Drugs / Vimseltinib
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed tenosynovial giant cell tumor 1 milestone | |||||
| Filed | EU (EMA) | — | tenosynovial giant cell tumor | 2024-07-19 | “today announced that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for vimseltinib” ono-pharma.com ↗ “In mid-July, the European Medicines Agency (EMA) accepted a Marketing Authorization Application (MAA) of vimseltinib” ono-pharma.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT07744802 | Sep → Dec 2026 expected | — | Deciphera Pharmaceuticals, LLC | Recruiting | No outcome recorded |
| Phase 1 | NCT07539090 | Jun → Oct 2026 expected | — | 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 22 trials | ||||||
| Phase 2 | NCT07832747 | Oct 2026 → Aug 2028 expected | tenosynovial giant cell tumor | Ono Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06619561 | Nov 2024 → Oct 2029 expected | chronic graft versus host disease | Deciphera Pharmaceuticals, LLC | Recruiting | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| 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 | Met primary |
News releases announcing trial results or a regulatory action · 21
| Date | Issuer | Release |
|---|---|---|
| 2025-10-18 | Ono Pharmaceutical Co., Ltd. | Results Deciphera Presents 2-Year Efficacy and Safety Results from MOTION Phase 3 Study of ROMVIMZA™(vimseltinib) in Patients with Tenosynovial Giant Cell Tumor (TGCT) at the European Society for Medical Oncology Congress 2025 ono-pharma.com ↗
Vimseltinib demonstrated statistically significant and clinically meaningful benefit vs placebo in antitumor response |
| 2025-10-18 | Deciphera Pharmaceuticals, LLC | Results Deciphera Presents 2-Year Efficacy and Safety Results from MOTION Phase 3 Study of ROMVIMZA™ (vimseltinib) in Patients with Tenosynovial Giant Cell Tumor (TGCT) at the European Society for Medical Oncology Congress 2025 deciphera.com ↗
Vimseltinib demonstrated statistically significant and clinically meaningful benefit vs placebo in antitumor response |
| 2025-09-18 | Ono Pharmaceutical Co., Ltd. | Regulatory Deciphera Receives European Commission Approval of ROMVIMZA™ (vimseltinib) for the Treatment of Tenosynovial Giant Cell Tumor (TGCT) ono-pharma.com ↗
Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; “Ono”), today announced that the European Commission (EC) has approved ROMVIMZA™ (vimseltinib) in the European Union (EU) for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability 1 . |
| 2025-09-17 | Deciphera Pharmaceuticals, LLC | Regulatory Deciphera Receives European Commission Approval of ROMVIMZA™ (vimseltinib) for the Treatment of Tenosynovial Giant Cell Tumor (TGCT) deciphera.com ↗
Vimseltinib is the first and only therapy with marketing authorization for the treatment of TGCT in the European Union |
| 2025-07-28 | Ono Pharmaceutical Co., Ltd. | Regulatory Deciphera Announces Positive CHMP Opinion for ROMVIMZA™ (vimseltinib) for the Treatment of Tenosynovial Giant Cell Tumor (TGCT) ono-pharma.com ↗
Vimseltinib is the first and only therapy with a positive CHMP opinion for the treatment of TGCT in the European Union |
| 2025-07-28 | Deciphera Pharmaceuticals, LLC | Regulatory Deciphera Announces Positive CHMP Opinion for ROMVIMZA™ (vimseltinib) for the Treatment of Tenosynovial Giant Cell Tumor (TGCT) deciphera.com ↗ |
| 2025-02-17 | Ono Pharmaceutical Co., Ltd. | Regulatory U.S. FDA Grants Full Approval of Deciphera’s ROMVIMZA™ (vimseltinib) for the Treatment of Symptomatic Tenosynovial Giant Cell Tumor (TGCT) ono-pharma.com ↗
Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President: Toichi Takino; “Ono”) announced that the U.S. Food and Drug Administration (FDA) has approved ROMVIMZA TM (vimseltinib), a kinase inhibitor, for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity. |
| 2025-02-15 | Deciphera Pharmaceuticals, LLC | Regulatory U.S. FDA Grants Full Approval of Deciphera’s ROMVIMZA™ (vimseltinib) for the Treatment of Symptomatic Tenosynovial Giant Cell Tumor (TGCT) deciphera.com ↗ |
| 2024-08-16 | Ono Pharmaceutical Co., Ltd. | Regulatory U.S. Food and Drug Administration Accepts for Priority Review Deciphera’s New Drug Application for Vimseltinib for the Treatment of Patients with Tenosynovial Giant Cell Tumor (TGCT) ono-pharma.com ↗ |
| 2024-07-19 | Ono Pharmaceutical Co., Ltd. | Regulatory European Medicines Agency Accepts Deciphera’s Marketing Authorization Application for Vimseltinib for Treatment of Patients with Tenosynovial Giant Cell Tumor (TGCT) ono-pharma.com ↗ |
| 2024-06-03 | Deciphera Pharmaceuticals, LLC | Results Deciphera Pharmaceuticals Announces Oral Presentation of Results from MOTION Pivotal Phase 3 Study of Vimseltinib in Patients with Tenosynovial Giant Cell Tumor (TGCT) at the 2024 ASCO Annual Meeting and Online Publication in The Lancet deciphera.com ↗ |
| 2023-10-30 | Deciphera Pharmaceuticals, LLC | Results Deciphera Pharmaceuticals Announces Positive Top-line Results from MOTION Pivotal Phase 3 Study of Vimseltinib in Patients with Tenosynovial Giant Cell Tumor (TGCT) and Updated Results from Phase 1/2 Study of Vimseltinib in TGCT deciphera.com ↗
MOTION Study Met Primary Endpoint with Objective Response Rate (ORR) at Week 25 of 40% Compared to 0% for Placebo (p<0.0001) |
| 2022-09-11 | Deciphera Pharmaceuticals, LLC | Results Deciphera Pharmaceuticals, Inc. Presents Updated Phase 1/2 Data for Vimseltinib in TGCT at the European Society for Medical Oncology (ESMO) Congress 2022 deciphera.com ↗
Updated Results for Vimseltinib Showed Objective Response Rate of 69% in Phase 1, 53% in Phase 2 Cohort A, and 46% in Phase 2 Cohort B; Demonstrated a Clinical Benefit Rate of 100% Across All Phase 1/2 Patients |
| 2021-09-17 | Deciphera Pharmaceuticals, LLC | Results Deciphera Pharmaceuticals Presents New Clinical Study Results Across Pipeline at the European Society for Medical Oncology (ESMO) Congress 2021 deciphera.com ↗
Updated Results for Vimseltinib Showed Objective Response Rate of 47% in Patients with Tenosynovial Giant Cell Tumor (TGCT) |
| 2020-11-11 | Deciphera Pharmaceuticals, LLC | Results Deciphera Presents Updated Preliminary Data from DCC-3014, its CSF1R Inhibitor Program, in Tenosynovial Giant Cell Tumor Patients at the Connective Tissue Oncology Society (CTOS) 2020 Virtual Annual Meeting deciphera.com ↗
The preliminary results presented in TGCT patients at the CTOS 2020 Virtual Annual Meeting demonstrated highly encouraging evidence of anti-tumor activity, and DCC-3014 was shown to be generally well-tolerated. |
| 2019-11-13 | Deciphera Pharmaceuticals, LLC | Results Deciphera Pharmaceuticals, Inc. to Present Data from DCC-3014 and Ripretinib Programs at the Connective Tissue Oncology Society (CTOS) 2019 Annual Meeting deciphera.com ↗
We are excited to share preliminary data from the initial TGCT patients enrolled in the ongoing Phase 1 study of DCC-3014. |
| 2019-10-29 | Deciphera Pharmaceuticals, LLC | Results Deciphera Pharmaceuticals Presents Updated Data from Ripretinib and DCC-3014 Programs at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics deciphera.com ↗
The data are being presented today at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston. |
| 2019-01-02 | Deciphera Pharmaceuticals, LLC | Results Deciphera Pharmaceuticals Announces Positive, Preliminary, Top-Line Clinical Data for the Ongoing Phase 1 Clinical Study with DCC-3014 and an Update on Future Development Plans deciphera.com ↗
DCC-3014, A Highly-Selective and Potent Small Molecule Inhibitor of CSF1R, Demonstrates Tolerability, Pharmacokinetics and Biomarker Mechanistic Proof-of-Concept (mPoC) in Patients with Advanced Malignancies |
| 2016-04-20 | Deciphera Pharmaceuticals, LLC | Results Deciphera’s Highly-Selective Small Molecule CSF1R Immunokinase Inhibitor, DCC-3014, Demonstrates Potent Macrophage Checkpoint Inhibition as a Single Agent and In Combination with an Anti-PD1 Inhibitor deciphera.com ↗
In addition, DCC-3014, which was designed as a highly-specific macrophage immunomodulatory agent based on the company’s Switch Control Inhibitor platform, demonstrated significantly enhanced anti-tumor activity when used in combination with an anti-PD-1 checkpoint inhibitor in preclinical cancer models. |
| 2016-03-17 | Deciphera Pharmaceuticals, LLC | Results Deciphera Pharmaceuticals to Present Data on its Highly-Selective Small Molecule CSF1R Immunokinase Inhibitor, DCC-3014, at American Association for Cancer Research Annual Meeting 2016 deciphera.com ↗
In preclinical cancer models, DCC-3014 was shown to significantly enhance anti-tumor activity when used in combination with an anti-PD-1 checkpoint inhibitor. |
| 2014-03-17 | Deciphera Pharmaceuticals, LLC | Results Deciphera Pharmaceuticals Presents Preclinical Data on Rebastinib and DCC-3014 at AACR Tumor Microenvironment Conference deciphera.com ↗
Preclinical Data Demonstrate Potent Inhibition of Tumor Microenvironment Mechanisms with Rebastinib; Durable Inhibition of FMS Kinase and Bone Protection in Bone Tumor Microenvironment with DCC-3014 |
All press releases naming this drug 25 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Vimseltinib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03069469 ↗ |
| 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 ↗ |