	Growth Rate (CAGR 2022-2027)
North America	0.75	4.2%
Europe	0.50	3.9%
Asia-Pacific	0.25	6.8%

Major players in the market are Eli Lilly (manufactures Alimta), and several biosimilar developers are preparing for generic entry, expected by 2025 as patent protections expire in key markets.

What Are the Key Market Drivers and Challenges?

Drivers:

• Rising lung cancer prevalence globally
• Approval of pemetrexed in combination therapies, including with pembrolizumab
• Growing preference for targeted therapy over traditional chemotherapy in certain settings

Challenges:

• Competition from other antifolates and targeted agents
• Patent expiration and generic replication reducing prices
• Side effects such as myelosuppression, requiring supportive care

What Are Future Market Projections?

The market is expected to grow at a compound annual growth rate (CAGR) of 5% from 2023 to 2028, reaching approximately USD 2 billion by 2028. Key factors influencing this growth include:

• Expansion into early-stage NSCLC and mesothelioma in previously unapproved markets
• Use in combination regimens as frontline treatment
• Development of predictive biomarkers for personalized therapy

The pace of development of novel formulations, such as liposomal or depot versions, could create new revenue streams, although none are currently in late-stage trials.

How Will Competition and Biosimilar Entry Affect Market Dynamics?

Eli Lilly’s patent protections are set to expire in the U.S. by late 2024 and in the EU by 2025. Biosimilar manufacturers are expected to launch products at reduced prices, potentially reducing the average selling price (ASP) of pemetrexed disodium by 20-30%. This will pressure Eli Lilly to focus on combination therapies and expanding indications.

Summary of Key Data Points

• 20 ongoing clinical trials, with a focus on expanding indications and optimizing combination therapies
• 2022 global market valued at USD 1.5 billion
• Market growth forecast at 5% CAGR through 2028
• Patent expiry scheduled for 2024-2025, opening biosimilar competition
• Major applications continue coverage in NSCLC and mesothelioma

Key Takeaways

• Pemetrexed disodium remains a cornerstone in lung cancer treatment, with ongoing efforts to diversify its uses.
• The market is poised for moderate growth, driven by expanding indications and combination therapies.
• Patent expiry and biosimilar entry will lower prices and intensify competition.
• Clinical trial activity suggests ongoing innovation, possibly leading to new formulations and indications.
• Emerging regional markets, particularly in Asia-Pacific, will support future growth.

FAQs

1. What are the primary indications for pemetrexed disodium?
First-line treatment for non-small cell lung cancer and malignant pleural mesothelioma.

2. When will biosimilars likely enter the market?
Biosimilars are expected to launch in late 2024 in the U.S. and in 2025 in Europe.

3. What clinical developments could extend pemetrexed’s market exclusivity?
New combination regimens, biomarker-driven therapy, or formulation improvements.

4. How does pemetrexed compare to other antifolates?
It has demonstrated superior efficacy in NSCLC and mesothelioma compared to earlier antifolates like methotrexate.

5. What are the key challenges facing pemetrexed disodium?
Generic competition, side effect management, and stiff competition from emerging targeted therapies.

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References

1. ClinicalTrials.gov (2023). Pemetrexed clinical studies.
2. MarketWatch (2023). Global oncology drug market analysis.
3. Eli Lilly (2022). Annual report.
4. U.S. Patent and Trademark Office (2022). Pemetrexed patent expiration dates.
5. European Medicines Agency (2022). Summary of product characteristics for Alimta.