Data updated: May 26, 2026
PEMETREXED FOR INJECTION (pemetrexed)
Oncology
PEMETREXED FOR INJECTION is indicated for the treatment of Non-Small Cell Lung Cancer; Malignant Pleural Mesothelioma.
Source: FDA Label • Dr. Reddy's
How PEMETREXED FOR INJECTION Works
Pemetrexed is a folate analog metabolic inhibitor that disrupts folate-dependent metabolic processes essential for cell replication. It enters cells via the reduced folate carrier and membrane folate-binding protein transport systems. Once intracellular, it is converted into polyglutamate forms by the enzyme folylpolyglutamate synthetase. These polyglutamate forms are retained within the cell and inhibit three key enzymes: thymidylate synthase (TS), dihydrofolate reductase (DHFR), and glycinamide ribonucleotide formyltransferase (GARFT). By inhibiting these enzymes, pemetrexed prevents the de novo biosynthesis of thymidine and purine nucleotides, thereby inhibiting DNA and RNA synthesis and halting cell division.
Source: FDA Label
Details
- Status
- Prescription
- First Approved
- N/A
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
PEMETREXED FOR INJECTION Approval History
No approval records found
What PEMETREXED FOR INJECTION Treats
2 indicationsPEMETREXED FOR INJECTION is approved for 2 conditions . These indications span multiple therapeutic areas including oncology, immunology, and more.
- Non-Small Cell Lung Cancer
- Malignant Pleural Mesothelioma
Source: FDA Label
PEMETREXED FOR INJECTION Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
4
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
9
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
Unlock 17 more competitors across all three rings.
Upgrade to Pro Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in PEMETREXED FOR INJECTION's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications PEMETREXED FOR INJECTION treats. First-in-class if their pivotal trials read out positive.
Tiragolumab MTIG7192A / RG6058 ~ Mixed — Ph3 readout
Hoffmann-La Roche TIGIT · monoclonal antibody (anti-TIGIT) · 10 Phase 3 trials
Ceralasertib AZD6738 ~ Mixed — Ph3 readout
AstraZeneca ATR · small-molecule ATR kinase inhibitor · 2 Phase 3 trials
Uliledlimab TJ004309
TJ Biopharma Co., Ltd. NT5E · monoclonal antibody (anti-CD73) · 1 Phase 3 trial
Drugs Similar to PEMETREXED FOR INJECTION
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
ALIMTA
PEMETREXED DISODIUM
Eli Lilly
Shared indications:
Non-Small Cell Lung CancerMalignant Pleural Mesothelioma
AXTLE
PEMETREXED DIPOTASSIUM
AVYXA HOLDINGS
Shared indications:
Non-Small Cell Lung CancerMalignant Pleural Mesothelioma
PEMETREXED
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Shared indications:
Non-Small Cell Lung CancerMalignant Pleural Mesothelioma
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Clinical Trial Registry
487 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06875310 | CA239-0004 CA2390004 | Ph 3 | recruiting | A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4) |
| NCT07005102 | M25-287 2024-518586-10 | Ph 2, Ph 3 | recruiting | A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Adult Participants With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer |
| NCT06151574 | 1479-0008 2023-504308-27-00, U1111-1294-1407 | Ph 3 | active not recruiting | Beamion LUNG-2: A Study to Test Whether Zongertinib (BI 1810631) Helps People With Advanced Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment |
| NCT03793179 | NCI-2018-03695 NCI-2018-03695, EA5163 | Ph 3 | active not recruiting | Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer |
| NCT06772623 | M24-536 2024-514465-18, 2024-514465-18-00 | Ph 1, Ph 2 | recruiting | Study to Evaluate Adverse Events and Efficacy of Intravenous (IV) Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Adult Participants With Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease, and No Actionable Genomic Alterations |
| NCT06694454 | 10001609 001609-C | Ph 1, Ph 2 | recruiting | Neoadjuvant Inhaled Azacytidine With Platinum-Based Chemotherapy and Durvalumab (MEDI4736) - a Combined Epigenetic-Immunotherapy (AZA-AEGEAN) Regimen for Operable Early-Stage Non-Small Cell Lung Cancer (NSCLC) |
| NCT05775289 results posted | BO44178 | Ph 2 | active not recruiting | A Study of Tobemstomig Plus Platinum-Based Chemotherapy vs Pembrolizumab Plus Platinum-Based Chemotherapy in Participants With Previously Untreated Non-Small Cell Lung Cancer |
| NCT05001880 | NCI-2021-08573 NCI-2021-08573, A092001 | Ph 2 | recruiting | Chemotherapy With or Without Immunotherapy for Peritoneal Mesothelioma |
| NCT06448754 eVOLVE-01 | D798KC00001 2023-509482-20-00 | Ph 2 | recruiting | Volrustomig Priming Regimens Exploratory Phase II Platform Study |
| NCT05198830 | NCI-2021-14403 NCI-2021-14403, CASE1522 | Ph 2 | recruiting | Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer |
| NCT03337698 Morpheus Lung results posted | BO39610 2017-001267-21 | Ph 1, Ph 2 | terminated | A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer) |
| NCT04245085 ABC-lung results posted | ETOP 15-19 MO40586 | Ph 2 | completed | ABC-lung: Atezolizumab, Bevacizumab and Chemotherapy in EGFR-mutant Non-small Cell Lung Carcinoma |
| NCT06119581 SUNRAY-01 | 18612 J3M-MC-JZQB, U1111-1288-0565 | Ph 3 | recruiting | A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer |
| NCT06074588 | 2870-004 2023-503539-16-00, jRCT2031240108 | Ph 3 | active not recruiting | Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004) |
| NCT03819465 MAGELLAN | D933IC00001 2018-001748-74 | Ph 1 | active not recruiting | A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC |
| NCT07252739 | 3475-01J U1111-1321-3999, 2025-521939-36-00 | Ph 2 | recruiting | KEYMAKER-U01 Substudy 01J: A Study of Pembrolizumab Plus MK-1084 in Participants With Non-Small Cell Lung Cancer (NSCLC) With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) G12C Mutations (MK-3475-01J/KEYMAKER-U01J) |
| NCT03607539 results posted | CIBI308C302 | Ph 3 | completed | Efficacy and Safety Evaluation of Sintilimab in Patients With Advanced or Metastatic Non-squamous NSCLC |
| NCT06793215 Krascendo 2 | CO45042 | Ph 3 | recruiting | A Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Participants With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer |
| NCT06096844 | NCI-2023-08628 NCI-2023-08628, EA5221 | Ph 3 | recruiting | Chemotherapy Combined With Immunotherapy Versus Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial |
| NCT07190248 | 1084-007 U1111-1307-9569, 2024-514500-14-00 | Ph 3 | recruiting | A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007) |
| NCT04538664 PAPILLON results posted | CR108850 61186372NSC3001, 2020-000633-40 | Ph 3 | active not recruiting | A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions |
| NCT06632327 | CTIU2317-A082304-S2402 NCI-2024-06356 | Ph 3 | recruiting | Comparing Impact of Treatment Before or After Surgery in Patients With Stage II-IIIB Resectable Non-small Cell Lung Cancer |
| NCT05870319 | SKB264-Ⅲ-09 | Ph 3 | active not recruiting | A Phase III Study of SKB264 for EGFR Mutant NSCLC Patients |
| NCT06431685 | LM-001 | Ph 1 | recruiting | Safety and Efficacy of Whole Brain LDRT+ICI+Intrathecal Chemotherapy in Refractory Meningeal Metastasis of Lung Cancer |
| NCT02609776 CHRYSALIS | CR108064 61186372EDI1001, 2018-003908-38 | Ph 1 | active not recruiting | Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer |
| NCT05498428 PALOMA-2 | CR109264 61186372NSC2002, 2022-000526-21 | Ph 2 | recruiting | A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer |
| NCT06459180 | 2870-020 MK-2870-020, TroFuse-020 | Ph 3 | recruiting | A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20) |
| NCT04988295 MARIPOSA-2 results posted | CR109061 61186372NSC3002, 2021-001825-33 | Ph 3 | active not recruiting | A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure |
| NCT04077463 Chrysalis-2 | CR108656 73841937NSC1001, 2020-000747-31 | Ph 1 | active not recruiting | A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer |
| NCT06312137 TroFuse-019 | 2870-019 2023-508012-35-00, MK-2870-019 | Ph 3 | recruiting | A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019) |
| NCT04083599 | GCT1042-01 2018-003716-47, IRAS ID: 263292 | Ph 1, Ph 2 | active not recruiting | GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors |
| NCT07063745 MountainTAP-29 | CA240-0029 2025-521511-40, U1111-1319-8383 | Ph 2, Ph 3 | recruiting | A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion |
| NCT05012254 NIVIPI-Brain | GECP 21/02_NIVIPI-Brain 2021-000425-27 | Ph 2 | active not recruiting | Nivolumab and Ipilimumab Plus Chemotherapy for Patients With Stage IV Lung Cancer With Brain Metastases |
| NCT06305754 | 2870-009 2023-504910-31-00, U1111-1288-3804 | Ph 3 | recruiting | Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009) |
| NCT05083481 | 1570-CL-0101 jRCT2031220527, KEYNOTE-E59 | Ph 1, Ph 2 | active not recruiting | A Study of ASP1570 Taken by Itself, or ASP1570 Taken Together With Either Pembrolizumab, Standard Therapies, or Both, in Adults With Solid Tumors |
| NCT07128199 REZILIENT4 | TAS6417-302 2025-521775-31-00 | Ph 3 | active not recruiting | A Study to Assess the Efficacy and Safety of Zipalertinib Versus Placebo for Adjuvant Treatment in Participants With Stage IB-IIIA NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection |
| NCT03456076 results posted | BO40336 2017-004331-37 | Ph 3 | active not recruiting | A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer |
| NCT06623422 | V940-009 2023-506327-29-00, U1111-1293-5814 | Ph 3 | recruiting | A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009) |
| NCT05067283 KANDLELIT-001 | 1084-001 MK-1084-001, jRCT2041220034 | Ph 1 | recruiting | A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001) |
| NCT05456256 HARMONIC | LTRN300-2LC01-OR21 | Ph 2 | recruiting | A Study of LP-300 With Carboplatin and Pemetrexed in Never Smokers With Advanced Lung Adenocarcinoma |
| NCT04585490 | IRB-54807 LUN0114, NCI-2021-09500 | Ph 3 | recruiting | Personalized Escalation of Consolidation Treatment Following Chemoradiotherapy and Immunotherapy in Stage III NSCLC in Stage III NSCLC |
| NCT05118854 | 2021-0649 NCI-2021-10907 | Ph 2 | recruiting | A Phase II Study of Neoadjuvant Sotorasib in Combination With Cisplatin or Carboplatin and Pemetrexed for Surgically Resectable Stage IIA-IIIB Non-Squamous Non-Small Cell Lung Cancer With a KRAS p.G12C Mutation |
| NCT05624996 | NRG-LU008 NCI-2022-08263, NRG-LU008 | Ph 3 | recruiting | Testing the Addition of High Dose, Targeted Radiation to the Usual Treatment for Locally-Advanced Inoperable Non-Small Cell Lung Cancer |
| NCT04736173 ARC-10 | ARC-10 2020-003562-39, PHRR210222-003371 | Ph 2 | active not recruiting | Study Evaluating Effectiveness and Safety of Zimberelimab and Domvanalimab in Lung Cancer |
| NCT06996782 ALTAIR | D702KC00001 2024-519786-22 | Ph 1, Ph 2 | recruiting | A Platform Study in Non-Small Cell Lung Cancer (NSCLC) |
| NCT06561386 RELATIVITY1093 | CA224-1093 2024-513682-40, U1111-1306-8896 | Ph 3 | recruiting | A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 Expression ≥ 1% |
| NCT05358548 | 032201 Pro2022000346 | Ph 2 | recruiting | ATATcH Alternating Treatment Plans for Advanced Cancer |
| NCT02486718 results posted | GO29527 2014-003205-15, 2023-505981-26-00 | Ph 3 | active not recruiting | Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010] |
| NCT03768063 IMbrella B | BO40729 2023-506184-34-00 | Ph 3 | active not recruiting | A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study |
| NCT06630325 results posted | STUDY00026643 NCI-2024-07664, STUDY00026643 | Ph 2 | terminated | A Precision Medicine Approach (SMMART-ACT) for the Treatment of Patients With Advanced Sarcoma, Prostate, Breast, Ovarian or Pancreatic Cancer |
Showing 50 of 487 trials
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Trial Timeline
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 FOR INJECTION FDA Label Details
Indications & Usage
PEMETREXED FOR INJECTION is indicated for the treatment of Non-Small Cell Lung Cancer; Malignant Pleural Mesothelioma.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.