Qinlock

(Ripretinib)

Phase 3Small molecule

Qinlock is a small molecule that works as a KIT/PDGFRA Inhibitor.[2] It is being investigated across 3 indications, with its most advanced program in Phase 3.[1]

Qinlock is one of 41 small molecule programs targeting Resectable. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

ResectableUnknown status

GISTRecruiting

AdvancedActive, not recruiting

ResectablePreclinical

Unknown status

GISTPreclinical

Recruiting

AdvancedPhase 3

Active, not recruiting

Competition

Competitive Landscape

43 competitors in Advanced

#DrugCompanyPhaseTrials

Remodulin

United Therapeutics

Phase 3

1 2

Lenvima

Eisai

Phase 2

3 3

Fludara

Sanofi

Phase 2

2 4

Yervoy

Bristol-Myers Squibb

Phase 2

2 5

Keytruda

Merck & Co.

Phase 2

2 6

Tecentriq

Roche

Phase 2

2 7

Beyfortus

BeiGene

Phase 2

1 8

Nolvadex

AstraZeneca

Phase 2

1 9

Avastin

Roche

Phase 2

1 10

Libtayo

Regeneron

Phase 2

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Phase 3Active, not recruiting

Gastrointestinal Stromal Tumors

NCT03673501

Q4 2028

Phase 3Active, not recruiting

Advanced

NCT05734105

Q1 2029

PreclinicalActive, not recruiting

GIST

NCT05957367

Clinical

Trials by Indication[1]

Treatment2 trials

A Study to Assess DCC-2618 and Sunitinib in Patients With Advanced GIST After Treatment With Imatinib

Completed·ZZai Lab (Shanghai) Co., Ltd.·Phase 2·NCT04633122·108 enrolled

Expanded Access Program of Ripretinib (DCC-2618) for the Treatment of Patients With Advanced GIST

Approved for marketing·DDeciphera Pharmaceuticals, LLC··NCT04148092

Advanced2 trials

A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib

Active, not recruiting·DDeciphera Pharmaceuticals, LLC·Phase 3·NCT05734105·54 enrolled

Ripretinib in Chinese Patients With Advanced GIST: a Real World Study

Unknown status·PPeking University··NCT05697107·308 enrolled

Resectable1 trial

Ripretinib Used for Resectable Metastatic GIST After Failure of Imatinib Therapy

Unknown status·RRenJi Hospital·N/A·NCT05132738·20 enrolled

Gastrointestinal Stromal Tumor1 trial

Ripretinib in Combination With Binimetinib in Patients With Gastrointestinal Stromal Tumor (GIST)

Withdrawn·DDeciphera Pharmaceuticals, LLC·Phase 1/2·NCT05080621

Interaction1 trial

A Drug-Drug Interaction Study to Evaluate the Effect of Ripretinib on the Pharmacokinetics of a CYP2C8 Probe Substrate in Patients with Advanced GIST

Completed·DDeciphera Pharmaceuticals, LLC·Phase 1·NCT04530981·13 enrolled

3 more indications

GIST1 trial

A Master Protocol for the Multi-Cohort, Phase 1/2 Study of DCC-3116 in Combination With Anticancer Therapies in Participants With Advanced Malignancies

Active, not recruiting·DDeciphera Pharmaceuticals, LLC·Preclinical·NCT05957367·94 enrolled

Gastrointestinal Stromal Tumors1 trial

A Phase 3, Interventional, Randomized, Multicenter, Open-Label Study of Ripretinib vs Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumor (GIST) After Treatment With Imatinib

Active, not recruiting·DDeciphera Pharmaceuticals, LLC·Phase 3·NCT03673501·453 enrolled

Unspecified1 trial

Ripretinib (QINLOCK®) According to Current SmPC

Completed·IiOMEDICO AG··NCT06619275·10 enrolled

Regulatory

FDA Approval Timeline[4]

May 15, 2020

QINLOCK

NDA NDA213973

May 15, 2020

QINLOCK

NDA NDA213973

Sep 15, 2022

QINLOCK

NDA NDA213973

Dec 29, 2022

QINLOCK

NDA NDA213973

Oct 26, 2023

QINLOCK

NDA NDA213973

May 6, 2025

QINLOCK

NDA NDA213973

Sources

References

[1]
ClinicalTrials.gov — 10 trial records for Ripretinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ripretinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Ripretinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA213973). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Qinlock. U.S. Food & Drug Administration.
[6]
PubMed — 1 publication indexed for Ripretinib. U.S. National Library of Medicine.
[7]
SEC EDGAR — Deciphera Pharmaceuticals, LLC company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: KIT/PDGFRA Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: DDeciphera Pharmaceuticals, LLC

Patent Landscape[5]

Patent Cliff

Jul 27, 2030

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8188113Jul 27, 2030

RE48731Jun 7, 2032

8461179May 15, 2034

12023327Aug 12, 2040

12023326Aug 12, 2040

37 more patents

12023325Aug 12, 2040

11529336Aug 12, 2040

11534432Aug 12, 2040

12318373Aug 12, 2040

11426390Aug 12, 2040

12295944Aug 12, 2040

11433056Aug 12, 2040

11813251Aug 12, 2040

11344536Aug 12, 2040

11266635Aug 12, 2040

11576904Aug 12, 2040

10966966Aug 12, 2040

12059411Aug 12, 2040

12059410Aug 12, 2040

12708617Dec 30, 2040

11911370Dec 30, 2040

11850240Dec 30, 2040

12064422Dec 30, 2040

11801237Dec 30, 2040

11918564Dec 30, 2040

12213967Dec 30, 2040

11896585Dec 30, 2040

12318374Dec 30, 2040

11576903Dec 30, 2040

11903933Dec 30, 2040

12226406Dec 30, 2040

11844788Dec 30, 2040

11969415Dec 30, 2040

12023328Dec 30, 2040

11850241Dec 30, 2040

11395818Dec 30, 2040

11612591Dec 30, 2040

11185535Dec 30, 2040

11793795Dec 30, 2040

12213968Dec 30, 2040

11969414Feb 8, 2041

11779572Oct 6, 2042

Key Publications[6]

Ripretinib in Advanced GIST After Prior Therapies: INVICTUS

Lancet OncolApr 14, 2022DOI: 10.1016/S1470-2045(22)00075-0

Qinlock

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Q4 2028

Q1 2029

Trials by Indication[1]

Treatment2 trials

Advanced2 trials

Resectable1 trial

Gastrointestinal Stromal Tumor1 trial

Interaction1 trial

GIST1 trial

Gastrointestinal Stromal Tumors1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

Key Publications[6]

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