Vimseltinib

Vimseltinib is a kinase inhibitor that inhibits colony-stimulating factor 1 receptor (CSF1R). In vitro, vimseltinib inhibited CSF1R autophosphorylation, signaling induced by CSF1 ligand binding, and proliferation of cells expressing CSF1R.

• ROMVIMZA is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity. ROMVIMZA is a kinase inhibitor indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.

• None.contraindicated

Recommended Dosage : 30 mg orally twice weekly, with a minimum of 72 hours between doses as described in the blister package. ( 2.1 ) See full prescribing information for dosage modifications due to hepatotoxicity and drug interactions. ( 2.2 , 2.3 ) 2.1 Recommended Dosage The recommended dosage of ROMVIMZA is 30 mg orally taken twice weekly, with a minimum of 72 hours between doses, as directed on the blister package [ see Clinical Pharmacology ( 12.3 ) ]. Instruct patients to follow the schedule on the blister package and to take ROMVIMZA on the same days each week. ROMVIMZA may be taken with or without food. Swallow ROMVIMZA capsules whole. Do not open, break, or chew the capsules. If a dose is missed by 48 hours or less, take the missed dose as soon as possible and take the next dose on its regularly scheduled day. If a dose is missed by more than 48 hours, skip the missed dose, and take the next dose on its regularly scheduled day. If vomiting occurs within 30 minutes of taking a dose, repeat that dose. Otherwise, take the next dose on its regularly scheduled day. 2.2 Dose Modifications for Adverse Reactions The recommended dose reductions for adverse reactions are provided in Table 1 . Table 1: Recommended Dose Reductions Dose Reduction Twice Weekly Dose First 20 mg Second 14 mg Permanently discontinue ROMVIMZA in patients who are unable to tolerate 14 mg orally twice weekly. The recommended dosage modifications for hepatotoxicity are summarized in Table 2 .

Hepatotoxicity: Elevated AST and ALT can occur. Evaluate liver tests prior to initiation of treatment and during treatment. ( 2.2 , 5.1 ) Embryo-fetal toxicity: Can cause fetal harm. Advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception. ( 5.2 , 8.1 , 8.3 ) Allergic Reactions to FD&C Yellow No. 5 (tartrazine) and No. 6 (Sunset Yellow FCF): 14 mg capsule contains FD&C Yellow No. 6 (Sunset Yellow FCF); 20 mg capsule contains FD&C Yellow No.5 (tartrazine) and No. 6 (Sunset Yellow FCF) as color additives, which may cause allergic reactions (including bronchial asthma) in certain susceptible patients. ( 5.3 ) Increased serum creatinine without affecting renal function: Increases in serum creatinine can occur. Use alternative measures that are not based on serum creatinine to assess renal function. ( 5.4 ) 5.1 Hepatotoxicity Cases of serious and fatal liver injury have occurred with the use of another kinase inhibitor that targets CSF1R [see Clinical Pharmacology ( 12.1 )]. Serious and fatal liver injury have not been observed with ROMVIMZA. Across clinical trials in 253 patients treated with ROMVIMZA, 2% had Grade 3 increased AST, and 1% had Grade 3 increased ALT. Dose interruptions occurred in 2% of patients and dose reductions occurred in 1% of patients due to AST/ALT increase. One patient discontinued therapy due to Grade 3 AST increased. Avoid ROMVIMZA in patients with pre-existing increased serum transaminases; total bilirubin or direct bilirubin (>ULN); or active liver or biliary tract disease, including ALP.

The following clinically significant adverse reactions are described elsewhere in the labeling: Hepatotoxicity [ see Warnings and Precautions ( 5.1 ) ] Most common adverse reactions (incidence ≥20%), including laboratory abnormalities are increased AST, periorbital edema, fatigue, rash, increased cholesterol, peripheral edema, face edema, decreased neutrophils, decreased leukocytes, pruritus, and increased ALT. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Deciphera Pharmaceuticals, LLC at 1-888-724-3274 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The pooled safety population described in the Warnings and Precautions reflects exposure to ROMVIMZA in 83 patients with TGCT enrolled in the double-blind portion and in 35 patients with TGCT in the open-label portion who crossed over to ROMVIMZA in MOTION, and in 135 patients with TGCT or solid tumors in other clinical trials. The safety of ROMVIMZA was evaluated in 83 adult patients with TGCT in MOTION [ see Clinical Studies ( 14 ) ]. MOTION excluded patients with bilirubin, AST, or ALT >ULN. All patients received ROMVIMZA twice weekly until disease progression or unacceptable toxicity. Among these patients, 82% were exposed for 6 months or longer and 30% were exposed for greater than one year.

Lactation: Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on data from animal studies and its mechanism of action, ROMVIMZA can cause fetal harm when administered to a pregnant woman. There are no available data on vimseltinib use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In female rats administered vimseltinib during the period of organogenesis, fetal structural abnormalities occurred at exposures that were at least 3 times the recommended dose based on AUC ( see Data ) . Advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In a rat embryo-fetal development study, pregnant female rats were dosed once daily during the period of organogenesis (gestational days 6 to 17) at doses of 2.5, 5, or 15 mg/kg/day. Structural abnormalities (skeletal variations) occurred at ≥2.5 mg/kg/day (approximately 3 times the exposure at the recommended dose based on AUC).

Metabolism

Vimseltinib pharmacokinetic parameters were determined following a single oral dose of 30 mg or at steady state following multiple doses of 30 mg twice weekly and are provided as mean (CV%) unless otherwise specified. Vimseltinib peak plasma concentration (C max ) is 283 ng/mL (36%) or 747 ng/mL (39%) after a single dose or at steady state, respectively, and area under the time concentration curve (AUC 0-inf ) is 46,900 ng•h/mL (45%) after a single dose and AUC 0-24hr is 13,400 ng•h/mL (45%) at steady state.

• Feb 14, 2025NDANDA219304Deciphera Pharms

1. 1Fatigue11127%
2. 2Swelling Face5914%
3. 3Periorbital Swelling5012%
4. 4Pruritus4711%
5. 5Peripheral Swelling4411%
6. 6Headache358.4%
7. 7Eye Swelling348.1%
8. 8Nausea337.9%
9. 9Product Use Issue337.9%
10. 10Rash317.4%
11. 11Arthralgia276.5%
12. 12Product Dose Omission Issue276.5%
13. 13Hepatic Enzyme Increased266.2%
14. 14Pain204.8%
15. 15Periorbital Oedema194.5%

The 7 most recently updated of 7 ClinicalTrials.gov registrations naming Vimseltinib as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Evaluate the Effect of Vimseltinib on Pharmacokinetics of Combined Oral Contraceptive (Ethinyl Estradiol/Levonorgestrel)
  Recruiting · Phase 1 · Interventional · 24 enrolled · Deciphera Pharmaceuticals, LLC
  NCT07539090updated 2026-06-05
• Study of Vimseltinib for Tenosynovial Giant Cell Tumor
  Active not recruiting · Phase 3 · Interventional · 123 enrolled · Deciphera Pharmaceuticals, LLC
  NCT05059262updated 2026-03-20
• Evaluate the Effect of Vimseltinib on Organic Cation Transporter 2 (OCT2)
  Completed · Phase 1 · Interventional · 22 enrolled · Deciphera Pharmaceuticals, LLC
  NCT07158411updated 2026-02-11
• Evaluate the Effect of Vimseltinib on the Pharmacokinetics of a BCRP and OATP1B1 Substrate
  Completed · Phase 1 · Interventional · 20 enrolled · Deciphera Pharmaceuticals, LLC
  NCT07158398updated 2026-01-15
• Study of Vimseltinib (DCC-3014) in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor
  Active not recruiting · Phase 1 · Phase 2 · Interventional · 120 enrolled · Deciphera Pharmaceuticals, LLC
  NCT03069469updated 2025-12-18
• A Study to Evaluate Vimseltinib in Adults With Active Chronic Graft-Versus-Host Disease (cGVHD)
  Recruiting · Phase 2 · Interventional · 48 enrolled · Deciphera Pharmaceuticals, LLC
  NCT06619561updated 2025-12-15
• Tenosynovial Giant Cell Tumor (TGCT) Real-World Participant Experience With Vimseltinib
  Recruiting · Observational · 100 enrolled · Deciphera Pharmaceuticals, LLC
  NCT07075471updated 2025-11-05

Frequently asked questions

How does Vimseltinib work?

Vimseltinib is a kinase inhibitor that inhibits colony-stimulating factor 1 receptor (CSF1R). In vitro, vimseltinib inhibited CSF1R autophosphorylation, signaling induced by CSF1 ligand binding, and proliferation of cells expressing CSF1R.

What is Vimseltinib used for?

According to FDA labeling, Vimseltinib carries indications including: ROMVIMZA is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity. ROMVIMZA is a kinase inhibitor indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Vimseltinib?

Vimseltinib is classified as Other protein kinase inhibitors, Kinase Inhibitor, Breast Cancer Resistance Protein Inhibitors, Colony Stimulating Factor Receptor Type 1 (CSF-1R) Inhibitors, Kinase Inhibitors, Organic Cation Transporter 2 Inhibitors, P-Glycoprotein Inhibitors, Cellular Proliferation Alteration.

What are the brand names for Vimseltinib?

Vimseltinib is marketed under brand names including Romvimza.

What are the contraindications for Vimseltinib?

Vimseltinib labeling lists contraindications including: None.. Always consult the full prescribing information and a clinician.