Reyvow (lasmiditan) / Ildong, Eli Lilly, Daiichi Sankyo, Organon - LARVOL DELTA

Comparative Efficacy of Over-the-Counter versus Oral Prescription Medications for Acute Treatment of Episodic Migraine – A Meta-Analysis (PAINWeek 2025) - "Background: Oral over-the-counter (OTC) analgesics such as acetaminophen-aspirin-caffeine (AAC) and ibuprofen (IBU) are widely used as first-line treatments for episodic migraine. Recently approved oral prescription (Rx) agents including gepants (ubrogepant [UBR], rimegepant [RIM]) and a selective 5-HT1F agonist lasmiditan (LAS), offer alternative options... Thirty two studies evaluating OTC and Rx oral treatments for episodic migraine were included in the meta-analysis. All active treatments were superior to placebo across pain and associated symptom endpoints. For two-hour pain relief, the highest efficacy was observed with ibuprofen 400–600 mg (RR: up to 2.21) and AAC (RR: 1.77)."

Retrospective data • CNS Disorders • Migraine • Pain

Real-World Experience of Lasmiditan for the Acute Treatment of Migraine. (PubMed, J Clin Neurol) - "This was the first real-world study of lasmiditan in Korean patients with migraine. Although administered at a low dosage, lasmiditan was effective in approximately half of the patients. Dizziness was the most common adverse event, and it occurred at a higher rate than in clinical trials."

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

Evaluation of unmet needs and quality-of-care indicators among patients with migraine in the United States: 2021–2022 (AHS 2025) - "Following migraine QOC indicators selected based on current literature were assessed among diagnosed migraine patients: (1) migraine-related healthcare visits: emergency department (ED), urgent care, neurology, primary care, outpatient, inpatient hospitalizations in each full calendar year, and 30-day hospital readmission following the first hospitalization; (2) medication use: acute (generic [triptans, opioids, NSAIDs, ergotamines, barbiturates, and acetaminophen] and branded [Ubrogepant, Zavegepant, Lasmiditan, Rimegepant (when the first prescription is for less or equal to 8 pills)]) and preventive (oral migraine preventive medications[OMPM; anticonvulsants, antidepressants, antihypertensives, and other oral combination medications] and branded [CGRP mAbs, Botox, Atogepant, Rimegepant (when the first prescription is for >8 pills)]) migraine treatments; (3) other migraine-related diagnoses: acute medication overuse (AMO) based on medication utilization algorithm and..."

Clinical • CNS Disorders • Migraine • Pain

A retrospective cohort study comparing persistence between rimegepant and lasmiditan for the acute treatment of migraine in the US (AHS 2025) - "The rimegepant cohort was associated with a greater proportion of persistent patients compared to the lasmiditan cohort. This was seen regardless of lasmiditan index dose, chronic migraine diagnosis or prior repeated use of controlled substances. Results were robust to assumptions underlying the definition of persistence."

Retrospective data • CNS Disorders • Depression • Migraine • Pain • Psychiatry • Vascular Neurology

Real-world prescribing patterns in patients newly diagnosed with migraine in the United States from 2018 to 2021 (AHS 2025) - "Study outcomes included population demographics and clinical characteristics, utilization of acute migraine treatments (ergots, gepants, isometheptene combinations, lasmiditan, triptans), migraine-specific preventive treatments (CGRP mAbs, gepants, onabotulinumtoxin A), and other preventive treatments (beta-blockers, angiotensin converting enzyme inhibitors [ACEis], angiotensin receptor blockers [ARBs], anticonvulsants, memantine, serotonin-norepinephrine reuptake inhibitors [SNRIs], tricyclic antidepressants [TCAs]). Despite widely available migraine treatment guidelines, nearly half of patients newly diagnosed with migraine received no acute or preventive migraine prescription medications within 3 years of diagnosis. Prescribing non migraine-specific medications is common, with newer drug classes used infrequently."

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

The dual impact of ictal and interictal burden in migraine: an analysis from the ObserVational survey of the Epidemiology, tReatment, and Care Of MigrainE (OVERCOME) Japan second study. (PubMed, J Headache Pain) - "These results revealed that high interictal burden negatively affects multiple aspects of daily life in Japanese people with migraine independently of the impact of headaches."

Journal • Observational data • CNS Disorders • Migraine • Pain

Identifying Factors Associated with the Efficacy of Lasmiditan 50 mg as an Acute Treatment for Migraine Attacks Under Various Dosing Conditions in Real-World Clinical Practice. (PubMed, Neurol Int) - " Lasmiditan is likely to be effective in males with severe migraine classification and receiving CGRP-mAb treatment. If mild somnolence is a side effect, the drug can be continued and may be effective."

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

Comparative Risk of Major Adverse Cardiovascular Events among Patients who Initiate Treatment with Acute Migraine Agents (ISPOR 2025) - "Our study found that ubrogepant and rimegepant were associated with a lower risk of MACE compared to sumatriptan highlighting their potential as safer alternatives for patients with cardiovascular risk. No significant difference in MACE risk was observed between lasmiditan and sumatriptan suggesting the need for further research to better understand the cardiovascular safety profile of lasmiditan."

Adverse events • Clinical • Cardiovascular • CNS Disorders • Migraine • Myocardial Infarction • Pain

A fixed-dose combination of meloxicam and rizatriptan (Symbravo) for migraine. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • CNS Disorders • Migraine • Pain

Lasmiditan Induces Mitochondrial Biogenesis in Primary Mouse Renal Peritubular Endothelial Cells and Augments Wound Healing and Tubular Network Formation. (PubMed, Am J Physiol Cell Physiol) - "Lasmiditan treatment augmented MRPECs wound healing, endothelial tubular network formation (ETNF), enhanced barrier integrity, and blunted inflammatory-induced MV-EC dysfunctions. Together, these data suggest that lasmiditan induces MB and improves wound healing and ETNF of primary MRPECs in the presence/absence of pro-inflammatory agents, highlighting a potential therapeutic role for lasmiditan treatment in renal MV-EC dysfunction, AKI, and/or KD."

Journal • Preclinical • Acute Kidney Injury • Fibrosis • Glomerulonephritis • Immunology • Metabolic Disorders • Nephrology • Oncology • Renal Disease • TGFB1 • TNFA

Reyvow: Protection of compound patent in US/Japan until 2028 (Eli Lilly) - Annual Report 2024: Regulatory data protection in EU/Japan until 2032

Commercial • Patent • CNS Disorders • Migraine • Pain

The 5-HT1F Receptor Agonist Lasmiditan improves Cognition and Ameliorates Associated Cortico-Hippocampal Pathology in Aging Parkinsonian Mice. (PubMed, bioRxiv) - "Furthermore, in older (10-11.5 months old) mice, although the effects were milder, daily lasmiditan administration increased MB and bettered cognitive abilities. In essence, these findings indicate that repurposing lasmiditan could be a potent strategy to address PD-related cognitive decline."

Journal • Preclinical • CNS Disorders • Cognitive Disorders • Metabolic Disorders • Mood Disorders • Movement Disorders • Parkinson's Disease • Psychiatry • THY1

The impact of headache specialist density and the introduction of gepants and lasmitidan on prescriptions for acute migraine treatments: a regression and interrupted time series analysis. (PubMed, Front Neurol) - "In our interrupted time-series analysis, the introduction of the gepants and lasmiditan was linked to decreases in triptan utilization, except for eletriptan which remained stable, and rizatriptan which rose at a slower rate...Our study suggests increased headache provider availability is associated with more prescriptions for naratriptan, eletriptan, and almotriptan. Additionally, the introduction of the gepants and lasmiditan broadly decreased the utilization of triptans. Critically, there was a strong association between a pharmaceutical company's, Pfizer, payments to physicians and utilization of their medication, rimegepant."

Journal • CNS Disorders • Migraine • Pain

Lasmiditan and Different Triptans in Menstrual Migraine: A Bayesian Network Meta-analysis. (PubMed, Pain Ther) - "In terms of treatment efficacy for MM, lasmiditan was not worse than different triptans and was even better than some of the triptans in the rate of sustained freedom from pain. As an emerging treatment, lasmiditan is promising for the treatment of MM. However, more research needs to be carried out because of the lack of safety analysis for lasmiditan."

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

The Relationship Between Treatment Satisfaction and Medication Understanding Among Patients Taking a Novel Oral Pain Reliever: A Questionnaire-Based Cross-Sectional Study. (PubMed, Pain Ther) - "This study showed that a higher level of understanding of oral pain relievers is associated with higher satisfaction, which may be associated with lower discontinuation rates."

Journal • Observational data • Pain

PIONEER-PEDS1: A Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine (clinicaltrials.gov) - P3 | N=1633 | Recruiting | Sponsor: Eli Lilly and Company | Trial completion date: Jan 2025 ➔ Nov 2026 | Trial primary completion date: Jan 2025 ➔ Nov 2026

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

PIONEER-PEDS2: A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine (clinicaltrials.gov) - P3 | N=1000 | Recruiting | Sponsor: Eli Lilly and Company | Trial completion date: Mar 2026 ➔ Jan 2028 | Trial primary completion date: Mar 2026 ➔ Jan 2028

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

Abortive Treatments for Acute Migraine A Narrative Review of Lasmiditan and the Calcitonin GeneReceptor Peptide CGRP Receptor Antagonists (ASHP 2024) - No abstract available

Review • CNS Disorders • Migraine • Pain

Efficacy of lasmiditan, rimegepant and ubrogepant for acute treatment of migraine in triptan insufficient responders: systematic review and network meta-analysis. (PubMed, J Headache Pain) - "Lasmiditan, rimegepant, and ubrogepant are effective for acute treatment of migraine in triptan-insufficient responders, with high-dose lasmiditan showing the highest efficacy for pain control."

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

The FDA-Approved Drug Lasmiditan Augments Primary Mouse Renal Peritubular Endothelial Cell Wound Healing and Angiogenic Capacity (KIDNEY WEEK 2024) - "Together, these data reveal that lasmiditan augments MRPEC wound healing and angiogenic capacity, independently and in response to TNFα-induced cellular injury, suggesting a potential role for lasmiditan treatment in promoting vascular recovery post-kidney injury."

Preclinical • Acute Kidney Injury • Chronic Kidney Disease • Metabolic Disorders • Nephrology • Oncology • Renal Disease

Assessment of the 5HT1F receptor agonist, Lasmiditan, in Parkinsonian mice at early and advanced stages (Neuroscience 2024) - "We are currently analyzing 10-11.5 months old mice treated either daily or every other day with 1 mg/kg, IP Lasmiditan. and also correlating the behavioral phenotypes of individual mice with the cellular and molecular data."

Metastases • Preclinical • CNS Disorders • Mood Disorders • Parkinson's Disease • Psychiatry • TFAM • THY1

5-Hydroxytryptamine 1F Receptor Agonist Lasmiditan Differentially Regulates Successful Repair and Failed Repair Genes in a Mouse Model of Acute Kidney Injury. (PubMed, ACS Pharmacol Transl Sci) - "While 6 days of lasmiditan treatment had no effect on failed repair genes, the administration of lasmiditan for 12 days decreased the levels of vascular cell adhesion protein 1, tumor necrosis factor α, and interleukin-1β, which drive maladaptive repair. These data reveal that lasmiditan treatment post-AKI differentially regulates successful and failed repair gene expression in the renal cortex, likely contributing to the restoration of renal function and providing a potential targeted therapeutic pathway for the treatment of AKI."

Journal • Preclinical • Acute Kidney Injury • Cardiovascular • Chronic Kidney Disease • Dyslipidemia • Fibrosis • Immunology • Metabolic Disorders • Nephrology • Oncology • Renal Disease • Reperfusion Injury • IL1B • SLC5A1 • TNFA

Reyvow: Newly added patent in Orange Book (Orange Book) - Expiry of patent on Jul 6, 2040

Patent • Migraine

Comparative effects of drug interventions for the acute management of migraine episodes in adults: systematic review and network meta-analysis. (PubMed, BMJ) - "Overall, eletriptan, rizatriptan, sumatriptan, and zolmitriptan had the best profiles and they were more efficacious than the recently marketed drugs lasmiditan, rimegepant, and ubrogepant. Although cost effectiveness analyses are warranted and careful consideration should be given to patients with a high risk cardiovascular profile, the most effective triptans should be considered as preferred acute treatment for migraine and included in the WHO List of Essential Medicines to promote global accessibility and uniform standards of care."

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

Acute and preventive treatment of menstrual migraine: a meta-analysis. (PubMed, J Headache Pain) - "Sumatriptan and lasmiditan are effective first-line treatments for acute MM. For prevention, frovatriptan may be the more effective of triptans. Compared with triptans, CGRP monoclonal antibodies, here including erenumab and galcanezumab, are more effective in reducing headache days, and therefore, in preventing MM."

Journal • Retrospective data • CNS Disorders • Migraine • Pain