Wednesday, July 8, 2026

Drug profile · INN

selumetinib sulfate

selumetinib sulfate (KOSELUGO) is a dual specificity mitogen-activated protein kinase kinase; mek1/2 inhibitor. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 1
News articles 0
Drug details — selumetinib sulfate
US status
approved
Class
Route
ORAL
Patents
0
Programs
1
Data quality
0.84

Quick answer

selumetinib sulfate (KOSELUGO) is a dual specificity mitogen-activated protein kinase kinase; mek1/2 inhibitor. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN selumetinib sulfate
Brand KOSELUGO
Mechanism Dual specificity mitogen-activated protein kinase kinase; MEK1/2 inhibitor
Target Dual specificity mitogen-activated protein kinase kinase 1
Route ORAL
Formulation CAPSULE

Mechanism of action

Dual specificity mitogen-activated protein kinase kinase; MEK1/2 inhibitor

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

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. D1346C00015 Phase 1 · AstraZeneca · Neurofibromatosis Type 1 (NF1) Related Plexiform Neurofibrom

Related & competitor drugs

  1. binimetinib Antineoplastic and immunomodulating agents (L01)
  2. cobimetinib fumarate Dual specificity mitogen-activated protein kinase kinase 2 inhibitor
  3. mirdametinib Antineoplastic and immunomodulating agents (L01)
  4. trametinib dimethyl sulfoxide Dual specificity mitogen-activated protein kinase kinase 2 inhibitor
  5. cobimetinib Antineoplastic and immunomodulating agents (L01)
  6. refametinib Dual specificity mitogen-activated protein kinase kinase 2 inhibitor

Frequently asked questions

What is selumetinib sulfate?

selumetinib sulfate (KOSELUGO) is a dual specificity mitogen-activated protein kinase kinase; mek1/2 inhibitor. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for selumetinib sulfate?

KOSELUGO is a marketed brand name for selumetinib sulfate. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of selumetinib sulfate?

selumetinib sulfate 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.