Vimseltinib

Vimseltinib
Clinical data
Trade names	Romvimza
License data	US DailyMed: Vimseltinib;
Routes of; administration	By mouth
Drug class	Antineoplastic
ATC code	None;
Legal status
Legal status	US: ℞-only;
Identifiers
	IUPAC name 3-methyl-5-[6-methyl-5-[2-(1-methylpyrazol-4-yl)pyridin-4-yl]oxypyridin-2-yl]-2-(propan-2-ylamino)pyrimidin-4-one;
CAS Number	1628606-05-2;
PubChem CID	86267612;
IUPHAR/BPS	11190;
DrugBank	DB17520;
ChemSpider	95499700;
UNII	PX9FTM69BF;
KEGG	D12238;
ChEMBL	ChEMBL5095202;
Chemical and physical data
Formula	C23H25N7O2
Molar mass	431.500 g·mol−1
3D model (JSmol)	Interactive image;
	SMILES CC1=C(C=CC(=N1)C2=CN=C(N(C2=O)C)NC(C)C)OC3=CC(=NC=C3)C4=CN(N=C4)C;
	InChI InChI=1S/C23H25N7O2/c1-14(2)27-23-25-12-18(22(31)30(23)5)19-6-7-21(15(3)28-19)32-17-8-9-24-20(10-17)16-11-26-29(4)13-16/h6-14H,1-5H3,(H,25,27); Key:TVGAHWWPABTBCX-UHFFFAOYSA-N;

Vimseltinib, sold under the brand name Romvimza, is an anti-cancer medication used for the treatment of tenosynovial giant cell tumor.^[1]^[2] Vimseltinib is a kinase inhibitor.^[1]^[2] Vimseltinib is a macrophage colony-stimulating factor receptor antagonist.^[3]

The most common adverse reactions, including laboratory abnormalities, include increased aspartate aminotransferase, periorbital edema, fatigue, rash, increased cholesterol, peripheral edema, face edema, decreased neutrophils, decreased leukocytes, pruritus, and increased alanine aminotransferase.^[2]

Vimseltinib was approved for medical use in the United States in February 2025.^[2]

Medical uses

Vimseltinib is indicated for the treatment of adults with symptomatic tenosynovial giant cell tumor for which surgical resection will potentially cause worsening functional limitation or severe morbidity.^[1]^[2]

History

The efficacy of vimseltinib was evaluated in MOTION (NCT05059262), a double-blind, multicenter, randomized (2:1), placebo-controlled trial in participants with tenosynovial giant cell tumor for whom surgical resection may cause worsening functional limitation or severe morbidity.^[2] Eligible participants had a confirmed diagnosis of tenosynovial giant cell tumor with measurable disease (RECIST v1.1) with at least one lesion having a minimum size of 2 cm.^[2] Pp[-[p;articipants were randomized to placebo or vimseltinib, 30 mg twice weekly administered for 24 weeks, during the double-blind period (part 1).^[2] During the open-label period (part 2), patients could continue vimseltinib and those receiving placebos could crossover to vimseltinib.^[2] Randomization was stratified by tumor location (lower limb versus all other) and region (United States versus Non-US).^[2] A total of 123 participants were randomized: 83 to the vimseltinib arm and 40 to placebo during part 1.^[2]

The US. Food and Drug Administration (FDA) granted the application for vimseltinib priority review designation.^[2]

Society and culture

Legal status

Vimseltinib was approved for medical use in the United States in February 2025.^[2]^[4]

Names

Vimseltinib is the international nonproprietary name.^[5]

Vimseltinib is sold under the brand name Romvimza.^[1]^[2]

References

^ ^a ^b ^c ^d ^e https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219304s000lbl.pdf
^ ^a ^b ^c ^d ^e ^f ^g ^h ⁱ ^j ^k ^l ^m ⁿ "FDA approves vimseltinib for symptomatic tenosynovial giant cell tumor". U.S. Food and Drug Administration (FDA). 14 February 2025. Retrieved 16 February 2025. This article incorporates text from this source, which is in the public domain.
^ Caldwell TM, Ahn YM, Bulfer SL, Leary CB, Hood MM, Lu WP, et al. (October 2022). "Discovery of vimseltinib (DCC-3014), a highly selective CSF1R switch-control kinase inhibitor, in clinical development for the treatment of Tenosynovial Giant Cell Tumor (TGCT)". Bioorganic & Medicinal Chemistry Letters. 74: 128928. doi:10.1016/j.bmcl.2022.128928. PMID 35961460.
^ "U.S. FDA Grants Full Approval of Deciphera's Romvimza (vimseltinib) for the Treatment of Symptomatic Tenosynovial Giant Cell Tumor (TGCT)" (Press release). Deciphera Pharmaceuticals. 14 February 2025. Retrieved 16 February 2025 – via Business Wire.
^ World Health Organization (2021). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 85". WHO Drug Information. 35 (1). hdl:10665/340684.

External links

Clinical trial number NCT05059262 for "Study of Vimseltinib for Tenosynovial Giant Cell Tumor (MOTION)" at ClinicalTrials.gov

[Romvimza_FDA_label-1] ttps://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219304s000lbl.pdf

[FDA_vimseltinib-2] ^ ^a ^b ^c ^d ^e ^f ^g ^h ⁱ ^j ^k ^l ^m ⁿ "FDA approves vimseltinib for symptomatic tenosynovial giant cell tumor". U.S. Food and Drug Administration (FDA). 14 February 2025. Retrieved 16 February 2025. This article incorporates text from this source, which is in the public domain.

[Caldwell_2022-3] Caldwell TM, Ahn YM, Bulfer SL, Leary CB, Hood MM, Lu WP, et al. (October 2022). "Discovery of vimseltinib (DCC-3014), a highly selective CSF1R switch-control kinase inhibitor, in clinical development for the treatment of Tenosynovial Giant Cell Tumor (TGCT)". Bioorganic & Medicinal Chemistry Letters. 74: 128928. doi:10.1016/j.bmcl.2022.128928. PMID 35961460.

[4] "U.S. FDA Grants Full Approval of Deciphera's Romvimza (vimseltinib) for the Treatment of Symptomatic Tenosynovial Giant Cell Tumor (TGCT)" (Press release). Deciphera Pharmaceuticals. 14 February 2025. Retrieved 16 February 2025 – via Business Wire.

[5] World Health Organization (2021). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 85". WHO Drug Information. 35 (1). hdl:10665/340684.

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