Drug intelligence / Profile preview

romaciclib

Development stage
Phase 2
Lead developer
Ryvu Therapeutics
Modality
Small Molecules
Administration
Oral
01

Overview

Romaciclib is an investigational, orally bioavailable **small-molecule** inhibitor of **cyclin-dependent kinase 8 and cyclin-dependent kinase 19** being developed by Ryvu Therapeutics for hematologic malignancies. Public sources in the provided materials identify romaciclib as the canonical name for the same asset previously referred to as **RVU120** and **SEL120**. Its mechanism centers on inhibition of the mediator kinase module, with downstream suppression of STAT-dependent transcriptional programs and other resistance-associated signaling networks; in AML models it has shown synergy with venetoclax, including effects linked to caspase-dependent MCL-1 cleavage and suppression of IL6/JAK/STAT3 and PI3K/AKT/MTOR signaling. Clinical development described in the provided sources includes monotherapy and combination programs in relapsed or refractory AML and high-risk MDS, venetoclax-refractory AML, lower-risk myelodysplastic neoplasms with anemia, myelofibrosis, and advanced solid tumors. The drug is administered orally on intermittent 21-day schedules in current studies, and the most frequently reported treatment-related toxicities across studies include nausea and vomiting.

Other names
romaciclib
02

Targets

CDK19CDK8 (Cyclin-dependent kinase 8)

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