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Inixaciclib · NUV-422

Small molecule · Inhibitor of cyclin-dependent kinase 2 (CDK2), cyclin-dependent kinase 4 (CDK4) and cyclin-dependent kinase 6 (CDK6) · developed by Nuvation Bio

Phase 1/2 Most advanced trial (none active)

NUVB Developer

1 Registered trials

What is Inixaciclib?

Inixaciclib (NUV-422) is an orally bioavailable small molecule that inhibits cyclin-dependent kinases CDK2, CDK4 and CDK6. By blocking Rb phosphorylation early in G1 phase, it prevents the G1-S transition, leading to cell cycle arrest and apoptosis. It is being studied in breast cancer.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: NUV-422
Drug type: Small molecule
Targets: cyclin-dependent kinase 2 (CDK2), cyclin-dependent kinase 4 (CDK4), cyclin-dependent kinase 6 (CDK6)
Mechanism: Inhibitor of cyclin-dependent kinase 2 (CDK2), cyclin-dependent kinase 4 (CDK4) and cyclin-dependent kinase 6 (CDK6)
Pathways: Rb phosphorylation, G1-S cell cycle transition, apoptosis
Therapy area: Oncology
Developer: Nuvation Bio Inc. (NUVB)
FDA status: Investigational, not approved in the US. Most advanced trial: Phase 1/2
UNII: Q6460P4C0B

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT05191004	Phase 1/2	Advanced Breast Cancer	Withdrawn	NUVB

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Advanced Breast CancerBreast CancerBreast CarcinomaBreast TumorCancer of BreastCancer of the BreastMalignant Tumor of BreastMetastatic Breast Cancer

Other drugs acting on CDK2 / CDK4 / CDK6

Abemaciclib FDA approved Atirmociclib Phase 1/2 Milciclib Phase 2

More from Nuvation Bio

Taletrectinib FDA approved NUV-1511 Phase 1/2 NUV-868 Phase 1 Safusidenib Phase 3 Safusidenib Erbumine Early Phase 1

Sources

Updated Oct 11, 2026. Something wrong or missing? Report it on the NUVB page.

Follow NUVB, the company behind Inixaciclib

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z