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Sep 25, 2026Weekly roundupUpdated

Roche's Valium gets label update; trontinemab Alzheimer's trials continue as active, not recruiting

A labeling supplement for Valium (diazepam) was approved, while TRONTIER 1, TRONTIER 2, NXT007, and pegozafermin trials remain in earlier stages.

Roche's week included an FDA labeling action for Valium alongside continued progress across Alzheimer's, hemophilia, and metabolic programs.

  • The FDA approved a labeling supplement for Valium (diazepam), NDA013263, listed under sponsor Waylis Therap. The submission was a labeling-class supplement with status "AP" (approved) and a submission status date of 2026-09-24.
  • TRONTIER 2 (NCT07170150), Roche's Phase III trial of trontinemab in early symptomatic Alzheimer's disease, remains active not recruiting. The trial had an actual start date of 2025-11-12.1 It enrolled 1060 participants (actual), with a primary outcome of change from baseline to week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB).1
  • TRONTIER 1 (NCT07169578), the companion Phase III trontinemab trial, is also active not recruiting. It had an actual start date of 2025-09-17.2 The trial enrolled 1101 participants (actual).2
  • ZEBRHA 3 (NCT07838194), a Phase III trial of NXT007 prophylaxis in pediatric patients with hemophilia A, remains not yet recruiting. The study covers patients aged 0 to 11 years with severe or moderate congenital hemophilia A without factor VIII inhibitors, or hemophilia A of any severity with inhibitors, plus patients 12 to under 18 years weighing under 40 kg.3 Estimated enrollment is 50 participants.3 Roche is the lead sponsor with Chugai Pharmaceutical as collaborator.
  • A Phase 1 trial of pegozafermin (NCT07835243) remains not yet recruiting. The study will evaluate pharmacokinetics of a single subcutaneous dose administered in the abdomen, thigh, or upper arm in healthy participants.4 Estimated enrollment is 105 participants, with primary completion estimated for 2027-03-02.4
  • Results remain posted for an ocrelizumab extension study in multiple sclerosis (NCT03599245), now listed as completed. The study enrolled 1055 participants (actual).5 Participants received ocrelizumab as single 600 mg infusions every 24 weeks for two years.5

Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.