Drug intelligence / Profile preview

inixaciclib

Development stage
Discontinued
Lead developer
Nuvation Bio
Modality
Small Molecules
Administration
Oral
01

Overview

Inixaciclib (NUV-422) is a selective, orally administered small molecule inhibitor of cyclin-dependent kinases 2, 4, and 6 (CDK2/4/6). By inhibiting these kinases, inixaciclib blocks phosphorylation of the retinoblastoma protein (Rb) early in the G1 phase of the cell cycle and prevents CDK-mediated transition from G1 to S phase. This mechanism disrupts tumor cell proliferation and is designed to overcome resistance mechanisms seen with existing CDK4/6 inhibitors by also targeting CDK2. Inixaciclib was developed by Nuvation Bio for oncology indications including high-grade gliomas (such as glioblastoma multiforme), breast cancer (including hormone receptor positive/HER2 negative subtypes), and metastatic castration-resistant prostate cancer. The drug demonstrated favorable blood-brain barrier penetration and was granted FDA Fast Track designation for high-grade gliomas. However, clinical development was discontinued following safety concerns related to uveitis and regulatory feedback[1][2][4][5][7].

Other names
inixaciclibNUV-422NUV422NUV 422
02

Targets

CDK6 (Cyclin-dependent kinase 6)CDK4 (Cyclin-dependent kinase 4)CDK2 (Cyclin-dependent kinase 2)

Beyond the preview

Go deeper on inixaciclib.

Explore the evidence, development activity, and competitive landscape with Gosset’s full data platform.

Clinical trials

Full profile access

Follow clinical development from study design and recruitment through results.

  • Trial phase
  • Status
  • Readouts

Indications & development

Full profile access

Explore development by indication, patient population, and geography.

  • Indications
  • Development status
  • Countries

Licensing & deals

Full profile access

Trace asset ownership, licensing agreements, and commercial partnerships.

  • Partners
  • Deal terms
  • Milestones

Patents & exclusivity

Full profile access

Explore the patent landscape and regulatory exclusivity around an asset.

  • Patents
  • Expiration dates
  • Exclusivity

Competitive landscape

Full profile access

Compare development programs by target, modality, and indication.

  • Competing assets
  • Targets
  • Development stage

Research & analysis

Full profile access

Connect source evidence and development news to your research questions.

  • Publications
  • News
  • Analysis

Bring the full picture into focus.

See how Gosset can support your research on inixaciclib.

Explore the full profile

Gosset Free

Get started with Gosset.

Enter your work email and we’ll be in touch with next steps.

Work email preferred.

Book a call