Sanofi's week: AVAPRO label update, new belumosudil BE study, two TB trial results posted

Five items moved across Sanofi's pipeline and partnered programs this week, spanning a label update, a newly registered study, and results postings for two tuberculosis trials.

• FDA approved a labeling supplement for AVAPRO (irbesartan) tablets, with the submission covering three strengths: 300MG, 75MG, and 150MG formulations, with a submission status date of 2026-07-24.¹
• Sanofi registered a new Phase 1 study comparing belumosudil (REZUROCK) given as an oral suspension against the commercial tablet. The trial is an open-label, randomized, Phase 1, 2-treatment, 2-period, 2-sequence, cross-over bioequivalence study in healthy male participants ages 18 to 45², not yet recruiting, with an estimated enrollment of 58 participants.²
• Results were posted for TBTC Study 35, a CDC-sponsored dose-finding trial in which Sanofi is a collaborator. The study is designed to assess pharmacokinetics, safety and tolerability of rifapentine in a new once-weekly fixed dose combination with isoniazid over 12 weeks in HIV-infected and HIV-uninfected children ages 0 to 12 with latent TB infection³, and it is now completed with 69 participants actually enrolled.³
• Results were also posted for TBTC Study 29, a completed CDC-sponsored Phase 2 trial on rifapentine-containing regimens for the intensive phase of pulmonary TB treatment, another Sanofi collaboration. The study's primary endpoint was sputum culture conversion at 8 weeks⁴, and it enrolled 334 participants actually.⁴
• Sanofi is a collaborator on a newly posted, not-yet-recruiting German investigator-led study (VACC-UP) comparing bedside influenza vaccination plus counseling against counseling alone in patients hospitalized for acute coronary syndrome or heart failure, with an estimated enrollment of 482 participants.⁵