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

Effectiveness of atogepant in migraine with and without medication overuse: Pooled real-world analysis of two independent clinical cohorts. (PubMed, Neurol Sci) - "In this pooled real-world analysis, atogepant was associated with clinically meaningful short-term improvement in migraine frequency, disability, headache impact, and symptomatic medication use. Baseline MOH was associated with greater initial disease burden but did not appear to attenuate proportional treatment response. Because safety and persistence were documented differently in the two cohorts, pooled tolerability estimates should be interpreted descriptively."

Journal • Observational data • Real-world evidence • CNS Disorders • Migraine • Pain

Early improvements in function with atogepant as assessed by the Activity Impairment in Migraine-Diary: Post hoc analyses of three randomized, phase 3 clinical trials of atogepant for the preventive treatment of migraine. (PubMed, Headache) - "For preventive migraine treatment, atogepant once daily versus placebo was associated with early improvements in AIM-D individual and activity limitation items and with higher odds of achieving complete improvement for AIM-D domain scores in people with EM and CM, demonstrating early functional improvements across the migraine spectrum."

Clinical • Journal • P3 data • Retrospective data • CNS Disorders • Migraine • Pain

Systemic Inflammatory Syndrome and Probable DRESS Following Atogepant Initiation (EADV 2026) - No abstract available

Drugs for prevention of migraine. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • CNS Disorders • Migraine • Pain

Comparison table: Some drugs for migraine prevention. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • CNS Disorders • Migraine • Pain

VOR-GRIP: Effect of Atogepant on the Vestibulo-Ocular Reflex in Healthy Adults and Adults With Migraine (clinicaltrials.gov) - P4 | N=80 | Not yet recruiting | Sponsor: Konrad Peter Weber

New P4 trial • CNS Disorders • Migraine

The Brazilian Health Regulatory Agency (Anvisa) approved this Tuesday (September 8) the registration of the drug Aquipta (atogepant), indicated for adults who experience at least four migraine episodes monthly. (gov.br)

Approval • Migraine

Atogepant Met Primary and All Ranked Secondary Endpoints in Phase 3 LUNA (PRNewswire) - "The average reduction was 1.20 days with atogepant versus 0.40 days with placebo, corresponding to 0.80 fewer migraine days versus placebo (p<0.0001). Atogepant also demonstrated statistically significant and clinically meaningful improvements versus placebo across all eight ranked secondary endpoints (p<0.0001), including measures of headache burden, acute medication use, functional disability, cognitive function and responder outcomes....Survey data from the European Migraine and Headache Alliance Migraine in Women Survey provide additional context...Respondents described these attacks as more painful, longer lasting or more resistant to medication than non-menstrual attacks, and 68% reported they had never been offered a tailored treatment approach....AbbVie plans to submit these data to health authorities worldwide and present findings at future medical congresses."

P3 data: top line • Migraine

Asymmetric Synthesis of Chiral δ-Caprolactams: Access to a Key Intermediate of Ubrogepant. (PubMed, J Org Chem) - "Chiral δ-caprolactam constitutes the key pharmacophore of Calcitonin gene-related peptide receptor antagonists such as ubrogepant and atogepant, and its synthesis is quite challenging. The δ-caprolactam scaffold is first constructed via a one-pot process, followed by sequential installation of three stereocenters through crystallization-induced dynamic kinetic resolution and catalytic hydrogenation. This protocol offers distinct advantages, including the absence of enzymatic catalysis and column chromatography."

Journal

ECLIPSE: Study of Oral Atogepant Tablets to Assess Safety and Efficacy in Adult Participants With Migraine (clinicaltrials.gov) - P3 | N=2158 | Completed | Sponsor: AbbVie | Active, not recruiting ➔ Completed | N=1300 ➔ 2158

Enrollment change • Trial completion • CNS Disorders • Migraine

Systematic Review of Pharmacologic Treatment for Migraine Prevention in Adults: Report of the AAN Guidelines Subcommittee and the American Headache Society. (PubMed, Headache) - "This SR provides a comprehensive synthesis of evidence on pharmacologic migraine prevention in adults. High- and moderate-confidence findings confirm the efficacy of several established and newer preventive therapies and demonstrate improvements in patient-reported outcomes across multiple validated measures. These conclusions informed the development of evidence-based recommendations, presented in a companion publication, to guide clinicians in selecting preventive medications for adults with episodic and chronic migraine."

Journal • CNS Disorders • Migraine • Pain

Systematic Review of Pharmacologic Treatment for Migraine Prevention in Adults: Report of the AAN Guidelines Subcommittee and the American Headache Society. (PubMed, Neurology) - "This SR provides a comprehensive synthesis of evidence on pharmacologic migraine prevention in adults. High- and moderate-confidence findings confirm the efficacy of several established and newer preventive therapies and demonstrate improvements in patient-reported outcomes across multiple validated measures. These conclusions informed the development of evidence-based recommendations, presented in a companion publication, to guide clinicians in selecting preventive medications for adults with episodic and chronic migraine."

Journal • Review • CNS Disorders • Migraine • Pain

New Migraine Guidelines Expand Treatment Options For Migraine Prevention (RTTNews) - "The guidelines discuss how preventive medicines are different from medicines used to treat a migraine attack after it starts...The new guidelines recommend atogepant, erenumab, fremanezumab, galcanezumab, and eptinezumab as first-choice medicines for preventing migraine. These medicines are given in different ways...For people with episodic migraine, meaning migraine occurring on fewer than 15 days a month, the treatments with the strongest evidence of effectiveness include atogepant, eptinezumab, erenumab, fremanezumab, galcanezumab, propranolol, topiramate, and valproate....Botox is also an option for chronic migraine."

Clinical guideline • Migraine

Atogepant modulates brain connectivity in episodic migraine: a longitudinal exploratory fMRI study. (PubMed, Front Neurol) - "These preliminary findings may reflect either direct or indirect central modulation linked to atogepant treatment. A deeper understanding of the observed central changes may help to clarify the mechanisms underlying anti-CGRP therapies for migraine."

Journal • CNS Disorders • Migraine • Pain

PRAC adopted an update to section 5.1 of the SmPC to incorporate long-term safety, tolerability and efficacy data for oral atogepant based on final results from Category 3 Phase 3 study 3101-312-002. (European Medicines Agency) - The 156-week extension study evaluated long-term treatment with atogepant for the prevention of migraine in adults with chronic or episodic migraine. The RMP was also updated to version 2.3. [AI generated summary]

PRAC • Migraine

A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of atogepant for this indication compared with the current standard of care, on the basis of the proposed price relative to currently available therapies. [For acute treatment of migraine with or without aura in adults] (National Centre for Pharmacoeconomics, Ireland)

HEOR • Migraine

Safety and Efficacy of Atogepant for Migraine Prevention: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. (PubMed, Cureus) - "In general, atogepant was well tolerated and safe, demonstrating good safety and tolerability relative to other traditional preventive migraine medications. This study provides evidence supporting the effectiveness and tolerability of atogepant as an oral preventive treatment for episodic and chronic migraine."

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

Efficacy and safety of gepants in migraine management: a narrative review focusing on atogepant and rimegepant. (PubMed, J Oral Facial Pain Headache) - "Their use in clinical practice remains limited in France due to high cost and restricted reimbursement. Further real-world and long-term studies are needed to better define their place within current migraine management strategies."

Journal • Review • Cardiovascular • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Migraine • Pain

Global net revenues from the neuroscience portfolio were $3.228 billion, an increase of 20.3 percent on a reported basis, or 19.8 percent on an operational basis. (PRNewswire) - "Global Ubrelvy net revenues were $392 million, an increase of 16.0 percent on a reported basis, or 15.9 percent on an operational basis; Global Qulipta net revenues were $350 million, an increase of 30.9 percent on a reported basis, or 30.3 percent on an operational basis; Global Vyalev net revenues were $256 million."

Sales • Dystonia • Migraine • Parkinson's Disease

Qulipta: Data from P3 ATO MM trial (NCT06806293) for menstrual migraine prevention in 2026 (AbbVie) - Q2 2026 Results

P3 data • CNS Disorders • Migraine

Qulipta: Regulatory submission in EU for menstrual migraine prevention in 2026 (AbbVie) - Q2 2026 Results: Regulatory approval in EU for menstrual migraine prevention in 2027

EMA approval • EMA filing • CNS Disorders • Migraine • Pain

Real-life effectiveness, tolerability, and safety of atogepant: a prospective, observational, multicentre study by the Headache Study Group in Castile-La Mancha. (PubMed, Neurologia (Engl Ed)) - "Our findings confirm the effectiveness and safety of atogepant reported in clinical trials, although tolerability is poorer, which could compromise treatment adherence in clinical practice."

Journal • Observational data • CNS Disorders • Migraine • Pain

Atogepant Reduces Psychological Dependence on Acute Treatments Evaluated With the Leeds Dependence Questionnaire: A Prospective Study. (PubMed, Brain Behav) - "Preventive treatment with atogepant is associated with a significant reduction in psychological dependence on acute migraine medications, as measured by the LDQ. These findings support the need to assess dependence-like behavior in clinical migraine care and highlight the potential behavioral benefits of effective preventive treatments."

Journal • CNS Disorders • Migraine • Pain • Psychiatry

Tolerability, safety, and efficacy of atogepant versus topiramate in adults with migraine (TEMPLE): a randomised, head-to-head, phase 3b trial. (PubMed, Lancet Neurol) - P3 | "Atogepant 60 mg once daily showed better tolerability and efficacy across 24 weeks compared with topiramate. Although both topiramate and atogepant are established as effective oral migraine preventive treatments, their usefulness in clinical practice hinges on patients' ability to tolerate treatment. Our findings provide direct comparative evidence that might guide clinicians in selecting the most appropriate preventive therapy for their patients."

Head-to-Head • Journal • P3 data • CNS Disorders • Migraine • Pain

CGRP-pathway exposure during the pre-EBP interval in spontaneous intracranial hypotension: an exploratory retrospective case series. (PubMed, BMC Neurol) - "These observations are hypothesis-generating only and report temporal associations between CGRP-pathway initiation and short-term symptom changes in a highly selected cohort with comorbid chronic migraine. They do not demonstrate efficacy for SIH and should not be interpreted as endorsing CGRP-pathway therapy as a treatment for SIH. Prospective, controlled trials with validated headache and orthostatic endpoints, stratification by migraine status, and peripheral/CSF biomarker assessments are required."

Journal • Retrospective data • CNS Disorders • Hypotension • Migraine • Pain