AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, 3-ARM, STUDY TO INVESTIGATE PAIN RESPONSE WITH INTRANASAL ZAVEGEPANT COMPARED WITH PLACEBO IN THE ACUTE TREATMENT OF MULTIPLE MIGRAINE ATTACKS IN ADULT PARTICIPANTS

The purpose of this study to show that zavegepant 10 milligrams given through the nose provides:
* freedom from pain, 2 hours after taking the medicine for the first migraine attack.
* consistent freedom from pain, 2 hours after taking the medicine across 4 separate migraine attacks.
This study is seeking participants who:
* are 18 years of age or older.
* have migraine attacks present for at least 1 year with age onset before 50 years old.
* have migraine attacks, on average, lasting about 4 to 72 hours if not treated.
* have 3 to 8 attacks per month but less than15 headache days per month.
If the participant is fit to take part in the study, the participant will receive either the study medicine zavegepant or placebo. A placebo looks like zavegepant but does not contain active ingredients. The study medicine will be given using nasal spray device containing a single amount of zavegepant or matching placebo.
The participants will be instructed to take the study medicine at home if participants have a migraine headache which reaches moderate or severe pain intensity. The participants are expected to treat up to 4 migraines of moderate to severe intensity.
After taking the study medicine, the participant is not allowed to take any other medications for at least 2 hours after taking the study medicine or placebo. Participant can take other medicines after the 2 hours if the migraine is still present. The participant is expected to record on a paper log all medications taken throughout the study.
The study duration is around 26 weeks. This includes a 28-day screening window, up to 20 weeks of treatment period, and a follow up visit at about 4 weeks after taking the study medicine the last time.
The participant is expected to come into the study center up to 4 times. There will be up to 3 telephone contacts including one after taking the study medicine the first time or Month 1 whichever comes first, at Month 3 if the participant is still in the study, and a safety follow-up.
During the study, the participant is expected to complete two sets of questions in an app on a smartphone. This step is done before and after taking the study medicine. The participants must rate:
* Pain
* Pain symptoms
* How the participants are feeling
* General well-being

Start Date15 Sep 2025

Sponsor / Collaborator

Pfizer Inc.

NCT06453356

/ CompletedPhase 1

A PHASE 1 SINGLE INTRANASAL DOSE, OPEN-LABEL PHARMACOKINETIC STUDY OF ZAVEGEPANT IN HEALTHY LACTATING WOMEN

The purpose of the study is to look at the amount of zavegepant that is present in breast milk after single dose of zavegepant is sprayed through the nose in healthy breast-feeding women. This would allow to see if there are any possible risk to infants from medicines during breast-feeding.
The study is seeking for about 12 healthy breast-feeding females who are:
* 18 to 55 years of age.
* actively breast-feeding or producing breast milk.
* at least 2 weeks post-partum and not pregnant at present. Participants will not be allowed to breast-feed their infant from the evening of the day before to the first dose till 48 hours (2 days) after the dose.
Eligible participants will check into the clinical research unit (CRU) on Day -1. Participants will receive the zavegepant dose sprayed into the nose at the CRU on Day 1. The participants will stay at the CRU until the morning of Day 2. There will be collections of breast milk and plasma over 24 hours. Participants will be sent from the CRU on Day 2 and may begin to breastfeed their infant 48 hours (2 days) after the dose. A safety follow-up call will be done at about 28 to 35 days from the day the first dose of study medicine was given.

Start Date10 Jun 2024

Sponsor / Collaborator

Pfizer Inc.

NCT06401642

/ RecruitingPhase 4IIT

A Study to Assess Effectiveness and Tolerability of Zavegepant as an Acute Migraine Treatment Among Those Using CGRP Targeting Preventive Medications.

Zavegepant (Zavzpret) is approved for the acute treatment of migraine with or without aura in the US. The purpose of this study is to investigate the effectiveness and tolerability of zavegepant for the acute treatment of migraine attacks amongst participants who are using calcitonin gene-related peptide (CGRP) migraine preventive treatments.

Start Date22 Mar 2024

Sponsor / Collaborator

Mayo Clinic

100 Clinical Results associated with Zavegepant

100 Translational Medicine associated with Zavegepant

100 Patents (Medical) associated with Zavegepant

Literatures (Medical) associated with Zavegepant

01 Mar 2025·Headache: The Journal of Head and Face Pain

Comparative bioavailability of single‐dose zavegepant during and between migraine attacks: A phase 1, randomized, open‐label, fixed‐sequence, two‐period study

Article

Author: Liu, Jing ; Matschke, Kyle T. ; Bhardwaj, Rajinder ; Kamen, Lisa ; Madonia, Jennifer ; Bertz, Richard J. ; Collins, Julie L.

AbstractObjectiveTo compare the rate and extent of absorption of zavegepant 10 mg (therapeutic dose) or 20 mg (supratherapeutic dose) nasal spray during a migraine attack versus non‐migraine period, assess safety, and explore efficacy and the relationship between zavegepant concentration and therapeutic response.BackgroundPhysiologic changes occurring during a migraine attack could affect the pharmacokinetics of treatments for migraine.MethodsThis was a Phase 1, multicenter, open‐label, randomized, single‐dose, two‐period, fixed‐sequence, comparative bioavailability study. Participants with a history of 2–8 migraine attacks per month of moderate or severe pain intensity were randomized to a single dose of zavegepant 10 or 20 mg, administered intranasally during a migraine attack (Period 1) and in a non‐migraine period (Period 2). Blood samples were collected pre‐dose and at pre‐specified intervals up to 24 h post‐dose for plasma zavegepant concentration measurement. Safety was monitored throughout, and efficacy (migraine pain intensity score, nausea, photophobia, phonophobia, aura, and functional disability) assessed during Period 1. Plasma zavegepant pharmacokinetic parameters were calculated by standard noncompartmental methods, including maximum plasma concentration (Cmax), area under plasma concentration–time curve from time zero to infinity (AUC0–inf), and time of Cmax (Tmax).ResultsA total of 37 participants were evaluable for pharmacokinetics. Following administration of zavegepant 10 mg, geometric mean ratios for Period 1/Period 2 were 82.8% (90% confidence interval [CI] 60.5–113.2) for Cmax and 90.1% (90% CI 70.2–115.5) for AUC0–inf. Following administration of zavegepant 20 mg, geometric mean ratios for Period 1/Period 2 were 72.5% (90% CI 57.9–90.8) for Cmax and 73.4% (90% CI 58.8–91.7) for AUC0–inf. Averaging over the study period, geometric mean ratios for zavegepant 20 mg/10 mg were 142.5% (90% CI 118.6–171.4) for Cmax and 157.0% (90% CI 133.6–184.5) for AUC0–inf. Median Tmax was 0.5 h for both doses regardless of Period. Zavegepant was well tolerated in both study periods and effective during Period 1 at both dose levels. There was no apparent correlation between concentration at 0.5 h or 2 h post‐dose and efficacy outcomes.ConclusionZavegepant exposure was comparable during a migraine attack and a non‐migraine period, particularly at the therapeutic dose of 10 mg. When averaging over migraine and non‐migraine periods, there was a less‐than‐dose proportional increase in zavegepant exposure when the dose was doubled from 10 to 20 mg. The median Tmax was 0.5 h regardless of migraine attack or dose. Zavegepant 10 and 20 mg exhibited favorable safety profiles during migraine attacks and non‐migraine periods, and were effective to relieve pain, associated symptoms, and functional disability during migraine attacks, with no apparent correlation between zavegepant concentration and efficacy outcomes.

01 Feb 2025·Headache: The Journal of Head and Face Pain

Assessment of pharmacokinetic and pharmacodynamic interactions between zavegepant and sumatriptan: A phase 1, randomized, placebo‐controlled study in healthy adults

Article

Author: Croop, Robert ; Anderson, Matt S. ; Bhardwaj, Rajinder ; Bertz, Richard ; Donohue, Mary K. ; Matschke, Kyle ; Madonia, Jennifer ; Morris, Beth ; Liu, Jing

AbstractObjectiveTo evaluate the pharmacodynamic (PD) and pharmacokinetic (PK) interactions between zavegepant and sumatriptan in healthy adults.BackgroundZavegepant is a high‐affinity, selective, small‐molecule calcitonin gene–related peptide receptor antagonist administered as a nasal spray approved in the United States for the acute treatment of migraine. Triptans, including sumatriptan, are a different class of drugs for acute migraine treatment and are associated with a risk of increased blood pressure (BP). Hence, it is important to study the drug–drug interactions between zavegepant and sumatriptan due to potential coadministration in clinical settings.MethodsThis was a Phase 1, single‐center, partially blind, randomized, placebo‐controlled, single‐arm study. Eligible participants were males aged ≥ 18 and ≤ 40 years or females aged ≥ 18 and ≤ 50 years. On Day 1, participants received sumatriptan 2 × 6 mg subcutaneous injections (1 h apart) and were then randomized (6:1 ratio) to receive zavegepant 2 × 10 mg nasal spray (1 in each nostril) or placebo on Days 2 and 3. On Day 4, zavegepant or placebo was coadministered with sumatriptan after the second sumatriptan injection. BP, PK, and safety were evaluated at pre‐specified time points.ResultsForty‐two participants enrolled in the study received at least one dose of any treatment and were included in the safety analyses. Forty‐one participants who completed the study were included in the BP and PK analyses. The mean (standard deviation) time‐weighted average (TWA) of mean arterial pressure (MAP [sumatriptan + zavegepant 87.2 (6.8) vs. sumatriptan 86.9 (6.0)]), diastolic BP (DBP [sumatriptan + zavegepant 72.3 (6.8) vs. sumatriptan 72.1 (6.2)]), and systolic BP (SBP [sumatriptan + zavegepant 116.8 (10.2) vs. sumatriptan 116.2 (8.6)]) did not change following zavegepant and sumatriptan coadministration on Day 4 compared to sumatriptan alone on Day 1. Statistical comparisons of the TWA of MAP, DBP, and SBP between sumatriptan and zavegepant coadministration and sumatriptan alone were similar; the differences observed were 0.04 mmHg for MAP (90% confidence interval [CI]: −0.69, 0.77 mmHg), 0.00 mmHg for DBP (90% CI: −0.76, 0.76 mmHg), and 0.33 mmHg for SBP (90% CI: −0.97, 1.63 mmHg). Sumatriptan PK after sumatriptan and zavegepant coadministration versus sumatriptan alone was similar; the comparison ratios were 102.5% (90% CI: 100.7%, 104.2%) for AUC0‐inf and 104.1% (90% CI: 98.0%, 110.6%) for Cmax. A small difference in zavegepant PK exposure after sumatriptan and zavegepant coadministration versus zavegepant alone was not considered clinically relevant: the comparison ratios were 112.4% (90% CI: 103.4%, 122.3%) for AUC0–24 and 96.7% (90% CI: 88.9%, 105.2%) for Cmax. Overall, 90% (38/42) of participants experienced ≥ 1 treatment‐emergent adverse event that was mild or moderate in severity. All treatments were generally safe and well tolerated.ConclusionCoadministration of zavegepant with sumatriptan was safe and without PD or PK interactions in healthy adults.

01 Jan 2025·CPT: Pharmacometrics & Systems Pharmacology

Population pharmacokinetic modeling of zavegepant, a calcitonin gene‐related peptide receptor antagonist, in healthy adults and patients with migraine

Article

Author: Bertz, Richard ; Francis, Jose ; Hughes, Jim H. ; Liu, Jing ; Bhardwaj, Rajinder ; Comisar, Craig M.

AbstractZavegepant (ZAVZPRET™) is a high‐affinity, selective, small‐molecule calcitonin gene‐related peptide receptor antagonist available for acute treatment of migraine in adults. A population pharmacokinetic analysis was performed to describe zavegepant plasma concentration–time course, characterize bioavailability, and identify covariates affecting zavegepant exposure. The model was developed and validated using data from 10 phase I clinical studies, wherein zavegepant was administered intravenously, intranasally, or orally to healthy adults and patients with migraine. Plasma concentration–time data were analyzed using nonlinear mixed‐effects modeling. A three‐compartment model with first‐order elimination from the central compartment, and sequential zero‐ and first‐order absorption best described the observed plasma concentration–time course of zavegepant. Bioavailability was 5.1% and 0.65% for intranasal and oral treatment, respectively; absorption rate constants were 5.8 and 0.8 h−1, respectively. Body weight‐based empirical allometric scaling was applied using standard exponents (0.75 for clearance and 1 for volume of distribution). 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.

News (Medical) associated with Zavegepant

04 Sep 2024

·www.biospace.com

Lilly, Pfizer Take Meds Straight To Consumers in Renewed DTC Push

Various kinds of medical pills with Rx sign on smartphone screen , online pharmacy concept Atstock Productions/iStock Big Pharma has finally gotten its arms around something advocates have wanted for a long time: direct-to-consumer sales. Eli Lilly and Pfizer are leading the way. Big Pharma is finally beginning to offer what patient advocates have been asking for: a direct-to-consumer option to buy medicines straight from the manufacturer. This past week, Eli Lilly announced the addition of starter Zepbound vials to its DTC platform, called LillyDirect, expanding options for patients to self-pay for the popular weight loss drug. A day later, Pfizer announced the digital portal PfizerForAll , which provides access to the New York pharma giant’s vaccines, plus migraine and respiratory drugs. The two programs connect patients to telehealth care and a third-party service for the delivery of medicine. “It does just make the full digital telehealth pharmacy experience online really seamless,” Dedham Group Principal Manny Jurado told BioSpace . “It’s like you’re able to integrate everything into almost more or less a one-stop shop.” Jurado says these DTC approaches are a long time coming. Advocates have been calling for a new way for patients to access medicines that could help bring down costs by cutting out the so-called middle-men that pharma industry groups say push up prices. But DTC adoption has been slow. These latest announcements are a welcome advancement, Jurado said. “I’m sure pharma already had a lot of plans about this multiple years ago, but it’s now finally that we’re able to see it come to fruition,” he said, acknowledging the complexity of developing these programs in terms of compliance and regulatory hurdles. While the process cuts out the trip to the pharmacy, patients are not exactly receiving the medicine from Lilly or Pfizer’s personal storage rooms. Jurado said the pharmas have contracted third-party providers for the actual distribution. He noted that the DTC idea is not new. Amgen and AbbVie have existing platforms and the pharma industry has played around with the idea previously with minimal success. Now that Lilly and Pfizer are diving in, he suspects more—including Lilly’s chief rival Novo Nordisk —will follow suit. Zepbound Pushes Lilly Toward DTC Option Lilly was a natural entrant given the craze around Zepbound and the supply hurdles the company has faced. LillyDirect launched in January , just two months after Zepbound’s approval. Then last week, Lilly announced the availability of single-dose vials of Zepbound at a 50% discount compared to the list price of other treatments in the incretin class. CEO David Ricks said during a fourth quarter earnings call in February that the idea came from the challenges patients have experienced accessing obesity treatment. “Finding medicines in their pharmacies, that’s a been a challenge,” Ricks said on the call. “And I think particularly as supplies are tight, many patients report driving to five, six, seven pharmacies to find the medicine they need. This simplifies that process.” The direct pharmacy also gives patients confidence that they are getting a genuine Lilly-manufactured drug, as compounded or illicit versions of Zepbound have trickled into the market, the CEO added. “We haven’t thought about it as a way to create some new retail distribution business. It’s a way to serve the patients that want our medicines better,” Ricks said. But Lilly will benefit from getting new patients started on treatment, Jurado said. While the online pharmacy serves as an option for patients whose insurance has denied coverage of the weight loss drug, the single-dose vial offered through LillyDirect is just a starter dose—patients will eventually have to step up to a higher dose which will need to be accessed another way, according to Jurado. In addition, as the coverage landscape for weight loss medication evolves, cash-pay patients will likely switch over to insurance and long-term care. Lilly did not frame the new vial offering as a way to cut costs for patients. The drug launched last year in its injectable form with a list price of $1,059.87 a month for the various doses. But removing the injectable from the equation does lead to a savings in terms of the overall price and some of the manufacturing complexity. A number of third-party providers have been pulled together to deliver LillyDirect. EVERSANA and others are conducting pre-authorizations; Form Health and 9amHealth are doing the telehealth services; and TruePill and Amazon Pharmacy are offering the pharmacy services, among other providers. Pfizer tackles an ‘overwhelming’ system While Lilly is doubling down in DTC, Pfizer is just getting started. With PfizerForAll, patients can purchase prescription drugs, over-the-counter medications and diagnostic tests, available for pick-up at a local pharmacy or through home delivery. The service will also connect patients with in-person or online appointments with healthcare professionals and offer a scheduling tool for adult COVID-19, flu, pneumococcal pneumonia and respiratory syncytial virus (RSV) vaccinations. In addition, PfizerForAll provides access to the company’s savings programs, which include solutions for co-pay and insurance. “People often experience information overload and encounter roadblocks when making decisions for themselves or their family in our complex and often overwhelming U.S. healthcare system. This can be extremely time-consuming and lead to indecision or inaction – and as a result, poor health outcomes,” Aamir Malik, Pfizer’s executive vice president and chief U.S. commercial officer, said in an August 27 statement. “We are pleased to offer PfizerForAll to help relieve this burden on people, especially as we enter the fall season in the U.S., and streamline the path for those seeking better health.” While Lilly is trying to address a nearly insatiable demand for its weight loss drug, Jurado said that migraine medicines have also been in demand. Pfizer markets Nurtec and Zavzpret. “We’re seeing more and more of these pseudo-retail type products and retail therapies starting to make more sense from a direct-to-consumer standpoint and ease of online access,” Jurado said, adding that migraine treatment requires a neurologist, which can be hard to access. Pfizer has stated plans to expand the program, potentially to a broader range of conditions. In announcing PfizerForAll, Pfizer also did not mention slashing prices as a reason behind the move. While the program connects patients to existing affordability programs, no new options were released to coincide with the DTC launch. Ready, Set, Launch When contacted by BioSpace , AbbVie pointed to the Synthroid Delivers program, which offers the brand name thyroid hormone medicine directly to patients for $25 per month for a 90-day prescription. AbbVie uses Eagle Pharmacy to fulfill the orders. Amgen did not return multiple requests for comment, but STAT identified the company as one that has used virtual care in the past for its migraine drugs. Jurado suspects there may soon be more companies joining the DTC marketplace. “I would assume that there’s going to be a lot of other players who are either potentially launching, or are even thinking about launching,” Jurado said.

03 Jun 2024

·www.echemi.com

Neuroscience Takes Center Stage: MNCs Accelerate Investments in a Promising Field

The biopharmaceutical landscape is quietly undergoing a transformation, with neuroscience emerging as a hotspot amidst the industry's shifting dynamics. While the cancer therapy arena has seen setbacks with dual antibodies and ADCs, the metabolic disease space, led by weight loss treatments, has experienced a surge in popularity. Concurrently, the neuroscience (CNS) field is witnessing a renaissance, marked by clinical breakthroughs and a series of high-profile mergers and acquisitions. The renewed focus on neuroscience is driven by the immense unmet medical needs and recent advancements in fundamental research. According to WHO projections, neurological disorders are poised to become the second leading cause of death within the next 20 years. Alarmingly, the number of individuals diagnosed with Alzheimer's disease (AD) and other forms of dementia continues to rise, with an estimated 50 million people worldwide affected. Additionally, the prevalence of depression and severe mental illnesses is on the rise, with a worrying trend towards younger populations. Despite this growing burden, the efficacy of existing treatment options for neurological disorders remains below 50%, presenting a vast clinical demand and market potential. In this landscape, even minor therapeutic differences can lead to commercial success, as "you don't need a cure to have a blockbuster, just an incremental improvement." Moreover, the rapid advancements in sequencing technologies and the resulting drop in costs have enabled exponential growth in genetic research related to neurodegenerative diseases. By analyzing relevant genes, scientists have been able to identify critical signaling pathways and drug targets. The approval of Biogen's Aduhelm, the first Alzheimer's drug targeting the Aβ cascade, has served as a catalyst for the resurgence of the CNS field. Although Aduhelm faced challenges due to its significant side effects, leading to commercial failure, the recent full approval of Eisai and Biogen's Leqembi (lecanemab) in the United States and China marks a significant milestone. Leqembi is the first drug capable of slowing the progression of early-stage Alzheimer's disease, a landmark achievement in this notoriously difficult-to-treat field. Sensing the renewed promise of neuroscience, multinational corporations (MNCs) have accelerated their efforts to establish a presence in this space. However, the shadows of past failures have made them more cautious, leading them to favor low-risk, late-stage transactions that avoid the risks associated with early and mid-stage clinical trials. In 2022, Pfizer acquired Biohaven for $11.6 billion, gaining access to the migraine drug Nurtec ODT (rimegepant). In 2023, Pfizer's CGRP receptor antagonist nasal spray, Zavzpret, successfully obtained FDA approval. The neuroscience field has witnessed three major acquisition deals in 2023: Bristol Myers Squibb's $14 billion acquisition of Karuna Therapeutics, which provided the company with the schizophrenia drug KarXT; AbbVie's $8.7 billion purchase of Cerevel, securing the Parkinson's disease candidate Tavapadon and the schizophrenia and Alzheimer's psychosis candidate Emraclidine; and Biogen's $7.3 billion acquisition of Reata, gaining access to the Nrf2 activator Omaveloxolone for neurological indications. As the industry navigates the complexities of the neuroscience landscape, the promise of genetic research, advancements in AI-driven precision medicine, and the recent regulatory successes have ignited a renewed sense of optimism. The stage is set for MNCs to continue their aggressive pursuit of promising neuroscience assets, driven by the urgent need to address the growing burden of neurological disorders and the potential for significant commercial rewards.

AcquisitionDrug Approval

23 May 2024

·www.biospace.com

Pfizer Targets Another $1.5B in Cost Cuts By End of 2027

Pictured: Pfizer's signage outside its office in Canada/iStock, JHVEPhoto Pfizer in an SEC filing on Wednesday revealed its plans to implement a fresh round of cost cuts to generate savings of around $1.5 billion by the end of 2027. According to the SEC document, the $1.5-billion savings scheme is just the “first phase” of a multi-year program designed to “reduce our cost of goods sold.” The program will include structural changes to its network, operational adjustments to boost efficiency and improvements to its product portfolio. Pfizer expects to incur around $1.7 billion in one-time costs—primarily due to severance pay and implementation fees—as part of the first phase. The pharma will reflect these costs in 2024, while savings from the first phase will start being realized in 2025. Wednesday’s announcement adds to Pfizer’s ongoing $3.5 billion cost-cutting initiative unveiled in October 2023 and another $500 million in targeted savings announced in December 2023. The “multi-year, enterprise-wide cost realignment program” is designed to help the pharma weather the sharp drop in COVID-19 demand, which bottomed out its revenues in recent quarters, according to the company. In the third quarter of 2023, Pfizer reported its first quarterly decline since 2019. At the time, the pharma suffered a 42% year-over-year drop to bring in $13.2 billion in revenue. Sales of Paxlovid, its antiviral treatment for, cratered 97%, while its COVID-19 vaccine Comirnaty slipped 70%. Pfizer reported a 42% hit in full-year revenues last year, driven by a 92% and 72% drop in Paxlovid and Comirnaty sales, respectively. Excluding Paxlovid and Comirnaty, Pfizer’s revenue grew 7% operationally last year. The cost-cutting program will also involve layoffs, though the pharma has yet to specify how many employees will be affected. Pfizer expects to absorb a one-time upfront cost of $3 billion, primarily associated with severance and implementation fees. Pfizer also announced in its first-quarter 2024 earnings report that it culled four programs from its pipeline. The pharma will no longer be working on VTX-801, a recombinant gene therapy for Wilson disease. Zavzpret (zavegepant), its migraine nasal spray, will also no longer be developed as an oral preventive therapy. In Wednesday’s SEC filing, Pfizer cautioned that the savings from the first phase of its program are estimates and are “subject to a number of assumptions.” The pharma said its actual results may differ. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

VaccineGene Therapy

100 Deals associated with Zavegepant

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15688

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Acute migraine	United States	Pfizer Inc.	09 Mar 2023
Migraine Disorders	United States	Pfizer Inc.	09 Mar 2023

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Migraine Disorders	Phase 3	-	Pfizer Inc.	15 Sep 2025
Pain	Phase 3	-	Pfizer Inc.	15 Sep 2025
Acute migraine	Phase 3	China	Pfizer Inc.	29 Nov 2023
Acute migraine	Phase 3	South Korea	Pfizer Inc.	29 Nov 2023
Acute migraine	Phase 3	Taiwan Province	Pfizer Inc.	29 Nov 2023
Allergic asthma	Discovery	Canada	Pfizer Inc.	18 Oct 2021
COVID-19	Discovery	United States	Pfizer Inc.	25 Apr 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05960032 (CTgov)	Phase 1	Migraine Disorders	13	Zavegepant	qogcmcublk(didsfmrwxv) = ycruphnjvg lofzhenjhc (pghidmroas, xofekiggkc - pviqxgqofs) View more	-	06 Jan 2025
NCT06137703 (CTgov)	Phase 1	-	52	Zavegepant (Treatment A: Zavegepant 100 mg SGC)	dtfgtenjmt(eimspyknim) = fmxxfviyuc yypjzvfjqe (sbqcobhasq, siaynwbseh - mpmdngywnn) View more	-	01 Oct 2024
				DDM+Zavegepant (Treatment B: Zavegepant 100 mg IR+DDM)	dtfgtenjmt(eimspyknim) = tgzqsaxyit yypjzvfjqe (sbqcobhasq, axrawwmsbz - ludodnsygf) View more
NCT04408794 (Pubmed \| Cephalalgia) Manual	Phase 2/3	Migraine Disorders	603	Zavegepant 10mg nasal spray	(hevkyblwjh) = ehctwlpchr dihadjmhdn (uzdawpiito ) View more	Positive	01 Aug 2024
NCT04987944 (CTgov)	Phase 1	Allergic asthma	45	Placebo	tbdbhdygwu(wyjxcmuiwn) = mnznauowps arkcyrsbot (reotkqdfkw, jewfxegfkv - gupeplhluu) View more	-	19 Jul 2024
NCT04346615 (CTgov)	Phase 2/3	COVID-19	47	Zavegepant (BHV-3500) (Zavegepant)	yepymzssvj(ptpazyyosa) = lpumptukgh assbmidnld (xkmgbwsgyr, jtlfxbcnew - hplveycvvp) View more	-	02 May 2024
				Placebo (Placebo)	yepymzssvj(ptpazyyosa) = gxehbnuhyz assbmidnld (xkmgbwsgyr, cnezdabbgo - qwlperbbxq) View more
AAN2024	Not Applicable	Migraine Disorders	-	Rimegepant	efwnsnhlwq(wjgyyrsnzv) = ctdmkhmnck qrkloexbwm (wwglilbqox, 56.0%–60.2%) View more	-	09 Apr 2024
				Zavegepant	efwnsnhlwq(wjgyyrsnzv) = jdofrrrmbf qrkloexbwm (wwglilbqox, 56.4%–62.5%) View more
NCT04571060 \| NCT03872453 (P6-12.004, AAN2024)	Phase 3	Migraine Disorders	2,061	Zavegepant 10 mg	cqjsiecvqu(qwgkypfmwt) = fdphccwypm fdentisdtl (dwdwzsdaeo ) View more	Positive	09 Apr 2024
				Placebo	cqjsiecvqu(qwgkypfmwt) = pobhickjep fdentisdtl (dwdwzsdaeo ) View more
NCT03872453 \| NCT04571060 (AAN2023)	Not Applicable	Migraine Disorders	2,061	Zavegepant 10 mg nasal spray	zokeskcaty(nbpufdloor) = jsautkdjus syxvelxsdw (sdmjjopfaq ) View more	-	25 Apr 2023
				Placebo	zokeskcaty(nbpufdloor) = vxwyvqogrm syxvelxsdw (sdmjjopfaq ) View more
NCT04571060 (PL5.002, AAN2023)	Phase 3	Migraine Disorders	1,405	Zavegepant 10 mg nasal spray	(ztamnrawwo) = efwueyjhqx vdokvokpdr (ekvhgipghr ) View more	Positive	25 Apr 2023
				Placebo	(ztamnrawwo) = bukfpwgbzf vdokvokpdr (ekvhgipghr ) View more
AAN2023	Not Applicable	Migraine Disorders	2,061	Zavegepant nasal spray	vvqhhtduhg(ugldmtfkjh) = bngybuxupi btrtchqqwj (ttbrypmjem ) View more	-	25 Apr 2023
				Placebo	vvqhhtduhg(ugldmtfkjh) = toazahynak btrtchqqwj (ttbrypmjem ) View more

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis