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mirdametinib 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| MEK (MAPK kinase) tyrosine kinase inhibitors | 5808 | 1013101-36-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Mirdametinib is an inhibitor of mitogen-activated protein kinase kinases 1 and 2 (MEK1/2). MEK1/2 proteins are upstream regulators of the extracellular signal-related kinase (ERK) pathway.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Feb. 2, 2025 | FDA | SpringWorks Therapeutics | |
| July 17, 2025 | EMA | Merck Europe B.V. |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L01EE05 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS PROTEIN KINASE INHIBITORS Mitogen-activated protein kinase (MEK) inhibitors |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D047428 | Protein Kinase Inhibitors |
| FDA EPC | N0000175605 | Kinase Inhibitor |
| FDA MoA | N0000193943 | Mitogen-Activated Protein Kinase Kinase 1 Inhibitors |
| FDA MoA | N0000193944 | Mitogen-Activated Protein Kinase Kinase 2 Inhibitors |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:88286 | EC 2.7.12.2 (mitogen-activated protein kinase kinase) inhibitor |
Related Drugs by ATC class:
L01EE Mitogen-activated protein kinase (MEK) inhibitors 4 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Neurofibromatosis type 1 | indication | 92824003 | DOID:0111253 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 1MG | GOMEKLI | SPRINGWORKS | N219379 | Feb. 11, 2025 | RX | TABLET, FOR SUSPENSION | ORAL | 11453641 | Feb. 17, 2041 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 1MG | GOMEKLI | SPRINGWORKS | N219379 | Feb. 11, 2025 | RX | TABLET, FOR SUSPENSION | ORAL | 11806321 | Feb. 17, 2041 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 1MG | GOMEKLI | SPRINGWORKS | N219379 | Feb. 11, 2025 | RX | TABLET, FOR SUSPENSION | ORAL | 11819487 | Feb. 17, 2041 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 1MG | GOMEKLI | SPRINGWORKS | N219379 | Feb. 11, 2025 | RX | TABLET, FOR SUSPENSION | ORAL | 12011424 | Feb. 17, 2041 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 1MG | GOMEKLI | SPRINGWORKS | N219379 | Feb. 11, 2025 | RX | TABLET, FOR SUSPENSION | ORAL | 12037306 | Feb. 17, 2041 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 1MG | GOMEKLI | SPRINGWORKS | N219379 | Feb. 11, 2025 | RX | TABLET, FOR SUSPENSION | ORAL | 12090128 | Feb. 17, 2041 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 1MG | GOMEKLI | SPRINGWORKS | N219379 | Feb. 11, 2025 | RX | TABLET, FOR SUSPENSION | ORAL | 12263146 | Feb. 17, 2041 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 1MG | GOMEKLI | SPRINGWORKS | N219379 | Feb. 11, 2025 | RX | TABLET, FOR SUSPENSION | ORAL | 12295925 | Feb. 17, 2041 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 1MG | GOMEKLI | SPRINGWORKS | N219379 | Feb. 11, 2025 | RX | TABLET, FOR SUSPENSION | ORAL | 12357597 | Feb. 17, 2041 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 1MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | 11453641 | Feb. 17, 2041 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 1MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | 11806321 | Feb. 17, 2041 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 1MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | 11819487 | Feb. 17, 2041 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 1MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | 12011424 | Feb. 17, 2041 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 1MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | 12037306 | Feb. 17, 2041 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 1MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | 12263146 | Feb. 17, 2041 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 1MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | 12275688 | Feb. 17, 2041 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 1MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | 12295925 | Feb. 17, 2041 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 2MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | 11453641 | Feb. 17, 2041 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 2MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | 11806321 | Feb. 17, 2041 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 2MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | 11819487 | Feb. 17, 2041 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 2MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | 12037306 | Feb. 17, 2041 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 2MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | 12263146 | Feb. 17, 2041 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 2MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | 12275688 | Feb. 17, 2041 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 2MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | 12295925 | Feb. 17, 2041 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 1MG | GOMEKLI | SPRINGWORKS | N219379 | Feb. 11, 2025 | RX | TABLET, FOR SUSPENSION | ORAL | 11839595 | March 16, 2043 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 1MG | GOMEKLI | SPRINGWORKS | N219379 | Feb. 11, 2025 | RX | TABLET, FOR SUSPENSION | ORAL | 11883375 | March 16, 2043 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 1MG | GOMEKLI | SPRINGWORKS | N219379 | Feb. 11, 2025 | RX | TABLET, FOR SUSPENSION | ORAL | 12220390 | March 16, 2043 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 1MG | GOMEKLI | SPRINGWORKS | N219379 | Feb. 11, 2025 | RX | TABLET, FOR SUSPENSION | ORAL | 12257215 | March 16, 2043 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 1MG | GOMEKLI | SPRINGWORKS | N219379 | Feb. 11, 2025 | RX | TABLET, FOR SUSPENSION | ORAL | 12324791 | March 16, 2043 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 1MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | 11839595 | March 16, 2043 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 1MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | 11883375 | March 16, 2043 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 1MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | 12220390 | March 16, 2043 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 1MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | 12257215 | March 16, 2043 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 1MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | 12324791 | March 16, 2043 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 2MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | 11839595 | March 16, 2043 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 2MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | 11883375 | March 16, 2043 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 2MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | 12220390 | March 16, 2043 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 2MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | 12257215 | March 16, 2043 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 2MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | 12324791 | March 16, 2043 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 1MG | GOMEKLI | SPRINGWORKS | N219379 | Feb. 11, 2025 | RX | TABLET, FOR SUSPENSION | ORAL | 11806322 | April 9, 2043 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 1MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | 11806322 | April 9, 2043 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 2MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | 11806322 | April 9, 2043 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 1MG | GOMEKLI | SPRINGWORKS | N219379 | Feb. 11, 2025 | RX | TABLET, FOR SUSPENSION | ORAL | 12661330 | Feb. 5, 2044 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 1MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | 12661330 | Feb. 5, 2044 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 2MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | 12661330 | Feb. 5, 2044 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 1MG | GOMEKLI | SPRINGWORKS | N219379 | Feb. 11, 2025 | RX | TABLET, FOR SUSPENSION | ORAL | 12029711 | March 15, 2044 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 1MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | 12029711 | March 15, 2044 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 1MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | 12383517 | March 15, 2044 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 2MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | 12029711 | March 15, 2044 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 2MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | 12383517 | March 15, 2044 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 1MG | GOMEKLI | SPRINGWORKS | N219379 | Feb. 11, 2025 | RX | TABLET, FOR SUSPENSION | ORAL | 12390430 | Oct. 10, 2044 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 1MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | 12390430 | Oct. 10, 2044 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 2MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | 12390430 | Oct. 10, 2044 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 1MG | GOMEKLI | SPRINGWORKS | N219379 | Feb. 11, 2025 | RX | TABLET, FOR SUSPENSION | ORAL | Feb. 11, 2030 | NEW CHEMICAL ENTITY |
| 1MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | Feb. 11, 2030 | NEW CHEMICAL ENTITY |
| 2MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | Feb. 11, 2030 | NEW CHEMICAL ENTITY |
| 1MG | GOMEKLI | SPRINGWORKS | N219379 | Feb. 11, 2025 | RX | TABLET, FOR SUSPENSION | ORAL | Feb. 11, 2032 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 1MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | Feb. 11, 2032 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
| 2MG | GOMEKLI | SPRINGWORKS | N219389 | Feb. 11, 2025 | RX | CAPSULE | ORAL | Feb. 11, 2032 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Dual specificity mitogen-activated protein kinase kinase 1 | Kinase | INHIBITOR | Ki | 8.96 | DRUG LABEL | DRUG LABEL | |||
| Dual specificity mitogen-activated protein kinase kinase 2 | Kinase | INHIBITOR | Ki | 9.10 | DRUG LABEL | DRUG LABEL | |||
| Serine/threonine-protein kinase B-raf | Kinase | IC50 | 8.22 | CHEMBL | |||||
| Mitogen-activated protein kinase 1 | Kinase | IC50 | 7.60 | CHEMBL | |||||
| Dual specificity mitogen-activated protein kinase kinase 5 | Kinase | Kd | 6.09 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 391210-10-9 | SECONDARY_CAS_RN |
| CHEMBL507361 | ChEMBL_ID |
| C506614 | MESH_SUPPLEMENTAL_RECORD_UI |
| DB07101 | DRUGBANK_ID |
| 4043753 | VANDF |
| C5447979 | UMLSCUI |
| 4BM | PDB_CHEM_ID |
| 11299 | INN_ID |
| 9826528 | PUBCHEM_CID |
| 392768 | MMSL |
| 43745 | MMSL |
| d10257 | MMSL |
| 020002 | NDDF |
| 7935 | IUPHAR_LIGAND_ID |
| 86K0J5AK6M | UNII |
| 2705551 | RXNORM |
| D11675 | KEGG_DRUG |
| CHEBI:88249 | CHEBI |
| 86K0J5AK6M | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Gomekli | HUMAN PRESCRIPTION DRUG LABEL | 1 | 82448-130 | CAPSULE | 1 mg | ORAL | NDA | 28 sections |
| Gomekli | HUMAN PRESCRIPTION DRUG LABEL | 1 | 82448-130 | CAPSULE | 1 mg | ORAL | NDA | 28 sections |
| Gomekli | HUMAN PRESCRIPTION DRUG LABEL | 1 | 82448-134 | TABLET, FOR SUSPENSION | 1 mg | ORAL | NDA | 28 sections |
| Gomekli | HUMAN PRESCRIPTION DRUG LABEL | 1 | 82448-134 | TABLET, FOR SUSPENSION | 1 mg | ORAL | NDA | 28 sections |
| Gomekli | HUMAN PRESCRIPTION DRUG LABEL | 1 | 82448-260 | CAPSULE | 2 mg | ORAL | NDA | 28 sections |
| Gomekli | HUMAN PRESCRIPTION DRUG LABEL | 1 | 82448-260 | CAPSULE | 2 mg | ORAL | NDA | 28 sections |