MIRDAMETINIB
Gomekli (mirdametinib) is a small molecule pharmaceutical. Mirdametinib was first approved as Gomekli on 2025-02-11. The pharmaceutical is active against dual specificity mitogen-activated protein kinase kinase 1.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Gomekli
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Mirdametinib
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| GOMEKLI | SpringWorks Therapeutics | N-219389 RX | 2025-02-11 | 2 products, RLD, RS |
| GOMEKLI | SpringWorks Therapeutics | N-219379 RX | 2025-02-11 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| gomekli | New Drug Application | 2025-02-27 |
| mirdametinib | New Drug Application | 2025-02-17 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| plexiform neurofibroma | EFO_0000658 | D018318 | — |
Agency Specific
FDA
EMA
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Patent Expiration
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ATC Codes
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HCPCS
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Clinical
Clinical Trials
24 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 6 | 2 | — | — | — | 6 |
| Neurofibromatosis 1 | D009456 | — | Q85.01 | 1 | 3 | — | — | 1 | 4 |
| Neurofibromatoses | D017253 | — | Q85.00 | 1 | 3 | — | — | 1 | 4 |
| Neurofibroma | D009455 | EFO_0000622 | — | 1 | 3 | — | — | 1 | 4 |
| Non-small-cell lung carcinoma | D002289 | — | — | 2 | 2 | — | — | — | 3 |
| Colorectal neoplasms | D015179 | — | — | 2 | 1 | — | — | — | 2 |
| Plexiform neurofibroma | D018318 | EFO_0000658 | — | — | 1 | — | — | 1 | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 2 | — | — | — | 2 |
| Glioma | D005910 | EFO_0000520 | — | 2 | 2 | — | — | — | 2 |
| Melanoma | D008545 | — | — | 1 | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lung neoplasms | D008175 | — | C34.90 | 1 | — | — | — | — | 1 |
| Neurofibrosarcoma | D018319 | — | — | 1 | — | — | — | — | 1 |
| Nerve sheath neoplasms | D018317 | EFO_0000760 | — | 1 | — | — | — | — | 1 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Autonomic nervous system diseases | D001342 | EFO_0009532 | G90 | — | — | — | — | 1 | 1 |
| Histiocytic sarcoma | D054747 | — | C96.A | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | MIRDAMETINIB |
| INN | mirdametinib |
| Description | PD 0325901 is a hydroxamic acid ester that is benzhydroxamic acid (N-hydroxybenzamide) in which the hydroxamic acid group has been converted to the corresponding 2,3-dihydroxypropyl ester and in which the benzene ring has been substituted at position 2 by a (2-fluoro-4-iodophenyl)amino group and at positions 3 and 4 by fluorines (the R enantiomer). It has a role as an EC 2.7.12.2 (mitogen-activated protein kinase kinase) inhibitor and an antineoplastic agent. It is a hydroxamic acid ester, a secondary amino compound, a member of monofluorobenzenes, an organoiodine compound, a member of propane-1,2-diols and a difluorobenzene. |
| Classification | Small molecule |
| Drug class | tyrosine kinase inhibitors: tyrosine kinase inhibitors; MEK (MAPK kinase) inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C(NOC[C@H](O)CO)c1ccc(F)c(F)c1Nc1ccc(I)cc1F |
Identifiers
| PDB | — |
| CAS-ID | 391210-10-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL507361 |
| ChEBI ID | 88249 |
| PubChem CID | 9826528 |
| DrugBank | DB07101 |
| UNII ID | 86K0J5AK6M (ChemIDplus, GSRS) |
Target
Agency Approved
MAP2K1
MAP2K1
Organism
Homo sapiens
Gene name
MAP2K1
Gene synonyms
MEK1, PRKMK1
NCBI Gene ID
Protein name
dual specificity mitogen-activated protein kinase kinase 1
Protein synonyms
ERK activator kinase 1, MAPK/ERK kinase 1, MAPKK 1, MEK 1, protein kinase, mitogen-activated, kinase 1 (MAP kinase kinase 1)
Uniprot ID
Mouse ortholog
Map2k1 (26395)
dual specificity mitogen-activated protein kinase kinase 1 (P31938)
Alternate
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Variants
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Financial
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Trends
PubMed Central
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Safety
Black-box Warning
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Adverse Events
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15 adverse events reported
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