Publication of clinical trial results

The information given below and the relevant links to the clinical data fulfil the requirements of Articles 71-73 of the Ordinance on Therapeutic Products (Therapeutic Products Ordinance, TPO). They supplement the information published in association with the Swiss marketing authorisation for the medicinal product.

WELIREG®

Welireg® (belzutifan), film-coated tablets, each film-coated tablet contains 40 mg belzutifan.

Authorisation number: 68531

Date of Marketing Authorisation: 21-Mar-2024


Clinical Trials

A Phase 2 Study of Belzutifan (PT2977, MK-6482) for the Treatment of Von Hippel Lindau (VHL) Disease-Associated Renal Cell Carcinoma (RCC) (MK-6482-004)
NCT03401788

Publication:
Jonasch E, Dosnkov F, Iliopoulos O, Rathmell WK, Narayan VK, Maughan BL, Oudard S, Else T, Maranchie JK, Welsh SJ, Thamake S, Park EK, Perini RF, Linehan WM, Srinivasan R; MK-6482-004 Investigators. Belzutifan for Renal Cell Carcinoma in von Hippel-Lindau Disease. N Engl J Med. 2021 Nov 24;385(22):2036-2046. doi:10.1056/NEJMoa2103425.

CH-BEL-00025, 06/2024