GOMEKLI

GrowthSM

mirdametinib

NDAORALTABLET, FOR SUSPENSIONPriority Review
Approved
Feb 2025
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
9

Mechanism of Action

Mitogen-Activated Protein Kinase Kinase 1 Inhibitors

Pharmacologic Class:

Kinase Inhibitor

Clinical Trials (5)

NCT07279233Phase 1Not Yet Recruiting

To Assess the Enzyme Inducing Effects of Carbamazepine on the PK of Mirdametinib in Healthy Participants

Started Dec 2025
36 enrolled
HealthyVolunteer
NCT06997276Phase 1Recruiting

Effect of Hepatic Impairment on the Pharmacokinetics of Mirdametinib

Started May 2025
32 enrolled
HealthyHepatic Impairment
NCT06843967Phase 1/2Recruiting

A Study of Mirdametinib in Combination With Palbociclib in People With Liposarcoma

Started Feb 2025
NCT06159166Phase 1/2Recruiting

Mirdametinib Monotherapy in Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF).

Started Feb 2024
NCT05580770Phase 1/2Terminated

Mirdametinib + BGB-3245 in Advanced Solid Tumors

Started Feb 2023
23 enrolled
Advanced Solid Tumor

Loss of Exclusivity

LOE Date
Oct 10, 2044
226 months away
Patent Expiry
Oct 10, 2044
Exclusivity Expiry
Feb 11, 2032

Patent Records (5)

Patent #ExpiryTypeUse Code
12357597
Feb 17, 2041
U-4130
11084780
Feb 17, 2041
Substance
11453641
Feb 17, 2041
U-4130
11571402
Feb 17, 2041
Product
11806321
Feb 17, 2041
U-4130