Nurtec ODT (rimegepant ODT) / Pfizer - LARVOL DELTA

Efficacy and safety of rimegepant for the acute treatment of migraine in Black or African American adults: A post hoc pooled subgroup analysis from three randomized, placebo-controlled clinical trials. (PubMed, Headache) - P3 | "This pooled analysis showed rimegepant 75 mg was effective and well tolerated for migraine treatment in Black or African American adult participants."

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

Retrospective analysis of the tolerability and effectiveness of rimegepant for the acute treatment of migraine in adolescents. (PubMed, Headache) - "Rimegepant may be a safe and effective acute migraine treatment in adolescents. No adverse events occurred, and the medication appears to be safe and well-tolerated. These findings support the need for larger prospective and randomized controlled trials to further evaluate the tolerability and effectiveness of gepants in the pediatric population."

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

ARISE-A Chinese Real-world Study of Rimegepant for the Acute Treatment of Migraine (clinicaltrials.gov) - P=N/A | N=3000 | Active, not recruiting | Sponsor: Chinese PLA General Hospital | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2027 ➔ Jun 2027 | Trial primary completion date: Jan 2026 ➔ Sep 2025

Enrollment closed • Real-world evidence • Trial completion date • Trial primary completion date • CNS Disorders • Migraine • Pain

Sensory neurons drive immune exclusion by stimulating a dense extracellular matrix in the breast cancer tumor microenvironment. (PubMed, Cell) - "Collectively, our findings reveal a connection between sensory neurons and CAFs that obstructs antitumor immunity in TNBC. The CGRP antagonist rimegepant thus has clinical translational potential as an immuno-sensitizer to augment tumor immunotherapy."

Biomarker • Journal • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CAFs • CREB1

A Prospective Real World Study of Rimegepant in the Treatment of Migraine (clinicaltrials.gov) - P=N/A | N=173 | Completed | Sponsor: Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine | Recruiting ➔ Completed | N=100 ➔ 173 | Trial completion date: Dec 2025 ➔ Apr 2025

Enrollment change • Real-world evidence • Trial completion • Trial completion date • 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

A Pilot, Randomized, Placebo-Controlled Trial of Rimegepant on Visceral Sensation and Symptoms in Non-Constipation IBS Pain. (PubMed, Am J Physiol Gastrointest Liver Physiol) - P2 | "There were no serious adverse events or adverse events of ≥ Grade 3 severity. Rimegepant's effects on rectal sensation suggest further studies in non-constipation IBS pain are warranted."

Clinical • Journal • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Immunology • Migraine • Mood Disorders • Pain • Psychiatry

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

Migraine-induced cochlear injury triggers ZBP1-mediated PANoptosis via CGRP signaling. (PubMed, J Headache Pain) - "We demonstrated OHCs as the key targets in CM-induced, CGRP-mediated peripheral hearing impairment. CGRP exerts its pathogenic role by triggering a cascade of intracellular stress and inflammatory pathways, ultimately leading to cell death. These findings provide a phenotypic basis for a subtype of migraine-induced hearing loss, paving the way for auditory protection strategies."

Journal • CNS Disorders • Migraine • Otorhinolaryngology • Pain • IGF2BP1 • ZBP1

Rimegepant for the Treatment of Chronic Migraine: A Multicenter, Real-World Evidence Study (ChiCTR) - P4 | N=300 | Recruiting | Sponsor: The First Affiliated Hospital of Chongqing Medical University; The First Affiliated Hospital of Chongqing Medical University

New P4 trial • CNS Disorders • Migraine • Pain

Positioning rimegepant in migraine prophylaxis: updated evidence and emerging perspectives. (PubMed, Expert Rev Neurother) - "Its role may expand through rational combinations and investigation in other headache disorders. Persistence and long-term safety require careful monitoring, and reimbursement frameworks will determine its future clinical adoption."

Journal • Review • CNS Disorders • Migraine • Pain • Preventive care

RAISE: RimegepAnt effectIvenesS and tolErability as Migraine Preventive Treatment (clinicaltrials.gov) - P=N/A | N=100 | Recruiting | Sponsor: University of Florence | Trial completion date: Jan 2026 ➔ Sep 2027 | Trial primary completion date: Jan 2025 ➔ Jan 2027

Trial completion date • Trial primary completion date • CNS Disorders • Migraine • Pain

Gepant treAtments: EffectIveNess and tolERability (GAINER) (clinicaltrials.gov) - P=N/A | N=100 | Recruiting | Sponsor: University of Florence | Trial completion date: Jun 2025 ➔ Sep 2026

Trial completion date • CNS Disorders • Migraine • Pain

Investigation of the rimegepant effect on cerebral and extracerebral arteries during migraine attacks: a longitudinal magnetic resonance angiography study. (PubMed, Brain Commun) - "Rimegepant did not induce measurable constriction of cerebral or meningeal arteries during spontaneous migraine attacks. These findings support its vascular safety and indicate that effective migraine relief with calcitonin gene-related peptide receptor antagonists does not depend on vasoconstriction, in contrast to triptan therapy."

Journal • Cardiovascular • CNS Disorders • Migraine • Pain

MONITOR: Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant (clinicaltrials.gov) - P=N/A | N=780 | Recruiting | Sponsor: Pfizer | Active, not recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Migraine • Pain

A Study to Learn About the Safety and Effects of Rimegepant to Prevent Migraine in Chinese Subjects. (clinicaltrials.gov) - P3 | N=787 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Migraine • Pain

Cluster Headache Treatment With Rimegepant (clinicaltrials.gov) - P2 | N=20 | Completed | Sponsor: Mayo Clinic | Active, not recruiting ➔ Completed | N=10 ➔ 20

Enrollment change • Trial completion • Pain

Cost of rimegepant and lasmiditan associated adverse events, for acute treatment in migraine in Spain. (PubMed, Expert Rev Pharmacoecon Outcomes Res) - "The probability of RIM saving in all analysis was 100%. In accordance with this model, the favorable safety profile of RIM compared to LAS would generate savings for the SNHS in health-care resources in all the scenarios considered."

Adverse events • Journal • CNS Disorders • 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

Real-world analysis of headache recurrence and next-day medication use following acute migraine therapy: Insights from 3 million attacks in the Migrebot e-Diary (EHF-EHC 2025) - "Gepants demonstrated the lowest rates of headache recurrence and next-day medication use (rimegepant 25.64%/16.8%, ubrogepant 30.82%/22.22% respectively) Table 1. This large-scale, real-world analysis confirms that gepants are not only effective in initial pain relief but are also superior in sustaining treatment response and preventing headache recurrence compared to non-specific analgesics, ergots and triptans. This may reflect the preventive potential of this class. The consistency of results across years strengthens the validity of these findings."

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

The efficacy of gepants in the prophylactic management of migraine: A systematic review (EHF-EHC 2025) - "PubMed and BVS were searched through March 2025 for randomized controlled trials (RCTs) evaluating rimegepant or atogepant for migraine prevention. Gepants represent a safe and effective oral option for migraine prevention, with significant reductions in attack frequency and improved patientreported outcomes. 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 • Pain

Treatment switching after first Anti-CGRP MAb failure in migraine: Gepants or another MAb? (EHF-EHC 2025) - " This retrospective observational study included patients from a tertiary Headache Unit who switched to a gepant (atogepant or rimegepant) or to a second mAb following the failure of a first mAb between May 2024 and March 2025. Switching to a gepant or another mAb after failure of a first mAb shows similar overall outcomes. However, a trend towards a higher clinical response and better tolerability was observed in the gepant group, warranting further confirmation in prospective comparative studies. Fig."

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

Vestibular migraine response to gepant dual therapy – A case report (EHF-EHC 2025) - "In this vestibular migraine patient, gepants proved to be very effective in treating both headache and vertigo. The fact that rimegepant continues to be effective as acute medication in a patient already taking 60 mg of atogepant daily for prevention, suggests that there is room for additional CGRP blockade, without, in this case, inducing sideeffects. References 1."

Case report • Clinical • CNS Disorders • Fibromyalgia • Migraine • Musculoskeletal Pain • Otorhinolaryngology • Pain • Rheumatology • Vertigo