Drug

Tepotinib

Approved · EMA

ClassHepatocyte growth factor receptor inhibitorEmerging researchLate-stage development

Also known as Tepmetko.

RxNorm2477103 ChEMBLCHEMBL3402762 ATCL01EX21UNII1IJV77EI07

Research papers

Active clinical trials

Hepatocyte growth factor receptor

Primary target

Regulatory events

Latest activity

beta

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

A Phase II Single-arm Trial to Investigate Tepotinib in Advanced (Locally Advanced or Metastatic) Non-small Cell Lung Cancer With METex14 Skipping Alterations or MET Amplification (VISION)

Clinical trial2026-07-14Results posted · ClinicalTrials.gov

A Pilot Study of Tepotinib + Ivonescimab in Patients With Advanced METex14 Skipping Positive NSCLC

Clinical trial2026-06-11Results expected Q2 2029 · ClinicalTrials.gov

A Randomized Phase II Study of Tepotinib With or Without Ramucirumab in Participants With MET Exon 14 Skipping Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP SUB-STUDY)

Clinical trial2026-05-05Results expected Q2 2028 · ClinicalTrials.gov

A Proof-of-concept Trial With Safety Run of Tepotinib and Pembrolizumab in NSCLC Patients With and Without MET Exon 14 Mutations (POTENT)

Clinical trial2026-04-24Results expected Q1 2028 · ClinicalTrials.gov

An Open-Label Phase I/II Study to Evaluate the Safety and prelimiBasnary Efficacy of Amivantamab and Tepotinib Combination in MET-altered Non-small Cell Lung Cancer (NSCLC)

Clinical trial2026-03-11Results expected Q4 2027 · ClinicalTrials.gov

A Phase II, Two-arm Study to Investigate Tepotinib Combined With Osimertinib in MET Amplified, Advanced or Metastatic NSCLC Harboring Activating EGFR Mutations and Having Acquired Resistance to Prior Osimertinib Therapy (INSIGHT 2)

Clinical trial2026-02-27Results posted · ClinicalTrials.gov

Lazertinib and Tepotinib for EGFR Mutant NSCLC in MET Overexpressed or Amplified Who Progressed After Lazertinib Treatment: A Phase II Multi-center Trial

Clinical trial2026-02-23Results expected Q3 2029 · ClinicalTrials.gov

A Randomized Controlled Trial of Tepotinib vs Standard Treatment in Patients With Advanced MET Exon 14 Mutated Non-Small Cell Lung Cancer

Clinical trial2025-12-17Results expected Q1 2028 · ClinicalTrials.gov

The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy

Clinical trial2024-12-01Primary completion · ClinicalTrials.gov

Open-Label, Parallel-Group Phase 1 Study to Investigate the Effect of Various Degrees of Hepatic Impairment on the PK, Safety and Tolerability of the c-Met Kinase Inhibitor Tepotinib

Clinical trial2024-08-12Results posted · ClinicalTrials.gov

Approval: Tepmetko (EMA)

Regulatory2022-02-16EMA

Tepotinib in Non-Small-Cell Lung Cancer with <i>MET</i> Exon 14 Skipping Mutations.

Research2020-05-29The New England journal of medicine

Profile

Identifiers & mechanism

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

Canonical name

Tepotinib

Aliases & brands

Tepmetko

RxNorm CUI

2477103

ChEMBL ID

CHEMBL3402762

ATC codes

L01EX21

UNII

1IJV77EI07

Primary mechanism

Hepatocyte growth factor receptor inhibitor

Regulatory jurisdictions

ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Hepatocyte growth factor receptor

MET · P08581

INHIBITORHepatocyte growth factor receptor inhibitor

Regulatory timeline

1 event

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

2022-02-16

Latest approval

2022-02-16

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2022-02-16Approval

Approval: Tepmetko (EMA)

Indication: Tepmetko as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring alterations leading to… Show full indication

Tepmetko as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

Evidence ↗

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

Clinical trials

25 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

registered trials across all phases

LATEST COMPLETION 2022

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 25

Phase 110Phase 1 / 25Phase 29Phase 31

Late-stage studies

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

A Randomized Controlled Trial of Tepotinib vs Standard Treatment in Patients With Advanced MET Exon 14 Mutated Non-Small Cell Lung Cancer

RecruitingPH IIIIntergroupe Francophone de Cancerologie Thoraciquen=1332028

Recent completions

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

Phase I, Open-label, Single-sequence, Cross-over Study of the Effect of Multiple Doses of Itraconazole on Single-dose Tepotinib Pharmacokinetics in Healthy Participants

CompletedPH IMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germanyn=182022

Phase I, Open-Label, Single-sequence, Cross-Over Study of the Effect of Multiple Doses of Carbamazepine on Single-Dose Tepotinib Pharmacokinetics in Healthy Participants

CompletedPH IMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germanyn=182022

A Phase Ib/II Multicenter, Randomized, Open Label Trial to Compare Tepotinib (MSC2156119J) Combined With Gefitinib Versus Chemotherapy as Second-Line Treatment in Subjects With MET Positive, Locally Advanced or Metastatic NSCLC Harboring EGFR Mutation and Having Acquired Resistance to Prior EGFR-TKI Therapy (INSIGHT)

CompletedPH I/IIMerck KGaA, Darmstadt, Germanyn=882021

A Multicenter, Randomized, Phase Ib/II Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of MSC2156119J as Monotherapy Versus Sorafenib in Asian Subjects With MET+ Advanced Hepatocellular Carcinoma and Child-Pugh Class A Liver Function

CompletedPH I/IIMerck KGaA, Darmstadt, Germanyn=1172020

An Open-label, Single-dose, Randomized, 2-period, 2-sequence Cross-over, Single-center Phase I Trial in Healthy Subjects to Assess the Bioequivalence of Tepotinib TF3 Administered as 5 Tablets of 100 mg Versus 2 Tablets of 250 mg Dose Strength

CompletedPH IMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germanyn=182019

Open-Label, Parallel-Group Phase 1 Study to Investigate the Effect of Various Degrees of Hepatic Impairment on the PK, Safety and Tolerability of the c-Met Kinase Inhibitor Tepotinib

CompletedPH IEMD Serono Research & Development Institute, Inc.n=182019

Research activity

1 papers

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

Most influential

Tepotinib in Non-Small-Cell Lung Cancer with <i>MET</i> Exon 14 Skipping Mutations.

The New England journal of medicine · 2020 · 653 cites