Novartis registers new Phase 2 NIO752 tauopathy trial; Egaten results, six studies update

This week's registry activity centers on a newly posted Phase 2 study, alongside a completed trial with results and several collaborator-sponsored updates.

• Novartis Pharmaceuticals registered a Phase 2 basket study of NIO752 in primary tauopathies, covering three cohorts: PSP non-RS, CBS non-AD, and MAPT-FTLD. The trial is designed to evaluate safety, tolerability and pharmacodynamics of NIO752 against placebo, with 16 participants per cohort randomized before an open-label extension.¹ The study is listed as not yet recruiting, with enrollment of 48 participants (estimated)¹ and a start estimated for 2026-10-23.
• Novartis Pharmaceuticals sponsored a Phase 4 study of Egaten (triclabendazole) in fascioliasis patients 6 and older, testing the FDA approved dosing regimen of 2 doses of 10 mg/kg (given approximately 12 hours apart)². The study is listed as completed, with enrollment of 301 participants (actual)² and results first posted 2026-10-06.
• Novartis Pharmaceuticals is the lead sponsor of a Phase 3 study (ADD-VANTAGE) testing pelacarsen (TQJ230) against placebo in participants with established ASCVD and elevated Lp(a) who are also on background inclisiran treatment. The study is active, not recruiting, with enrollment of 246 participants (actual)³ and primary completion estimated for 2028-02-03.
• Novartis Pharmaceuticals sponsors a rollover study (KontRASt-R) allowing continued access to opnurasib (JDQ443), alone or with combination partners including TNO155, trametinib, cetuximab, or tislelizumab, for participants who benefited in earlier Novartis-sponsored opnurasib trials. The study is active, not recruiting, with enrollment of 25 participants (actual)⁴.
• Nathan Denlinger sponsors a Phase 1 trial, with Novartis listed as a collaborator, testing low dose total body irradiation added to standard lymphodepletion before tisagenlecleucel in relapsed or refractory large B-cell lymphoma. The study is recruiting, with enrollment of 18 participants (estimated)⁵.
• Emory University is the lead sponsor of a Phase 2 study of Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in African American men with metastatic castration-resistant prostate cancer, with the National Cancer Institute and Novartis listed as collaborators. The study is not yet recruiting, with enrollment of 88 participants (estimated)⁶ and a start estimated for 2026-11-02.
• Novartis Pharmaceuticals is the lead sponsor of a Phase 3 rollover extension program evaluating long-term safety of open-label iptacopan in adults with primary IgA nephropathy who completed two earlier Novartis trials. The study remains recruiting, with enrollment of 540 participants (estimated)⁷ and primary completion estimated for 2030-12-04.
• The University of Washington is the lead sponsor of a pilot chatbot study to support breast cancer screening among Black women, with Novartis Pharmaceuticals listed as a collaborator. The study is not yet recruiting, with a start estimated for 2026-10-26.