DelveInsight’s, “Migraine Pipeline Insight 2023” report provides comprehensive insights about 30+ companies and 30+ pipeline drugs in the Migraine pipeline landscape. It covers the Migraine pipeline drug profiles, including Migraine clinical trials and nonclinical stage products. It also covers the Migraine pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
Latest Developmental Activities in the Migraine Treatment Landscape
- On March 2023, the U.S. Food and Drug Administration (FDA) approved ZAVZPRET™ (zavegepant), the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the acute treatment of migraine with or without aura in adults. In its pivotal Phase 3 study, ZAVZPRET was statistically superior to placebo on the co-primary endpoints of pain freedom and freedom from most bothersome symptoms at two hours post-dose. The pivotal study also demonstrated pain relief as early as 15 minutes in a prespecified secondary endpoint versus placebo.
- In August 2022, Axsome Therapeutics, Inc. initiated a trial titled, “An Open-Label, Multiple-Dose Evaluation ofthe Efficacy and Safety of AXS-07 (Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults with a PriorInadequate Response to an Oral CGRP Inhibitor”. This is a multicenter, open-label trial to evaluate the efficacy and safety ofAXS-07 in subjects with migraine attacks and prior inadequate response to oral CGRP inhibitors. Eligible subjects will receiveopen-label AXS-07 for up to 8 weeks for at-home treatment of their next 4 migraine attacks. The trial is currently active with100 participants and is anticipated to be complete by December 2023.
- In July 2019, Axsome Therapeutics, Inc. initiated a trial titled, “An Open-Label, Long-Term Study to Assess theSafety and Efficacy of AXS-07 (MoSEIC Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults”. This studywas a Phase 3, multicenter, open-label, trial to evaluate the long-term safety and efficacy of intermittent chronic dosing withAXS-07 in subjects with migraine attacks. Eligible subjects took AXS-07 following the onset of a migraine. Subjects weretreated for up to 12 months. The trial was completed with 706 participants by September 2020.
- In October 2019, Axsome Therapeutics, Inc. initiated a trial titled, “A Randomized, Double-blind, Single-dose,Placebo-controlled Study to Assess the Efficacy and Safety of AXS-07 (Meloxicam and Rizatriptan) for the Acute Treatment ofMigraine in Adults”. AXS-07 tablets are formulated to provide an enhanced rate of absorption of meloxicam. This study isdesigned to evaluate the efficacy and safety of AXS-07 compared to placebo.
Discover the recent breakthroughs happening in the Migraine Pipeline landscape @ Migraine Pipeline Outlook
Key Takeaways from the Migraine Pipeline Report
- DelveInsight’s Migraine pipeline report depicts a robust space with 30+ active players working to develop 30+ pipeline therapies for Migraine treatment.
- The leading Migraine Companies include Satsuma Pharmaceuticals, Biohaven Pharmaceuticals, Allodynic Therapeutics, Vaxxinity, AbbVie, Pulmatrix, AEON Biopharma, Eli Lilly and Company, Trevena, Xoc Pharmaceuticals, Pharmaleads, Pear Therapeutics, and others.
- Promising Migraine Pipeline Therapies includes Lasmiditan, Sumavel DosePro, Sumatriptan, ZNS, Eptinezumab, AMG334, Oral Prophylactic, Frovatriptan 2.5 mg, topiramate, Almotriptan Malate, and others.
- The Migraine companies and academics are working to assess challenges and seek opportunities that could influence Migraine R&D. The Migraine pipeline therapies under development are focused on novel approaches to treat/improve Migraine.
Explore more information about NDA Approvals, Clinical Trials, Licensing, Mergers and Acquisition of the report @ Migraine Product Development Activities
Migraine Emerging Drugs Profile
- AXS-07: Axsome Therapeutics
AXS-07 is a novel, oral, rapidly absorbed, multi-mechanistic, investigational medicine. AXS-07 consists of MoSEIC (Molecular Solubility Enhanced Inclusion Complex) meloxicam and rizatriptan. AXS-07 is thought to act by inhibiting Calcitonin gene-related peptide (CGRP) release, reversing CGRP-mediated vasodilation, and inhibiting neuroinflammation, pain signal transmission, and central sensitization. Meloxicam is a new molecular entity for migraine enabled by MoSEIC™ technology, which results in rapid absorption of meloxicam while maintaining a long plasma half-life. AXS-07 is currently being developed for the acute treatment of migraine. The product is in the NDA submitted phase of development.
- STS-101: Satsuma Pharmaceuticals
STS101 combines the Satsuma powder technology with an easy-to-use nasal delivery device to create a reliable and convenient DHE product potentially able to provide the unique clinical advantages of DHE while overcoming the shortcomings of existing DHE products. TS101 has a number of key advantages that we believe may provide significant benefits over other acute treatments for migraine and result in robust and consistent clinical performance. These advantages arise from our proprietary dry-powder formulation, which incorporates a mucoadhesive drug carrier and engineered drug particle technologies, and our proprietary nasal delivery device. STS101 is an investigational product that is currently being evaluated in Phase 3 clinical trials for the acute treatment of migraine and is not approved by the U.S. Food and Drug Administration.
- Zavegepant: Biohaven Pharmaceuticals
Zavegepant (BHV-3500) is a third generation, high affinity, selective and structurally unique, small molecule CGRP receptor antagonist. The chemical properties of zavegepant make the product candidate potentially suitable for multiple routes of delivery, including nasal, subcutaneous, inhalation or oral administration.It is currently in Phase III stage of development for Migraine and is being developed by Biohaven Pharmaceuticals.
- TNX1900: Tonix Pharmaceuticals
TNX-1900(Oxytocin), Tonix’s proprietary potentiated intranasal oxytocin is in the pre-Investigational New Drug (IND) stage and is currently being studied as a candidate for prophylaxis of chronic migraine. Oxytocin is a naturally occurring human hormone that acts as a neurotransmitter in the brain. In clinical and preliminary research, it has been observed that increased oxytocin levels can relieve headaches. When oxytocin is delivered via the nasal route, it results in enhanced binding to receptors on neurons in the trigeminal system, inhibiting transmission of pain signals. Intranasal oxytocin has been well tolerated in several clinical trials in adults and children and has been shown to block calcitonin gene-related peptide (CGRP) release in animals, a pathway known to be critical to the pathogenesis of migraine attacks. TNX-1900 is believed to interrupt pain signals at the trigeminal ganglia by suppressing electrical impulses, a potentially different activity than drugs that just block CGRP. TNX-1900 is an investigational new drug and has not been approved for any indication.
Get More Information on the Migraine Drugs and Companies of Report @ Migraine Ongoing Clinical Trials Analysis
Scope of the Migraine Pipeline Report
- Coverage- Global
- Migraine Companies- Satsuma Pharmaceuticals, Biohaven Pharmaceuticals, Allodynic Therapeutics, Vaxxinity, AbbVie, Pulmatrix, AEON Biopharma, Eli Lilly and Company, Trevena, Xoc Pharmaceuticals, Pharmaleads, Pear Therapeutics, and others.
- Migraine Pipeline Therapies- Lasmiditan, Sumavel DosePro, Sumatriptan, ZNS, Eptinezumab, AMG334, Oral Prophylactic, Frovatriptan 2.5 mg, topiramate, Almotriptan Malate, and others
- Migraine Pipeline Segmentation: Product Type, Molecule Type, Mechanism of action, Route of administration
Find out more about the list of FDA-approved drugs for Migraine @ Migraine Treatment Landscape
Table of Content
- Introduction
- Executive Summary
- Migraine: Overview
- Pipeline Therapeutics
- Therapeutic Assessment
- Migraine– DelveInsight’s Analytical Perspective
- Late Stage Products (Pre-Registration)
- AXS-07: Axsome Therapeutics
- Drug profiles in the detailed report…..
- Last Stage Products (Phase III)
- STS-101: Satsuma Pharmaceuticals
- Drug profiles in the detailed report…..
- Mid Stage Products (Phase II)
- TNX1900: Tonix Pharmaceuticals
- Drug profiles in the detailed report…..
- Preclinical and Discovery Stage Products
- Drug name: Company Name
- Drug profiles in the detailed report…..
- Inactive Products
- Migraine Key Companies
- Migraine Key Products
- Migraine – Unmet Needs
- Migraine – Market Drivers and Barriers
- Migraine – Future Perspectives and Conclusion
- Migraine Analyst Views
- Migraine Key Companies
- Appendix
Got Queries? Find out the related information on Migraine Preclinical and Discovery Stage Products @ Migraine Drugs, Unmet Needs, and Recent Trends
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