Qulipta (atogepant) / Merck (MSD), AbbVie - LARVOL DELTA

AbbVie presents Phase 3 clinical trial at IHC…Atogepant surpasses Topiramate in migraine prevention (BioNews) - "The primary endpoint, the rate of treatment discontinuation due to adverse events, was 12.1% in the atogepant group compared to 29.6% in the topiramate group....Atogepant also achieved a significantly higher reduction rate, with 64.1% of patients experiencing a ≥50% reduction in mean monthly migraine days (MMD), compared with 39.3% in the topiramate group (RR 1.63, p<0.0001)."

P3 data • Migraine

Real-world data on Rimegepant for prophylaxis of episodic and chronic migraine in patients with at least three treatment failures. (IHC 2025) - "Patients with CM had tried amitriptyline, propranolol, candesartan, topiramate, pizotifen, venlafaxine, flunarazine, sodium valproate, onabotulinumtoxinA, CGRP mAbs and atogepant unless contraindicated with a minmum of 8 and maximum of 11 treatment failures. Conclusion Rimegepant is a well tolerated and effective prophylactic treatment option for EM and CM. Currently the data is on a small number of patients and we aim to report on a large cohort of patients in due course."

Clinical • Real-world • Real-world evidence • CNS Disorders • Migraine

Real-world Effectiveness, Safety and Tolerability of Atogepant in the Prevention of High-Frequency Episodic and Chronic Migraine: The GIANT Study (IHC 2025) - "Conclusion The GIANT study documents the real-life effectiveness, safety, and tolerability of atogepant for migraine prevention patients with prior therapeutic failures and comorbidities. It builds upon RCT data by highlighting rapid onset of action, meaningful reductions in pain intensity and interictal burden, high patient satisfaction, and effectiveness even in patients unresponsive to anti-CGRP mAbs."

Clinical • Real-world • Real-world effectiveness • Real-world evidence • CNS Disorders • Migraine

Tolerability, Safety, and Efficacy of Atogepant Versus Topiramate in Participants Requiring Preventive Treatment for Migraine: Results From the Head-To-Head TEMPLE Trial (IHC 2025) - "Conclusion Atogepant 60mg QD demonstrated superior tolerability and efficacy compared with topiramate. Atogepant was generally safe and well tolerated and no new safety signals were identified."

Clinical • Head-to-Head • Late-breaking abstract • CNS Disorders • Migraine • TOP1

USE OF ATOGEPANT IN THE PROPHYLAXIS OF REFRACTORY MIGRAINE: A LITERATURE REVIEW (IHC 2025) - "Conclusion Atogepant is effective in the prophylaxis of refractory migraine, showing the greatest benefit at a dose of 60 mg once daily. Its use represents an effective and generally well-tolerated therapeutic option for migraine prophylaxis, reducing attack frequency and improving patients' quality of life."

Review • CNS Disorders • Migraine

Survey on therapeutic efficacy and adherence in patients treated with Atogepant (IHC 2025) - "More than 50 per cent of patients reported a 2h plan-free when taking it concomitantly with a migraine attack. Adverse effects were negligible; some patients also reported weight loss."

Adherence • Clinical • CNS Disorders • Migraine

Response to Atogepant in refractory chronic migraine patients: a real world data from Hull Migraine Clinic. (IHC 2025) - "Patients had failed an average of 7.5 (range 5-11) treatments including amitriptyline 93%, propranolol 89%, candesartan 88%, topiramate 72%, pizotifen 39%, flunarazine 25%, venlafaxine 23%, sodium valproate 8% and all (100%) failed onabotulinumtoxinA and CGRP mAbs. It will be interesting to see a response in those with few treatment failures. Atogepant is an effective prophylaxis even in those non-responsive to other treatments."

Clinical • Real-world • Real-world evidence • CNS Disorders • Migraine

THE EFFICACY OF GEPANTS IN THE PROPHYLACTIC MANAGEMENT OF MIGRANE: A SYSTEMATIC REVIEW (IHC 2025) - "PubMed and BVS were searched through March 2025 for randomized controlled trials (RCTs) evaluating rimegepant or atogepant for migraine prevention. Their favorable safety profile and ease of use make them a valuable alternative to existing therapies. Further long-term, head-to-head studies are needed to confirm their sustained efficacy and comparative effectiveness."

Clinical • Review • CNS Disorders • Migraine

Indirect Treatment Comparison of the Efficacy and Safety of Atogepant Compared With Rimegepant in Japanese Participants for the Preventive Treatment of Episodic Migraine (IHC 2025) - "Methods The ITC included two randomized, double-blind, placebo (Pbo)-controlled trials for the preventive treatment of EM (RELEASE [Pbo N=134; Ato 60mg once daily N=132] and BHV3000-309 [Pbo N=244; Rime 75mg every other day N=240]) conducted among Japanese participants. Conclusion Among Japanese participants with EM, Ato demonstrated significant improvement in 2 of 3 efficacy outcomes compared with Rime and numerically higher MMD reduction. Ato demonstrated numerically lower TEAEs and AEs related d/c compared with Rime."

Clinical • CNS Disorders • Migraine

Milk and Plasma Pharmacokinetics of Single-Dose Atogepant in Healthy Lactating Women (IHC 2025) - "Mean (SD) plasma and milk atogepant PK parameters following 60mg single dose in healthy lactating women Plasma Breat Milk N 12 12 Cmax (ng/mL) 779 (344) 57.0 (23.3) Tmax (h) — a 2.0 (1.0 - 3.0) 1.0 (1.0 - 3.0) AUCinf (h*ng/mL) 3270 (1080) 239 (91.7) t1/2 (h) — b 4.69 (0.959) 3.32 (1.02) % of Dose Recovered in Milk - 0.0161 (0.00528) RID (%) — c - 0.189 (0.0738) a. Median (Min – Max) b. Harmonic Mean (Pseudo SD) c. RID = Relative infant dose Conclusion Atogepant average milk:plasma concentration ratio was 0.076 following a 60mg dose in lactating women. Based on lack of atogepant accumulation upon daily dosing, the low cumulative amount of atogepant excreted in breast milk and the low RID of 0.189%, atogepant may be considered, for the preventive treatment of migraine in lactating women."

Clinical • PK/PD data • CNS Disorders • Migraine

Atogepant Treatment Modulates Dopaminergic-Related Functional Connectivity in Episodic Migraine (IHC 2025) - "Conclusion Following three months of Atogepant treatment, all patients showed reductions in headache frequency with respect to baseline. Moreover, patients exhibited significant increased functional connectivity at follow-up within the mesocorticolimbic dopaminergic system (D1 receptor and DAT dopamine transporter), in a cluster centered in the medial orbitofrontal cortex."

CNS Disorders • Migraine

Trends in triptan, CGRP monoclonal antibody and gepant prescription rates in a large healthcare system in Boston, MA, USA from 2018-2024 (IHC 2025) - "Objective This study aims to describe triptan and CGRP inhibitor prescription rates by patient demographics in the Mass General Brigham Health System from 2018-2024 Methods We used electronic health record data from the Mass General Brigham Research Data Registry (RPDR) to identify patients 18 years or older with a migraine diagnosis (ICD-10 G43) and prescribed a triptan, CGRP monoclonal antibody (erenumab, galcanezumab, fremanezumab, eptinezumab) or gepant (ubrogepant, rimegepant, or atogepant) from May 1, 2018 and November 1, 2024. Conclusion Overall, there was an increase in the prescription rates for triptans, gepants and CGRP mABs in each demographic group from 2018-2024, although disparities were noted. Future analyses will investigate whether medical comorbidities and access to specialty clinics influence prescription rates."

Migraine

Biomolecular Effects of Atogepant in Episodic Migraine: the ATOM project (IHC 2025) - "Finally, we observed a reduction in miR-382-5p, miR-34a-5p, and miR-155 gene expression (p Conclusion Our preliminary findings showed that clinical improvement to atogepant in migraine individuals was associated with a modulation of the endocannabinoid system and specific miRNAs. Further studies are needed to elucidate if the observed results are a direct effect of gepant treatment or a compensatory mechanism related to the clinical improvement."

CNS Disorders • Migraine • MIR155 • MIR34A • miR-382

Economic Impact of Early Vs. Late Initiation of Atogepant for The Preventive Treatment of Migraine (IHC 2025) - "Conclusion Reducing 2-step edits / 1-step edit to 0-step edits for atogepant demonstrated annual cost savings of more than $1,000 per patient for US payors. These model-based estimates should be assessed in randomized trials of benefit designs."

HEOR • CNS Disorders • Migraine

A GraphRAG Approach to Query-Focused Summarization of Structured Electronic Health Record Data in Migraine Care Using Large Language Models (IHC 2025) - "This patient has undergone a sequence of 12 different medication orders, alternating between "eptinezumab" and "atogepant" in the later stages...This is followed by switches from "erenumab" to "fremanezumab" with 119 occurrences, and from "galcanezumab" to "fremanezumab" with 88 occurrences...Performance varies by query complexity, highlighting the importance of graph schema design and prompt engineering. This approach has strong potential for clinician-facing decision support and hypothesis generation in migraine research."

CNS Disorders • Migraine

Efficacy and Safety of CGRP Inhibitors in Migraine Prevention: A Comparative Review with Non-Pharmacological Strategies (IHC 2025) - "Results CGRP inhibitors, such as the monoclonal antibodies erenumab, fremanezumab, galcanezumab and eptinezumab, have shown efficacy in reducing migraine days and improving quality of life...In addition, inhibitors such as gepants (rimegepant and atogepant) have been developed as alternatives for patients who cannot use monoclonal antibodies...The choice of therapy should take into account the patient's clinical profile and preferences. Non-pharmacological therapies, although less effective in isolation, have value in an integrated approach and can enhance results when combined with pharmacological treatment."

Clinical • Review • CNS Disorders • Migraine • ADCYAP1

Atogepant Demonstrates Greater Improvement in Function Using the Activity Impairment in Migraine-Diary (AIM-D) During Interictal Days: Post-Hoc Analysis From the PROGRESS Chronic Migraine Trial (IHC 2025) - "On interictal days, participants taking placebo sometimes demonstrated a worsening of AIM-D scores. Our results suggest that treatment with atogepant 60mg QD effectively reduces interictal burden and minimizes the disruptive effects of migraine between attacks."

Retrospective data • CNS Disorders • Migraine

Weight Loss With Atogepant in Participants With Migraine and Overweight or Obesity: Interim Analysis of a Phase 3, Multicenter, Open-Label, 156-Week Extension Study (IHC 2025) - "Conclusion In a migraine trial subpopulation enriched for cardiovascular risk factors, clinical meaningful weight loss was observed with atogepant 60mg QD throughout the first year of open-label treatment. After one year of treatment, nearly one-third of participants with overweight or obesity experienced a ≥5% weight reduction, averaging 10kg of weight loss."

Clinical • P3 data • P3 data: top line • CNS Disorders • Migraine

Effectiveness and tolerability of the combination of onabotulinumtoxinA and atogepant for migraine prevention in Norway: the SYNERGY real-world study (IHC 2025) - "Finally, 49/82 patients (59.7%) had at least one AE, all mild; none led to discontinuation. Conclusion The study demonstrates effectiveness, tolerability, and high PGIC scores for atogepant in add-on to BoNTA at 24 weeks in a real-world setting in a difficult-to-treat population."

Clinical • Real-world • Real-world evidence • CNS Disorders • Migraine

Impact of atogepant on patient-reported outcomes for the preventive treatment of migraine in Japanese participants (EAN 2025) - "Patient-reported outcomes showed improvements from baseline with atogepant 60 mg QD treatment and these persisted over 52weeks."

Clinical • Patient reported outcomes • CNS Disorders • Migraine • Pain

Early Experience Treating Vestibular Migraine with Small Molecule CGRP Antagonists (AAO-HNSF 2025) - "The gepants used included ubrogepant, rimegepant, atogepant, and zavegepant. Gepants can be effective medications for the treatment of vestibular migraine."

CNS Disorders • Migraine • Otorhinolaryngology • Pain • Vertigo

ECLIPSE: Study of Oral Atogepant Tablets to Assess Safety and Efficacy in Adult Participants With Migraine (clinicaltrials.gov) - P3 | N=1300 | Recruiting | Sponsor: AbbVie | Trial completion date: Nov 2025 ➔ Nov 2026

Trial completion date • CNS Disorders • Migraine • Pain

The role of Atogepant in migraine prevention: a systematic review and meta-analysis. (PubMed, BMC Neurol) - "Atogepant is a highly effective CGRP antagonist for migraine prevention, however, it is associated with increased incidence of GI side effects. Further studies are needed to comprehensively investigate the relationship between atogepant dosage and migraine improvement and safety profile."

Clinical • Journal • Retrospective data • Review • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Migraine • Pain

Pharmacological characterization of ubrogepant and atogepant in cAMP assays at human, rat, and mouse calcitonin family receptors in transfected cells. (PubMed, Biochem Pharmacol) - "Collectively, our data show that while these compounds are most potent at the CGRP receptor, they have activity at other receptors from the calcitonin receptor family, and this activity differs between species. Our data provide a framework for understanding the activity of ubrogepant and atogepant in rat, mouse and human studies."

Journal • Preclinical • CNS Disorders • Migraine • Pain • ADM

Effectiveness and tolerability of atogepant as preventive treatment in resistant individuals with chronic migraine: Six-month real-world evidence. (PubMed, Cephalalgia) - "All participants had failed a median of six previous preventive treatments, including CGRP-monoclonal antibodies (mAbs) (68%) and onabotulinumtoxin-A (BoNT-A) (14%). TEAEs were reported by 53% of participants, with constipation (28%) and fatigue (16%) being the most common.ConclusionsAtogepant 60 mg daily demonstrated meaningful clinical benefit and good tolerability in real-world individuals with treatment-resistant chronic migraine over a 24-week period. These findings extend data from RCTs and real-world studies limited to 12-week period of observation, supporting atogepant as an effective option even in individuals with prior CGRP-mAb failure."

HEOR • Journal • Real-world evidence • CNS Disorders • Constipation • Depression • Fatigue • Gastroenterology • Gastrointestinal Disorder • Migraine • Mood Disorders • Pain • Psychiatry