Substance / Medication

Belzutifan

Overview

Active Ingredient
belzutifan
RxNorm CUI
2567226
Labeler: Merck Sharp & Dohme LLCUpdated: 2025-05-14T00:00:00.000ZFull label on DailyMed

Boxed Warning

FDA Black Box Warning

Exposure to WELIREG during pregnancy can cause embryo-fetal harm. Verify pregnancy status prior to the initiation of WELIREG. Warnings and Precautions (5.3) Drug Interactions (7.2) Use in Specific Populations (8.1 8.3) [see,,,]. Advise patients of these risks and the need for effective non-hormonal

Contraindications

When this intervention should not be used

None.

Indications & Related Conditions

Conditions associated via SNOMED clinical relationships

Administration & Protocol

Dosing, route, and treatment protocol

Detailed dosage and administration information is available in the full FDA drug label.

View full prescribing information on DailyMed

Monitoring & Follow-Up

Biomarkers relevant to this intervention via related conditions

No monitoring biomarkers have been mapped yet. Biomarker-intervention linkages are derived through related conditions and will expand as the knowledge graph grows.

Research Evidence

Published studies and systematic reviews

Sort:
Innovative solutions? Belzutifan therapy for hemangioblastomas in Von Hippel-Lindau disease: A systematic review and single-arm meta-analysis.
Palavani Lucca B, Camerotte Raphael, Vieira Nogueira Bernardo et al. · J Clin Neurosci · 2024
PMID: 39128437Meta-Analysis
FDA Approval Summary: Belzutifan for Patients with Advanced Renal Cell Carcinoma.
Fallah Jaleh, Heiss Brian L, Joeng Hee-Koung et al. · Clin Cancer Res · 2024
PMID: 39248780RCTFull text (PMC)
Belzutifan for Advanced Pheochromocytoma or Paraganglioma.
Jimenez Camilo, Andreassen Mikkel, Durand Alice et al. · N Engl J Med · 2025
PMID: 41124218Trial
Belzutifan versus Everolimus for Advanced Renal-Cell Carcinoma.
Choueiri Toni K, Powles Thomas, Peltola Katriina et al. · N Engl J Med · 2024
PMID: 39167807Trial
Phase I LITESPARK-001 study of belzutifan for advanced solid tumors: Extended 41-month follow-up in the clear cell renal cell carcinoma cohort.
Jonasch Eric, Bauer Todd M, Papadopoulos Kyriakos P et al. · Eur J Cancer · 2024
PMID: 38008031Trial
Belzutifan for von Hippel-Lindau Disease: Pancreatic Lesion Population of the Phase 2 LITESPARK-004 Study.
Else Tobias, Jonasch Eric, Iliopoulos Othon et al. · Clin Cancer Res · 2024
PMID: 38393723TrialFull text (PMC)

Research data from MEDLINE/PubMed

Benefits & Expected Outcomes

Benefits, expected outcomes, efficacy data, and NNT (Number Needed to Treat) are pending physician authorship and evidence review.

Risks & Side Effects

Adverse reaction and safety data for this drug is sourced from the FDA-approved label.

View adverse reactions & drug interactions on DailyMed

Related Symptoms

Symptoms associated with conditions this intervention addresses

No related symptoms have been mapped yet. Symptom linkages are derived through associated conditions.

Alternatives & Comparisons

Alternative treatments, comparison data, and clinical decision support are pending physician authorship.

Medical Disclaimer

This information is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider regarding any medical condition or treatment plan.

Do not start, stop, or change any treatment without consulting your healthcare provider.

Quick Facts

Type
Substance / Medication
Fully Specified Name
Belzutifan (substance)
SNOMED CT
41129411000001102
UMLS CUI
C5418188
RxNorm CUI
2567226
Labeler
Merck Sharp & Dohme LLC

Clinical Data

This intervention maps to 1 entities in the Ltrl knowledge graph.

1
Conditions
0
Biomarkers
0
Specialists
0
Symptoms

Data is sourced from SNOMED CT, UMLS, and the Ltrl clinical knowledge graph. Content sections marked as pending require physician authorship. Consult a healthcare provider before starting any treatment.