Wednesday, July 8, 2026

Drug profile · INN

vimseltinib

vimseltinib (ROMVIMZA) is an FDA-listed pharmaceutical active ingredient. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved Antineoplastic and immunomodulating agents (L01) L01EX
US status approved
Patents linked 0
Pipeline programs 1
News articles 0
Drug details — vimseltinib
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
ORAL
Patents
0
Programs
1
Data quality
0.84

Quick answer

vimseltinib (ROMVIMZA) is an FDA-listed pharmaceutical active ingredient. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN vimseltinib
Brand ROMVIMZA
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route ORAL
Formulation CAPSULE
ATC code L01EX

Approval history

Authority Status Date
FDA approved
EMA approved

Pipeline programs

  1. Mumps vaccine, Live (MV) Approved · Sinovac Research and · Mumps

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)

Frequently asked questions

What is vimseltinib?

vimseltinib (ROMVIMZA) is an FDA-listed pharmaceutical active ingredient. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for vimseltinib?

ROMVIMZA is a marketed brand name for vimseltinib. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of vimseltinib?

vimseltinib has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.