Drug

Pemetrexed

Approved · EMA

ClassThymidylate synthase inhibitorEmerging researchLate-stage developmentSteady momentum

Also known as Alimta, Axtle, Pemfexy, Pemrydi RTU.

RxNorm68446 ChEMBLCHEMBL225072 ATCL01BA04UNII04Q9AIZ7NO

Research papers

Active clinical trials

Protein targets

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

SUNRAY-01, A Global Pivotal Study in Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in Those With PD-L1 Expression ≥50% or LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed, Platinum Regardless of PD-L1 Expression

Clinical trial2026-07-20Results expected Q4 2027 · ClinicalTrials.gov

A Randomized, Double-Blind Phase 2/3 Study of Fianlimab (Anti-LAG-3 Antibody), Cemiplimab (Anti-PD-1 Antibody), and Chemotherapy Versus Cemiplimab and Chemotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Irrespective of PD-L1 Expression Levels

Clinical trial2026-07-15Results expected Q1 2030 · ClinicalTrials.gov

A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)

Clinical trial2026-07-10Results expected Q4 2029 · ClinicalTrials.gov

A Randomized, Open-Label, Multicenter Phase 3 Clinical Study of SKB264 in Combination With Pembrolizumab Versus Chemotherapy in Combination With Pembrolizumab as First-Line Treatment for PD-L1 Negative Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

Clinical trial2026-07-08Results expected Q4 2026 · ClinicalTrials.gov

Market withdrawal: Pemetrexed Sandoz (EMA)

Regulatory2024-10-09EMA

Phase III KEYNOTE-789 Study of Pemetrexed and Platinum With or Without Pembrolizumab for Tyrosine Kinase Inhibitor‒Resistant, <i>EGFR</i>-Mutant, Metastatic Nonsquamous Non-Small Cell Lung Cancer.

Research2024-08-22Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Market withdrawal: Ciambra (EMA)

Regulatory2023-10-12EMA

Pembrolizumab Plus Pemetrexed and Platinum in Nonsquamous Non-Small-Cell Lung Cancer: 5-Year Outcomes From the Phase 3 KEYNOTE-189 Study.

Research2023-02-21Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Atezolizumab Plus Chemotherapy for First-Line Treatment of Nonsquamous NSCLC: Results From the Randomized Phase 3 IMpower132 Trial.

Research2020-12-14Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer

Osimertinib or Platinum-Pemetrexed in EGFR T790M-Positive Lung Cancer.

Research2016-12-06The New England journal of medicine

Approval: Pemetrexed Fresenius Kabi (EMA)

Regulatory2016-07-22EMA

Approval: Armisarte (previously Pemetrexed Actavis) (EMA)

Regulatory2016-01-18EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Pemetrexed

Aliases & brands

AlimtaAxtlePemfexyPemrydi RTU

RxNorm CUI

68446

ChEMBL ID

CHEMBL225072

ATC codes

L01BA04

UNII

04Q9AIZ7NO

Primary mechanism

Thymidylate synthase inhibitor

Regulatory jurisdictions

ema

Pharmacology & targets

3 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Thymidylate synthase

TYMS · P04818

INHIBITORThymidylate synthase inhibitor

Dihydrofolate reductase

DHFR · P00374

INHIBITORDihydrofolate reductase inhibitor

Trifunctional purine biosynthetic protein adenosine-3

GART · P22102

INHIBITORGAR transformylase inhibitor

Regulatory timeline

8 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2004-09-20

Latest approval

2016-07-22

Authorities

EMA

Total events

emaEuropean Medicines Agency· 8 events

2024-10-09Market withdrawalMarket

Market withdrawal: Pemetrexed Sandoz (EMA)

Indication: Malignant pleural mesothelioma Pemetrexed Sandoz in combination with cisplatin is indicated for the treatment of chemotherapy naive patients with unresectable malignant pleural… Show full indication

Malignant pleural mesothelioma Pemetrexed Sandoz in combination with cisplatin is indicated for the treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Sandoz in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Pemetrexed Sandoz is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Pemetrexed Sandoz is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.

Evidence ↗

2023-10-12Market withdrawalMarket

Market withdrawal: Ciambra (EMA)

Indication: Malignant pleural mesothelioma Ciambra in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural… Show full indication

Malignant pleural mesothelioma Ciambra in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Ciambra in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Ciambra is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Ciambra is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.

Evidence ↗

2016-07-22Approval

Approval: Pemetrexed Fresenius Kabi (EMA)

Indication: Malignant pleural mesothelioma Pemetrexed Fresenius Kabi in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant… Show full indication

Malignant pleural mesothelioma Pemetrexed Fresenius Kabi in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Fresenius Kabi in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Pemetrexed Fresenius Kabi is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Pemetrexed Fresenius Kabi is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

194 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

194

registered trials across all phases

LATEST COMPLETION 2026

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 194

Phase 125Phase 1 / 214Phase 295Phase 2 / 35Phase 347Phase 43Phase N / A5

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Pemetrexed Plus Apatinib Maintenance Treatment in Patients With Non-squamous Non-small Cell Lung Cancer Patients Who Have Not Progressed After 4 Cycles of Induction Chemotherapy of Pemetrexed in Combination With Platinum-based Regimen: A Prospective, Open, One-arm Clinical Study

WithdrawnPH IVXinqiao Hospital of Chongqing2022

Individualized Pemetrexed Dosing in Patients With Non-small Cell Lung Cancer or Mesothelioma Based on Renal Function to Improve Treatment Response

CompletedPH IVRadboud University Medical Centern=102021

Randomised, Controlled Study Comparing Chemotherapy Plus Intercalated EGFR-Tyrosine Kinase Inhibitors Combination Therapy With EGFR-Tyrosine Kinase Inhibitors Alone Therapy as First-line Treatment for Patients With Non-Small-Cell Lung Cancer

Unknown statusPH IVQilu Hospital of Shandong Universityn=2502017

RecruitingPH IIIMerck Sharp & Dohme LLCn=6752032

Active, not recruitingPH II/IIIRegeneron Pharmaceuticalsn=1602031

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Randomized, Double Blind, Phase 3 Study of Platinum-Based Chemotherapy With or Without INCMGA00012 in First-Line Metastatic Squamous and Nonsquamous Non-Small Cell Lung Cancer (POD1UM-304)

CompletedPH IIIIncyte Corporationn=5832026

A Phase 2 Randomized Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

CompletedPH IIBristol-Myers Squibbn=4682026

Phase II Clinical Trial to Evaluate the Preliminary Efficacy, Safety and Pharmacokinetic Characteristics of PM8002 Injection Combined With Standard Chemotherapy in the First-line Treatment of Subjects With Inoperable Malignant Mesothelioma

CompletedPH IIBiotheus Inc.n=312026

A Phase 3 Study of Pembrolizumab in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Followed by Pembrolizumab and Maintenance Olaparib vs Maintenance Pemetrexed in the First-Line Treatment of Participants With Metastatic Nonsquamous Non-Small-Cell Lung Cancer (NSCLC)

CompletedPH IIIKey trialMerck Sharp & Dohme LLCn=1,0032026

A Randomized, Double-Blind, Phase 3 Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy as First Line Treatment for Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)

CompletedPH IIIMerck Sharp & Dohme LLCn=7392026

A Phase II/III, Randomized, Double-Blind, Placebo-Controlled Study of Tiragolumab in Combination With Atezolizumab Plus Pemetrexed and Carboplatin/Cisplatin Versus Pembrolizumab Plus Pemetrexed and Carboplatin/Cisplatin in Patients With Previously Untreated Advanced Non-Squamous Non-Small-Cell Lung Cancer

CompletedPH II/IIIHoffmann-La Rochen=5422025

Research activity

8 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20042024

Most influential

Osimertinib or Platinum-Pemetrexed in EGFR T790M-Positive Lung Cancer.

The New England journal of medicine · 2017 · 2,677 cites

First-line crizotinib versus chemotherapy in ALK-positive lung cancer.

The New England journal of medicine · 2014 · 2,470 cites

Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2004 · 1,749 cites

Pembrolizumab Plus Pemetrexed and Platinum in Nonsquamous Non-Small-Cell Lung Cancer: 5-Year Outcomes From the Phase 3 KEYNOTE-189 Study.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023 · 505 cites

Atezolizumab Plus Chemotherapy for First-Line Treatment of Nonsquamous NSCLC: Results From the Randomized Phase 3 IMpower132 Trial.

Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2021 · 352 cites

Phase III KEYNOTE-789 Study of Pemetrexed and Platinum With or Without Pembrolizumab for Tyrosine Kinase Inhibitor‒Resistant, <i>EGFR</i>-Mutant, Metastatic Nonsquamous Non-Small Cell Lung Cancer.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024 · 162 cites

Related diseases

2 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Active research areas

Carcinoma, Non-Small-Cell Lung6 Lung Neoplasms6

Related drugs

8 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Carboplatin

Studied across 4 of the same disease areas as Pemetrexed in the shared literature.

4 shared diseases3 shared papers

Cisplatin

Studied across 4 of the same disease areas as Pemetrexed in the shared literature.

4 shared diseases3 shared papers

Guanine

Studied across 4 of the same disease areas as Pemetrexed in the shared literature.

4 shared diseases2 shared papers

Docetaxel

Studied across 4 of the same disease areas as Pemetrexed in the shared literature.

4 shared diseases1 shared paper

Pembrolizumab

Studied across 2 of the same disease areas as Pemetrexed in the shared literature.

2 shared diseases2 shared papers

Platinum

Studied across 2 of the same disease areas as Pemetrexed in the shared literature.

2 shared diseases2 shared papers

Atezolizumab

Studied across 3 of the same disease areas as Pemetrexed in the shared literature.

3 shared diseases1 shared paper

Crizotinib

Studied across 3 of the same disease areas as Pemetrexed in the shared literature.

3 shared diseases1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.