Clinical Trials

Sulfatinib is being evaluated across multiple clinical trials ranging from early phase I to phase II to investigate its pharmacokinetics, bioavailability, and therapeutic efficacy. These studies encompass healthy volunteers and patients with advanced solid tumors, neuroendocrine tumors, thyroid carcinoma, and relapsed or refractory osteosarcoma. Sponsored by academic institutions and pharmaceutical developers such as Hutchison MediPharma, trial recruitment statuses range from completed evaluations to protocols not yet recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05590572 NOT_YET_RECRUITING
Osteosarcoma
Second Affiliated Hospital, Zhejiang University, School of Medicine
 2023-01 PHASE1; PHASE2
NCT02549937 COMPLETED
Tumors
Hutchmed
 2015-11 PHASE1; PHASE2
NCT02614495 COMPLETED
Thyroid Carcinoma
Hutchison Medipharma Limited
 2016-02-24 PHASE2
NCT03627520 COMPLETED
Healthy
Hutchison Medipharma Limited
 2018-04-02 EARLY_PHASE1
NCT03483259 COMPLETED
Relative Bioavailability
Hutchison Medipharma Limited
 2018-04-02 PHASE1
NCT03627520 Completed
Healthy
Hutchison Medipharma Limited|Hutchmed
 2018-04-02 Early Phase 1
NCT03483259 Completed
Relative Bioavailability
Hutchison Medipharma Limited|Hutchmed
 2018-04-02 Phase 1
NCT02267967 COMPLETED
Neuroendocrine Tumors
Hutchison Medipharma Limited
 2014-10-31 PHASE1
NCT02320409 COMPLETED
Healthy
Hutchison Medipharma Limited
 2014-12 PHASE1
NCT02320409 Completed
Healthy
Hutchison Medipharma Limited|Hutchmed
 2014-12 Phase 1
NCT02133157 COMPLETED
Tumor
Hutchison Medipharma Limited
 2010-04 PHASE1
NCT02133157 Completed
Tumor
Hutchison Medipharma Limited|Hutchmed
 2010-04 Phase 1

(data from https://clinicaltrials.gov, updated on 2022-10-21)

Check the Sulfatinib product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sulfatinib is a potent, selective small-molecule inhibitor that targets VEGFR1, VEGFR2, VEGFR3, FGFR1, and CSF1R tyrosine kinases. By dual-blocking receptor-mediated angiogenic signaling and CSF1R-dependent tumor-associated macrophage recruitment, sulfatinib suppresses tumor microenvironment remodeling, neovascularization, and cell proliferation, which provides therapeutic relevance in treating neuroendocrine tumors and advanced solid 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.