Ubrelvy (ubrogepant) / Merck (MSD), AbbVie - LARVOL DELTA

Gepants: targeting the CGRP pathway for migraine relief. (PubMed, Front Pharmacol) - "Several new agents (atogepant, ubrogepant, rimegepant, and zavegepant) expand therapeutic options beyond traditional triptans and monoclonal antibodies. Gepants represent a valuable advancement in migraine therapy, offering effective acute and preventive options with favorable tolerability, particularly for patients who cannot use triptans or who have cardiovascular risk factors. Ongoing studies will clarify long-term safety, real-world effectiveness, and potential roles in combination or sequential therapy."

Journal • Review • Cardiovascular • CNS Disorders • Fatigue • 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. The consistency of results across years strengthens the validity of these findings. Digital diary data provides crucial insights into long-term treatment performance, directly informing clinical practice for improved migraine management."

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

Ubrogepant utilization during prodrome: A case report (EHF-EHC 2025) - "The success the patient demonstrated with administering ubrogepant at prodrome underscores the importance of the timing of acute treatment for migraine. Educating patients on prodrome symptoms and the potential benefits of treating migraine episodes before headache onset may be a path to reducing or preventing disability and improving patients" quality of life."

Case report • Clinical • CNS Disorders • Migraine • Musculoskeletal Pain

Evaluation of the safety and efficacy of ubrogepant in the acute treatment of migraine in patients also taking CGRP-targeting monoclonal antibodies (EHF-EHC 2025) - "Ubrogepant maintains comparable efficacy and safety profiles regardless of concurrent CGRP mAb use. These findings support its role as an acute migraine treatment for patients already on preventive CGRP mAb therapy."

Clinical • CNS Disorders • Migraine • Pain

Real-world patient satisfaction and effectiveness of ubrogepant and atogepant for migraine in Israel: Interim analysis of COBRA study (EHF-EHC 2025) - P | "In this real-world study , UBRO for acute therapy and ATO for prevention of migraine demonstrated patient satisfaction and effectiveness. Acknowledgements AbbVie and the authors would like to thank the study coordinators who participated in the study: Tal Maya, Li-Bareket Kisler, Liora Catane, Janet Ben-Mordechay, Yara sfadi, Mor Aharon, Almog Edry, Marciano Sara and Zipi Hybloom."

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

Cost-effectiveness analysis of ubrogepant, rimegepant, and zavegepant for acute migraine treatment vs usual care. (PubMed, Am J Manag Care) - "Ubrogepant, rimegepant, and zavegepant are not cost-effective options for acute migraine treatment but may be appropriate for patients experiencing 2 or fewer migraines per month. If a gepant is to be prescribed, rimegepant is the most cost-effective option of the 3."

Clinical • HEOR • Journal • CNS Disorders • Migraine • Pain

Patient-centered outcomes in the acute treatment of migraine: a prospective, real-world, longitudinal survey study (UNIVERSE II) comparing migraine patients who switch from a prior triptan to another triptan or ubrogepant. (PubMed, Pain Manag) - "The ubrogepant cohort was more likely to prefer their new treatment to their prior triptan (75.7% vs 63.0%; adjusted OR = 1.93; [95% CI, 1.05-3.59]; p = 0.035) and reported better meaningful relief at 2 hours compared to prior triptan (75.7% vs 59.0%; adjusted OR = 2.30; [95% CI, 1.26-4.27]; p = 0.007). This real-world study demonstrated people with migraine who switched from a triptan to ubrogepant reported better outcomes than those who switched to a different triptan."

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

Cost-Effectiveness Analysis of Ubrogepant, Rimegepant, and Zavegepant for Acute Migraine Treatment vs Usual Care (AJMC) - "None of the gepants were cost-effective at willingness-to-pay thresholds of $50,000, $100,000, or $150,000 per QALY. Among the 3 gepants, rimegepant was the most cost-effective option; it had an incremental cost-effectiveness ratio of $93,700.20 per QALY compared with ubrogepant and was both less costly and more effective than zavegepant."

HEOR • Migraine

Ubrelvy: Newly added patents in Orange Book (Orange Book) - Expiry on Jan 30, 2035

Patent • Migraine

Global net revenues from the neuroscience portfolio were $2.841 billion... (PRNewswire) - "Global Botox Therapeutic net revenues were $985 million, an increase of 16.1 percent on a reported basis, or 15.8 percent on an operational basis; Global Ubrelvy net revenues were $354 million, an increase of 31.5 percent; Global Qulipta net revenues were $288 million, an increase of 64.1 percent on a reported basis, or 63.1 percent on an operational basis."

Sales • Migraine

Computational chemistry-based structure-guiding engineering of ω-transaminases to enhance catalytic activity and enantioselectivity toward bulky ketones. (PubMed, Int J Biol Macromol) - "Ubrogepant is a clinically approved migraine drug, and the precise enantioselective synthesis of Ubrogepant Chiral Intermediate (UCI) is critical for its efficacy...Furthermore, M12 was assayed for its optimal reaction conditions, and under optimal conditions, M12's performance was improved markedly, yielding >99 % conversion rate and a 4.43-fold increase of Kcat value relative to its baseline. Generally, this strategy was proved to be highly effective for engineering high-performance ω-TA, holding great potential for rational enzyme design."

Journal • CNS Disorders • Migraine • Pain

A Trial Investigating Lu AG09222 With Ubrogepant in Participants With Migraine (clinicaltrials.gov) - P1 | N=43 | Completed | Sponsor: H. Lundbeck A/S | Recruiting ➔ Completed

Trial completion • CNS Disorders • Migraine • Pain

Early Experience Treating Vestibular Migraine with Small Molecule CGRP Antagonists (AAO-HNSF 2025) - "The gepants used included ubrogepant, rimegepant, atogepant, and zavegepant. Gepants can be effective medications for the treatment of vestibular migraine."

CNS Disorders • Migraine • Otorhinolaryngology • Pain • Vertigo

Migraine Medication Effects on Urinary Symptoms (clinicaltrials.gov) - P=N/A | N=200 | Enrolling by invitation | Sponsor: The Cleveland Clinic | Trial completion date: May 2026 ➔ Dec 2026 | Trial primary completion date: May 2025 ➔ May 2026

Trial completion date • Trial primary completion date • CNS Disorders • Interstitial Cystitis • Migraine • Musculoskeletal Pain • Overactive Bladder • Pain

Safety and Efficacy of Ubrogepant in the Acute Treatment of Migraine in Patients also Taking CGRP-Targeting Monoclonal Antibodies (IHC 2025) - "These findings support its role as an acute migraine treatment for patients already on preventive CGRP mAb therapy. Future studies should explore long-term outcomes and potential interactions between these treatments."

Clinical • CNS Disorders • Migraine

Trends in triptan, CGRP monoclonal antibody and gepant prescription rates in a large healthcare system in Boston, MA, USA from 2018-2024 (IHC 2025) - "Objective This study aims to describe triptan and CGRP inhibitor prescription rates by patient demographics in the Mass General Brigham Health System from 2018-2024 Methods We used electronic health record data from the Mass General Brigham Research Data Registry (RPDR) to identify patients 18 years or older with a migraine diagnosis (ICD-10 G43) and prescribed a triptan, CGRP monoclonal antibody (erenumab, galcanezumab, fremanezumab, eptinezumab) or gepant (ubrogepant, rimegepant, or atogepant) from May 1, 2018 and November 1, 2024. Conclusion Overall, there was an increase in the prescription rates for triptans, gepants and CGRP mABs in each demographic group from 2018-2024, although disparities were noted. Future analyses will investigate whether medical comorbidities and access to specialty clinics influence prescription rates."

Migraine

Evaluation of the Effect of Anti-CGRP medications on Blood Pressure: Review of FDA documents (IHC 2025) - "CGRP-targeting monoclonal antibodies (mAbs), including eptinezumab, fremanezumab, galcanezumab and erenumab, and gepants, which are small molecule CGRP receptor antagonists such as rimegepant, ubrogepant and zavagepant, have shown significant efficacy in reducing migraine frequency and severity. BP monitoring remains advisable in patients with hypertension or cardiovascular risk. Long- term studies in high-risk populations are needed to confirm real-world safety."

Review • Migraine

Quantifying Placebo Response in Randomized Phase 2 and 3 Trials of Anti-CGRP Targeting Therapies for the Acute Treatment of Migraine: A Systematic Review and Meta-Analysis (IHC 2025) - "Subgroup analysis by drug type showed response rates of 47.5% for rimegepant, 51.4% for zavegepant, and 48.1% for ubrogepant. Limitations in the number and heterogeneity of trials by site, intervention assignment, and phase restricted further analysis. Further high-quality RCTs are needed to better assess contextual contributors to placebo response."

P2 data • Retrospective data • Review • CNS Disorders • Migraine

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-HT 1F 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

Pharmacological characterization of ubrogepant and atogepant in cAMP assays at human, rat, and mouse calcitonin family receptors in transfected cells. (PubMed, Biochem Pharmacol) - "Collectively, our data show that while these compounds are most potent at the CGRP receptor, they have activity at other receptors from the calcitonin receptor family, and this activity differs between species. Our data provide a framework for understanding the activity of ubrogepant and atogepant in rat, mouse and human studies."

Journal • Preclinical • CNS Disorders • Migraine • Pain • ADM

The binding mechanism of Covalent Organic Frameworks (COFs) to Calcitonin Gene-Related Peptide Receptors (CGRPRs). (PubMed, Int J Biol Macromol) - "To assess the efficacy and inhibitory effects of COF structures on the CLR/RAMP1 complex, two antimigraine drugs, ubrogepant and rimegepant, were used as controls. However, further investigation is necessary to explore a broad range of COF structures that can be investigated initially at the molecular and mathematical scales. Thereafter, the selected COFs may undergo further evaluation, such as laboratory feasibility tests, in vitro or in vivo studies."

Journal • CNS Disorders • Migraine • Pain • CALCRL

Long-term Extension Study to Assess Safety and Tolerability of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Pediatric Participants (Ages 6-17) (clinicaltrials.gov) - P3 | N=1200 | Enrolling by invitation | Sponsor: AbbVie | Trial completion date: May 2027 ➔ Jan 2028 | Trial primary completion date: May 2027 ➔ Jan 2028

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

AbbVie Beats on Q2 Earnings & Sales, Stock Up on Raised '25 EPS View (Yahoo Finance) - "Sales from the neuroscience portfolio increased 24% to $2.68 billion, driven by higher sales of Botox Therapeutic, depression drug Vraylar and migraine drugs Ubrelvy and Qulipta. Neuroscience sales beat the Zacks Consensus Estimate and our model estimate of $2.47 billion and $2.48 billion, respectively. While Botox Therapeutic sales rose 14.2% to $928 million, sales of Vraylar increased 16.3% to $900 million. Sales of Ubrelvy totaled $338 million, up 47.2%. Qulipta sales increased 76.9% to $267 million. Sales of Vyalev, the recently approved transformative therapy for advanced Parkinson’s disease, totaled $98 million, compared with $63 million in the first quarter."

Sales • Depression • Migraine • Pain • Parkinson's Disease

Situational Prevention of Migraine Attacks: Can Early Treatment Change the Conversation? (PubMed, Drugs) - "A study of ubrogepant used during prodrome showed improved prodrome symptoms and reduced the chances of proceeding to the headache phase of migraine compared with placebo...In this article, we discuss the data available on treating migraine attacks early, both during prodrome phase and for the situational prevention of migraine during predictable triggers. Further clinical and real-world data are needed to continue to explore this concept and provide better management options for patients."

Journal • Review • CNS Disorders • Fatigue • Migraine • Musculoskeletal Pain • Pain

Ubrelvy: Newly added patent in Orange Book (Orange Book) - Expiry on Jan 30, 2035

Patent • Migraine