Clinical Trials

Multiple clinical trials evaluate ripretinib across Phase 1, Phase 2, and Phase 3 studies, primarily focusing on gastrointestinal stromal tumors, advanced systemic mastocytosis, and other advanced malignancies. Research efforts are conducted by pharmaceutical sponsors, including Deciphera Pharmaceuticals LLC and Zai Lab, alongside academic institutions such as Peking University and Sun Yat-Sen University. With trial statuses ranging from active recruitment and completed to withdrawn or expanded access, these investigations include evaluations of safety, pharmacokinetics, and efficacy compared to standard therapies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05734105 ACTIVE_NOT_RECRUITING
GIST
Deciphera Pharmaceuticals, LLC
 2023-12-13 PHASE3
NCT06507683 RECRUITING
Gastrointestinal Stromal Tumors
First Affiliated Hospital of Chongqing Medical University
 2024-05-28
NCT05957367 RECRUITING
GIST
Deciphera Pharmaceuticals, LLC
 2023-09-28 PHASE1; PHASE2
NCT05080621 WITHDRAWN
Gastrointestinal Stromal Tumors
Deciphera Pharmaceuticals, LLC
 2021-11 PHASE1; PHASE2
NCT05132738 UNKNOWN
Gastrointestinal Stromal Tumors
RenJi Hospital
 2021-08-01
NCT04530981 COMPLETED
GIST - Gastrointestinal Stromal Tumor
Deciphera Pharmaceuticals, LLC
 2021-09-22 PHASE1
NCT04633122 COMPLETED
Gastrointestinal Stromal Tumor(GIST)
Zai Lab (Shanghai) Co., Ltd.
 2020-11-25 PHASE2
NCT05080621 Withdrawn
Gastrointestinal Stromal Tumors
Deciphera Pharmaceuticals LLC
 2021-11 Phase 1|Phase 2
NCT03673501 ACTIVE_NOT_RECRUITING
Gastrointestinal Stromal Tumors
Deciphera Pharmaceuticals, LLC
 2019-02-08 PHASE3
NCT04633122 Completed
Gastrointestinal Stromal Tumor(GIST)
Zai Lab (Shanghai) Co. Ltd.|Zai Lab (Hong Kong) Ltd.
 2020-11-25 Phase 2
NCT02571036 Completed
Gastrointestinal Stromal Tumors|Advanced Systemic Mastocytosis|Advanced Cancers
Deciphera Pharmaceuticals LLC
 2015-11 Phase 1

(data from https://clinicaltrials.gov, updated on 2025-12-17)

Check the Ripretinib (DCC-2618) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ripretinib acts as a switch pocket control inhibitor that selectively binds to wild-type and mutant KIT and PDGFR-alpha kinase domains, thereby blocking downstream signal transduction and cellular proliferation. This targeted inhibition suppresses oncogenic signaling across drug-resistant kinase mutations, resulting in impaired tumor survival and clinical relevance in gastrointestinal stromal tumors.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.