ASC36 is Ascletis Pharma's proprietary once-monthly to once-quarterly subcutaneous amylin receptor peptide agonist developed for the treatment of obesity. The extended dosing interval, delivered by proprietary formulation chemistry, is positioned to differentiate from the once-weekly amylin analog cagrilintide (in Novo Nordisk's CagriSema combination) and the once-weekly Zealand-Roche petrelintide plus the emerging Metsera MET-233i and AstraZeneca AZD6234 candidates.
Ascletis (HKEX: 1672) submitted the U.S. Investigational New Drug applications for ASC36 and ASC36_35FDC on July 5, 2026, received FDA IND clearance shortly after, and initiated two Phase 1 U.S. studies August 10, 2026. Enrollment continues through early September 2026. ASC36_35FDC is a once-monthly subcutaneous fixed-dose combination of ASC36 plus ASC35 (Ascletis's own GLP-1R/GIPR peptide agonist), engaging three validated obesity targets (amylin receptor plus GLP-1R plus GIPR) in a single injection.
Preclinical differentiation: in head-to-head diet-induced-obesity rat studies, ASC36 monotherapy demonstrated approximately 91% greater relative body weight reduction versus petrelintide and approximately 32% greater versus Eli Lilly's eloralintide. If the Phase 1 tolerability profile confirms the preclinical case, ASC36 would enter Phase 2 in mid-2027 as one of the most convenience-differentiated non-incretin obesity peptides in development. Stories here cover clinical readouts, deal milestones, and the broader amylin analog category. See [[ascletis-pharma]], [[amylin-receptor-peptide-agonist]], and [[petrelintide]] for adjacent threads.
Ascletis Pharma (HKEX: 1672) continued enrollment through early September 2026 in the two U.S. Phase 1 studies of ASC36 (a once-monthly to once-quarterly subcutaneous amylin receptor peptide agonist for obesity) and ASC36_35FDC (a once-monthly subcutaneous fixed-dose combination of ASC36 plus GLP-1R/GIPR peptide agonist ASC35) initiated August 10, 2026 following FDA IND clearance July 5. In head-to-head diet-induced-obesity rat studies, ASC36 monotherapy demonstrated approximately 91% greater relative body weight reduction versus Zealand-Roche's petrelintide and approximately 32% greater versus Eli Lilly's eloralintide. If the Phase 1 tolerability profile confirms preclinical differentiation, ASC36 would enter the amylin analog Phase 2 field alongside Novo Nordisk's cagrilintide-in-CagriSema, AstraZeneca's AZD6234 (Milan EASD 2026 September 28-October 2 readout), Metsera's MET-233i, and the Roche-Zealand petrelintide-plus-enicepatide combination Phase 2 initiation planned mid-2026.
On July 5, Ascletis submitted two INDs to the FDA: ASC36, a peptide amylin receptor agonist dosed once monthly to once quarterly by injection, and ASC36_35, a co-formulation pairing ASC36 with the GLP-1R/GIPR agonist peptide ASC35. In diet-induced obese rat studies, ASC36 monotherapy showed roughly 91% and 32% greater relative body-weight reduction than petrelintide and eloralintide, and the ASC36_35 combination showed about 51% greater reduction than co-administered eloralintide plus tirzepatide. The filings push amylin biology further into the obesity race.
Ascletis Pharma will present multiple poster sessions at ECO 2026 covering programs beyond the already-presented ASC30. ASC47, an adipose-targeting thyroid hormone receptor beta (THRβ) agonist designed for muscle-preserving weight loss, demonstrated up to 111.8% greater relative weight loss when combined with semaglutide vs semaglutide monotherapy in obesity participants. ASC36, a once-monthly next-generation amylin receptor agonist peptide, posted a 32-day average observed half-life — six times longer than Zealand's petrelintide. ASC35, a once-monthly next-generation GLP-1R/GIPR dual agonist peptide, showed a 14-day average observed half-life (six times longer than tirzepatide) and 71% more relative weight loss than tirzepatide in a diet-induced obesity mouse model. Session Thursday May 14, 18:00-19:15 TRT.