CLINICAL TRIALS PROFILE FOR PEMETREXED

All Clinical Trials for PEMETREXED

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00005636 ↗	Cisplatin With or Without Pemetrexed Disodium in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot be Removed by Surgery	Completed	National Cancer Institute (NCI)	Phase 3	1999-11-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if cisplatin is more effective with or without pemetrexed disodium for malignant mesothelioma of the pleura. PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin with or without pemetrexed disodium in treating patients who have malignant mesothelioma of the pleura that cannot be removed by surgery.
NCT00005636 ↗	Cisplatin With or Without Pemetrexed Disodium in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot be Removed by Surgery	Completed	Memorial Sloan Kettering Cancer Center	Phase 3	1999-11-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if cisplatin is more effective with or without pemetrexed disodium for malignant mesothelioma of the pleura. PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin with or without pemetrexed disodium in treating patients who have malignant mesothelioma of the pleura that cannot be removed by surgery.
NCT00006007 ↗	LY231514 Plus Gemcitabine in Treating Women With Metastatic Breast Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2000-12-01	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 combining LY231514 plus gemcitabine in treating women who have metastatic breast cancer.
NCT00006007 ↗	LY231514 Plus Gemcitabine in Treating Women With Metastatic Breast Cancer	Completed	Alliance for Clinical Trials in Oncology	Phase 2	2000-12-01	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 combining LY231514 plus gemcitabine in treating women who have metastatic breast cancer.
NCT00022646 ↗	Pemetrexed Disodium Plus Gemcitabine in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2001-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug and giving the drugs in different ways may kill more tumor cells. PURPOSE: Randomized phase II trial to compare the effectiveness of three different regimens of pemetrexed disodium plus gemcitabine in treating patients who have locally advanced or metastatic non-small cell lung cancer.
NCT00022646 ↗	Pemetrexed Disodium Plus Gemcitabine in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer	Completed	Alliance for Clinical Trials in Oncology	Phase 2	2001-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug and giving the drugs in different ways may kill more tumor cells. PURPOSE: Randomized phase II trial to compare the effectiveness of three different regimens of pemetrexed disodium plus gemcitabine in treating patients who have locally advanced or metastatic non-small cell lung cancer.

Clinical Trial Conditions for PEMETREXED

Condition Name

Condition Name for PEMETREXED
Intervention	Trials
Non-small Cell Lung Cancer	188
Non Small Cell Lung Cancer	85
Lung Cancer	80
Carcinoma, Non-Small-Cell Lung	68

Condition MeSH

Condition MeSH for PEMETREXED
Intervention	Trials
Carcinoma, Non-Small-Cell Lung	669
Lung Neoplasms	566
Mesothelioma	101
Mesothelioma, Malignant	99

Clinical Trial Locations for PEMETREXED

Trials by Country

Trials by Country for PEMETREXED
Location	Trials
China	786
Japan	476
Italy	456
Spain	420
India	90

Trials by US State

Trials by US State for PEMETREXED
Location	Trials
California	223
New York	202
Texas	201
Florida	192
Pennsylvania	183

Clinical Trial Progress for PEMETREXED

Clinical Trial Phase

Clinical Trial Phase for PEMETREXED
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	38
PHASE2	67

Clinical Trial Status

Clinical Trial Status for PEMETREXED
Clinical Trial Phase	Trials
Completed	354
Recruiting	277
Not yet recruiting	123

Clinical Trial Sponsors for PEMETREXED

Sponsor Name

Sponsor Name for PEMETREXED
Sponsor	Trials
Eli Lilly and Company	171
National Cancer Institute (NCI)	111
AstraZeneca	53

Sponsor Type

Sponsor Type for PEMETREXED
Sponsor	Trials
Other	851
Industry	751
NIH	111

Last updated: July 24, 2026

Pemetrexed Clinical Trials Update, Market Analysis, and Patent/Exclusivity-Linked Projections (2026)

Pemetrexed (pemetrxed, marketed as pemetrexed disodium; original brand Alimta) remains a core antifolate for non-small cell lung cancer (NSCLC) and malignant pleural mesothelioma. The near-term market trajectory is tied to (1) ongoing line- and combination-extensions in NSCLC, (2) durability of brand pricing and payer coverage, and (3) competitive pressure from generic pemetrexed and any new authorized generics in major markets. This analysis maps trial activity signals to market risk by geography, regimen, and patent-exclusivity timing.

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What is the latest clinical trial update for pemetrexed in NSCLC and mesothelioma?

Which pemetrexed studies are currently driving the clinical readout cycle?

Key ongoing and recent trial themes for pemetrexed align with:

• Front-line and maintenance strategies in NSCLC (often with platinum doublets and/or immunotherapy backbones).
• Back-end salvage in non-squamous histology, including regimen sequencing and switching.
• Mesothelioma treatment intensification and schedule optimization with pemetrexed-based combinations.

What endpoints matter for pemetrexed trial valuation?

Trials most likely to move market share are those with:

• Progression-free survival (PFS) and overall survival (OS) improvements versus pemetrexed-eligible comparators.
• Clinically meaningful response rates in non-squamous NSCLC or epithelioid mesothelioma.
• Toxicity profiles that preserve dosing intensity and reduce discontinuation.

Regimen-level signal mapping (high intent)

• NSCLC: pemetrexed + platinum ± maintenance/combination with checkpoint inhibitors.
• Mesothelioma: pemetrexed + cisplatin as backbone; additional studies target response durability and sequencing.

(No specific trial identifiers, sponsors, phases, enrollment sizes, or top-line readout dates were provided in the request. A complete, citation-grade “latest update” requires trial-level bibliographic and registry data.)

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How big is the pemetrexed market, and what segment mix drives revenue?

Where is pemetrexed revenue concentrated?

Revenue concentration is typically driven by:

• NSCLC incidence and line-of-therapy mix (first-line, maintenance, and subsequent therapy).
• Mesothelioma incidence and regional adoption of pemetrexed-based standard-of-care.
• Payer formularies that favor established dosing schedules and predictable toxicity.

What segments determine unit demand?

Demand shifts with:

• Use in non-squamous NSCLC (histology eligibility).
• Conversion of new patients entering treatment pathways (e.g., first-line combinations).
• Migration from brand to generic/authorized generic as exclusivity declines (see patent timing section).

Market sensitivity factors

• Drug acquisition cost and payer contracting for generic pemetrexed.
• Competitive substitutions in immunotherapy-heavy regimens.
• Availability constraints from manufacturing or supply chain events.

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When does pemetrexed lose exclusivity, and what generic entry risks exist?

What is the generic and biosimilar exclusivity landscape for pemetrexed?

Pemetrexed is a small-molecule antimetabolite; biosimilar risk is not applicable. The relevant exclusivity mechanics are:

• Patent expirations for active ingredient and formulation/manufacturing/process improvements.
• Regulatory exclusivity, if any, tied to specific new indications or dosing regimens.
• Orange Book listing status for each marketed NDA and dosage form strength.

What are the practical generic risks?

For pemetrexed, the biggest commercial risk typically comes from:

• Paragraph IV challenges and settlements tied to Orange Book-listed patents.
• Authorized generics that can mute price erosion timing.
• Retail vs hospital channel contracting dynamics.

(No Orange Book listing identifiers, expiration dates, patent numbers, or NDA references were provided in the request. A litigation-grade exclusivity timeline requires those patent records.)

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What patent estate strength protects pemetrexed formulations and methods of use?

Which patent categories most affect pemetrexed competition?

• Drug substance and composition-of-matter patents (highest impact).
• Formulation patents (e.g., lyophilized product characteristics, reconstitution/use guidance).
• Process and manufacturing patents.
• Method-of-use patents tied to specific indications or combinations (often less durable than composition patents).

How does this translate to market share durability?

If composition-of-matter patents have expired, brand protection shifts to:

• Remaining formulation/process patents.
• Orange Book listings linked to line-of-therapy and indication specificity.
• Any negotiated exclusivity arrangements with generic entrants.

(Patent numbers and statuses are not included in the prompt; producing a complete estate map would require Orange Book and court docket inputs.)

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How does pemetrexed compare with competing NSCLC regimens, and what does that imply for pricing?

Competitive substitution risks

Pemetrexed faces substitution pressure from regimens using:

• Other antifolates or multi-target cytotoxics in combination chemotherapy slots.
• Immunotherapy-first strategies where chemotherapy selection is driven by histology, biomarkers, and clinician preference.

Why pemetrexed keeps demand

Pemetrexed persists where:

• Clinical evidence supports consistent benefit in non-squamous disease segments.
• Standard-of-care pathways incorporate pemetrexed-based chemotherapy.
• Toxicity management is well characterized and dosing is stable.

Pricing implication

Once generic coverage is broad, brand pricing leverage narrows and revenue becomes volume-led. Market forecasts therefore depend more on:

• Total treated population entering pemetrexed-eligible settings.
• Uptake of combination regimens that preserve pemetrexed as the chemotherapy backbone.

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What clinical trial pipeline signals matter most for market projection (PFS/OS, sequencing, tolerance)?

Market-moving trial types

• Randomized trials demonstrating OS or PFS advantage for pemetrexed-containing regimens.
• Studies establishing pemetrexed as a backbone across immunotherapy contexts.
• Trials that reduce grade 3-4 toxicity or improve treatment adherence.

Non-market-moving signals

• Single-arm response studies without confirmatory endpoints.
• Studies in small subgroups that do not change guideline positioning.

(Registry-level trial inventory is not included in the request; a precise pipeline forecast requires trial IDs, phases, enrollment, and expected completion dates.)

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What do payer and channel dynamics imply for pemetrexed revenue through 2027–2030?

Channel-level drivers

• Hospital purchasing dominates for oncology injectables.
• Payer contracting favors lowest acquisition cost once generic competition is established.
• Physician preference is influenced by administration burden and known toxicity.

Revenue projection mechanics

A practical projection decomposes into:

• Treated patient volume (incidence x eligible proportion x line-of-therapy share).
• Units per regimen (dosing frequency and cycle count).
• Net price after rebates/discounts (brand vs generic mix).

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Key takeaways for pemetrexed clinical and market outlook

• Pemetrexed remains anchored in NSCLC and malignant pleural mesothelioma treatment pathways where it is used as a chemotherapy backbone.
• Market risk is driven primarily by small-molecule generic erosion and any remaining formulation/process patent constraints, not biosimilar entry.
• Trial value hinges on randomized evidence that changes sequencing or expands pemetrexed eligibility across immunotherapy-based regimens.
• Near-to-mid term revenue durability depends on generic penetration speed and payer contracting, not on the emergence of biosimilar competition.

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FAQs

1. Which patient populations are most likely to sustain pemetrexed demand in NSCLC?
2. Do pemetrexed-based regimens show differential benefit by histology or biomarker status?
3. What factors accelerate generic substitution for pemetrexed in hospital formularies?
4. How do immunotherapy combinations change pemetrexed line-of-therapy share?
5. What manufacturing or supply risks can affect pemetrexed availability and net pricing?

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References (APA)

No sources were provided or cited in the request, so no citation list is generated.