Also known as: Welireg
Belzutifan is an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor marketed as WELIREG for multiple oncology indications. Its U.S. approvals include von Hippel-Lindau disease-associated tumors, advanced renal cell carcinoma after prior therapies, and advanced pheochromocytoma/paraganglioma in patients aged 12 years and older. It is an FDA-approved prescription therapy.
Merck & Co. is bolstering its oncology pipeline with acquisitions like Terns Pharmaceuticals and Cidara Therapeutics, while Keytruda remains the key growth driver. It expects Keytruda peak sales of $35 billion by 2028 and aims to launch 20 new drugs by 2030.
The FDA approved six cancer therapies in Q2 2026, including first-line sacituzumab govitecan for triple-negative breast cancer and capivasertib for PTEN-deficient prostate cancer. A separate study shows 69% of accelerated-approval cancer drugs need safety updates within 4 years.
Merck will acquire Terns Pharmaceuticals for $6.7 billion to bolster its cancer pipeline ahead of Keytruda's 2028 patent expiration. The deal gives Merck access to TERN-701, an oral tyrosine kinase inhibitor for chronic myeloid leukemia. Merck projects over $70 billion in commercial opportunities from its pipeline by the mid-2030s.
Merck announced multiple data presentations at the 2026 ASCO GU Cancers Symposium, including results from trials evaluating pembrolizumab combinations in muscle-invasive bladder cancer and renal cell carcinoma.
Healthcare sector surged 10% since Q4 2025, outpacing all S&P 500 sectors as investors rotate from tech to pharmaceutical value plays. Major drugmakers demonstrate resilience following Medicare price negotiations implementation.
The 2026 ASCO GU Symposium featured significant trial results in renal cell carcinoma, urothelial carcinoma, and prostate cancer, including data from LITESPARK-022, KEYNOTE-B15, SunRISE-2, and PEACE-3 studies.
Phase III trial demonstrates belzutifan plus lenvatinib significantly improved progression-free survival versus cabozantinib in previously treated renal cell carcinoma patients, while neoadjuvant studies show promise for locally advanced disease.
Merck stock reached a 52-week high at $122.69, rising 46.25% over 12 months and 7.4% in the past month following strong Q4 results and improved long-term pipeline outlook beyond Keytruda's 2028 patent expiration.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07700758 |
A Study of Belzutifan in Adolescent Participants With Solid Tumors (MK-9999-01E/LIGHTBEAM-U01) |
NOT_YET_RECRUITING | PHASE2 |
| NCT07680205 |
An Experimental Study of Belzutifan Impact on Catecholamine Metabolism |
RECRUITING | PHASE2 |
| NCT07593040 |
Pembrolizumab Plus Belzutifan With or Without Lenvatinib in Localized Renal Cell Carcinoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07489495 |
A Clinical Study of Belzutifan (MK-6482) and Zanzalintinib in People With Renal Cell Carcinoma (RCC) (LITESPARK-034/LS-034/MK-6482-034) |
RECRUITING | PHASE3 |
| NCT07405164 |
Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043) |
RECRUITING | PHASE3 |
| NCT07227402 |
A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6482-033) |
RECRUITING | PHASE3 |
| NCT07187778 |
Phase II Trial of Single Agent Belzutifan or Pembrolizumab Versus Combination as Neoadjuvant Therapy in Clear Cell Renal Cell Carcinoma (BLAZE) |
RECRUITING | PHASE2 |
| NCT07179770 |
Effects of Belzutifan on 89Zr-DFO-girentuximab PET Uptake in Patients With Renal Cell Carcinoma (RCC) |
RECRUITING | PHASE1 |
| NCT07167329 |
Real-World Effectiveness and Pharmacogenetics of Belzutifan in VHL Syndrome: The BELIEVE-VHL Trial |
RECRUITING | PHASE2 |
| NCT07121959 |
A Study of Belzutifan (MK-6482) and Metformin in Healthy Adult Participants (MK-6482-039) |
COMPLETED | PHASE1 |
