Zavzpret (zavegepant nasal spray) / Pfizer - LARVOL DELTA

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

Real-World Data Highlight Patient-Reported Benefits of Intranasal Zavegepant for Acute Migraine (NeurologyLive) - "In a real-world study conducted at the Cleveland Clinic, patients using 10-mg intranasal zavegepant (Zavzpret; Pfizer) for acute migraine reported meaningful pain relief, improved daily functioning, and high willingness to reuse the therapy through the validated migraine treatment optimization questionnaire-5 (MTOQ-5)....Presented at the 2025 American Headache Society (AHS) Annual Meeting, lead author Eric Dunn, DO, a neurologist at Cleveland Clinic, and colleagues evaluated patient-reported outcomes of individuals using 10-mg intranasal zavegepant for acute migraine treatment. Overall, the drug exemplified encouraging results, including benefits on pain relief, functional improvement, and a high willingness to reuse....As for acute efficacy, 45.0% of patients reported achieving complete pain relief within 2 hours of treatment at least half the time, 28.3% reported this benefit less than half the time, and 26.7% never achieved pain relief within that timeframe."

Real-world • Real-world evidence • Migraine

Adverse events associated with gepants: a pharmacovigilance analysis based on the FDA adverse event reporting system. (PubMed, J Headache Pain) - "The present pharmacovigilance study systematically revealed the significant risk signals of gepants. The common AEs and unique AEs of the four gepants were also identified and explored. Our results would provide valuable reference for the safe use of gepants, guiding personalized drug selection in clinical practice."

Adverse events • Journal • CNS Disorders • Constipation • Fatigue • Gastroenterology • Gastrointestinal Disorder • 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 phase 1 study of the breast milk and plasma pharmacokinetics of zavegepant 10 mg intranasal dose in healthy lactating women (AHS 2025) - "A single intranasal dose of 10 mg zavegepant is generally safe and well tolerated in healthy lactating women and the estimated infant exposure to zavegepant via breast milk is very low."

Clinical • P1 data • PK/PD data • CNS Disorders • Migraine • Pain

Long-term safety and tolerability of zavegepant 10 mg nasal spray by dosing frequency: Post-hoc analysis of a phase 2/3 open-label study (AHS 2025) - P2/3 | "Zavegepant displayed a similar safety profile in individuals with migraine who administered <2, 2 to <4, or ≥4 sprays/month over a period of 52 weeks, with a majority in each subgroup reporting a reduction in mean MMDs."

Clinical • P2/3 data • Retrospective data • Back Pain • CNS Disorders • Migraine • Musculoskeletal Pain • Pain

Real-world outcomes of zavegepant use in a tertiary care setting using migraine treatment optimization questionnaire-5 (MTOQ-5) (AHS 2025) - "Although a phase 3 clinical trial demonstrated the efficacy, favorable tolerability, and safety of zavegepant, further investigations are necessary to establish its long-term safety and consistency of effect. This study represents the first retrospective, real-world patient-reported outcome study on the use of zavegepant using the validated MTOQ-5. Our data implies that zavegepant is a strong option among the CGRP class for acute therapy with a quick onset of efficacy and improvement in pain and MBS."

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

A Pharmacokinetic Study of Zavegepant Nasal Spray in Healthy Adults Comparing Conventional Venous Blood Sampling With Patient-Centric Microsampling. (PubMed, Clin Transl Sci) - P1 | "For Tasso-Plus versus venous phlebotomy, 39 of 41 (95.1%) data pairs met concentration correlation criteria (difference within 20% of the mean), median zavegepant concentration-time profiles were comparable, and 90% confidence intervals for geometric mean ratios for AUClast and Cmax were wholly within the range of bioequivalence acceptance (80%-125%). The results of this study confirm that it is feasible to use serum derived from Tasso-Plus collection of whole capillary blood as a reliable PCS approach for PK analysis of zavegepant."

Journal • PK/PD data

A Study to Learn About the Study Medicine Called Zavegepant (PF-07930207) in Children With a History of Migraine (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Migraine • Pain

A Study to Learn About Zavegepant as the Acute Treatment of Migraine in Asian Adults (clinicaltrials.gov) - P3 | N=1414 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Migraine • Pain

Expert consensus on gepants for acute and preventive treatment of migraine in Thailand. (PubMed, J Headache Pain) - No abstract available

Journal • Review • CNS Disorders • Migraine • Pain

Clinical evaluation of zavegepant for the acute treatment of migraine. (PubMed, J Manag Care Spec Pharm) - "This review was prepared by the University of Connecticut School of Pharmacy Academy of Managed Care Pharmacy (AMCP) Student Chapter. The student author group won the AMCP National Pharmacy and Therapeutics competition for their zavegepant product review in March 2024."

Journal • Review • CNS Disorders • Migraine • Pain

A Study to Learn About the Study Medicine Called Zavegepant (PF-07930207) in Children With a History of Migraine (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Pfizer

New P1 trial • CNS Disorders • Migraine • Pain

Long-term safety and tolerability of zavegepant 10-mg nasal spray with concomitant use of anti-calcitonin gene-related peptide monoclonal antibodies or other select preventive migraine medications: Results from a phase 2/3 open-label study. (PubMed, Headache) - "Self-administration of ZAV 10-mg nasal spray for the acute treatment of migraine up to 8 times/month for up to 52 weeks appeared well-tolerated irrespective of concomitant use of CGRP mAbs or OSPs."

Journal • P2/3 data • Back Pain • Cardiovascular • CNS Disorders • Infectious Disease • Migraine • Musculoskeletal Pain • Novel Coronavirus Disease • Pain

Cost-effectiveness Analysis of Zavegepant in Acute Migraine Treatment (ISPOR 2025) - "Zavegepant is cost-effective compared with rimegepant for the acute treatment of migraine under the threshold of $100,000 per QALY gained."

Cost effectiveness • HEOR • CNS Disorders • Migraine • Pain

Head-to-head relief: ubrogepant, rimegepant, and zavegepant in migraine treatment. (PubMed, Pain Manag) - "The NNT values for achieving pain freedom at two hours were 9 for rimegepant, 11 for zavegepant, and 12 for ubrogepant, which are comparable to NSAIDs such as naproxen (NNT = 11). Triptans demonstrated lower NNTs, indicating higher efficacy. Gepants offer effective, well-tolerated alternatives with no significant cardiovascular risk and minimal potential for medication-overuse headache."

Head-to-Head • Journal • Review • Cardiovascular • CNS Disorders • Migraine • Pain

A Study to Learn About Zavegepant as the Acute Treatment of Migraine in Asian Adults (clinicaltrials.gov) - P3 | N=1238 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Migraine • Pain

The efficacy and safety of zavegepant nasal inhalation versus oral calcitonin-gene related peptide receptor antagonists in the acute treatment of migraine: a systematic review and network meta-analysis of the literature. (PubMed, J Headache Pain) - "Zavegepant 10 mg can quickly relieve symptoms and has no significant difference in safety compared with oral drugs, which can provide rapid and safe efficacy in the acute treatment of migraine. However, compared with other oral CGRP receptor antagonists, zavegepant 10 mg by nasal inhalation has no obvious advantage in long-term symptom relief rate."

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

Comparative Efficacy of AXS-07 vs. Gepants for Acute Treatment of Migraine: A Network Meta-Analysis (AAN 2025) - "The NMA favors AXS-07 over rimegepant, ubrogepant, and zavegepant for acute migraine. AXS-07 is particularly effective in achieving 2-hour and 2-24 hour sustained pain freedom, offering a promising therapeutic alternative for patients with inadequate response to prior treatments."

Retrospective data • CNS Disorders • Migraine • Pain

Health Technology Assessment: Evaluation of 8 CGRP-Targeted Therapy Drugs for the Treatment of Migraine. (PubMed, Drug Des Devel Ther) - "The final assessment result scores from highest to lowest were rimegepant (84.5 points), erenumab (75.78 points), galcanezumab (74.02 points), fremanezumab (73.93 points), atogepant (72.64 points), eptinezumab (71.69 points), ubrogepant (70.37 points), zavegepant (56.44 points). Rimegepant, erenumab, fremanezumab, atogepant, galcanezumab, eptinezumab, ubrogepant can be entered into the medication list of medical institutions as strongly recommended drugs."

Journal • Review • CNS Disorders • Migraine • Pain

Deconvoluting zavegepant drug-drug interactions: A phase I study to evaluate the effects of rifampin and itraconazole on zavegepant pharmacokinetics. (PubMed, Clin Transl Sci) - "This Phase I, open-label, fixed-sequence study evaluated the effects of itraconazole (a strong cytochrome P450 3A4 [CYP3A4] and P-glycoprotein [P-gp] inhibitor) on the pharmacokinetics of intranasal/oral zavegepant and the effects of rifampin (a strong inducer of CYP3A4 and P-gp; and an inhibitor of organic anion transporting polypeptide 1B3 [OATP1B3]) on oral zavegepant in healthy participants. These results suggest that OATP1B3 and intestinal P-gp are the more prominent pathways, as opposed to CYP3A4, for a zavegepant drug-drug interaction. Coadministration of OATP1B3 inhibitors with zavegepant nasal spray should be avoided."

Journal • P1 data • PK/PD data • CNS Disorders • Migraine • Pain • CYP3A4

Effects of multiple-dose administration of zavegepant nasal spray on the single-dose pharmacokinetics of ethinyl estradiol-levonorgestrel. (PubMed, Headache) - "Co-administration of zavegepant nasal spray with a single dose of an oral contraceptive resulted in no clinically meaningful changes (<12% increase) in EE-LNG exposure."

Journal • PK/PD data • CNS Disorders • Migraine • Pain

Sex/Gender Equity Considerations in Clinical Trials of Gepants for Migraine: A Systematic Review (ISPOR-EU 2024) - " We identified 17 unique trials of the following: rimegepant (6 RCTs), atogepant (5 RCTs), ubrogepant (4 RCTs), and zavegepant (2 RCTs). Despite the well-established gendered nature of disease and high proportions of women recruited, gepants trials for migraine did not appear to fulfil sex/gender health equity considerations in study design, conduct, analysis, and reporting. This oversight may affect the health technology assessment process leading to potential biases and inequities in healthcare recommendations and policies."

Clinical • Review • CNS Disorders • Migraine • Pain

Population pharmacokinetic modeling of zavegepant, a calcitonin gene-related peptide receptor antagonist, in healthy adults and patients with migraine. (PubMed, CPT Pharmacometrics Syst Pharmacol) - "Age (range 18-71 years), race, ethnicity, sex, renal function, and co-administration of oral contraceptives or sumatriptan did not significantly change zavegepant pharmacokinetics. Moderate hepatic impairment (Child-Pugh score 7-9) or co-administration of rifampin decreased elimination clearance of oral zavegepant by ~40%. The zavegepant population pharmacokinetic model adequately characterized zavegepant concentration-time profiles, the bioavailability of intranasal and oral zavegepant, as well as the effect of intrinsic and extrinsic factors on zavegepant pharmacokinetics."

Journal • PK/PD data • CNS Disorders • Hepatology • Migraine • Pain

Implications of trinodal inhibitions and drug repurposing in MAPK pathway: A putative remedy for breast cancer. (PubMed, Comput Biol Chem) - "Additionally, a total of 1867 repurposed analgesic, antibiotic, and antiparasitic drugs, including Zavegepant (-13.399 kcal/mol for PDPK1), Adozelesin (-11.74 kcal/mol for mTOR) and Modoflaner (-11.29 kcal/mol for PDPK1), showed promising binding energetics while targeting our triad points than other compounds used. This approach prompts for mitigating not only breast cancer but other elusive diseases as well, with state-of-the-art multitargeted therapies coupled with bioinformatic strategies."

Journal • Breast Cancer • Oncology • Pain • Solid Tumor • mTOR • PDPK1