Emgality (galcanezumab-gnlm) / Eli Lilly, Daiichi Sankyo, AffaMed Therap, Organon - LARVOL DELTA

Delayed urticaria during treatment with anti-CGRP monoclonal antibodies in migraine. (PubMed, Headache) - "Anti-CGRP mAb-associated urticaria in this case series was delayed and likely non-immunoglobulin E (non-IgE)-mediated. Our experience supports that in selected patients with delayed urticaria, individualized management, including H1 antihistamine premedication, may allow continuation of effective migraine prophylaxis. Larger cohorts are needed to identify risk factors and to inform general management recommendations."

Journal • Allergy • Cardiovascular • CNS Disorders • Dermatology • Immunology • Migraine • Pain • Urticaria

Post-marketing safety of CGRP monoclonal antibodies and gepants: A systematic review of spontaneous reporting system data. (PubMed, Headache) - "This systematic review confirms that CGRP inhibitors have a manageable yet complex safety profile. It distinguishes rare, serious cerebrovascular events (RCVS, CeAD) associated with some mAbs but not with gepants, as well as shared adverse effects such as Raynaud's phenomenon and alopecia. Significant heterogeneity in safety profiles-from erenumab's pronounced constipation SDR to zavegepant's unique dysgeusia-challenges the view of CGRP inhibitors as a monolithic category. These findings provide a clear rationale for personalized risk assessment, enabling clinicians to tailor treatment to individual patient profiles."

Journal • P4 data • Review • Alopecia • Cardiovascular • CNS Disorders • Constipation • Fatigue • Gastroenterology • Gastrointestinal Disorder • Immunology • Migraine • Pain • Rheumatology • Vascular Neurology • ROR1

RACIAL AND ETHNIC DISPARITIES IN ADOPTION OF NOVEL CGRP THERAPIES FOR MIGRAINE PREVENTION: A RETROSPECTIVE COHORT STUDY USING THE KOMODO RESEARCH DATASET (ISPOR 2026) - "OBJECTIVES: To evaluate racial disparities in uptake of calcitonin gene-related peptide (CGRP) therapies (Erenumab, Fremanezumab, Galcanezumab, Eptinezumab, Atogepant, or Rimegepant) for migraine prevention among adults in the United States. This retrospective cohort study was conducted using the Komodo Research Dataset and Komodo Race and Ethnicity. CGRP initiation remained low across all groups. Although median time to initiation was similar, cumulative incidence patterns suggest differential adoption over time."

Retrospective data • CNS Disorders • Migraine • Pain

TITLE: COST-UTILITY ANALYSIS OF CALCITONIN GENE-RELATED PEPTIDE ANTIBODIES FOR PATIENTS WITH CHRONIC MIGRAINE: A UNITED STATES PAYER PERSPECTIVE (ISPOR 2026) - "At current prices, CGRP monoclonal antibodies were not cost-effective compared with best supportive care from a U.S. payer perspective. These findings may inform payer decision-making regarding coverage and reimbursement for chronic migraine prevention."

Clinical • HEOR • CNS Disorders • Migraine • Pain

Risk Stratification of Hypertension Induced by CGRP Antagonist in Migraine Treatment: A Retrospective Observational Analysis (AAN 2026) - "With the growing use of the Gpant class of drugs and other CGRP inhibitors in clinical settings, it is critical to determine which populations are most at risk for developing this side effect.Design/ 250 patients prescribed any CGRP antagonist, including erenumab, fremanezumab, galcanezumab, eptinezumab, and the gepants (ubrogepant, rimegepant, atogepant, zavegepant).Variables extracted included: age at start, sex, and body mass index (BMI). Hypertension following CGRP initiation is an early event, occurring within the first few months.Once developed, hypertension tends to persist, with no new cases after 3 months. The pattern is similar across drug classes, indicating that risk is likely related to the CGRP pathway blockade rather than a specific molecule."

Retrospective data • Cardiovascular • Chronic Kidney Disease • CNS Disorders • Diabetes • Hypertension • Metabolic Disorders • Migraine • Nephrology • Obstructive Sleep Apnea • Pain • Renal Disease • Respiratory Diseases • Sleep Disorder

Sleep and anti-calcitonin gene related (CGRP) drugs: current evidence and perspectives. (PubMed, Sleep Med Rev) - "Although results are inconsistent across instruments, emerging data suggest that anti-CGRP mAbs and gepants, particularly erenumab, galcanezumab, and atogepant, can improve subjective sleep quality and objective measures such as sleep efficiency in some cases. Evidence for fremanezumab and eptinezumab remains scarce, whereas large-scale pharmacovigilance datasets indicate low rates of insomnia, somnolence, or abnormal dreams. Overall, current findings suggest that CGRP inhibition impacts the sleep system, but the mechanisms of this interaction remain partly understood, representing a promising area for mechanistic exploration and clinical application. Future studies with standardized sleep endpoints are needed to distinguish direct neuropharmacological effects from indirect benefits mediated by improvement in migraine burden."

Journal • Review • CNS Disorders • Insomnia • Migraine • Pain • Sleep Disorder

A Real-World Study of CGRP Monoclonal Antibodies for Migraine: Long-Term Effectiveness and Treatment Adherence. (PubMed, Eur J Neurol) - "CGRP mAbs were associated with a long-term reduction in migraine frequency and favorable tolerability."

Journal • Observational data • Real-world evidence • Retrospective data • CNS Disorders • Mental Retardation • Migraine • Pain • Psychiatry

Comparative Efficacy and Safety of CGRP Monoclonal Antibodies and Oral Gepants for Migraine Prevention: Evidence from Randomized Controlled Trials and Network Meta-analysis (AAN 2026) - "Treatments included erenumab (n = 3,276), fremanezumab (n = 2,481), galcanezumab (n = 2,348), eptinezumab (n = 1,912), and atogepant (n = 1,196). CGRP monoclonal antibodies and oral gepants demonstrated consistent, durable efficacy and excellent safety for migraine prevention, with overall low risk of bias across included trials."

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

CGRP Monoclonal Antibodies vs Gepants: Risk of Vascular Outcomes: A TriNetX Multicenter Electronic Medical Record Analysis (AAN 2026) - "Real-world evidence comparing vascular risk between mAbs and gepants remains limited.Design/ We conducted a cross-sectional study using the TriNetX® database to identify adults with migraine (ICD-10 G43) prescribed CGRP mAbs (erenumab, galcanezumab, fremanezumab, eptinezumab) or gepants (atogepant, rimegepant). CGRP mAbs were linked to greater vascular risk than gepants. Elevated risk among never-users may reflect underlying clinical characteristics, prescribing patterns, and possibly a protective effect of CGRP inhibitors. These findings stress the need for prospective studies to clarify causality and guide vascular safety monitoring."

Clinical • Cardiovascular • CNS Disorders • Hypertension • Migraine

Comparative Effectiveness and Safety of Preventive Treatments for Vestibular Migraine: A Systematic Review and Network Meta-analysis (AAN 2026) - "Propranolol ranked highest (P-score: 0.794; -7.04 attacks/month, 95% CI -12.77 to -1.31), followed by valproic acid (-5.95, 95% CI -9.01 to -2.89) and venlafaxine (-5.94, 95% CI -8.98 to -2.90). All evaluated treatments effectively reduce vertigo frequency in vestibular migraine. While propranolol showed the largest effect, this relied on indirect evidence. Galcanezumab offers the best balance of efficacy, tolerability, and evidence quality."

HEOR • Retrospective data • Review • CNS Disorders • Migraine • Otorhinolaryngology • Pain • Vertigo

Emgality Transfer into Breast Milk (AAN 2026) - "Monoclonal antibodies used in other neurological conditions (such as rituximab, ocrelizumab) have previously shown low transfer into breast milk. An oral CGRP receptor antagonist, rimegepant, has a low RID in human breast milk; until this study, no published data were available on the transfer of galcanezumab, an injectable CGRP monoclonal antibody, into human breast milk. Understanding the transfer into breast milk of highly effective migraine therapies such as galcanezumab is crucial to providing women safe, effective treatments for headaches, especially during the postpartum period when at high risk of migraine recrudescence."

CNS Disorders • Migraine

Could galcanezumab modulate inflammatory cytokines? A single-centre exploratory study. (PubMed, J Neurol) - "This study highlights distinct cytokine profiles associated with chronic and episodic migraine. Treatment with galcanezumab was associated with a transient reduction in both pro- and anti-inflammatory cytokines during the first month of therapy. These findings support the hypothesis that CGRP could influence the inflammatory pathways in migraine pathophysiology."

Journal • CNS Disorders • Inflammation • Migraine • Pain • IFNG • IL10 • IL1B • IL6 • TNFA

REBUILD-2: A Study of Galcanezumab (LY2951742) in Participants 12 to 17 Years of Age With Chronic Migraine (clinicaltrials.gov) - P3 | N=312 | Active, not recruiting | Sponsor: Eli Lilly and Company | Trial primary completion date: Sep 2025 ➔ Dec 2025

Trial primary completion date • CNS Disorders • Migraine • Pain

Normal delivery following use of galcanezumab until the first and second trimesters of pregnancy: A report of 2 cases. (PubMed, Medicine (Baltimore)) - "The safety of galcanezumab administration in pregnant women has only been reported in scattered case reports, and further case studies are needed. It is considered necessary to continue to monitor newborns for the development of neurological abnormalities, including higher brain functions."

Journal • CNS Disorders • Migraine • Pain

Safety and efficacy of calcitonin gene-related peptide antagonists for cluster headache: a systematic review and meta-analysis. (PubMed, BMC Neurol) - "Calcitonin gene-related peptide antagonists provide preventive benefit with acceptable safety in cluster headache. These findings should be interpreted as supportive but less definitive. Larger, long-term, placebo-controlled randomized trials are needed to confirm efficacy and guide clinical use."

Journal • Retrospective data • Review • Chronic Cluster Headache • Pain

Identifying cardiac safety signals of disproportionate reporting for CGRP antagonists: evidence from the FDA Adverse Event Reporting System. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "CGRP antagonists included monoclonal antibodies (erenumab, fremanezumab, galcanezumab, eptinezumab) and small-molecule receptor antagonists (rimegepant, ubrogepant, atogepant). These results are hypothesis-generating and reflect reporting patterns rather than incidence or relative risk; therefore, they should not be interpreted as evidence of causality or as patient-level cAE risk factors. Continued post-marketing surveillance and confirmatory pharmacoepidemiologic studies in well-defined populations are warranted.  CLINICAL TRIAL NUMBER: Not applicable."

Adverse events • Journal • Cardiovascular • CNS Disorders • Coronary Artery Disease • Migraine • Pain

Effectiveness and safety of anti-CGRP monoclonal antibodies in hemiplegic migraine: an individual patient quantitative analysis. (PubMed, J Headache Pain) - No abstract available

Journal • Review • CNS Disorders • Migraine • Pain

Evaluating dual calcitonin gene-related peptide antagonists for chronic migraine prevention. (PubMed, Headache) - "Trialing two preventive CGRP antagonists may be an effective approach for some patients with chronic migraine who have exhausted other preventive treatment options, with some patients in this study experiencing a significant reduction in headache frequency and severity. Prospective studies with larger, more diverse populations should be completed to confirm these findings and investigate any potential stroke risks."

Journal • Cardiovascular • CNS Disorders • Ischemic stroke • Migraine • Pain

High-density EEG in the eyes closed condition reveals early reduction of alpha oscillations after galcanezumab: A pilot study in migraine. (PubMed, Clin Neurophysiol) - "These findings point to a cortical effect of galcanezumab in migraine patients as early as 7 days after treatment. The EC condition appears particularly sensitive and should be included in future evaluations."

Journal • CNS Disorders • Migraine • Pain

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

Botulinum Toxin Type A for the Prevention of Migraines: An Umbrella Review of Systematic Reviews. (PubMed, Toxins (Basel)) - "Overall, quantitative evidence indicated favorable effects of BoNT-A compared with placebo for chronic migraines, across headache frequency, headache severity, and acute medication use, but less efficacy than topiramate and the CGRP monoclonal antibodies (CGRPmAbs) galcanezumab and fremanezumab. Although botulinum toxin type A is widely used as a preventive treatment for chronic migraines, the available evidence supports its efficacy at a moderate level. Further head-to-head and long-term analyses are needed to clarify its comparative role alongside newer biologic treatments."

Journal • Review • 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

Efficacy of single-dose galcanezumab 240 mg on episodic or refractory chronic cluster headache: prospective, 4-week, real-world evidence from the GRASP study group. (PubMed, Front Neurol) - "A single 240 mg dose of galcanezumab significantly reduced attack frequency, pain, and duration in both patients with eCH and refractory cCH, improved quality of life and patients' satisfaction, and was well-tolerated. These real-world findings support the use of galcanezumab mostly in eCH, while larger studies are needed to clarify its role in cCH."

HEOR • Journal • Real-world evidence • Chronic Cluster Headache • Pain

Anti-CGRP for Inflammation and Pain Modulation in Small Fiber Neuropathy/Fibromyalgia (clinicaltrials.gov) - P4 | N=26 | Completed | Sponsor: Duke University | N=20 ➔ 26

Enrollment change • Fibromyalgia • Inflammation • Musculoskeletal Pain • Neuralgia • Pain • Rheumatology

REBUILD: A Study of Galcanezumab (LY2951742) in Participants 6 to 17 Years of Age With Episodic Migraine (clinicaltrials.gov) - P3 | N=533 | Active, not recruiting | Sponsor: Eli Lilly and Company | Recruiting ➔ Active, not recruiting | N=325 ➔ 533

Enrollment change • Enrollment closed • CNS Disorders • Migraine • Pain