Vorolanib Clinical Trials

Size	Price	Qty
2mg	USD 187

Clinical Trials

Numerous clinical trials spanning early to late phases have evaluated vorolanib for diverse oncological and ophthalmological indications, such as advanced solid tumors, metastatic renal cell carcinoma, non-small cell lung cancer, thymic carcinoma, and age-related macular degeneration. Sponsored by academic medical centers and biopharmaceutical companies, these studies assess vorolanib as monotherapy or combined with checkpoint inhibitors or targeted agents. Recruitment statuses across these evaluations range from actively recruiting and completed to suspended or terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07047001	ACTIVE_NOT_RECRUITING	Renal Cell Carcinoma (RCC); Adjuvant	Dong Wen	2025-04-24	PHASE2
NCT07165418	NOT_YET_RECRUITING	Renal Cell Carcinoma (RCC)	Peking University Cancer Hospital & Institute	2025-09-25	PHASE3
NCT06577961	NOT_YET_RECRUITING	Kidney Cancer; RCC; Renal Cell Carcinoma	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	2024-08-31	PHASE1; PHASE2
NCT06585878	NOT_YET_RECRUITING	Renal Cell Carcinoma; RCC; Kidney Cancer	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	2024-09-01
NCT07386158	RECRUITING	Vorolanib; Clear Cell Renal Cell Carcinoma (ccRCC); Neoadjuvant Therapy	Sun Yat-sen University	2025-07-10	PHASE2
NCT06728852	RECRUITING	Advanced Non-small Cell Lung Cancer (NSCLC); Recurrent or Metastatic Lung Cancer; Third-line and Beyond Therapy; Angiogenesis Inhibition in Oncology	Li-kun Chen	2024-12-01	PHASE2
NCT06523049	NOT_YET_RECRUITING	Renal Cell Carcinoma; Immunotherapy; Molecular Targeted Therapy	Hao Zeng	2024-08	PHASE2
NCT06406673	UNKNOWN	Extensive Small Cell Lung Cancer	Henan Cancer Hospital	2023-10-16	PHASE2
NCT03583086	COMPLETED	Thymic Carcinoma; Non-small Cell Lung Cancer; Refractory Thoracic Tumors; Small-Cell Lung Cancer	Vanderbilt-Ingram Cancer Center	2018-07-10	PHASE1; PHASE2
NCT04373369	TERMINATED	Extensive-stage Small Cell Lung Cancer	Washington University School of Medicine	2020-10-07	PHASE2
NCT04126668	Completed	Advanced Malignant Solid Tumors	AnewPharma	2019-12-19	Phase 1
NCT03511222	TERMINATED	Solid Tumor; Hepatocellular Carcinoma; Gastric Cancer; Gastroesophageal Junction Adenocarcinoma	Washington University School of Medicine	2018-09-11	PHASE1
NCT03511222	Terminated	Solid Tumor\|Hepatocellular Carcinoma\|Gastric Cancer\|Gastroesophageal Junction Adenocarcinoma	Washington University School of Medicine\|Xcovery Holdings Inc.	2018-09-11	Phase 1
NCT02577458	Unknown status	Renal Cell Carcinoma Recurrent	AnewPharma\|Peking University Cancer Hospital & Institute	2015-09	Phase 1
NCT02452385	Suspended	Age-Related Macular Degeneration	AnewPharma\|West China Hospital	2015-03	Phase 1

(data from https://clinicaltrials.gov, updated on 2025-07-09)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Vorolanib acts as an oral dual receptor tyrosine kinase inhibitor that selectively binds to and inhibits vascular endothelial growth factor receptor (VEGFR) and platelet-derived growth factor receptor (PDGFR), thereby blocking downstream pro-angiogenic signal transduction cascades. By suppressing receptor autophosphorylation and downstream cellular proliferation and capillary sprout formation, vorolanib disrupts tumor neovascularization and cell survival, demonstrating therapeutic potential in solid tumors such as renal cell carcinoma and non-small cell lung cancer.

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>).