Friday, July 10, 2026

Drug profile · INN

selumetinib

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

FDA: approved EMA: approved TGA: approved
US status approved
Patents linked 0
Pipeline programs 5
News articles 0
Drug details — selumetinib
US status
approved
Class
Route
ORAL
Patents
0
Programs
5
Data quality
0.84

Quick answer

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

Key facts

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

Mechanism of action

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

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Pipeline programs

  1. KOMET D134BC00001 Phase 3 · AstraZeneca · Neurofibromatosis Type 1 (NF1) with Symptomatic, Inoperable
  2. SELUMETINIB for Metastatic breast cancer Phase 2 · Istituto Gentili Italia · Metastatic breast cancer
  3. SPRINKLE D1346C00004 Phase 2 · AstraZeneca · Neurofibromatosis Type 1 (NF1) Related Plexiform Neurofibrom
  4. Selumetinib Phase 2 · United Therapeutics Europe · Malignant Peripheral Nerve Sheath Tumors
  5. Selumetinib Phase 2 · United Therapeutics Europe · Metastatic Thyroid Gland Carcinoma

Frequently asked questions

What is selumetinib?

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

What is the brand name for selumetinib?

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

What is the US approval status of selumetinib?

selumetinib 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.