Drug · Small Molecule

Ribociclib

CI-DRUG-00000518Explore in graph →NCIt C95701 CHEMBL3545110 CIViC Approved

Regulatory

Approvals (11)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

health-canada-dpdRegulatory11 approval records from 3 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as KISQALI (DIN 02473569) under ATC L01EF02 RIBOCICLIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Apr 27, 2018	health-canada-dpd
EU EMA	Malignant Breast Neoplasm	Early breast cancer Kisqali in combination with an aromatase inhibitor is indicated for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer at high risk of recurrence (see section 5.1 for selection criteria). In pre- or perimenopausal women, or in men, the aromatase inhibitor should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. Advanced or metastatic breast cancer Kisqali is indicated for the treatment of women with HR-positive, HER2-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist.	approved	Aug 22, 2017	ema
US FDA	—	Efficacy supplement 2026-07-01 (see label)

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 2 days agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	65	33	24	144	11	CA, EU, US	Mar 13, 2017	Dec 21, 2010
Malignant Breast Neoplasm	Approved	Phase 4	34	18	14	63	3	EU, US	Mar 13, 2017	Sep 6, 2013
Malignant Lung Neoplasm	Phase2	Phase 2	3	2	0	6	0	—	—	May 14, 2015
Malignant Central Nervous System Neoplasm	Phase2	Phase 2	2	1	0	8

Curated evidence

Clinical evidence (12)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–12 of 12 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
CDK4 Overexpression2
Palbociclib + Ribociclib

Clinical trials

Trials with this intervention (155)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 151–155 of 155 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT03081234	Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- Intermediate Risk Early Breast Cancer(EarLEE-2)	withdrawn	Phase 3	0	Novartis PharmaceuticalsINDUSTRY	0	Mar 15, 2018	clinicaltrials
NCT03096912	A Study Assessing Efficacy & Safety of Ribociclib in Patients With Advanced Well/Dedifferentiated Liposarcoma

Molecule

Record

Kind: Small Molecule
Mechanism: Cyclin-dependent kinase 4 inhibitor; Cyclin-dependent kinase 6 inhibitor
Targets: 2 genes
UNII: BG7HLX2919
Aliases: 7-Cyclopentyl-N,N-dimethyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide, Kisqali, KISQALI, LEE 011, LEE-011, LEE011, LEE-011A, LEE011A, NVP-LEE011, Ribociclib, Ribociclib Succinate

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (4)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01EF02	RIBOCICLIB
DIN (Health Canada)	02473569	KISQALI
DPD drug code