Drugs / Ripretinib
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Qinlock | — | 2021-11-18 | europa.eu ↗ |
| Approved | US (FDA) | QINLOCK | — | 2020-05-15 | fda.gov ↗ |
Trials 10 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT07618377 | Jul 2026 → Feb 2028 expected | gastrointestinal stromal tumor | Ono Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT04530981 | Sep 2021 → Nov 2023 | gastrointestinal stromal tumor | Deciphera Pharmaceuticals, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02571036 | Nov 2015 → Apr 2022 | gastrointestinal stromal tumor, systemic mastocytosis | Deciphera Pharmaceuticals, LLC | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05080621 | Nov 2021 → Nov 2025 | gastrointestinal stromal tumor | Deciphera Pharmaceuticals, LLC | Withdrawn | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT04633122 | Nov 2020 → Jul 2022 | gastrointestinal stromal tumor | Zai Lab (Shanghai) Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT04282980 | Apr 2020 → Feb 2021 | gastrointestinal stromal tumor | Zai Lab (Shanghai) Co., Ltd. | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT05734105 | Dec 2023 → Dec 2027 expected | gastrointestinal stromal tumor | Deciphera Pharmaceuticals, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03673501 | Feb 2019 → Sep 2021 overdue | gastrointestinal stromal tumor | Deciphera Pharmaceuticals, LLC | Active not recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT05132738 | Aug 2021 → Nov 2023 | gastrointestinal stromal tumor | RenJi Hospital | Unknown | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04148092 | — | gastrointestinal stromal tumor | Deciphera Pharmaceuticals, LLC | Approved for marketing | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05957367 Background | Sep 2023 → Mar 2027 expected | gastrointestinal stromal tumor | Deciphera Pharmaceuticals, LLC | Recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT03353753 Comparator | Feb 2018 → May 2019 | gastrointestinal stromal tumor | Deciphera Pharmaceuticals, LLC | Completed | No outcome recorded |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ripretinib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05734105 ↗ |
| Known as | DCC-2618 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02571036 ↗ |
| Known as | Qinlock | “The results of this study led to ripretinib, also known by the brand name Qinlock®, being approved in the USA by regulators as the only medication for adults with advanced GIST...” PMID 34661454 ↗ Oct 2021 |
| Action | Inhibit | “inhibits KIT and PDGFRA signaling.” PMID 36514034 ↗ Dec 2022 |
| Modality | Small molecule | — CHEMBL4216467 ↗ |
| Route | Oral | “DCC-2618 tablets in escalating dose cohorts given orally BID (twice daily) every 12 hours or once daily (QD) for repeated 28-day cycles.” NCT02571036 ↗ |
| Target | KIT | “inhibits KIT and PDGFRA signaling.” PMID 36514034 ↗ Dec 2022 |
| Target | PDGFRA | “inhibits KIT and PDGFRA signaling.” PMID 36514034 ↗ Dec 2022 |