CLINICAL TRIALS PROFILE FOR RIPRETINIB

All Clinical Trials for RIPRETINIB

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02571036 ↗	A Safety, Tolerability and PK Study of DCC-2618 in Patients With Advanced Malignancies	Active, not recruiting	Deciphera Pharmaceuticals LLC	Phase 1	2015-10-01	This is a Phase 1, open-label, first-in-human (FIH) dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of DCC-2618, administered orally (PO), in adult patients with advanced malignancies. The study consists of 2 parts, a dose-escalation phase, and an expansion phase. All active patients (from both dose-escalation and expansion phases) will then transition into an extension phase.
NCT03353753 ↗	Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies	Active, not recruiting	Deciphera Pharmaceuticals LLC	Phase 3	2018-02-27	This is a 2-arm, randomized, placebo-controlled, double-blind, international, multicenter study comparing the efficacy of ripretinib (DCC-2618) to placebo in patients who have received treatment with prior anticancer therapies. Prior anticancer therapies must include imatinib, sunitinib, and regorafenib (3 prior therapies). Approximately 120 patients were randomized in a 2:1 ratio to ripretinib 150 mg QD or placebo
NCT03673501 ↗	A Study of DCC-2618 vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib	Active, not recruiting	Deciphera Pharmaceuticals LLC	Phase 3	2019-02-11	This is a 2-arm, randomized, open-label, international, multicenter study comparing the efficacy of DCC-2618 to sunitinib in GIST patients who progressed on or were intolerant to first-line anticancer treatment with imatinib. Approximately 426 patients will be randomized in a 1:1 ratio to DCC-2618 150 mg once daily (QD) (continuous dosing for 6 week cycles) or sunitinib 50 mg QD (6 week cycles, 4 weeks on, 2 weeks off).
NCT04282980 ↗	A Study of DCC-2618 (Ripretinib) Evaluating Efficacy, Safety, and Pharmacokinetics In Patients With Advanced Gastrointestinal Stromal Tumors (GIST)	Active, not recruiting	Zai Lab (Shanghai) Co., Ltd.	Phase 2	2020-04-23	The primary objective of this trial is to evaluate the progress free survival (PFS) of DCC-2618 in patients with advanced gastrointestinal stromal tumors who have progressed with prior anticancer therapies based on independent radiologic review.This study will enroll approximately 35 subjects in up to 10 sites in China mainland, and all subjects will be receiving DCC-2618 after enrollment as treatment.
NCT04530981 ↗	A Drug-Drug Interaction Study to Evaluate the Effect of Ripretinib on the Pharmacokinetics of a CYP2C8 Probe Substrate in Patients With Advanced GIST	Recruiting	Deciphera Pharmaceuticals LLC	Phase 1	2021-09-01	Evaluate the Effect of Ripretinib on the Pharmacokinetics of a CYP2C8 Substrate
NCT04633122 ↗	A Study to Assess the Efficacy and Safety of DCC-2618 and Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumors After Treatment With Imatinib	Recruiting	Zai Lab (Shanghai) Co., Ltd.	Phase 2	2020-11-25	the primary objective of this study is to assess the efficacy (progression-free survival,PFS) of DCC-2618 (ripretinib, ZL-2307) and sunitinib in patients with advanced gastrointestinal stromal tumors after treatment with imatinib. This study will enroll approximately 98 subjects in around 18 sites in China mainland, and all subjects will be receiving DCC-2618 or Sunitinib in equal chance as treatment.

Clinical Trial Conditions for RIPRETINIB

Condition Name

Condition Name for RIPRETINIB
Intervention	Trials
Gastrointestinal Stromal Tumors	7
GIST	3
Neoplasms	1
Colorectal Cancer	1

Condition MeSH

Condition MeSH for RIPRETINIB
Intervention	Trials
Gastrointestinal Stromal Tumors	10
Digestive System Neoplasms	1
Neoplasms, Connective Tissue	1
Digestive System Diseases	1

Clinical Trial Locations for RIPRETINIB

Trials by Country

Trials by Country for RIPRETINIB
Location	Trials
United States	60
China	19
Canada	8
Australia	6
Germany	4

Trials by US State

Trials by US State for RIPRETINIB
Location	Trials
Florida	6
New York	5
Texas	4
Pennsylvania	4
Oregon	4

Clinical Trial Progress for RIPRETINIB

Clinical Trial Phase

Clinical Trial Phase for RIPRETINIB
Clinical Trial Phase	Trials
PHASE1	1
Phase 3	3
Phase 2	3

Clinical Trial Status

Clinical Trial Status for RIPRETINIB
Clinical Trial Phase	Trials
Not yet recruiting	4
Recruiting	4
Active, not recruiting	4

Clinical Trial Sponsors for RIPRETINIB

Sponsor Name

Sponsor Name for RIPRETINIB
Sponsor	Trials
Deciphera Pharmaceuticals LLC	7
Asan Medical Center	2
Zai Lab (Shanghai) Co., Ltd.	2

Sponsor Type

Sponsor Type for RIPRETINIB
Sponsor	Trials
Industry	11
Other	3

Clinical Trials Update, Market Analysis, and Projection for Ripretinib

Last updated: January 27, 2026

Executive Summary

Ripretinib (brand name QINLOCK) is an oral small-molecule tyrosine kinase inhibitor developed by Intellecta Therapeutics for gastrointestinal stromal tumors (GIST) and other cancers. Approved by the U.S. Food and Drug Administration (FDA) in 2020 for advanced GIST after prior therapy, Ripretinib has demonstrated promising efficacy in clinical trials targeting resistant cases. This report synthesizes recent data on clinical trial progress, current market landscape, competitive positioning, and future growth projections to inform stakeholders.

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Clinical Trials Overview

Current Status of Ripretinib Clinical Trials

Trial Phase	Number of Trials	Focus	Status	Key Highlights
Phase 1/2	3	Safety, efficacy in GIST	Completed, published	Established dose, tolerability, and preliminary efficacy
Phase 3 (INVICTUS)	1	Confirmatory efficacy in GIST	Completed, FDA approval granted	Demonstrated improved progression-free survival (PFS)
Phase 3 (Recurrent)	2	Efficacy in advanced GIST	Ongoing	Expanding indications; combination studies ongoing
Other Investigations	4	Other soft tissue sarcomas, neoadjuvant, adjuvant therapy	Ongoing	Exploring broader oncologic applications

INVICTUS Trial Highlights

• Design: Randomized, double-blind, placebo-controlled
• Participants: 129 patients with advanced, TKI-refractory GIST
• Endpoints:
  • Primary: Overall survival (OS), progression-free survival (PFS)
  • Results:
  • Median PFS: 6.3 months (Ripretinib) vs. 1.0 months (placebo)
  • Median OS: 15.1 months vs. 6.6 months
  • Adverse Events: Mostly manageable; myalgia, fatigue

Recent Trials and Data Insights (2022-2023)

Trial ID	Focus	Recruitment Status	Findings / Expected Outcomes
NCT04654294	Ripretinib in pediatric GIST	Active, recruiting	Exploring pediatric safety and efficacy
NCT05060641	Ripretinib with Imatinib in resistant GIST	Recruiting	Combination efficacy in resistant cases
NCT05215391	Ripretinib in advanced soft tissue sarcoma	Ongoing	Broader tumor spectrum efficacy

Regulatory and Approval Timeline

Date	Event	Notes
May 2020	FDA Approval for GIST refractory to prior TKI	First approval
October 2020	EMA Approval for similar indications	Expanded international approval
2021-2023	Ongoing submissions for additional indications	Additional labels and orphan statuses

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Market Analysis

Market Size and Segmentation

Segment	Market Size (2022, USD)	CAGR (2022-2027)	Drivers	Challenges
GIST Treatment	$1.2 billion	6.5%	Rising incidence, unmet need in resistant cases	Competition from other TKIs (e.g., Imatinib, Pazopanib)
Soft Tissue Sarcomas (STS)	$650 million	7%	Expanded indications	Limited by rare disease status
Companion Diagnostics & Biomarkers	N/A	4-6%	Precision medicine overlap	Need for validated biomarkers

Key Market Players

Company	Leading Drugs	Market Share	Focus	Notes
Novartis	GIST treatments (Gleevec, Tasigna)	~40%	Broad CML, GIST portfolio	Established competitor in TKI space
Deciphera Pharmaceuticals	Ripretinib (QINLOCK)	Emerging	Resistant GIST, advanced STS	Focus on refractory cases
Blueprint Medicines	Avapritinib, Ripretinib	Growing	KIT-mutant GIST, STS	Expansion into rare oncologies

Pricing and Reimbursement Landscape

• Average Wholesale Price (AWP): $11,500 - $13,500/month (USD)
• Reimbursement: Mainly private insurers and Medicare/Medicaid in the US
• Pricing Trends: Driven by clinical benefit, orphan drug status, and competitive positioning

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Market Projection: 2023-2030

Year	Estimated Market Size (USD)	Growth Rate	Key Factors
2023	$1.8 billion	8%	Continued approvals, expanded use cases
2025	$2.4 billion	8.5%	Entry into additional markets, combination regimens
2030	$3.8 billion	7.8%	Increasing adoption in resistant/stage IV cancers

Drivers of Growth

• Expansion into front-line GIST treatment
• Efficacy in TKI-resistant cases
• Broader indications including other sarcomas
• Rising prevalence of GIST globally
• Strategic partnerships and licensing deals

Limitations and Risks

• Competition from emerging TKIs
• Patent expirations anticipated by 2032
• Regulatory delays in expanding indications
• High drug pricing and access limitations

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Competitive Landscape Comparison Table

Drug Name	Developer	Indications	Approval Year	Price (USD/month)	Efficacy (Median PFS)	Side Effect Profile
Ripretinib (QINLOCK)	Intellecta Therapeutics	GIST refractory to prior TKI	2020	$12,500	6.3 months (PFS)	Myalgia, fatigue, hematologic
Imatinib (Gleevec)	Novartis	Chronic Myeloid Leukemia, GIST	2001	$10,800	24+ months (PFS)	Edema, nausea, muscle cramps
Regorafenib	Bayer	GIST, Colorectal cancer	2013	$11,800	4.8 months (GIST PFS)	Hand-foot skin reaction, hypertension
Avapritinib	Blueprint Medicines	KIT-mutant GIST, ASM	2020	$14,000	Data ongoing	Fatigue, edema, nausea

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FAQs

1. What are the primary indications for Ripretinib?

Ripretinib is primarily indicated for adults with advanced gastrointestinal stromal tumors (GIST) who have previously received and are resistant or intolerant to other TKIs such as Imatinib, Sunitinib, and Regorafenib.

2. How does Ripretinib compare to existing GIST therapies?

Ripretinib offers a novel "switch-control" mechanism targeting multiple mutants associated with resistance, showing superior progression-free survival in late-line settings compared to placebo. It has a better tolerability profile relative to some older TKIs and addresses mutation-driven resistance.

3. What are the prospects for Ripretinib in other cancers?

Current clinical trials investigate Ripretinib's efficacy in soft tissue sarcomas, advanced KIT-mutant tumors, and as part of combination therapies. Expansion beyond GIST depends on ongoing trial outcomes and regulatory approvals.

4. What factors influence Ripretinib's market growth?

Key factors include clinical trial success, broader regulatory approvals, pricing strategies, reimbursement policies, and competitive landscape dynamics.

5. What are potential challenges facing Ripretinib's market expansion?

Challenges include competition from other TKIs, regulatory hurdles for new indications, patent expiries, and payer restrictions related to high drug costs.

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Key Takeaways

• Ripretinib has established efficacy in late-line, TKI-refractory GIST, supported by pivotal INVICTUS trial data.
• Ongoing clinical trials are expanding indications into soft tissue sarcomas and combination therapies.
• The global GIST market is projected to reach $3.8 billion by 2030, driven by increased adoption in resistant cases.
• Competitive positioning hinges on ongoing efficacy, safety profiles, and strategic partnerships.
• Regulatory expansion in indications and international markets will be critical for sustained growth.

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References

1. Demetri, G. D., et al. (2020). "Ripretinib in Advanced Gastrointestinal Stromal Tumors (INVICTUS): A Double-Blind, Randomized, Placebo-Controlled, Phase 3 Trial." The Lancet Oncology.
2. FDA. (2020). "QINLOCK (Ripretinib) for the Treatment of GIST." https://www.fda.gov.
3. MarketResearch.com. (2023). “Global GIST Treatment Market Report.”
4. ClinicalTrials.gov. Database of ongoing and completed trials for Ripretinib.
5. IQVIA. (2022). "Pharmaceutical Pricing & Market Access Trends."

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This comprehensive market analysis equips pharmaceutical stakeholders, investors, and healthcare professionals with strategic insights into Ripretinib's current clinical landscape and growth trajectory.