How many clinical trials are studying Ribociclib 400mg?

3 recruiting trials in our tracked data involve Ribociclib 400mg.

What conditions is Ribociclib 400mg being studied for?

In our tracked recruiting trials, Ribociclib 400mg is being studied in trials for Breast Cancer, HER2 Negative Breast Cancer, Advanced Breast Cancer.

Ribociclib 400mg: clinical trials recruiting now

Q: Is Ribociclib 400mg FDA-approved?

Yes. According to the FDA drug label available through openFDA, Ribociclib 400mg is an FDA-approved drug.

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Ribociclib 400mg appears in the FDA drug-label database. Marketed as KISQALI.

FDA-approved use

KISQALI is a kinase inhibitor indicated: in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence. ( 1 ) for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer in combination with: an aromatase inhibitor as initial endocrine-based therapy; or fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy. ( 1 ) 1.1 Early Breast Cancer KISQALI is indicated in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence. 1.2 Advanced or Metastatic Breast Cancer KISQALI is indicated for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer in combination with: an aromatase inhibitor as initial endocrine-based therapy; or fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy…

FDA label via openFDA

Phase breakdown

Phase 1 2 Phase 2 2

Conditions being studied

Condition	Trials
Breast Cancer · Ribociclib 400mg for Breast Cancer	3
HER2 Negative Breast Cancer	2
Advanced Breast Cancer	1
Metastatic Breast Cancer	1
PIK3CA Mutation	1
Solid Tumor, Adult	1
Unresectable Solid Tumor	1

Recruiting trials involving Ribociclib 400mg

First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast Cancer
NCT05216432 · Phase: Phase 1 · Ages: 18 Years and older · Sex: All (male and female) · 37 locations
Impact of Omitting Chemo Based on Patient's Selection for ER-Positive, HER2-Negative Breast Cancer With Ribociclib and Endocrine Therapy
NCT06953882 · Phase: Phase 2 · Ages: 18 Years and older · Sex: All (male and female) · 1 location
Ribociclib for HR-positive HER2-negative Metastatic Breast Cancer
NCT07164976 · Phase: Phase 1, Phase 2 · Ages: 18 Years and older · Sex: All (male and female) · 1 location

Common questions

Is Ribociclib 400mg FDA-approved?

Yes, marketed as KISQALI.

How many recruiting trials involve Ribociclib 400mg?

3 recruiting trials across 7 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.