Wednesday, July 8, 2026

Drug profile · INN

binimetinib

binimetinib (MEKTOVI) is a dual specificity mitogen-activated protein kinase kinase 1 inhibitor. Associated with Pierre Fabre Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved PMDA: approved Antineoplastic and immunomodulating agents (L01) L01EE03
US status approved
Patents linked 6
Pipeline programs 15
News articles 0
Drug details — binimetinib
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
ORAL
Patents
6
Programs
15
Data quality
0.89

Quick answer

binimetinib (MEKTOVI) is a dual specificity mitogen-activated protein kinase kinase 1 inhibitor. Associated with Pierre Fabre Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN binimetinib
Brand MEKTOVI
Mechanism Dual specificity mitogen-activated protein kinase kinase 1 inhibitor
Target Dual specificity mitogen-activated protein kinase kinase 1
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route ORAL
Formulation TABLET
ATC code L01EE03

Mechanism of action

Dual specificity mitogen-activated protein kinase kinase 1 inhibitor

Primary target: Dual specificity mitogen-activated protein kinase kinase 1

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
PMDA approved

Pipeline programs

  1. C4221016 Phase 3 · First Biotech (Australia) · Metastatic or unresectable locally advanced BRAF V600E/K mut
  2. IMFINZI for Advanced Biliary Cancer (ABC) Phase 3 · Ningbo Cancer Hospital · Advanced Biliary Cancer (ABC)
  3. Binimetinib Phase 2 · United Therapeutics Europe · Locally Advanced Pancreatic Carcinoma
  4. Binimetinib Phase 2 · United Therapeutics Europe · Metastatic Colorectal Carcinoma
  5. C4221008 Phase 2 · First Biotech (Australia) · Non-small Cell Lung Cancer
  6. C4221023 Phase 2 · First Biotech (Australia) · Metastatic or unresectable locally advanced BRAF V600E/K mut
  7. EORTC 1612-MG Phase 2 · Ningbo Cancer Hospital · BRAF V600 mutation–positive unresectable or metastatic melan
  8. Encorafenib + Binimetinib Phase 2 · Regeneron UK · Melanoma BRAF V600E/K Mutated

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)
  1. US 12252511

    Process for the preparation of cyclic depsipeptides

    Expires Mon Mar 13 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 11739123

    Process for the preparation of cyclic depsipeptides

    Expires Mon Aug 24 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 11053284

    Process for the preparation of cyclic depsipeptides

    Expires Mon Jul 01 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 10689419

    Process for the preparation of cyclic depsipeptides

    Expires Mon Jun 18 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 10100089

    Process for the preparation of cyclic depsipeptides

    Expires Mon Oct 11 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 9523691

    Use of the olfactomedin-4 protein (OLFM4) in colorectal cancer diagnosis

    Expires Mon Dec 15 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is binimetinib?

binimetinib (MEKTOVI) is a dual specificity mitogen-activated protein kinase kinase 1 inhibitor. Associated with Pierre Fabre Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for binimetinib?

MEKTOVI is a marketed brand name for binimetinib. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of binimetinib?

binimetinib has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.