NDAORALTABLET, FOR SUSPENSIONPriority Review
Approved
Feb 2025
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
10
Data completeness
6/8 — Strong
Priority Review
GOMEKLI (mirdametinib) by SpringWorks Therapeutics is mitogen-activated protein kinase kinase 1 inhibitors [moa]. First approved in 2025.
Drug data last refreshed 18h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GOMEKLI (mirdametinib) is an oral MEK1 inhibitor tablet approved February 2025 by SpringWorks Therapeutics. It selectively inhibits mitogen-activated protein kinase kinase 1 to modulate cellular signaling pathways implicated in neurofibromatosis and related conditions. The drug represents a targeted kinase approach to managing proliferative disorders.
Growth18.0 years to LOE
Early-stage product in growth phase with nascent commercial infrastructure; moderate team expansion expected as market adoption accelerates.
Mechanism of Action
Mitogen-Activated Protein Kinase Kinase 1 Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (10)
A Study of Mirdametinib in People With Central Nervous System Tumors
Started Apr 2026
26 enrolled
Central Nervous System TumorsGlioma
To Assess the Enzyme Inducing Effects of Carbamazepine on the PK of Mirdametinib in Healthy Participants
Started Dec 2025
36 enrolled
HealthyVolunteer
Effect of Hepatic Impairment on the Pharmacokinetics of Mirdametinib
Started May 2025
32 enrolled
HealthyHepatic Impairment
A Study of Mirdametinib in Combination With Palbociclib in People With Liposarcoma
Started Feb 2025
54 enrolled
Well Differentiated LiposarcomaDedifferentiated LiposarcomaLiposarcoma+6 more
Mirdametinib Monotherapy in Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF).
Started Feb 2024
24 enrolled
NF1Cutaneous NeurofibromaMonotherapy
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.