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

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

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

Lasmiditan ameliorates serotonergic itch in mice: Possible involvement of 5-HT1F receptors. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "Further, the levels of TLR-4, IL-31, CGRP & TRPV4 were substantially reduced upon the administration of Lasmiditan (1 mg/kg). We found that Lasmiditan is effective in reducing serotonergic itch in mice through its interaction with the 5-HT1F receptor in the skin tissue of mice."

Journal • Preclinical • CNS Disorders • Dermatology • Migraine • Pain • Pruritus • TLR4

Effectiveness and tolerability of lasmiditan as acute migraine treatment (DART): a real-world multicentric Italian study (EAN 2024) - P | "Our real-world data support lasmiditan effectiveness in the acute treatment of migraine. Adverse events were reported in 53.1% of attacks."

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

Real-world effectiveness and tolerability of Lasmiditan: A prospective multicentric cohort study (EAN 2024) - No abstract available

Clinical • Real-world • Real-world effectiveness • Real-world evidence • CNS Disorders • Epilepsy • Pain

Which combination of comorbidity makes migraine treatment impossible? A graphical approach (AHS 2024) - "For example, the medication sumatriptan and ergotamine are both nodes in this graph...There is no contra-indication to memantine, galcanezumab, fremanezumab, eptinezumab, rimegepant, and ubrogepant except for allergic reaction to the medication and pregnancy...However, assuming the failure of the CGRP antagonists, lasmiditan, and memantine, then the minimum number of comorbidities that makes picking an abortive medication impossible is 9...The inclusion of uncontrolled hypertension is only applicable if the relative contraindication for erenumab in hypertension is included... Our study seeks to elucidate the landscape of medical comorbidities influencing the selection of migraine prevention and abortive medications. Despite the diverse comorbidities considered, no combination of abortive or prevention medications was found to be entirely contraindicated for migraine patients. However, cardiac comorbidities such as uncontrolled hypertension or hypotension, prior coronary..."

CNS Disorders • Epilepsy • Migraine • Myasthenia Gravis • Pain

Efficacy of Lasmiditan as a Secondary Treatment for Migraine Attacks after Unsuccessful Treatment with a Triptan. (PubMed, Neurol Int) - "The AEs associated with this treatment strategy were mild and lasted for a short time. This study suggested that the combination of triptan and lasmiditan is promising for the treatment of migraine and should be studied in a randomized placebo-controlled trial."

Journal • CNS Disorders • Migraine • Pain

Safety profile of lasmiditan: a retrospective post-marketing pharmacovigilance study based on the real-world data of FAERS database. (PubMed, Expert Opin Drug Saf) - "The importance of heightened clinical vigilance regarding paresthesia in females and dizziness in males was underscored. Additionally, it is advised to administer a lower initial dose for elderly patients."

Adverse events • Journal • P4 data • Real-world • Real-world evidence • Retrospective data • Cardiovascular • CNS Disorders • Migraine • Pain

Efficacy of lasmiditan used as a secondary treatment for migraine attacks after unsuccessful treatment with a triptan (AHS 2024) - "Based on the results obtained, we would recommend a step care treatment, consisting of initial triptan followed by lasmiditan if needed, for treating the symptoms of migraines."

Clinical • CNS Disorders • Migraine • Pain

Acute Therapy of Migraine: What is new? (PubMed, Fortschr Neurol Psychiatr) - "Four triptans are now available over-the-counter in Germany which has a major influence on self-medication. The main new introduction was the 5HT1F-agonist lasmiditan as an alternative to triptans."

Journal • CNS Disorders • Migraine • Pain