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

Drugs for Migraine Prophylaxis. (PubMed, Dtsch Arztebl Int) - "The new prophylactic drugs against migraine are effective, well-tolerated, and especially useful for patients for whom traditional oral migraine prophylactic drugs and onabotulinum toxin A are ineffective, not tolerated, or contraindicated."

Journal • CNS Disorders • Migraine • Pain

Real-World Insights into Dual Calcitonin Gene-Related Peptide (CGRP) Therapies for Chronic Migraine: A Retrospective Review. (PubMed, Pain Physician) - "Dual-CGRP regimens may enhance migraine symptom control by reducing headache severity without causing significant adverse events. However, these findings need confirmation through randomized, placebo-controlled clinical trials that use larger sample sizes."

Clinical • Journal • Real-world evidence • Retrospective data • CNS Disorders • Migraine • Pain

Responders and super-responders to atogepant after 24 weeks of treatment in migraine: real-world evidence from the GIANT-2 study. (PubMed, J Headache Pain) - No abstract available

HEOR • Journal • Real-world evidence • CNS Disorders • Migraine • Pain

Safety analysis of gepants for migraine treatment: A pharmacovigilance study using the FDA Adverse Event Reporting System (FAERS) database. (PubMed, Headache) - "Gepants display distinct AE profiles, with oral agents linked to gastrointestinal and neurological effects and intranasal zavegepant associated with respiratory irritation. Continued post-marketing surveillance is essential to inform personalized migraine management and guide future CGRP-targeted drug development."

Adverse events • Journal • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Migraine • Pain

STAR: Italian Real-life obServational Study on the effecTiveness, sAfety and Tolerability of Atogepant in Migraine Patients (clinicaltrials.gov) - P=N/A | N=500 | Active, not recruiting | Sponsor: University of Florence | Recruiting ➔ Active, not recruiting | N=100 ➔ 500 | Trial primary completion date: Sep 2025 ➔ Nov 2025

Enrollment change • Enrollment closed • Trial primary completion date • CNS Disorders • Migraine • Pain

Comparative effects of anti-CGRP monoclonal antibodies and atogepant on migraine disability, sleep quality, and attack frequency: A 12-month observational study (EHF-EHC 2025) - " This retrospective observational study included patients with chronic migraine refractory to first-line preventives, treated with erenumab, galcanezumab, fremanezumab, or atogepant. Anti-CGRP therapies reduced migraine burden in patients with refractory chronic migraine. Notably, erenumab was associated with a strong correlation between disability and sleep quality. Atogepant showed promising early improvements in sleep in selected patients."

Clinical • Observational data • CNS Disorders • Migraine • Pain • Sleep Disorder

Survey on adherence and tolerability of atogepant used as migraine preventive treatment (EHF-EHC 2025) - "Overall, atogepant proved to be a welltolerated treatment, with high adherence in clinical practice. Clinical efficacy was maintained despite some missed pills. Mild adverse events were declared by half of participants, mainly nausea and slight weight loss"

Adherence • CNS Disorders • Migraine • Pain

Atogepant for vestibular migraine: Preliminary clinical experience in two patients (EHF-EHC 2025) - "Atogepant showed promising efficacy in reducing migraine burden and vestibular symptoms in these VM cases. These preliminary findings suggest potential for CGRP receptor antagonists in VM management, but larger controlled studies are needed to establish definitive efficacy and safety in this population."

Clinical • CNS Disorders • Migraine • Otorhinolaryngology • Pain • Vertigo

Real-world use of atogepant: Experience from a secondary-level hospital (EHF-EHC 2025) - "Atogepant demonstrated sustained efficacy and favorable tolerability in real-world clinical practice and may represent a promising therapeutic option for patients with refractory migraine. The primary limitation of the study was the relatively small sample size. Fig."

Clinical • Real-world • Real-world evidence • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Migraine

Efficacy and tolerability of atogepant during the perimenstrual phase of female cycle (EHF-EHC 2025) - "Preliminary data suggest that atogepant may reduce the burden of menstrually related migraine. The treatment was well tolerated in this cohort. Ongoing data collection will further clarify the impact of hormonal fluctuations on treatment response throughout the menstrual cycle."

Clinical • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Migraine

The chronopharmacology of atogepant in migraine prevention: A real-world evaluation of influence of timing of administration on effectiveness and tolerability (EHF-EHC 2025) - "Timing of atogepant administration (morning vs. evening) did not affect overall effectiveness or tolerability. However, a greater MIDAS score reduction in evening users was observed."

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

Atogepant in episodic cluster headache: A case report on efficacy and tolerability (EHF-EHC 2025) - "Previous preventive therapies with high-dose verapamil (240 mg twice daily) and topiramate (50 mg/day) offered limited benefit, with 1-2 bouts of the disease each year. This case suggests that atogepant may represent a promising preventive approach for selected patients with episodic cluster headache, particularly when conventional treatments fail. Although adverse effects limited its use in this case, the rapid and complete response warrant further investigation. Controlled studies are warranted to assess its efficacy, safety and potential role in the management of cluster headache."

Case report • Clinical • Anorexia • Pain

Migraine worsening after excellent initial response to galcanezumab (EHF-EHC 2025) - "Several prophylactics were tried (topiramate, amitriptyline, and atogepant) with no improvement...However, in the last few months of treatment, she experienced recrudescence of symptoms – she's now awaiting treatment with eptinezumab...While he tried several preventive medications (topiramate, amitriptyline, venlafaxine and valproic acid), he was also medicated with corticosteroids... Recent literature and medical experience refer to Galcanezumab as a good sustained treatment to refractory migraine. However, these cases highlight the situations in which, despite the initial response being great, there's no prolonged effect on pain relief."

Cardiovascular • CNS Disorders • Complement-mediated Rare Disorders • Hepatology • Hereditary Angioedema • Migraine • Pain

Efficacy, safety, and tolerability of atogepant in migraine patients from the UAE (EHF-EHC 2025) - "Atogepant effectively reduced monthly migraine days in both chronic and episodic migraine patients and was generally safe and well-tolerated among patients in the UAE."

Clinical • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Migraine • Pain

Combining anti-CGRP antibodies with atogepant: Safety and efficacy in a patient cohort (EHF-EHC 2025) - "Treatments included erenumab (n=1), fremanezumab (n=11), galcanezumab (n=6), and eptinezumab (n=9). In this real-world cohort, combining antiCGRP mAbs with atogepant appears to be safe and may offer additional benefit."

Clinical • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Insomnia • Migraine • Sleep Disorder

Patient-reported outcomes of atogepant versus topiramate in participants requiring preventive treatment for migraine: Results from the head-tohead TEMPLE trial (EHF-EHC 2025) - "Atogepant 60 mg QD demonstrated clinically meaningful and statistically superior improvements in all secondary functional outcomes compared with topiramate."

Clinical • Head-to-Head • Patient reported outcomes • CNS Disorders • Migraine • Pain • TOP1

Mid-term effectiveness and tolerability of atogepant in the prevention of migraine: A real life, prospective, multicentric study (the STAR study) (EHF-EHC 2025) - "The multicentric STAR study confirms atogepant effectiveness and tolerability at 24-week follow-up."

Clinical • CNS Disorders • Migraine • Pain

Refractory chronic cluster headache: A new therapeutic option (EHF-EHC 2025) - "Acute therapy with oral zolmitriptan 5 mg, subcutaneous sumatriptan 6 mg, and oxygen were used, with moderate effect. Preventive treatment included prednisolone and occipital nerve block during exacerbations, and verapamil, both as monotherapy and in combination with topiramate and lithium in various regimens... Treating refractory chronic cluster headache is challenging, as it is highly disabling for the patient. Although other therapies targeting CGRP have not shown clear benefit in clinical trials, especially in chronic forms, atogepant may offer a promising alternative."

Anorexia • Cardiovascular • Chronic Cluster Headache • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Hypertension • Migraine • Pain

Use of gepants in the acute treatment and bout modulation of cluster headache: A retrospective case series (EHF-EHC 2025) - "Notably, no traditional preventive therapies (e.g., verapamil, corticosteroids) were used during the reported bout Retrospective case series of six CH patients who used gepants during a recent cluster bout...Rimegepant 70 mg (every other day, 16–28 days) was used by four patients; two used atogepant 60 mg/day (28 days)... Gepants may represent a promising and well-tolerated therapeutic option for both acute treatment and bout modulation in episodic CH, even in the absence of traditional preventive therapies. Their efficacy in chronic CH remains uncertain. These preliminary findings warrant confirmation in prospective, controlled studies"

Retrospective data • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Migraine • Pain

Real-world evaluation of rimegepant usage and switch patterns in a single tertiary headache center (EHF-EHC 2025) - "Figure 1 illustrates the monthly utilization of rimegepant with/without onabotulinumtoxinA or other CGRP mAbs...Among those switches, galcanezumab (93) and fremanezumab (60) were the most common immediate prior CGRP preventives...Among those, there were 80 switches to atogepant and 59 to fremanezumab... Real-world data demonstrate rimegepant's versatility as both acute and preventive therapy. Its dual indication enables flexible dosing strategies, serving as a preventive for CGRP-naïve patients and as an effective CGRP preventive option within treatment algorithms. Fig."

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

Four-year real-world efficacy and tolerability of anti-CGRP therapies in a tertiary headache centre in England (EHF-EHC 2025) - " A total of 548 treatments were initiated in 415 patients (rimegepant: n=57; atogepant: n=60; erenumab: n=283; fremanezumab: n=136; galcanezumab: n=12). Real-world efficacy broadly aligns with clinical trial data, though our galcanezumab findings are limited by small sample size. While direct comparisons outside of randomised trials are limited, agents differed in both effectiveness and tolerability. Rimegepant was well tolerated but was associated with the lowest effectiveness at 12 weeks."

Clinical • Real-world • Real-world effectiveness • Real-world evidence • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Migraine • Pain

Satisfaction rates and self-reported adverse events of antiCGRP therapies for migraine prevention – Focus on patient perspectives (EHF-EHC 2025) - "4% of questionnaires corresponded to patients on Atogepant, 9.3% on Erenumab , 24.4% on Eptinezumab, 29% on Galcanezumab and 32% on Fremanezumab. More than half of our patients reported significant improvement with antiCGRP therapy. Selfreported adverse events were more frequent (56%) than previously reported. Most frequent, were gastrointestinal symptoms and local skin reactions."

Adverse events • Clinical • Cardiovascular • CNS Disorders • Hypertension • Migraine • Pain

Adverse effects and predictors of their occurrence in a series of patients with resistant migraine treated with atogepant (EHF-EHC 2025) - "In our cohort, higher body weight was associated with a greater incidence of adverse effects related to Atogepant. Further studies are needed to confirm these data and determine whether this association is related to the absorption, transport, or metabolism of this drug."

Adverse events • Clinical • CNS Disorders • Constipation • Dermatology • Gastroenterology • Gastrointestinal Disorder • Migraine • Pain • Pruritus • Sleep Disorder

Real-world evidence of safety and effectiveness of atogepant: A prospective study from a Portuguese tertiary centre (EHF-EHC 2025) - "Most patients (89%) had previously been treated with multiple prophylactic therapies (including antidepressants, antiepileptics, antihypertensives, OnabotulinumtoxinA, and anaesthetic blocks), and 16 patients with anti-CGRP monoclonal antibodies, with a median of 4 previous treatments, while 6 patients were naïve. Preliminary findings indicate that atogepant shows substantial promise in reducing both headache and migraine days in a real-world setting, with a favourable tolerability profile. However, the study is still in the patient inclusion phase, therefore we hope to obtain more results to attest to its efficacy and safety."

Clinical • HEOR • Real-world • Real-world evidence • Anesthesia • Anorexia • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Insomnia • Migraine • Sleep Disorder

Comparison of atogepant versus topiramate on cognitive function as assessed by the PROMIS cognitive function abilities subset SF 6a v2.0 for participants requiring preventive treatment for migraine: Results from the head-to-head TEMPLE trial (EHF-EHC 2025) - "Ato 60 mg QD demonstrated greater improvements in cognitive function compared with topi through Week 24. Fig. 1"

Head-to-Head • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Migraine • Pain • TOP1