#Non-Peptide-Small-Molecule

2 stories

Clinical Trials September 11, 2026 · View digest

AbbVie Qulipta (Atogepant) Meets Primary and All Eight Secondary Endpoints of Phase 3 LUNA Trial in Menstrual Migraine; First Potential FDA-Approved Therapy Specifically for Perimenstrual Migraine

AbbVie (NYSE: ABBV) announced Friday September 11, 2026 positive topline results from the Phase 3 LUNA trial evaluating Qulipta (atogepant, an oral calcitonin gene-related peptide receptor antagonist small molecule) for the preventive treatment of menstrual migraine in adults. LUNA is a multicenter randomized double-blind placebo-controlled trial that enrolled 468 adult women with pure menstrual migraine or menstrually-related migraine across sites in Europe and Asia; participants took atogepant for 7 consecutive days starting 3 days before the onset of menses, repeated over 3 menstrual cycles. Atogepant reduced perimenstrual migraine days by a mean of 1.20 days versus 0.40 days with placebo (0.80 fewer migraine days versus placebo, p<0.0001) and met all 8 ranked secondary endpoints (p<0.0001). No treatment is currently FDA-approved specifically for menstrual migraine. AbbVie plans to submit the LUNA data to health authorities and present at future medical congresses. Qulipta is already approved in the U.S. for adults with episodic migraine and chronic migraine — the LUNA readout supports a distinct short-term perimenstrual dosing regimen and potentially a dedicated label expansion. CGRP is a neuropeptide involved in migraine pathophysiology; atogepant is a small-molecule CGRP receptor antagonist rather than a peptide itself.

Clinical Trials September 8, 2026 · View digest

Structure Therapeutics Reports 16.2% Mean Weight Loss at 72 Weeks With Oral Aleniglipron in ACCESS OLE Plus First-in-Human Data for ACCG-2671 Oral Amylin/Calcitonin Dual Agonist

Structure Therapeutics (NASDAQ: GPCR) reported Tuesday September 8, 2026 positive data across two lead oral small-molecule obesity programs. Aleniglipron (oral small-molecule GLP-1 receptor agonist, formerly GSBR-1290) reached mean 16.2% body weight loss at 72 weeks at the 180 mg dose in the ACCESS Phase 2b open-label extension (11.6% at 45 mg, 14.4% at 90 mg), with no observed weight-loss plateau; fewer than 5% of participants discontinued for adverse events using the improved 2.5 mg starting dose with four-week titration. The Phase 3 ACCOMPLISH program enrolls up to 3,600 adults with obesity plus comorbidity (ACCOMPLISH-1) and up to 1,100 with obesity plus type 2 diabetes (ACCOMPLISH-2), with topline expected H2 2028. Separately, ACCG-2671 (oral small-molecule dual amylin and calcitonin receptor agonist) posted first-in-human Phase 1/2a single-ascending-dose data in 31 healthy volunteers: 3.3% body weight reduction after a single 10 mg dose at Day 24, ~6-day half-life supporting once-weekly dosing, CTX-1 bone resorption biomarker reduction ~60% by Day 2, no serious adverse events, no drug-induced liver injury, no nausea or vomiting at 1-2 mg doses (dose-related GI effects at 5+ mg). A 12-week multiple-ascending-dose trial in obese participants is enrolling with topline expected H1 2027. Despite the data, GPCR shares fell in Tuesday trading on incumbent-class competitive concerns.