A realistic timeline, based on where the Phase 3 programme is now, looks like this: FDA submission in the U.S.: late 2026 or 2027 FDA approval: 2027 or 2028 UK MHRA review: typically 12 to 24 months after FDA approval NHS access through a NICE appraisal: a separate process, usually 12 to 24 months after MHRA approval The earliest UK private access through online pharmacies, mirroring how Mounjaro and Wegovy first launched here, is likely 2027 or 2028
After 46 weeks of treatment: 0.6 mg dose: 6.2% mean body weight reduction 2.4 mg dose: 12.5% mean body weight reduction 3.6 mg dose: 13.2% mean body weight reduction 4.8 mg dose: 14.9% mean body weight reduction (all randomized) 4.8 mg dose: 18.7% mean body weight reduction (completers only) Placebo: 2.8% mean body weight reduction Among completers at the 4.8 mg dose, 68.8% achieved at least 10% weight loss, 67% achieved at least 15%, and 40% achieved at least 20% weight loss
Retesting should have a defined purpose, such as confirming an unexpected result or evaluating a clinician-guided intervention
For the final steps of mutant construction and confirmation, recombinant colonies were selected by plating on 7H10-ADC with the appropriate antibiotic/supplement and confirmed by PCR using specific primers (Supplementary Table 2 and Fig
B., Rijkers, A