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Romvimza (VIMSELTINIB)
Romvimza works by blocking a specific enzyme that helps cancer cells grow and survive.
Romvimza (vimseltinib) is a small molecule kinase inhibitor developed by Deciphera Pharmaceuticals. It is approved by the FDA for the treatment of symptomatic tenosynovial giant cell tumor (TGCT) in patients where surgical resection would cause significant functional limitation or severe morbidity. Romvimza is a patented medication with no generic manufacturers available. The exact mechanism of action and pharmacokinetic properties of Romvimza are not publicly disclosed. It is currently owned and marketed by Deciphera Pharmaceuticals.
At a glance
| Generic name | VIMSELTINIB |
|---|---|
| Sponsor | Deciphera Pharms |
| Drug class | Kinase Inhibitor [EPC] |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2025 |
Mechanism of action
Vimseltinib is a kinase inhibitor that inhibits colony-stimulating factor 1 receptor (CSF1R). In vitro, vimseltinib inhibited CSF1R autophosphorylation, signaling induced by CSF1 ligand binding, and proliferation of cells expressing CSF1R.
Approved indications
- symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity
Common side effects
- Periorbital edema
- Fatigue
- Peripheral edema
- Face edema
- Rash
- Pruritus
- Hypertension
- Neuropathy
- Lacrimation increased
- Dry eye
- Increased AST
- Increased cholesterol
Drug interactions
- P-gp substrates
- P-gp substrates
- BCRP substrates
- OCT2 substrates
- P-gp substrates
- BCRP substrates
- OCT2 substrates
- P-gp substrates
- BCRP substrates
- OCT2 substrates
- P-gp substrates
- BCRP substrates
Key clinical trials
- Study of Vimseltinib for Tenosynovial Giant Cell Tumor (PHASE3)
- Evaluate the Effect of Vimseltinib on Organic Cation Transporter 2 (OCT2) (PHASE1)
- Evaluate the Effect of Vimseltinib on the Pharmacokinetics of a BCRP and OATP1B1 Substrate (PHASE1)
- Study of Vimseltinib (DCC-3014) in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor (PHASE1,PHASE2)
- A Study to Evaluate Vimseltinib in Adults With Active Chronic Graft-Versus-Host Disease (cGVHD) (PHASE2)
- Tenosynovial Giant Cell Tumor (TGCT) Real-World Participant Experience With Vimseltinib
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |