Romvimza (vimseltinib)
An approved treatment for Tenosynovial Giant Cell Tumor.
Drug facts
The same compound appears under different names depending on the context. Here is how to identify Vimseltinib wherever you encounter it, plus the key facts at a glance.
- Generic name
- Vimseltinib
- Brand name
- Romvimza
- Development code
- DCC-3014
- Drug class
- CSF1R kinase inhibitor
- Manufacturer
- Deciphera Pharmaceuticals (part of Ono Pharmaceutical)
- How it's taken
- Oral capsule
A capsule from Deciphera taken twice a week for symptomatic tenosynovial giant cell tumor (TGCT) when surgery could worsen joint function or cause severe harm. The FDA approved it on February 14, 2025. In the MOTION trial, tumors shrank in 40% of people on Romvimza by week 25 and in none on placebo.
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Where Vimseltinib fits
Surgery is the usual first treatment for TGCT, but the tumor often comes back, and repeat surgery can damage the joint. Romvimza is approved for people with symptoms whose surgery could worsen function or cause severe harm. Turalio (pexidartinib), another CSF1R blocker, is also approved for TGCT.
How Vimseltinib works
Tenosynovial giant cell tumor grows in the lining of a joint or tendon. A small group of tumor cells makes too much of a signal called CSF1, which draws in inflammatory cells that make up most of the tumor's bulk, according to Deciphera. Vimseltinib blocks CSF1R, the receptor that signal acts on, so fewer of those cells are drawn in and the tumor can shrink.
Side effects and safety
- Liver. Raised AST and ALT can occur; across 253 treated people, 2% had grade 3 AST and 1% grade 3 ALT rises. Another CSF1R drug has caused serious liver injury, not seen with Romvimza.
- Pregnancy. Can harm an unborn baby; effective birth control is advised during treatment and for 1 month after the last dose.
- Dye allergy. The 20mg capsule contains FD&C Yellow No. 5 (tartrazine), which can cause allergic reactions, more often in people sensitive to aspirin.
- Creatinine. Blood creatinine can rise without kidney damage and returns to normal after stopping, so kidney function is checked with tests that do not rely on creatinine.
- Liver tests before starting, twice a month for the first 2 months, then every 3 months for the first year
- A pregnancy test before starting for anyone who could become pregnant
In the MOTION trial through week 25, the most common side effects on Romvimza compared with placebo were swelling around the eyes (60% against 21%), fatigue (59% against 38%), rash (47% against 5%), swelling of the legs or feet (33% against 8%), face swelling (31% against 8%) and itching (29% against 8%). Raised liver enzymes were common in blood tests: AST rose in 92% of people on Romvimza against 11% on placebo.
The label notes that another CSF1R drug has caused serious and fatal liver injury, which has not been seen with Romvimza, and asks for regular liver tests. It can harm an unborn baby, so effective birth control is advised during treatment and for 1 month after the last dose, with no breastfeeding in that time. There is no boxed warning.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Vimseltinib
Take 30mg by mouth twice a week, at least 72 hours apart and on the same 2 days each week, following the schedule on the blister pack. Capsules can be taken with or without food and are swallowed whole. A dose up to 48 hours late can still be taken; after that it is skipped. If side effects need it, the dose can be lowered to 20mg and then 14mg twice a week.
Availability and cost
Only available as the brand-name product.
Help paying for Romvimza
Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE. Pick your insurance below to see which offers fit you.
Good to know: Deciphera AccessPoint offers a case manager, insurance and coverage checks, out-of-pocket cost estimates, a copay program for commercially insured patients with an annual maximum, and help finding foundation funding or free medicine for eligible patients. Call 1-833-432-2237 (1-833-4DACCES), Monday to Friday, 8am to 8pm Eastern.
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Clinical trial results
MOTION (NCT05059262) was a Phase 3, double-blind trial that randomized 123 adults with TGCT not suited to surgery, 83 to Romvimza and 40 to placebo for 24 weeks. By week 25, tumors shrank by the standard RECIST measure in 40% of people on Romvimza (5% completely) against 0% on placebo. People on Romvimza also gained more joint range of motion (a 14.6% larger improvement), and 48.2% had a meaningful drop in pain against 22.5% on placebo. Among those who responded, 85% kept the response for 6 months or longer.
Development history
Deciphera developed vimseltinib under the code DCC-3014. The FDA approved Romvimza on February 14, 2025 with Fast Track designation and Priority Review, and the European Commission approved it in September 2025. Ono Pharmaceutical acquired Deciphera in 2024.
Explore Tenosynovial Giant Cell Tumor trials
Other Tenosynovial Giant Cell Tumor treatments
Common questions about Vimseltinib
▸What is Vimseltinib (Romvimza)?
A capsule from Deciphera taken twice a week for symptomatic tenosynovial giant cell tumor (TGCT) when surgery could worsen joint function or cause severe harm. The FDA approved it on February 14, 2025. In the MOTION trial, tumors shrank in 40% of people on Romvimza by week 25 and in none on placebo.
▸How does Vimseltinib work?
Tenosynovial giant cell tumor grows in the lining of a joint or tendon. A small group of tumor cells makes too much of a signal called CSF1, which draws in inflammatory cells that make up most of the tumor's bulk, according to Deciphera. Vimseltinib blocks CSF1R, the receptor that signal acts on, so fewer of those cells are drawn in and the tumor can shrink.
▸What are the side effects of Vimseltinib?
In the MOTION trial through week 25, the most common side effects on Romvimza compared with placebo were swelling around the eyes (60% against 21%), fatigue (59% against 38%), rash (47% against 5%), swelling of the legs or feet (33% against 8%), face swelling (31% against 8%) and itching (29% against 8%). Raised liver enzymes were common in blood tests: AST rose in 92% of people on Romvimza against 11% on placebo. The label notes that another CSF1R drug has caused serious and fatal liver injury, which has not been seen with Romvimza, and asks for regular liver tests. It can harm an unborn baby, so effective birth control is advised during treatment and for 1 month after the last dose, with no breastfeeding in that time. There is no boxed warning.
▸How is Vimseltinib taken?
Take 30mg by mouth twice a week, at least 72 hours apart and on the same 2 days each week, following the schedule on the blister pack. Capsules can be taken with or without food and are swallowed whole. A dose up to 48 hours late can still be taken; after that it is skipped. If side effects need it, the dose can be lowered to 20mg and then 14mg twice a week.
▸Is Vimseltinib FDA approved?
Yes, Vimseltinib (Romvimza) is FDA approved (2025) for the treatment of Tenosynovial Giant Cell Tumor.
▸What is Romvimza used for?
Romvimza (vimseltinib) is FDA-approved for adults with symptomatic tenosynovial giant cell tumor (TGCT) when surgery could worsen how the joint works or cause severe harm. It is taken as a capsule twice a week.
▸How well did Romvimza work in the MOTION trial?
By week 25, tumors shrank in 40% of people on Romvimza and in none on placebo, and 5% saw the tumor disappear on scans. People on Romvimza also had more improvement in joint movement and pain than those on placebo.
▸Does Romvimza affect the liver?
Raised liver enzymes were common in MOTION, and the label calls for liver tests before starting, twice a month for the first 2 months, then every 3 months for the first year. The label says serious liver injury seen with another CSF1R drug has not been seen with Romvimza.
▸How is Romvimza different from Turalio?
Both block CSF1R and are approved for TGCT. Romvimza is taken twice a week, while Turalio (pexidartinib) is taken twice a day with a low-fat meal and carries a boxed warning for serious and potentially fatal liver injury, according to its label.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. National Library of Medicine, DailyMed · 2026-06. ROMVIMZA (vimseltinib) capsules: Prescribing Information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f73c7a62-9601-4df0-810f-100f515d79ea
- U.S. Food and Drug Administration · 2025-02-14. FDA approves vimseltinib for symptomatic tenosynovial giant cell tumor. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vimseltinib-symptomatic-tenosynovial-giant-cell-tumor
- Deciphera Pharmaceuticals · 2025-02-14. U.S. FDA Grants Full Approval of Deciphera's ROMVIMZA (vimseltinib) for the Treatment of Symptomatic Tenosynovial Giant Cell Tumor. https://www.deciphera.com/news/us-fda-grants-full-approval-decipheras-romvimzatm-vimseltinib-treatment-symptomatic
- Deciphera Pharmaceuticals · 2025-09-17. Deciphera Receives European Commission Approval for ROMVIMZA. https://www.deciphera.com/news/deciphera-receives-european-commission-approval-for-romvimza
- U.S. National Library of Medicine, DailyMed. TURALIO (pexidartinib) capsules: Prescribing Information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7b0ec4bf-b2ac-49ee-96af-7740ad3f2e16
- ClinicalTrials.gov. MOTION: A Phase 3 Study of Vimseltinib in Tenosynovial Giant Cell Tumor. https://clinicaltrials.gov/study/NCT05059262
- Deciphera Pharmaceuticals. Deciphera AccessPoint patient support. https://www.decipheraaccesspoint.com/