WELIREG belzutifan

Drug Class

Hypoxia-inducible factor 2 alpha (HIF-2α) inhibitor

Mechanism

Inhibits HIF-2α transcription factor binding to its partner ARNT, reducing the expression of genes involved in cell proliferation, angiogenesis, and tumor growth under hypoxic conditions.

Approved Indication

Treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery.

What This Means For Patients

WELIREG is not distributed through mainland China's retail pharmacy network. Uwell Cloud can help arrange a purchase channel for this medicine, sourced and dispatched from Hong Kong; clinical administration support in China can be coordinated on request. Availability and eligibility for any specific patient are determined by clinical review.

Regulatory Approvals

• FDA — Approved (2021) — Sources
• NMPA — Approved (2024) — Sources
• EMA — Approved (2025) — Sources

Pivotal Clinical Evidence

• LITESPARK-004 — Jonasch et al., N Engl J Med 2021 (NCT03401788) — Sources

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215383s000lbl.pdf
• https://www.nmpa.gov.cn/