Vimseltinib
Romvimza (vimseltinib) is a small molecule pharmaceutical. Vimseltinib was first approved as Romvimza on 2025-02-14.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Romvimza
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Vimseltinib
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ROMVIMZA | Deciphera Pharmaceuticals | N-219304 RX | 2025-02-14 | 3 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| romvimza | New Drug Application | 2026-06-26 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| giant cell tumor of tendon sheath | — | D000070779 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
VIMSELTINIB, ROMVIMZA, DECIPHERA PHARMS | |||
| 2030-02-14 | NCE | ||
ATC Codes
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HCPCS
No data
Clinical
Clinical Trials
10 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Giant cell tumor of tendon sheath | D000070779 | — | — | 1 | 2 | 1 | — | 1 | 4 |
| Pigmented villonodular synovitis | D013586 | EFO_1001106 | M12.2 | 1 | 1 | 1 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 1 | 1 | — | — | — | 1 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | 1 | — | — | — | 1 |
| Fibrosis | D005355 | — | — | — | 1 | — | — | — | 1 |
| Respiratory tract diseases | D012140 | — | — | — | 1 | — | — | — | 1 |
| Graft vs host disease | D006086 | — | D89.81 | — | 1 | — | — | — | 1 |
| Immune system diseases | D007154 | — | D89.9 | — | 1 | — | — | — | 1 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | 1 | — | — | — | 1 |
| Bronchiolitis obliterans | D001989 | EFO_0007183 | J44.81 | — | 1 | — | — | — | 1 |
| Bronchial diseases | D001982 | — | — | — | 1 | — | — | — | 1 |
| Obstructive lung diseases | D008173 | — | — | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 4 | — | — | — | — | 4 |
| Sarcoma | D012509 | — | — | 1 | — | — | — | — | 1 |
| Leiomyosarcoma | D007890 | — | — | 1 | — | — | — | — | 1 |
| Fibrosarcoma | D005354 | — | — | 1 | — | — | — | — | 1 |
| Liposarcoma | D008080 | — | — | 1 | — | — | — | — | 1 |
| Malignant fibrous histiocytoma | D051677 | — | — | 1 | — | — | — | — | 1 |
| Dermatofibrosarcoma | D018223 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Vimseltinib |
| INN | vimseltinib |
| Description | Vimseltinib, sold under the brand name Romvimza, is an anti-cancer medication used for the treatment of tenosynovial giant cell tumor. Vimseltinib is a kinase inhibitor. Vimseltinib is a macrophage colony-stimulating factor receptor antagonist.
|
| Classification | Small molecule |
| Drug class | tyrosine kinase inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Cc1nc(-c2cnc(NC(C)C)n(C)c2=O)ccc1Oc1ccnc(-c2cnn(C)c2)c1 |
Identifiers
| PDB | — |
| CAS-ID | 1628606-05-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL5095202 |
| ChEBI ID | — |
| PubChem CID | 86267612 |
| DrugBank | DB17520 |
| UNII ID | PX9FTM69BF (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Trends
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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490 adverse events reported
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