Ireland
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Priya Life Science Compound trial record
Compound · clinical trials

Vimseltinib clinical trials

Also listed in trial records as DCC-3014
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 5 trials in our USA, UK, France, Spain, Italy, Netherlands, Poland, Canada, Australia, Germany, Switzerland, Norway and Japan registers that name Vimseltinib as an intervention. Synced 9 Nov 2026
5Current trials
2Recruiting now
2Lead sponsors
13Country registers
At a glance

Vimseltinib is named as an intervention in 5 current clinical trials in our USA, UK, France, Spain, Italy, Netherlands, Poland, Canada, Australia, Germany, Switzerland, Norway and Japan registers. 2 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Deciphera Pharmaceuticals, LLC (4). The most-studied condition is Tenosynovial Giant Cell Tumor.

Where Vimseltinib is approved

All regulators →

Of the three regulators tracked here, the first to approve Vimseltinib was the US, on 14 Feb 2025. It is approved in 2 of the 3 regulators tracked here.

USUnited States (FDA)
14 Feb 2025
Romvimza
NDA219304 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
17 Sep 2025
Romvimza
EMA product page
First centralised authorisation
CACanada (Health Canada)
No new-drug Notice of Compliance since 1994
First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

Vimseltinib patents and exclusivity

Expiry tracker →

Protections still running for marketed products containing Vimseltinib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.

US FDA Orange Book Romvimza
  • 13 listed patents; the last listed expires 30 Apr 2045 (US 12686672).
  • Latest patent on the drug substance itself: 6 Dec 2044 (US 12528787).
  • Exclusivity NCE: New chemical entity, until 14 Feb 2030.
See the Orange Book listing for NDA 219304
EU European Commission, orphan market exclusivity
  • ROMVIMZA for treatment of tenosynovial giant cell tumour, localised and diffuse type: until 24 Sep 2035. Union Register

Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.

What health systems spend on Vimseltinib

All medicines →
ENNHS England
Not dispensed in the community in England in the last 12 months under this name
Net ingredient cost, community prescriptions
USUS Medicaid
$2.7m
108 prescriptions in 2025 · Romvimza
Amount Medicaid reimbursed, before rebates

From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.

How Vimseltinib works

All drug targets →
Diseases it has been tested for in clinical trials, by furthest phase
  • Pigmented villonodular synovitisPhase 3
  • Chronic graft versus host diseasePhase 2
  • SarcomaPhase 1

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL5095202, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 11190, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

Patient leaflets for Vimseltinib

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

  • IE
    Ireland: 3 products on the HPRA list
    Each product record links to the HPRA, which publishes the leaflet and SmPC.
  • EU
    European Union: Romvimza
    EMA product information: package leaflet and summary of product characteristics in every EU language.
  • UK
    United Kingdom: Search MHRA Products
    Patient information leaflets and SmPCs for UK-licensed products.
  • US
    United States: Search DailyMed
    FDA-approved labels, including patient and medication guides.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Trials by status

  • Recruiting240%
  • Not yet open120%
  • Active, closed240%

Trials by phase

  • Phase 2240%
  • Phase 3120%
  • Phase 1/2120%
  • Phase 1120%
01

Clinical trials of Vimseltinib

5 trials
StudyPhaseStatusLead sponsorRegisters
A Study to Evaluate Vimseltinib in Adults With Active Chronic Graft-Versus-Host Disease (cGVHD)
NCT06619561 · Chronic Graft-Versus-Host Disease (cGVHD)
Phase 2 Recruiting Deciphera Pharmaceuticals, LLC USA
Evaluate the Effect of Vimseltinib on P-glycoprotein (P-gp) Inhibition in Healthy Male Participants
NCT07744802 · Healthy Male Participants
Phase 1 Recruiting Deciphera Pharmaceuticals, LLC USA
A Study of DCC-3014 to Evaluate the Efficacy, Safety, and Pharmacokinetics in Subjects With TGCT
NCT07832747 · ClinicalTrials.gov ↗ · Tenosynovial Giant Cell Tumor
Phase 2 Not yet open Ono Pharmaceutical Co., Ltd Japan
Study of Vimseltinib for Tenosynovial Giant Cell Tumor
NCT05059262 · Tenosynovial Giant Cell Tumor, Pigmented Villonodular Synovitis, Giant Cell Tumor of Tendon Sheath
Phase 3 Active, closed Deciphera Pharmaceuticals, LLC UK, USA, Germany, France, Spain, Italy, Netherlands, Poland, Switzerland, Norway, Canada, Australia
Study of Vimseltinib (DCC-3014) in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor
NCT03069469 · Advanced Malignant Neoplasm, Pigmented Villonodular Synovitis, Giant Cell Tumor of Tendon Sheath
Phase 1/2 Active, closed Deciphera Pharmaceuticals, LLC UK, USA, France, Spain, Italy, Netherlands, Poland, Canada, Australia

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Vimseltinib across our data

Ireland · EU · US

The same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.

Licensed in Ireland (HPRA)

3 single-substance products containing Vimseltinib on the HPRA medicines list.

All 3 Irish products →

Supply shortages

No entry for Vimseltinib in the EMA, FDA or German BfArM shortage lists we track.

03

Conditions studied with Vimseltinib

7 conditions
Tenosynovial Giant Cell Tumor3Pigmented Villonodular Synovitis2Giant Cell Tumor of Tendon Sheath2Tenosynovial Giant Cell Tumor, Diffuse1Advanced Malignant Neoplasm1Healthy Male Participants1Chronic Graft-Versus-Host Disease (cGVHD)1
06

Related compounds

07

Questions about Vimseltinib trials

How many clinical trials are testing Vimseltinib?

5 current trials in our USA, UK, France, Spain, Italy, Netherlands, Poland, Canada, Australia, Germany, Switzerland, Norway and Japan registers name Vimseltinib (also registered as DCC-3014) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.

Are Vimseltinib trials recruiting patients?

Yes. 2 of the 5 trials are recruiting: 2 with sites in USA. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Vimseltinib clinical trials?

Deciphera Pharmaceuticals, LLC (4) and Ono Pharmaceutical Co., Ltd (1). The number in brackets is how many trials each organisation leads.

Is Vimseltinib licensed in Ireland?

Yes. The HPRA medicines list includes 3 single-substance products containing Vimseltinib, for example ROMVIMZA 14 mg hard capsules (Deciphera Pharmaceuticals (Netherlands) B.V.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.

Is there a Vimseltinib shortage?

Not in the lists we track: Vimseltinib has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Vimseltinib works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Vimseltinib works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Vimseltinib (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.