Pfizer wins two FDA labeling supplements; obesity trial roster unchanged

The week's most notable development was a pair of FDA label updates, alongside no new registrations in Pfizer's obesity pipeline beyond what was previously logged.

• The FDA approved a labeling supplement for Azulfidine EN-tabs (sulfasalazine), sponsored by Pfizer. The supplement covers delayed-release tablets at 500MG strength and was approved as submission number 139, with the submission status dated 2026-10-14.¹
• The FDA also approved a labeling supplement for injectable Methotrexate Sodium products, sponsored by Hospira. The approval, submission number 144, covers multiple injectable strengths and formulations including preservative-free versions, with the submission status dated 2026-10-15.²
• The Phase 3 "VESPER-JW" study of once-weekly berobenatide in Japanese adults with obesity remains recruiting. The purpose of this clinical study is to learn about safety and effects of berobenatide (PF-08653944) in adults with obesity disease, a condition where a person has too much body fat, which can harm their health and increase the risk of other medical problems.³ About 180 adults will take part in this study.³
• The Phase 3 once-weekly berobenatide study in Chinese adults with overweight or obesity remains recruiting. The purpose of this study is to learn whether berobenatide is safe and effective for adults in China who have overweight or obesity, compared with a placebo, which looks like the study treatment but does not contain active medicine.⁴ Enrollment is estimated at 300 participants.⁴
• The Phase 3 "VESPER-SWITCH" study, testing a switch from weekly semaglutide or tirzepatide to monthly berobenatide for weight maintenance, remains recruiting. The purpose of this study is to learn about the safety and effectiveness of berobenatide in adults with overweight or obesity who have already lost weight while taking semaglutide or tirzepatide.⁵ Enrollment is estimated at 660 participants.⁵
• A Phase 1 multiple ascending dose study of PF-08656795 in adults with overweight or obesity remains not yet recruiting. This study will look at how different amounts of the study medicine, called PF-08656795, are tolerated and act in adults with overweight or obesity.⁶ Enrollment is estimated at 150 participants.⁶
• A Phase 1 single-dose study comparing delivery systems for berobenatide in adults with overweight or obesity remains not yet recruiting. This is a single dose study to learn how safe and effective the study medicine is using different delivery systems for adults with overweight or obesity.⁷ Enrollment is estimated at 144 participants.⁷
• A Phase 3 study of once-monthly berobenatide (PF-08653944) in Chinese adults with overweight or obesity remains not yet recruiting. The purpose of this study is to learn whether berobenatide (PF-08653944) is safe and effective for adults in China who are overweight or obese, compared with a placebo.⁸ About 432 adults will take part in this study.⁸