ROMVIMZA (vimseltinib)
Romvimza treats adults with symptomatic tenosynovial giant cell tumor (TGCT). It helps patients when surgical removal of the tumor might lead to severe morbidity or cause worsening functional limitations. This medication provides a therapeutic option for managing these specific tumors when surgery is not ideal.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2025-02-14
- Patent Cliff
- 2045
- Routes
- ORAL
- Dosage Forms
- CAPSULE
ROMVIMZA Approval History
What ROMVIMZA Treats
1 indicationsROMVIMZA is approved for 1 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Tenosynovial Giant Cell Tumor
ROMVIMZA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to ROMVIMZA
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07539090 | DCC-3014-01-010 | Ph 1 | recruiting | Evaluate the Effect of Vimseltinib on Pharmacokinetics of Combined Oral Contraceptive (Ethinyl Estradiol/Levonorgestrel) |
| NCT05059262 MOTION results posted | DCC-3014-03-001 2024-513624-42-00 | Ph 3 | active not recruiting | Study of Vimseltinib for Tenosynovial Giant Cell Tumor |
| NCT07158411 | DCC-3014-01-008 | Ph 1 | completed | Evaluate the Effect of Vimseltinib on Organic Cation Transporter 2 (OCT2) |
| NCT07158398 | DCC-3014-01-007 | Ph 1 | completed | Evaluate the Effect of Vimseltinib on the Pharmacokinetics of a BCRP and OATP1B1 Substrate |
| NCT03069469 | DCC-3014-01-001 2024-514933-39-00 | Ph 1, Ph 2 | active not recruiting | Study of Vimseltinib (DCC-3014) in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor |
| NCT06619561 | DCC-3014-02-001 | Ph 2 | recruiting | A Study to Evaluate Vimseltinib in Adults With Active Chronic Graft-Versus-Host Disease (cGVHD) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ROMVIMZA FDA Label Details
Indications & Usage
FDA Label (PDF)ROMVIMZA is indicated for the treatment of Tenosynovial Giant Cell Tumor.
ROMVIMZA Patents & Exclusivity
Patents (10 active)
Exclusivity
Pro Intelligence Preview
Deep insights for ROMVIMZA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2045
- • 90 active patents
Trial Analysis
- • 6 total trials
- • Stage: Growth
Competitive Landscape
- • 1 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment