Drugs / Vimseltinib

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) ROMVIMZA 2026-06-26 fda.gov
Approved EU (EMA) Romvimza 2025-09-17 europa.eu
Approved US (FDA) ROMVIMZA 2025-02-14 fda.gov

Trials 7 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 14 trials
Phase 1 NCT07539090 Jun → Aug 2026 overdue Deciphera Pharmaceuticals, LLC Recruiting No outcome recorded
Phase 1 NCT07158411 Nov 2025 → Jan 2026 Deciphera Pharmaceuticals, LLC Completed No outcome recorded
Phase 1 NCT07158398 Oct → Dec 2025 Deciphera Pharmaceuticals, LLC Completed No outcome recorded
Phase 1 NCT04242238 Jan 2020 → Aug 2025 dedifferentiated liposarcoma, leiomyosarcoma, myxofibrosarcoma, undifferentiated pleomorphic sarcoma Memorial Sloan Kettering Cancer Center Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT03069469 Feb 2017 → Aug 2028 expected cancer, tenosynovial giant cell tumor, diffuse type Deciphera Pharmaceuticals, LLC Active not recruiting No outcome recorded
Phase 21 trial
Phase 2 NCT06619561 Nov 2024 → Oct 2029 expected chronic graft versus host disease Deciphera Pharmaceuticals, LLC Recruiting No outcome recorded
Phase 31 trial
Phase 3 NCT05059262 Oct 2021 → Aug 2023 overdue tenosynovial giant cell tumor, diffuse type, tenosynovial giant cell tumor, localized type Deciphera Pharmaceuticals, LLC Active not recruiting No outcome recorded

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 9 sources stand behind the page.

FieldValueCited text
Known as Vimseltinib ClinicalTrials.gov intervention name — accepted as the source's own label NCT07158398
5

NCT06619561

NCT05059262

NCT07158411

NCT03069469

NCT07539090

Known as DCC-3014 ClinicalTrials.gov intervention name — accepted as the source's own label NCT04242238
Known as DP-6865 ChEMBL registry synonym — accepted as the source's own label CHEMBL5095202
Action Inhibit “CSF1R Inhibitor” NCT04242238
Modality Small molecule “Vimseltinib is an oral switch-control tyrosine kinase inhibitor” PMID 37593881 Aug 2023
Route Oral “DCC-3014 will be administered in pill form.” NCT04242238
Target CSF1R CSF1R Inhibitor” NCT04242238