Merck posts three JANUMET-family label updates; TERN-601 obesity data still stands out

This week's Merck items are three routine diabetes-drug labeling actions alongside previously reported obesity trial results.

• The FDA approved a labeling supplement for JANUMET, described as a tablet combining metformin hydrochloride and sitagliptin phosphate, sponsored by MSD SUB MERCK¹, with the submission status dated 2026-08-11 and the label posted 2026-08-18.
• The FDA approved a labeling supplement for JANUMET XR, an extended-release tablet form combining metformin hydrochloride and sitagliptin phosphate, sponsored by MSD SUB MERCK², with the same 2026-08-11 status date and label posted 2026-08-18.
• The FDA approved a labeling supplement for SEGLUROMET, a tablet combining ertugliflozin and metformin hydrochloride, sponsored by MSD SUB MERCK, under standard review priority³, with the same 2026-08-11 status date.
• Terns, a Merck subsidiary, previously reported completed results from its Phase 2a "FALCON" trial of oral GLP-1 receptor agonist candidate TERN-601 in adults with overweight or obesity, enrolling 167 participants⁴. At the 12-week primary endpoint, percent change in body weight was -2.11 for the 250 mg dose, -3.85 for 500 mg slow titration, -4.87 for 500 mg, -3.31 for 750 mg, and -0.30 for placebo, with ANOVA p-values of 0.0561, 0.0002, <0.0001, and 0.0016⁴.