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DRUG:

Romvimza (vimseltinib)

i
Other names: DCC-3014, DCC 3014, DCC3014
Associations
Trials
Company:
Ono Pharma
Drug class:
CSF-1R inhibitor, FMS kinase inhibitor
Associations
Trials
12d
Properties of FDA-approved small molecule protein kinase inhibitors: a 2026 update. (PubMed, Pharmacol Res)
The following ten drugs received FDA approval in 2025 - avutometinib (inhibiting MEK1/2 in serous ovarian carcinomas), defactinib (blocking FAK in low grade serous ovarian carcinomas), delgocitinib (antagonizing the JAK family in hand eczema), mirdametinib (inhibiting MEK1/2 in type I neurofibromatosis), remibrutinib (blocking BTK in chronic spontaneous urticaria), rilzabrutinib (antagonizing BTK in chronic immune thrombocytopenia), sunvozertinib (blocking mutant exon 21 insertion EGFR NSCLC), taletrectinib (inhibiting mutant ROS1 in NSCLC), vimseltinib (blocking CSF1R in tenosynovial giant cell tumors), and zongertinib (antagonizing mutant HER2 in NSCLC). This article summarizes the physicochemical properties of all 94 FDA-approved small molecule protein kinase inhibitors including the molecular weight, number of hydrogen bond donors/acceptors, ligand efficiency, lipophilic efficiency, polar surface area, and solubility. A total of 45 of the 94 FDA-approved drugs have a least one Lipinski rule of five violation.
FDA event • Review • Journal
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EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CSF1R (Colony stimulating factor 1 receptor)
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EGFR mutation
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Gomekli (mirdametinib) • Avmapki (avutometinib) • Hernexeos (zongertinib) • Fakzynja (defactinib) • Ibtrozi (taletrectinib) • Zegfrovy (sunvozertinib) • Rhapsido (remibrutinib) • Romvimza (vimseltinib)
13d
Investigating vimseltinib in tenosynovial giant cell tumors. (PubMed, Expert Opin Pharmacother)
Furthermore, there is an absence of severe toxicities that have arisen with other agents in the TGCT treatment space, specifically liver failure. Vimseltinib is a favorable option for patients with TGCTs and further efforts to determine its place in the sequence of overall management are needed.
Review • Journal
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CSF1R (Colony stimulating factor 1 receptor)
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Turalio (pexidartinib) • Romvimza (vimseltinib)
23d
Evaluate the Effect of Vimseltinib on the Pharmacokinetics of a BCRP and OATP1B1 Substrate (clinicaltrials.gov)
P1, N=20, Completed, Deciphera Pharmaceuticals, LLC | Active, not recruiting --> Completed | Trial completion date: Jun 2026 --> Dec 2025 | Trial primary completion date: Jun 2026 --> Dec 2025
Trial completion • Trial completion date • Trial primary completion date
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Romvimza (vimseltinib)
26d
Evaluate the Effect of Vimseltinib on Organic Cation Transporter 2 (OCT2) (clinicaltrials.gov)
P1, N=20, Active, not recruiting, Deciphera Pharmaceuticals, LLC | Recruiting --> Active, not recruiting
Enrollment closed
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metformin • Romvimza (vimseltinib)
26d
Evaluate the Effect of Vimseltinib on the Pharmacokinetics of a BCRP and OATP1B1 Substrate (clinicaltrials.gov)
P1, N=20, Active, not recruiting, Deciphera Pharmaceuticals, LLC | Recruiting --> Active, not recruiting
Enrollment closed
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Romvimza (vimseltinib)
3ms
Evaluate the Effect of Vimseltinib on Organic Cation Transporter 2 (OCT2) (clinicaltrials.gov)
P1, N=20, Recruiting, Deciphera Pharmaceuticals, LLC | Not yet recruiting --> Recruiting
Enrollment open
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metformin • Romvimza (vimseltinib)
4ms
Enrollment change
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Romvimza (vimseltinib)
4ms
Evaluate the Effect of Vimseltinib on the Pharmacokinetics of a BCRP and OATP1B1 Substrate (clinicaltrials.gov)
P1, N=20, Recruiting, Deciphera Pharmaceuticals, LLC | Not yet recruiting --> Recruiting
Enrollment open
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Romvimza (vimseltinib)
5ms
New P1 trial
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Romvimza (vimseltinib)
5ms
New P1 trial
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metformin • Romvimza (vimseltinib)
5ms
Study of DCC-3014 in Combination With Avelumab in Patients With Advanced or Metastatic Sarcomas (clinicaltrials.gov)
P1, N=32, Completed, Memorial Sloan Kettering Cancer Center | Active, not recruiting --> Completed | Trial completion date: Jan 2026 --> Aug 2025 | Trial primary completion date: Jan 2026 --> Aug 2025
Trial completion • Trial completion date • Trial primary completion date
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Bavencio (avelumab) • Romvimza (vimseltinib)
6ms
Tenosynovial Giant Cell Tumor (TGCT) Real-World Participant Experience With Vimseltinib (clinicaltrials.gov)
P=N/A, N=100, Recruiting, Deciphera Pharmaceuticals, LLC | Not yet recruiting --> Recruiting
Enrollment open • Real-world evidence
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Romvimza (vimseltinib)