QINLOCK (ripretinib)
QINLOCK treats adults with advanced gastrointestinal stromal tumor (GIST). It is used for patients who have already received three or more previous kinase inhibitor therapies, including imatinib. This medication provides an option for those whose cancer has progressed after multiple prior treatments.
How QINLOCK Works
This drug works by inhibiting tyrosine kinases, specifically targeting KIT and PDGFRA proteins. By blocking these receptors and their various mutations, it interferes with the signaling pathways that allow tumors to grow. It also shows activity against other proteins like PDGFRB, TIE2, VEGFR2, and BRAF in laboratory tests.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2020-05-15
- Patent Cliff
- 2042
- Routes
- ORAL
- Dosage Forms
- TABLET
QINLOCK Approval History
What QINLOCK Treats
1 indicationsQINLOCK is approved for 1 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Gastrointestinal Stromal Tumor
QINLOCK Target & Pathway
ProTarget
A kinase in the MAPK signaling pathway that regulates cell growth. BRAF mutations (especially V600E) occur in melanoma, colorectal, and thyroid cancers, causing uncontrolled cell proliferation. Inhibiting mutant BRAF blocks this aberrant growth signal.
QINLOCK 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?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to QINLOCK
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05957367 | DCC-3116-01-002 2024-516476-15-00 | Ph 1, Ph 2 | recruiting | A Study of Inlexisertib (DCC-3116) in Combination With Anticancer Therapies in Participants With Advanced Malignancies |
| NCT04633122 results posted | ZL-2307-003 | Ph 2 | completed | A Study to Assess DCC-2618 and Sunitinib in Patients With Advanced GIST After Treatment With Imatinib |
| NCT03673501 INTRIGUE results posted | DCC-2618-03-002 | Ph 3 | active not recruiting | A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib |
| NCT05734105 INSIGHT | DCC-2618-03-003 2022-503058-37-00 | Ph 3 | active not recruiting | A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib |
| NCT04530981 | DCC-2618-01-007 | Ph 1 | completed | A Drug-Drug Interaction Study to Evaluate the Effect of Ripretinib on the Pharmacokinetics of a CYP2C8 Probe Substrate in Patients with Advanced GIST |
| NCT05080621 | DCC-2618-01-008 | Ph 1, Ph 2 | withdrawn | Ripretinib in Combination With Binimetinib in Patients With Gastrointestinal Stromal Tumor (GIST) |
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.
QINLOCK FDA Label Details
Indications & Usage
FDA Label (PDF)QINLOCK is indicated for the treatment of Gastrointestinal Stromal Tumor.
QINLOCK Patents & Exclusivity
Patents (41 active)
Exclusivity
Pro Intelligence Preview
Deep insights for QINLOCK
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2042
- • 41 active patents
Trial Analysis
- • 6 total trials
- • Stage: Expansion
Competitive Landscape
- • 2 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