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avutometinib 🐶 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 | 5770 | 946128-88-7 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Avutometinib is a reversible inhibitor of RAF kinases and MEK1/2. Avutometinib inhibits RAF/MEK pathway signaling by binding to RAF kinases and MEK1/2, resulting in inhibition of phosphorylation of downstream extracellular signal-related kinase (ERK). Avutometinib in combination with defactinib enhanced inhibition of cell proliferation in vitro and anti-tumor activity in mouse tumor models including LGSOC.
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 |
|---|---|---|---|
| May 5, 2025 | FDA | Verastem Oncology |
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 |
|---|---|---|
| FDA EPC | N0000175605 | Kinase Inhibitor |
| FDA MoA | N0000193943 | Mitogen-Activated Protein Kinase Kinase 1 Inhibitors |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:79091 | EC 2.7.11.24 (mitogen-activated protein kinase) inhibitor |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Ovarian cancer | indication | 363443007 | DOID:2394 |
🐶 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 0.8MG BASE;EQ 200MG BASE | AVMAPKI FAKZYNJA CO-PACK (COPACKAGED) | VERASTEM INC | N219616 | May 8, 2025 | RX | CAPSULE, TABLET | ORAL | 11400090 | Oct. 29, 2038 | TREATMENT OF ADULT PATIENTS WITH KRAS-MUTATED RECURRENT LOW-GRADE SEROUS OVARIAN CANCER (LGSOC) WHO HAVE RECEIVED PRIOR SYSTEMIC THERAPY, IN COMBINATION WITH DEFACTINIB |
| EQ 0.8MG BASE;EQ 200MG BASE | AVMAPKI FAKZYNJA CO-PACK (COPACKAGED) | VERASTEM INC | N219616 | May 8, 2025 | RX | CAPSULE, TABLET | ORAL | 11517573 | Sept. 11, 2040 | TREATMENT OF ADULT PATIENTS WITH KRAS-MUTATED RECURRENT LOW-GRADE SEROUS OVARIAN CANCER (LGSOC) WHO HAVE RECEIVED PRIOR SYSTEMIC THERAPY, IN COMBINATION WITH AVUTOMETINIB |
| EQ 0.8MG BASE;EQ 200MG BASE | AVMAPKI FAKZYNJA CO-PACK (COPACKAGED) | VERASTEM INC | N219616 | May 8, 2025 | RX | CAPSULE, TABLET | ORAL | 11517573 | Sept. 11, 2040 | TREATMENT OF ADULT PATIENTS WITH KRAS-MUTATED RECURRENT LOW-GRADE SEROUS OVARIAN CANCER (LGSOC) WHO HAVE RECEIVED PRIOR SYSTEMIC THERAPY, IN COMBINATION WITH DEFACTINIB |
| EQ 0.8MG BASE;EQ 200MG BASE | AVMAPKI FAKZYNJA CO-PACK (COPACKAGED) | VERASTEM INC | N219616 | May 8, 2025 | RX | CAPSULE, TABLET | ORAL | 11873296 | Dec. 29, 2042 | TREATMENT OF ADULT PATIENTS WITH KRAS-MUTATED RECURRENT LOW-GRADE SEROUS OVARIAN CANCER (LGSOC) WHO HAVE RECEIVED PRIOR SYSTEMIC THERAPY, IN COMBINATION WITH DEFACTINIB |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 0.8MG BASE;EQ 200MG BASE | AVMAPKI FAKZYNJA CO-PACK (COPACKAGED) | VERASTEM INC | N219616 | May 8, 2025 | RX | CAPSULE, TABLET | ORAL | May 8, 2030 | NEW CHEMICAL ENTITY |
| EQ 0.8MG BASE;EQ 200MG BASE | AVMAPKI FAKZYNJA CO-PACK (COPACKAGED) | VERASTEM INC | N219616 | May 8, 2025 | RX | CAPSULE, TABLET | ORAL | May 8, 2032 | TREATMENT OF ADULT PATIENTS WITH KRAS-MUTATED RECURRENT LOW-GRADE SEROUS OVARIAN CANCER (LGSOC) WHO HAVE RECEIVED PRIOR SYSTEMIC THERAPY |
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 | IC50 | 9.68 | DRUG LABEL | DRUG LABEL | |||
| RAF proto-oncogene serine/threonine-protein kinase | Kinase | INHIBITOR | IC50 | 7.25 | IUPHAR | ||||
| Serine/threonine-protein kinase B-raf | Kinase | Kd | 8.15 | CHEMBL | |||||
| Dual specificity mitogen-activated protein kinase kinase 2 | Kinase | Kd | 7.43 | CHEMBL | |||||
| Dual specificity mitogen-activated protein kinase kinase 5 | Kinase | Kd | 5.70 | CHEMBL | |||||
| RAF proto-oncogene serine/threonine-protein kinase | Kinase | INHIBITOR | IC50 | 7.25 | IUPHAR |
External reference:
| ID | Source |
|---|---|
| CHU | PDB_CHEM_ID |
| CHEMBL3264002 | ChEMBL_ID |
| C577924 | MESH_SUPPLEMENTAL_RECORD_UI |
| 11867 | IUPHAR_LIGAND_ID |
| C5708875 | UMLSCUI |
| CHEBI:78825 | CHEBI |
| CHEMBL3264004 | ChEMBL_ID |
| DB15254 | DRUGBANK_ID |
| 11815 | INN_ID |
| D12515 | KEGG_DRUG |
| 946128-90-1 | SECONDARY_CAS_RN |
| 16719221 | PUBCHEM_CID |
| 44326 | MMSL |
| d10300 | MMSL |
| 020105 | NDDF |
| 020106 | NDDF |
| D0D4252V97 | UNII |
| 2714514 | RXNORM |
| D0D4252V97 | INXIGHT DRUGS |
Pharmaceutical products:
None