KISQALI (ribociclib succinate)
Kisqali helps adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. It treats patients with stage II and III early breast cancer who face a high risk of recurrence, as well as those with advanced or metastatic disease. This medication is used in combination with other endocrine-based therapies, such as aromatase inhibitors or fulvestrant, to help manage the cancer's progression.
How KISQALI Works
This drug works by blocking specific proteins called cyclin-dependent kinases (CDK) 4 and 6, which are involved in the signaling pathways that drive cell growth and division. By inhibiting these kinases, the medication prevents the phosphorylation of the retinoblastoma protein, causing cancer cells to stop their growth cycle in the G1 phase. This process reduces the proliferation of tumor cells and is often more effective when combined with antiestrogen therapies.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2017-03-13
- Patent Cliff
- 2036
- Revenue
- $1.3B (Q4-2025)
- Routes
- ORAL
- Dosage Forms
- TABLET
KISQALI Approval History
What KISQALI Treats
1 indicationsKISQALI is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Breast Cancer
KISQALI Target & Pathway
ProTarget
KISQALI Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in KISQALI's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications KISQALI treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to KISQALI
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07391774 | NCI-2026-00634 NCI-2026-00634, EA1242 | Ph 3 | not yet recruiting | 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 Trial |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
KISQALI FDA Label Details
Indications & Usage
FDA Label (PDF)KISQALI is indicated for the treatment of Breast Cancer.
KISQALI Patents & Exclusivity
Patents (12 active)
Exclusivity
Pro Intelligence Preview
Deep insights for KISQALI
Revenue Insights
- • Q4-2025: $1.3B
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • 31 active patents
Trial Analysis
- • 101 total trials
- • Stage: Growth
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment