TheraRadar
Data updated: May 26, 2026

PEMETREXED DISODIUM

Trial Activity: Stable 10 active trials
Oncology Approved 2022-05-25

PEMETREXED DISODIUM is indicated for the treatment of Non-Small Cell Lung Cancer; Malignant Pleural Mesothelioma.

Source: FDA Label • ACCORD HLTHCARE
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How PEMETREXED DISODIUM Works

Pemetrexed disrupts folate-dependent metabolic processes essential for cell replication. It enters cells via the reduced folate carrier and is converted into active polyglutamate forms by the enzyme folylpolyglutamate synthetase. These polyglutamated metabolites are retained within cells and inhibit three key enzymes in the de novo biosynthesis of thymidine and purine nucleotides: thymidylate synthase (TS), dihydrofolate reductase (DHFR), and glycinamide ribonucleotide formyltransferase (GARFT). Polyglutamation is more extensive in tumor cells than normal tissues, resulting in prolonged drug action in malignant cells.

Source: FDA Label

Development Insights

National Cancer Institute (NCI) conducting 10 trials (25%)
106 indications explored (Broad Platform)
→ stage iv non-small cell lung cancer (9 trials)
→ lung cancer (6 trials)
→ stage iiia non-small cell lung cancer (5 trials)
10
Indications
--
Phase 3 Trials
4
Years on Market

Details

Status
Prescription
First Approved
2022-05-25
Routes
INTRAVENOUS
Dosage Forms
POWDER, SOLUTION

Companies

ACCORD HLTHCARE QILU PHARM HAINAN AMNEAL Pfizer PRINSTON INC Apotex NANG KUANG PHARM CO Novartis Dr. Reddy's ZYDUS PHARMS BIOCON PHARMA Baxter Fresenius Kabi JIANGSU HANSOH PHARM HETERO LABS LTD VI RELIANCE LIFE PHARMOBEDIENT MEITHEAL EUGIA PHARMA
Active Ingredient: PEMETREXED DISODIUM

PEMETREXED DISODIUM Approval History

2023
2024
2025
2026
Original
New Indication
New Form
Label Update
111 FDA actions from 2022 to 2025
Dec 2025 SUPPL
Label · Labeling
FDA Letter Label
Oct 2025 SUPPL
Label · Labeling
Aug 2025 SUPPL
Label · Labeling

What PEMETREXED DISODIUM Treats

2 indications

PEMETREXED DISODIUM is approved for 2 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Non-Small Cell Lung Cancer
  • Malignant Pleural Mesothelioma
Source: FDA Label

PEMETREXED DISODIUM Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Direct competitors

4

Same target(s) AND same indication — head-to-head.

AXTLE
AVYXA HOLDINGS
2024 2 indic.
PEMETREXED
Teva
2020 2 indic.

MoA expansion candidates

9

Same target(s), different indications — where else is this mechanism being explored?

VYKOURA
AVYXA HOLDINGS
2026 5 indic.
JYLAMVO
SHORLA
2022 6 indic.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

AVOPEF
AVYXA HOLDINGS
2026 2 indic.
RYBREVANT FASPRO
Johnson &
2025 1 indic.
Unlock 17 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to PEMETREXED DISODIUM

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ALIMTA
PEMETREXED DISODIUM
2 shared
Eli Lilly
Shared indications:
Non-Small Cell Lung CancerMalignant Pleural Mesothelioma
AXTLE
PEMETREXED DIPOTASSIUM
2 shared
AVYXA HOLDINGS
Shared indications:
Non-Small Cell Lung CancerMalignant Pleural Mesothelioma
PEMETREXED
PEMETREXED SODIUM
2 shared
Teva
Shared indications:
Non-Small Cell Lung CancerMalignant Pleural Mesothelioma
View all 20 similar drugs Pro
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Clinical Trial Registry

41 trials
Trial Sponsor ID Phase Status Title
NCT04267848 NCI-2020-00751 NCI-2020-00751, A081801 Ph 3 recruiting Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO])
NCT06475300 BL-B01D1-204-05 Ph 2 recruiting A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors
NCT03228537 results posted NCI-2017-01230 NCI-2017-01230, S1619 Ph 1 active not recruiting Atezolizumab, Pemetrexed Disodium, Cisplatin, and Surgery With or Without Radiation Therapy in Treating Patients With Stage I-III Pleural Malignant Mesothelioma
NCT04092283 NCI-2019-06124 NCI-2019-06124, EA5181 Ph 3 active not recruiting Testing the Addition of an Antibody to Standard Chemoradiation Followed by the Antibody for One Year to Standard Chemoradiation Followed by One Year of the Antibody in Patients With Unresectable Stage III Non-Small Cell Lung Cancer
NCT01064648 results posted NCI-2011-02015 NCI-2011-02015, CDR0000665415 Ph 1, Ph 2 active not recruiting Pemetrexed Disodium and Cisplatin With or Without Cediranib Maleate in Treating Patients With Malignant Pleural Mesothelioma
NCT04158141 results posted NRG-LU006 NCI-2019-07141, NRG-LU006 Ph 3 terminated Testing the Addition of Targeted Radiation Therapy to Surgery and the Usual Chemotherapy Treatment (Pemetrexed and Cisplatin [or Carboplatin]) for Stage I-IIIA Malignant Pleural Mesothelioma
NCT02535312 results posted NCI-2015-00127 NCI-2015-00127, PHI-76 Ph 1, Ph 2 active not recruiting Methoxyamine, Cisplatin, and Pemetrexed Disodium in Treating Patients With Advanced Solid Tumors or Mesothelioma That Cannot Be Removed by Surgery or Mesothelioma That Is Refractory to Pemetrexed Disodium and Cisplatin or Carboplatin
NCT04379635 BGB-A317-315 CTR20200821 Ph 3 active not recruiting Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC)
NCT03366766 results posted 17P.556 JT 11371 Ph 2 terminated Nivolumab Plus Cisplatin/Pemetrexed or Cisplatin/Gemcitabine as Induction in Resectable Non-Small Cell Lung Cancer
NCT04895735 MC200708 NCI-2021-04161, 20-010144 Ph 2 active not recruiting MC200708 Pemetrexed and Pembrolizumab for the Treatment of Recurrent and/or Metastatic Salivary Gland Cancer
NCT03137771 results posted NRG-LU002 NCI-2016-00849, NRG-LU002 Ph 2 active not recruiting Maintenance Chemotherapy With or Without Local Consolidative Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer
NCT06659042 2024IIT-145 Ph 2 recruiting Perioperative Tislelizumab for Resectable II-IIIB(N2) KRAS-mutated Nonsquamous Non-small Cell Lung Cancer
NCT01993810 RTOG 1308 NCI-2013-01850, RTOG 1308 Ph 3 completed Comparing Photon Therapy To Proton Therapy To Treat Patients With Lung Cancer
NCT03971474 results posted S1800A NCI-2019-00703, S1800A Ph 2 completed Ramucirumab and Pembrolizumab Versus Standard of Care in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer (A Lung-MAP Non-Match Treatment Trial)
NCT01001910 results posted 08-04-097 NCI-2013-01208, 08-015 Ph 2 completed Pemetrexed and Carboplatin in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
NCT02426658 results posted IRB00032417 NCI-2015-00596, CCCWFU 62115 Ph 2 completed Pemetrexed Disodium in Treating Patients With Stage IV Non-small Cell Lung Cancer and ECOG Performance Status 3
NCT02607423 EA5123 NCI-2015-01054, EA5123 Ph 2 withdrawn Fludeoxyglucose F-18 PET/CT in Predicting Response to Chemotherapy in Patients With Stage IIIA Non-small Cell Lung Cancer That Can Be Removed by Surgery
NCT02535325 NCI-2015-01408 NCI-2015-01408, CASE 5514 Ph 1 completed Methoxyamine Hydrochloride, Pemetrexed Disodium, Cisplatin, and Radiation Therapy in Treating Patients With Stage IIIA-IV Non-small Cell Lung Cancer
NCT04061590 19702 NCI-2019-04763 Ph 2 withdrawn Pembrolizumab With or Without Chemotherapy Before Surgery in Treating Patients With Stage I-IIIA Non-Small Cell Lung Cancer
NCT00698815 results posted NCI-2009-00471 NCI-2009-00471, CDR0000589102 Ph 2 completed Pemetrexed and/or Sunitinib as Second-Line Therapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
NCT01085630 results posted CALGB-30901 CALGB-30901, U10CA180821 Ph 2 completed Pemetrexed Disodium/Observation in Treating Patients W/ Malignant Pleural Mesothelioma w/Out Progressive Disease After 1st Line Chemotherapy
NCT02693717 results posted 2015-0592 NCI-2016-00390, 2015-0592 Ph 2 terminated Pemetrexed Disodium in Treating Patients With Previously Treated Metastatic Urothelial Cancer
NCT01958372 2013-021 NCI-2013-01835, 1307012220 Ph 1 completed Radiation Therapy, Chemotherapy, and Soy Isoflavones in Treating Patients With Stage IIIA-IIIB Non-Small Cell Lung Cancer
NCT01784640 12-001489 NCI-2013-00410, L-05 Ph 1 completed Pemetrexed Disodium and Hsp90 Inhibitor AUY922 in Treating Patients With Previously Treated Stage IV Non-Small Cell Lung Cancer
NCT02134912 results posted S1300 NCI-2014-00685, S1300 Ph 2 terminated S1300: Pemetrexed Disodium With or Without Crizotinib in Treating Patients With Stage IV Non-Small Cell Lung Cancer That Has Progressed After Crizotinib
NCT01664754 11-003323 NCI-2012-01250 Ph 1 completed Exemestane, Pemetrexed Disodium, and Carboplatin in Treating Post-Menopausal Women With Stage IV Non-Small Cell Lung Cancer
NCT00573989 results posted IRB00003457 P30CA012197, CCCWFU-60107 Ph 1, Ph 2 terminated Intensity-Modulated Radiation Therapy, Pemetrexed, and Erlotinib in Treating Patients With Recurrent or Second Primary Head and Neck Cancer
NCT01935947 results posted NCI-2013-00949 NCI-2013-00949, NA_00081948/J1309 Ph 2 terminated Azacitidine and Entinostat Before Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer
NCT01041781 results posted CALGB-30801 CALGB-30801, CDR0000662707 Ph 3 terminated Gemcitabine Hydrochloride or Pemetrexed Disodium and Carboplatin With or Without Celecoxib in Treating Patients With Advanced Non-Small Cell Lung Cancer
NCT00691301 results posted GOG-0076GG GOG-0076GG, CDR0000597154 Ph 2 completed Pemetrexed and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
NCT00703638 2007LS086 0712M22703 Ph 1 completed Sorafenib, Pemetrexed, and Cisplatin in Treating Patients With Advanced Solid Tumors
NCT01344824 results posted LCCC 0825 P30CA016086 Ph 2 completed Carboplatin, Pemetrexed Disodium, and Bevacizumab for Patients With Stage III or IV Non-Small Cell Lung Cancer Who Are Light/Never Smokers
NCT00863512 results posted CALGB-30506 CALGB-30506, CDR0000636895 Ph 3 terminated Chemotherapy or Observation in Treating Patients With Early Stage Non-Small Cell Lung Cancer
NCT00798603 results posted NCCTG-N0821 NCI-2009-00670, CDR0000626346 Ph 2 completed Pemetrexed, Carboplatin, and Bevacizumab as First-Line Therapy in Treating Older Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
NCT01723800 12219 NCI-2012-02161 Ph 1 completed PI3K Inhibitor BKM120, Carboplatin, and Pemetrexed Disodium in Treating Patients With Stage IV Non-Small Cell Lung Cancer
NCT01953419 PEM001 Ph 2 completed Phase II Study of Pemetrexed in Advanced or Recurrent Gastric Cancer After Chemotherapy
NCT01450384 MCC-13874 NCI-2011-03035, P30CA016059 Ph 1 completed Pemetrexed Disodium and Sorafenib Tosylate in Treating Patients With Advanced Solid Tumors
NCT00738881 MARVEL results posted NCI-2009-00663 NCI-2009-00663, CDR0000612010 Ph 3 terminated Pemetrexed Disodium or Erlotinib Hydrochloride as Second-Line Therapy in Treating Patients With Advanced Non-small Cell Lung Cancer
NCT00660816 results posted CASE2507 P30CA043703, CASE2507 Ph 2 completed Pemetrexed or Docetaxel With or Without Erlotinib in Stage IIIB or Stage IV Non-Small Cell Lung Cancer
NCT01928160 VICC THN 1303 NCI-2013-01385, VICC THN 1303 Ph 2 withdrawn Pemetrexed Disodium and Carboplatin or Cisplatin With or Without Erlotinib Hydrochloride in Treating Patient With Stage IV Non-Small Cell Lung Cancer Resistant to First-Line Therapy With Erlotinib Hydrochloride or Gefitinib
NCT01105390 E1B09 NCI-2011-02068, U10CA021115 Ph 2 withdrawn AMG 102, Pemetrexed Disodium, and Cisplatin in Treating Patients With Malignant Pleural Mesothelioma
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

PEMETREXED DISODIUM FDA Label Details

Indications & Usage

FDA Label (PDF)

PEMETREXED DISODIUM is indicated for the treatment of Non-Small Cell Lung Cancer; Malignant Pleural Mesothelioma.

Looking for the branded version?

ALIMTA

Full clinical data, patents, trials, and competitive landscape for pemetrexed disodium.

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Data Sources

FDA Approval: ANDA203485 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment