Last reviewed 2026-04-20 · How we verify

TEPOTINIB

FDA-approved approved Small molecule Quality 15/100

At a glance

Generic name	TEPOTINIB
Modality	Small molecule
Phase	FDA-approved
First approval	2020

Approved indications

No approved indications tracked.

Common side effects

Edema
Fatigue
Nausea
Diarrhea
Musculoskeletal pain
Dyspnea
Decreased lymphocytes
Decreased albumin
Decreased sodium
Increased gamma-glutamyltransferase
Increased amylase
Increased ALT

Key clinical trials

PhI/II Study of Amivantamab and Tepotinib Combo in MET-altered Non-small Cell Lung Cancer (PHASE1, PHASE2)
A Study of Tepotinib Plus Osimertinib in Osimertinib Relapsed MET Amplified NSCLC (INSIGHT 2) (PHASE2)
Lazertinib & Tepotinib for EGFR Mutant NSCLC in MET Overexpressed or Amplified Who Progressed After Lazertinib Treatment (PHASE2)
Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has a MET Exon 14 Skipping Gene Change (An Expanded Lung-MAP Treatment Trial) (PHASE2)
Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION) (PHASE2)
Tepotinib vs Standard Treatment in Patients With Advanced MET Exon 14 Mutated Non-Small Cell Lung Cancer Previously Treated (PHASE3)
POTENT - Tepotinib in Combination With Pembrolizumab in NSCLC (PHASE1)
Tepotinib Hepatic Impairment Trial (PHASE1)

Patents

Patent	Expiry	Type

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
FDA label	Mechanism, indications, dosing, boxed warnings, drug interactions
ClinicalTrials.gov	Trial enrolment, design, endpoints, results
FDA Orange Book	Patents + exclusivity