NDAORALCAPSULEPriority Review
Approved
Feb 2025
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
8
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 26m 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. It targets Colony Stimulating Factor Receptor Type 1 to modulate immune cell populations. The specific clinical indication(s) have not been disclosed in available data.
Growth18.5 years to LOE
As a newly approved product in growth phase with no established competitors, ROMVIMZA offers early-career opportunity in a nascent market with potential for rapid team expansion and commercial scaling.
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 (8)
Evaluate the Effect of Vimseltinib on P-glycoprotein (P-gp) Inhibition in Healthy Male Participants
Started Sep 2026
20 enrolled
Healthy Male Participants
Evaluate the Effect of Vimseltinib on Pharmacokinetics of Combined Oral Contraceptive (Ethinyl Estradiol/Levonorgestrel)
Started Jun 2026
27 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
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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.