Zavegepant for Asthma

No longer recruiting at 14 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Biohaven Pharmaceuticals, Inc.

Compensation: Varies

Number of Visits: 2

Duration: 28 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, Zavegepant, to determine its effectiveness for asthma. Participants will randomly receive either the active drug or a placebo, a pill resembling the drug but without active ingredients. The trial aims to assess whether Zavegepant is safe and effective in reducing asthma symptoms compared to the placebo. It is suitable for individuals with asthma who frequently experience symptoms impacting their daily life. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that zavegepant is generally well tolerated, with most participants experiencing only mild or moderate side effects. Importantly, studies have found that zavegepant does not cause drowsiness or tiredness, common concerns with many treatments. Tested for migraines, it proved safe for adults. While typically used for migraines, the data provides some confidence about its overall safety. However, this trial is in an early stage, primarily focusing on assessing safety in humans. More research is needed to fully understand its safety for treating asthma. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for asthma?

Zavegepant is unique because it offers a new approach to treating asthma by targeting the calcitonin gene-related peptide (CGRP) pathway, which is different from traditional treatments like inhaled corticosteroids or beta-agonists. This novel mechanism may help reduce inflammation and improve breathing with fewer side effects often associated with current therapies. Researchers are excited about Zavegepant as it could provide a more effective and safer alternative for asthma management, potentially transforming the standard of care for patients struggling with this condition.

What evidence suggests that this trial's treatments could be effective for asthma?

Research has shown that Zavegepant, which participants in this trial may receive, effectively treats migraines, providing significant relief from pain and other symptoms. Studies have found that Zavegepant nasal spray works better than a placebo, offering quick pain relief. While these studies focus on migraines, the results suggest Zavegepant might also help with other inflammatory conditions, such as asthma. The drug blocks certain pathways that cause inflammation and pain. Although specific data for asthma is not yet available, the positive results for migraines suggest Zavegepant could potentially alleviate asthma symptoms. ^{6 7 8 9 10}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

Inclusion Criteria

You have asthma.

Exclusion Criteria

I'm sorry, it seems that the criterion is missing. Could you please provide more information?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Zavegepant 150 mg BID or matching placebo

28 days

Daily administration

Allergen Challenge

Allergen inhalation challenge performed to assess asthmatic response

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

13 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Zavegepant

How Is the Trial Designed?

Group I: BHV3500 Experimental Treatment 1 Intervention

Zavegepant 150 mg BID

Group II: Placebo Placebo Group 1 Intervention

Matching placebo 150 mg BID

Who Is Running the Clinical Trial?

Biohaven Pharmaceuticals, Inc.

Lead Sponsor

Trials

49

Recruited

30,100+

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

Zavegepant, a new CGRP receptor antagonist developed by Pfizer, was approved in March 2023 as a nasal spray for the acute treatment of migraines in adults, marking a significant advancement in migraine therapy.

An oral formulation of zavegepant is also in development, indicating ongoing efforts to provide more treatment options for individuals suffering from chronic and episodic migraines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zavegepant: First Approval. Dhillon, S.[2023]

Zavegepant (Zavzpret) is an effective nasal spray approved for treating acute migraines in adults, but it is not intended for preventive use.

Common side effects include taste disorders, nausea, nasal discomfort, and vomiting, and it should not be used with intranasal decongestants as they can reduce its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Nasal Spray for Migraine Headaches. Aschenbrenner, DS.[2023]

In a Phase 2/3 trial involving 1673 participants, zavegepant nasal spray at doses of 10 mg and 20 mg was found to be effective in achieving pain freedom and alleviating the most bothersome migraine symptoms within 2 hours, outperforming placebo.

The safety profile of zavegepant was favorable, with most adverse events being mild to moderate, such as dysgeusia and nausea, and no indication of serious liver toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zavegepant nasal spray for the acute treatment of migraine: A Phase 2/3 double-blind, randomized, placebo-controlled, dose-ranging trial. Croop, R., Madonia, J., Stock, DA., et al.[2023]

Zavegepant nasal spray is significantly more effective than placebo in achieving pain freedom and relief from the most bothersome symptoms of migraine within 2 hours, with odds ratios of 1.6 and 1.4 respectively.

The nasal spray also shows a higher likelihood of sustained pain freedom between 2 and 48 hours (OR = 1.74), although the difference in pain relapse rates was not statistically significant, indicating a need for further research on its long-term safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zavegepant nasal spray for the acute treatment of migraine: A meta analysis. Waqas, M., Ansari, FUR., Nazir, A., et al.[2023]

In phase 2/3 trials, intranasal zavegepant at doses of 10 mg and 20 mg significantly improved pain relief and freedom from bothersome migraine symptoms compared to placebo, with 22.5% and 23.1% of patients achieving pain freedom, respectively.

Zavegepant demonstrated a safety profile similar to placebo, with common side effects including dysgeusia and nasal discomfort, making it a potentially convenient alternative to traditional migraine treatments like triptans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zavegepant Intranasal Spray for Migraines. Martirosov, AL., Giuliano, C., Shupp, M., et al.[2023]

Citations

1. zavzpret.pfizerpro.com zavzpret.pfizerpro.com/about/efficacy

Efficacy Info & Study Results In Study 1, ZAVZPRET was tested for superiority versus placebo using a robust statistical analysis model, that applied a hierarchical gate-keeping procedure to ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10615551/

Zavegepant nasal spray for the acute treatment of migraine This meta-analysis confirms the effectiveness of Zavegepant nasal spray in treating acute migraine, with significant improvements in pain and symptom relief.

3. jmcp.org jmcp.org/doi/10.18553/jmcp.2025.31.6.598

Clinical evaluation of zavegepant for the acute treatment ... Zavegepant achieved statistically significant improvements over placebo in multiple secondary outcomes, including pain relief at 15 minutes ...

4. thelancet.com thelancet.com/journals/laneur/article/PIIS1474-4422(22)00517-8/fulltext

Safety, tolerability, and efficacy of zavegepant 10 mg nasal ... Zavegepant 10 mg nasal spray was efficacious in the acute treatment of migraine, with favourable tolerability and safety profiles. Additional ...

5. fda.gov fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-zavzpret

Drug Trials Snapshots: ZAVZPRET Pain freedom and most bothersome symptom (MBS) freedom were assessed at two hours postdose as the primary outcome measures. The efficacy of ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2023/216386s000lbl.pdf

ZAVZPRET (zavegepant) nasal spray - accessdata.fda.gov The safety of ZAVZPRET for the acute treatment of migraine in adults has been evaluated in two randomized, double-blind, placebo-controlled trials (Study 1 ...

7. zavzpret.pfizerpro.com zavzpret.pfizerpro.com/safety-dosing/safety

Safety & Side Effects ZAVZPRET® (zavegepant) was generally well tolerated in two pivotal clinical trials · Most AEs were mild or moderate · Not associated with sedation or fatigue in ...

8. zavzpret.com zavzpret.com/

ZAVZPRET™ (zavegepant) Migraine Medication | Safety Info ZAVZPRET is not used to prevent migraine attacks. It is not known if ZAVZPRET is safe and effective in children. Please click here for full Prescribing ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39210835/

Long-term safety of zavegepant nasal spray for the acute ... Conclusions: One year of zavegepant 10 mg nasal spray up to eight times per month was safe and well tolerated.Trial registration: Clinicaltrials.gov: ...

10. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/appletter/2023/216386Orig1s000ltr.pdf

Zavzpret (zavegepant) nasal spray - accessdata.fda.gov 4408-4. A pediatric open-label safety study under PREA to evaluate the long-term safety of zavegepant in migraine patients ages 6 through 17 ...