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- || Zavzpret (zavegepant nasal spray) / Pfizer
PK/PD data, Journal: Population pharmacokinetic modeling of zavegepant, a calcitonin gene-related peptide receptor antagonist, in healthy adults and patients with migraine. (Pubmed Central) - Nov 4, 2024
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.
- zavegepant oral (BHV-3500 oral) / Pfizer
Phase classification, Enrollment change: Safety and Efficacy Active Drug vs. Placebo in Subjects With Asthma (clinicaltrials.gov) - Jul 18, 2024
P1, N=45, Terminated, Sponsor: Pfizer
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. Phase classification: P1b --> P1 | N=15 --> 45
- zavegepant oral (BHV-3500 oral) / Pfizer
Evidence for lack of drug-drug interaction between intranasal zavegepant and oral CGRP inhibitors for treatment of migraine based on literature analysis () - Jun 18, 2024 - Abstract #AHS2024AHS_356;
Phase classification: P1b --> P1 | N=15 --> 45 Clinically relevant DDIs between intranasal zavegepant and oral CGRP inhibitors rimegepant, atogepant and ubrogepant are not expected.
- ||||||||| zavegepant oral (BHV-3500 oral) / Pfizer
Trial termination: A Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention (clinicaltrials.gov) - May 3, 2024
P2/3, N=542, Terminated, Sponsor: Pfizer
Active, not recruiting --> Terminated; Strategic decision to discontinue the study based on adjusted clinical development plan. This decision is not based on any safety concerns.
- ||||| zavegepant oral (BHV-3500 oral) / Pfizer
Enrollment closed, Enrollment change: A Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention (clinicaltrials.gov) - Mar 21, 2024
P2/3, N=538, Active, not recruiting, Sponsor: Pfizer
This decision is not based on any safety concerns. Recruiting --> Active, not recruiting | N=1440 --> 538
- Zavzpret (zavegepant nasal spray) / Pfizer
Physiologically-based Pharmacokinetic Modeling for Assessment of the Drug-drug Interaction Potential of Zavegepant (Colorado Convention Center | Exhibit Hall B-E) - Mar 8, 2024 - Abstract #AAN2024AAN_3210;
Models predicted DDI of intranasal zavegepant with single-dose (SD) or MD rifampin, cyclosporine A (OATP1B3, NTCP, and P-gp inhibitor), and moderate (efavirenz) or strong (carbamazepine) CYP3A4 and/or P-gp inducers...PBPK modeling and observed clinical pharmacokinetic data support zavegepant labeling recommendations that CYP3A4 inhibitors/inducers or P-gp inhibitors do not have clinically relevant effects on zavegepant exposure. OATP1B3/NTCP inhibitors may significantly increase zavegepant exposure and co-administration should be avoided.
- |||||| zavegepant oral (BHV-3500 oral) / Pfizer
Enrollment open, Enrollment change: A Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention (clinicaltrials.gov) - Feb 13, 2024
P2/3, N=1440, Recruiting, Sponsor: Pfizer
OATP1B3/NTCP inhibitors may significantly increase zavegepant exposure and co-administration should be avoided. Active, not recruiting --> Recruiting | N=435 --> 1440
- ||||| zavegepant oral (BHV-3500 oral) / Pfizer
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: A Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention (clinicaltrials.gov) - Jan 17, 2024
P2/3, N=435, Active, not recruiting, Sponsor: Pfizer
Active, not recruiting --> Recruiting | N=435 --> 1440 Recruiting --> Active, not recruiting | N=1440 --> 435 | Trial completion date: Dec 2028 --> Mar 2024 | Trial primary completion date: Dec 2027 --> Mar 2024
- ||| zavegepant oral (BHV-3500 oral) / Pfizer
New P1 trial: A Study to Learn About the Study Medication, Zavegepant, in Healthy Volunteers (clinicaltrials.gov) - Nov 18, 2023
P1, N=52, Completed, Sponsor: Pfizer
- ||| zavegepant oral (BHV-3500 oral) / Pfizer
Trial completion date: A Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention (clinicaltrials.gov) - Aug 14, 2023
P2/3, N=1440, Recruiting, Sponsor: Pfizer
Recruiting --> Active, not recruiting | N=1440 --> 435 | Trial completion date: Dec 2028 --> Mar 2024 | Trial primary completion date: Dec 2027 --> Mar 2024 Trial completion date: Dec 2027 --> Dec 2028
- ||| zavegepant oral (BHV-3500 oral) / Pfizer
Trial termination: Safety and Efficacy Active Drug vs. Placebo in Subjects With Asthma (clinicaltrials.gov) - Jul 20, 2023
P1b, N=15, Terminated, Sponsor: Pfizer
Completed --> Terminated; Strategic decision to discontinue the study based on adjusted clinical development plan. This decision is not based on any safety concerns.
- || zavegepant oral (BHV-3500 oral) / Pfizer
Trial completion, Enrollment change: Safety and Efficacy Active Drug vs. Placebo in Subjects With Asthma (clinicaltrials.gov) - May 22, 2023
P1b, N=15, Completed, Sponsor: Pfizer
This decision is not based on any safety concerns. Recruiting --> Completed | N=24 --> 15
- ||||| zavegepant oral (BHV-3500 oral) / Pfizer
Enrollment change, Trial completion date, Trial primary completion date: A Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention (clinicaltrials.gov) - Mar 29, 2023
P2/3, N=1440, Recruiting, Sponsor: Pfizer
Recruiting --> Completed | N=24 --> 15 N=2900 --> 1440 | Trial completion date: Jul 2023 --> Dec 2027 | Trial primary completion date: Jul 2023 --> Dec 2027
- Zavzpret (zavegepant nasal spray) / Pfizer
Effects of the Strong CYP3A4 and P-glycoprotein Inhibitor Itraconazole on the Pharmacokinetics of Oral and Intranasal Zavegepant (Both in-person and online) - Mar 12, 2023 - Abstract #AAN2023AAN_3303;
Increased exposure following oral zavegepant with itraconazole is likely due to itraconazole inhibition of gastrointestinal P-gp. Overall, all treatments were well tolerated and exhibited a favorable safety profile.
- | zavegepant oral (BHV-3500 oral) / Pfizer
Trial completion date, Trial primary completion date: Safety and Efficacy Active Drug vs. Placebo in Subjects With Asthma (clinicaltrials.gov) - Oct 12, 2022
P1b, N=24, Recruiting, Sponsor: Biohaven Pharmaceuticals, Inc.
Overall, all treatments were well tolerated and exhibited a favorable safety profile. Trial completion date: Nov 2022 --> Mar 2023 | Trial primary completion date: Oct 2022 --> Feb 2023
- | zavegepant oral (BHV-3500 oral) / Pfizer
Trial completion date, Trial primary completion date: Safety and Efficacy Active Drug vs. Placebo in Subjects With Asthma (clinicaltrials.gov) - Jun 21, 2022
P1b, N=24, Recruiting, Sponsor: Biohaven Pharmaceuticals, Inc.
Trial completion date: Nov 2022 --> Mar 2023 | Trial primary completion date: Oct 2022 --> Feb 2023 Trial completion date: Jun 2022 --> Nov 2022 | Trial primary completion date: Jun 2022 --> Oct 2022
- |||| zavegepant oral (BHV-3500 oral) / Pfizer
Trial completion date, Trial primary completion date: A Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention (clinicaltrials.gov) - May 23, 2022
P2/3, N=2900, Recruiting, Sponsor: Biohaven Pharmaceutical Holding Company Ltd.
Trial completion date: Jun 2022 --> Nov 2022 | Trial primary completion date: Jun 2022 --> Oct 2022 Trial completion date: Sep 2022 --> Jul 2023 | Trial primary completion date: Sep 2022 --> Jul 2023
- || zavegepant oral (BHV-3500 oral) / Pfizer
Enrollment open: Safety and Efficacy Active Drug vs. Placebo in Subjects With Asthma (clinicaltrials.gov) - Oct 26, 2021
P1b, N=24, Recruiting, Sponsor: Biohaven Pharmaceuticals, Inc.
Trial completion date: Sep 2022 --> Jul 2023 | Trial primary completion date: Sep 2022 --> Jul 2023 Not yet recruiting --> Recruiting
- || zavegepant oral (BHV-3500 oral) / Pfizer
New P1 trial: Safety and Efficacy Active Drug vs. Placebo in Subjects With Asthma (clinicaltrials.gov) - Aug 3, 2021
P1b, N=24, Not yet recruiting, Sponsor: Biohaven Pharmaceuticals, Inc.
- |||||| zavegepant oral (BHV-3500 oral) / Pfizer
Enrollment open: A Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention (clinicaltrials.gov) - Mar 29, 2021
P2/3, N=2900, Recruiting, Sponsor: Biohaven Pharmaceutical Holding Company Ltd.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | zavegepant oral (BHV-3500 oral) / Pfizer
New P2/3 trial: A Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention (clinicaltrials.gov) - Mar 17, 2021
P2/3, N=2900, Not yet recruiting, Sponsor: Biohaven Pharmaceutical Holding Company Ltd.