How many clinical trials are running for ribociclib?

ClinicalTrials.gov lists more than 16 phase 2–4 ribociclib trials. This page tracks the 16 largest by enrolment: 6 phase 2, 8 phase 3, and 2 phase 4 among them, with 5 actively recruiting. Updated daily.

Are there clinical trials for Kisqali?

Kisqali is the brand name for ribociclib, so ribociclib trials on ClinicalTrials.gov cover it. ClinicalTrials.gov lists more than 16 phase 2–4 ribociclib trials. This page tracks the 16 largest by enrolment: 6 phase 2, 8 phase 3, and 2 phase 4 among them, with 5 actively recruiting. Updated daily.

Where does this data come from?

All trial data is sourced from ClinicalTrials.gov (CTGov) and refreshed on this page daily.

Can I compare ribociclib against other drugs?

Yes. The free ComplyRx Trial Pipeline tool compares up to five drugs side by side on one timeline, with PNG and PDF export. Add any competitor in the search box above.

Targeted & bispecific oncology · Live ClinicalTrials.gov data

Ribociclib (Kisqali) clinical trial pipeline

The timeline below tracks the 16 largest phase 2–4 ribociclib (Kisqali) trials on ClinicalTrials.gov by enrolment, 5 of them actively recruiting. The next phase 3 primary completion among them is expected Feb 2029. Refreshed daily. Add up to four competitors to compare pipelines side by side.

16+

Major trials tracked

Phase 3 trials

Actively recruiting

Feb 2029

Next phase 3 primary completion

11,522

Participants across trials

Novartis Pharmaceuticals

Lead sponsor by trial count

ribociclib (16)11 active2014–2035

Hide completed

ribociclib

Key

Actual date

Anticipated

Forecast to primary completion

RecruitingActive, not recruitingNot yet recruitingCompletedUnknown status

'14

'16

'18

'20

'22

'24

'26

'28

'30

'32

'34

ribociclib

MONALEESA-7P3

MONALEESA-3P3

LEADERP2

RIGHT ChoiceP2

Match MelP2

Cyclin Dependant Kinase 4/6 (CDK4/6) Inhibitors as a Second Line Treatment in Metastatic Breast Cancer PatientsP3

RIBOLARISP2

Roll-over Study to Allow Continued Access to RibociclibP4

Adjuvant WIDERP3

Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutantP2

Clinical and PP4

NoLEEtaP3

A Phase ll, Interventional, Single-arm Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib and Fulvestrant in Chinese Patients With PIK3CA-mutant, HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer.P2

SERAFA-1P3

Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low TrialP3

SIE-3P3

Upcoming readouts

9 ahead · ribociclib

Select a trial to load its full ClinicalTrials.gov record.

Key ribociclib trials

Top 12 of the 16 tracked phase 2–4 trials, ordered by phase and status. Trial names open the full ComplyRx trial page; NCT ids link to ClinicalTrials.gov.

Trial	Title	Phase	Status	Primary completion
NCT05161195	Roll-over Study to Allow Continued Access to Ribociclib	Phase 4	Active, not recruiting	Jun 2030
NCT07487129	Clinical and P: Clinical and Pharmacoeconomic Assessment of CDK4/6 Inhibitors for Treatment of Breast Cancer in …	Phase 4	Completed	Oct 2025
NCT07647328	SERAFA-1: A Phase IIIb Study to Evaluate Camizestrant Plus Ribociclib in ER-positive, HER2-negative Advanc…	Phase 3	Recruiting	Feb 2029
NCT07391774	Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Horm…	Phase 3	Recruiting	Jul 2029
NCT05827081	Adjuvant WIDER: Phase IIIb Study of Ribociclib + ET in Early Breast Cancer	Phase 3	Recruiting	Sept 2029
NCT07237256	NoLEEta: Chemotherapy De-escalation in HR +, HER2-, Intermediate-risk Early Breast Cancer Treated With Ad…	Phase 3	Recruiting	Nov 2033
NCT07340658	SIE-3: A Study to Investigate the Efficacy and Safety of Letrozole SIE Compared With Femara® (Both Comb…	Phase 3	Not yet recruiting	Feb 2029
NCT02278120	MONALEESA-7: Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negativ…	Phase 3	Completed	Aug 2017
NCT02422615	MONALEESA-3: Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Canc…	Phase 3	Completed	Nov 2017
NCT05670054	Cyclin Dependant Kinase 4/6 (CDK4/6) Inhibitors as a Second Line Treatment in Metastatic Breast …	Phase 3	Unknown	Oct 2023
NCT05843253	Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-…	Phase 2	Recruiting	Aug 2029
NCT03285412	LEADER: CDK 4/6 Inhibitor, Ribociclib, With Adjuvant Endocrine Therapy for ER-positive Breast Cancer	Phase 2	Active, not recruiting	Apr 2026

Track ribociclib with ComplyRx

Get an alert when a trial changes status, moves its completion date, or a new trial registers in scope. Checked nightly against ClinicalTrials.gov.

Track ribociclib

Compare ribociclib vs amivantamab Compare ribociclib vs tarlatamab

FAQ

How many clinical trials are running for ribociclib?: ClinicalTrials.gov lists more than 16 phase 2–4 ribociclib trials. This page tracks the 16 largest by enrolment: 6 phase 2, 8 phase 3, and 2 phase 4 among them, with 5 actively recruiting. Updated daily.
Are there clinical trials for Kisqali?: Kisqali is the brand name for ribociclib, so ribociclib trials on ClinicalTrials.gov cover it. ClinicalTrials.gov lists more than 16 phase 2–4 ribociclib trials. This page tracks the 16 largest by enrolment: 6 phase 2, 8 phase 3, and 2 phase 4 among them, with 5 actively recruiting. Updated daily.
Where does this data come from?: All trial data is sourced from ClinicalTrials.gov (CTGov) and refreshed on this page daily.
Can I compare ribociclib against other drugs?: Yes. The free ComplyRx Trial Pipeline tool compares up to five drugs side by side on one timeline, with PNG and PDF export. Add any competitor in the search box above.

Upcoming readouts

Key ribociclib trials

Track ribociclib with ComplyRx

Related drug pipelines

FAQ

Keep followingwhat matters.

Keep following
what matters.