Belzutifan is a hypoxia-inducible factor inhibitor indicated for 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). MedsAcross supplies Belzutifan for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
WELIREG is a hypoxia-inducible factor inhibitor indicated: von Hippel-Lindau disease for 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.
Source: US FDA prescribing information
Belzutifan is an inhibitor of hypoxia-inducible factor 2 alpha (HIF-2α). HIF-2α is a transcription factor that plays a role in oxygen sensing by regulating genes that promote adaptation to hypoxia. Under normal oxygen levels, HIF-2α is targeted for ubiquitin-proteasomal degradation by VHL protein. Lack of functional VHL protein results in stabilization and accumulation of HIF-2α. Upon stabilization, HIF-2α translocates into the nucleus and interacts with hypoxia-inducible factor 1 beta (HIF-1β) to form a transcriptional complex that induces expression of downstream genes, including genes associated with cellular proliferation, angiogenesis, and tumor growth. Belzutifan binds to HIF-2α, and in conditions of hypoxia or impairment of VHL protein function, belzutifan blocks the HIF-2α-HIF-1β interaction, leading to reduced transcription and expression of HIF-2α target genes.
Source: US FDA prescribing information
The recommended dosage of WELIREG in adult patients is 120 mg administered orally once daily with or without food. The recommended dosage of WELIREG in pediatric patients 12 years and older is based on bodyweight: Patients weighing 40 kg or greater: 120 mg orally once daily. Patients weighing less than 40 kg: 80 mg orally once daily
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Boxed warning (embryo-fetal toxicity): Exposure to WELIREG during pregnancy can cause embryo-fetal harm. Verify pregnancy status prior to the initiation of WELIREG. Advise patients of these risks and the need for effective non-hormonal contraception. WELIREG can render some hormonal contraceptives ineffective. Anemia: Monitor for anemia before initiation of and periodically throughout treatment with WELIREG. Withhold, reduce dose, or permanently discontinue WELIREG based on severity. Hypoxia: Monitor oxygen saturation before initiation of, and periodically throughout, treatment with WELIREG. For hypoxia at rest, withhold until resolved, resume at reduced dose, or discontinue depending on severity. For life-threatening hypoxia, permanently discontinue WELIREG.
Source: US FDA prescribing information
The following clinically significant adverse reactions are discussed elsewhere in the labeling: Anemia Hypoxia Cardiac Dysfunction with Concomitant Use of WELIREG and Lenvatinib VHL disease: Most common (≥25%) adverse reactions, including laboratory abnormalities, were decreased hemoglobin, fatigue, increased creatinine, headache, dizziness, increased glucose, and nausea. ccRCC: Most common (≥25%) adverse reactions for WELIREG, including laboratory abnormalities, in combination with pembrolizumab were decreased hemoglobin, increased alanine aminotransferase (ALT), fatigue, increased aspartate aminotransferase (AST), decreased lymphocytes, and increased alkaline phosphatase.
Source: US FDA prescribing information
UGT2B17 or CYP2C19 Inhibitors: Monitor for signs and symptoms of anemia and hypoxia and reduce the dosage of WELIREG as recommended. Sensitive CYP3A4 Substrates: Avoid coadministration of WELIREG with sensitive CYP3A4 substrates for which minimal decrease in concentration may lead to reduced efficacy of the substrate.
Source: US FDA prescribing information
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Belzutifan, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Welireg 40 mg tabletOral | Merck Sharp & Dohme | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Belzutifan in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 1 presentations of Belzutifan and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Belzutifan, including Welireg.
Yes. The US FDA first approved Belzutifan on 13 August 2021, according to Drugs@FDA.
Yes. Belzutifan has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Belzutifan is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Belzutifan is classified under ATC code L01XX74 (Belzutifan).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.