NDAORALCAPSULEPriority Review
Approved
Feb 2025
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
7
Data completeness
4/8 — Partial
Priority Review
ROMVIMZA (vimseltinib) by Cipher Pharmaceuticals is colony stimulating factor receptor type 1 (csf-1r) inhibitors [moa]. First approved in 2025.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ROMVIMZA (vimseltinib) is an oral CSF-1R kinase inhibitor approved by the FDA on February 14, 2025, as a small-molecule targeted therapy. It selectively inhibits Colony Stimulating Factor Receptor Type 1 to modulate immune and inflammatory pathways. The specific approved indication(s) have not been disclosed in available data.
Growth18.7 years to LOE
As a recently approved product in growth phase with no competitors disclosed, the brand team is likely expanding rapidly with investment in field sales, market development, and MSL roles.
Mechanism of Action
Colony Stimulating Factor Receptor Type 1 (CSF-1R) Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
Evaluate the Effect of Vimseltinib on Pharmacokinetics of Combined Oral Contraceptive (Ethinyl Estradiol/Levonorgestrel)
Started Jun 2026
24 enrolled
Healthy Participants
Evaluate the Effect of Vimseltinib on Organic Cation Transporter 2 (OCT2)
Started Nov 2025
22 enrolled
Healthy Participants
Evaluate the Effect of Vimseltinib on the Pharmacokinetics of a BCRP and OATP1B1 Substrate
Started Oct 2025
20 enrolled
Healthy Participants
MOVE: Tenosynovial Giant Cell Tumor (TGCT) Real-World Participant Experience With Vimseltinib
Started Sep 2025
100 enrolled
Tenosynovial Giant Cell Tumor
A Study to Evaluate Vimseltinib in Adults With Active Chronic Graft-Versus-Host Disease (cGVHD)
Started Nov 2024
48 enrolled
Chronic Graft-Versus-Host Disease (cGVHD)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.