Approval Probability
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Label indication ZAVZPRET is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use ZAVZPRET is not indicated for the preventive treatment of migraine. ZAVZPRET is a calcitonin gene-related peptide receptor antagonist indicated for the acute treatment of migraine with or without aura in adults. ( 1 ) Limitations of Use ZAVZPRET is not indicated for the preventive treatment of migraine. ( 1 ) FDA label
Also known as Zavegepant (BHV-3500), BHV3500
Zavegepant · 6 trials · 4 indications
Pain freedom was defined as pain intensity being none at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe).
MBS was selected from nausea, phonophobia or photophobia before dosing by the participants. In this outcome measure, percentage of participants who recorded an MBS (present) before dosing and did not have the MBS (absent) at the time of evaluation (i.e., 2 hours post-dose) were reported.
Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the electronic clinical outcome assessment (eCOA) handheld device. Pain freedom was defined as pain level of none post-dose.
Minimal pain is defined as 0 or 1 on the 0-4 numerical rating scale.
An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in participants or clinical investigation participants administered an investigational (medicinal) product that does not necessarily have a causal relationship with this treatment. An SAE was defined as any event that met any of the following criteria at any dose: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received study drug; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the other serious outcomes.
Clinically significant laboratory abnormalities were defined as Grades 3 to 4 laboratory test results according to numeric laboratory test criteria found in Common Technical Criteria for Adverse Events Version 5.0 (2017) if available; otherwise, according to Division of Acquired Immune Deficiency Syndrome. Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1 (2017) for glucose, low-density lipoprotein (LDL)-cholesterol, uric acid, and urinalysis. Laboratory test groups of clinical interest included hematology, serum chemistry, and urinalysis. Participants must have had a non-missing measurement in to be included for a given parameter. Laboratory results were presented in US units.
Cmax is defined as the maximum observed plasma concentration of zavegepant after administration of a single dose
Tmax is defined as the time to reach maximum observed plasma concentration
AUC (0 - inf) is defined as area under the concentration-time curve from time 0 to infinity.
| Arm | Type | Description |
|---|---|---|
| Zavegepant | EXPERIMENTAL | Zavegepant intranasal 10 mg |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Zavegepant (BHV-3500) | EXPERIMENTAL | 10 mg intranasal (IN) up to 8 times per month, up to 1 year |
| Zavegepant 5 mg | EXPERIMENTAL | Participants administered a single intranasal dose of zavegepant 5 mg on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization. The dose was administered using Aptar Unidose System (UDS) liquid spray device. |
| Zavegepant 10 mg | EXPERIMENTAL | Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization. The dose was administered using Aptar UDS liquid spray device. |
| Zavegepant 20 mg | EXPERIMENTAL | Participants administered a single intranasal dose of zavegepant 20 mg on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization. The dose was administered using Aptar UDS liquid spray device. |
| Name | Type | Description |
|---|---|---|
| Zavegepant | DRUG | The participants will receive single active dose sufficient to treat 1 migraine headache of moderate or severe intensity within Treatment Phase. |
| Placebo | DRUG | Single dose of matching placebo taken within Treatment Phase. |
| Zavegepant 20 mg | DRUG | Participants will administer zavegepant 10 mg twice in quick succession (once into the left nostril, once into the right nostril, for a total of 20mg) to treat up to 3 separate cluster headache attacks maintaining a minimum interval of 48 hours between administrations. |
| Zavegepant (BHV-3500) | DRUG | 10 mg IN up to 8 times per month, up to 1 year |
| Zavegepant matching placebo | DRUG | A single dose of placebo matched to zavegepant |
| Intranasal Aptar Pharma Unit Dose System | DEVICE | A single-dose intranasal device |
Inclusion Criteria: * Asian participants aged 18 years or older at screening. * Participants with minimum 1 year history of migraine (with or without aura) prior to the Screening Visit, consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, inc...
Top 5 of 8 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 13 | PHASE3 | Atogepant, Ubrogepant, MEDI0618 |
| Pfizer Inc. | PFE | 11 | PHASE3 | Rimegepant, Zavegepant |
| Eli Lilly and Company | LLY | 2 | PHASE3 | Galcanezumab |
| Amgen Inc. | AMGN | 2 | PHASE3 | Erenumab |
| Evommune, Inc. | EVMN | 1 | PHASE2 | EVO756 |
Zavegepant is being developed for the acute treatment of migraine and for cluster headache. It is a small molecule studied in adults and, in one pediatric trial, in children with a history of migraine. It is given intranasally.
Zavegepant targets CALCRL and RAMP1, which together form the CGRP receptor. It acts as an antagonist at this receptor. Blocking the CGRP receptor is the mechanism studied for acute migraine treatment.
Zavegepant is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor of the clinical trials listed for the drug.
Zavegepant is in Phase 2 development overall, with individual trials spanning Phase 1 through Phase 3. It is investigational and is not approved. Completed studies include two Phase 3 trials in migraine, and an active Phase 1 pediatric trial is recruiting.
Zavegepant trials include NCT07714369, a Phase 2 intranasal study in episodic cluster headache that is not yet recruiting, and NCT06995729, a recruiting Phase 1 study in children with a history of migraine. Completed trials are NCT05989048 in Asian adults and NCT04571060 in adults with acute migraine.
Yes, BHV-3500 is an alternative name for zavegepant. Other names used for the same compound include Zavegepant 10 mg, Zavegepant 20 mg, Zavegepant IN, and Zavegepant 10 mg IN, where IN refers to the intranasal formulation.