Migraine Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

Migraine Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight’s, “Migraine Pipeline Insight 2025” report provides comprehensive insights about 30+ companies and 30+ pipeline drugs in Migraine pipeline landscape. It covers the Migraine pipeline drug profiles, including clinical 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.

Explore the comprehensive insights by DelveInsight and stay ahead in understanding the Migraine Treatment Landscape. Click here to read more @ Migraine Pipeline Outlook

Key Takeaways from the Migraine Pipeline Report

  • In April 2025, Pfizer announced a study is to learn about the effect of a study medicine called rimegepant in adolescents who have frequent migraine attacks. Rimegepant is a tablet that dissolves when you put it on or under your tongue.
  • In April 2025, AstraZeneca conducted a phase 2 study is to evaluate the safety and efficacy of SC MEDI0618 compared to placebo in participants with episodic migraine. The study includes a cohort of participants who have a history of unsuccessful treatment with ≥ 3 small molecule migraine preventive treatments from different classes and are eligible to receive an aCGRP therapy (aCGRP-N); the study also includes a smaller cohort of participants who have failed one or more aCGRP therapies (aCGRP-IRs).
  • In April 2025, AbbVie organized a phase 3 study to Evaluate the Efficacy, Safety, and Tolerability of Ubrogepant for the Preventive Treatment of Menstrual Migraine With an Open-Label Extension. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. Menstrual migraine (MM) is defined as migraine attacks that occur within the perimenstrual period (PMP) in at least 2 out of 3 menstrual cycles.
  • In April 2025, Manistee Therapeutics announced a clinical trial is to learn if drug MTX101 works to treat acute migraine attacks in adults. It will also learn about the safety of the drug MTX101.
  • 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 such as ​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 such as ALD403 (Eptinezumab), Ketorolac, Sumatriptan, divalproex sodium, Erenumab, GSK1838262, ALD403 and others.

Stay informed about the cutting-edge advancements in Migraine Treatments. Download for updates and be a part of the revolution in Neurology care @ Migraine Clinical Trials Assessment

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.

The Migraine pipeline report provides insights into

  • The report provides detailed insights about companies that are developing therapies for the treatment of Migraine with aggregate therapies developed by each company for the same.
  • It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Migraine Treatment.
  • Migraine Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
  • Migraine Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
  • Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Migraine market.

Get a detailed analysis of the latest innovations in the Migraine pipeline. Explore DelveInsight’s expert-driven report today! @ Migraine Unmet Needs

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 report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

  • Intra-articular
  • Intraocular
  • Intrathecal
  • Intravenous
  • Ophthalmic
  • Oral
  • Parenteral
  • Subcutaneous
  • Topical
  • Transdermal

Migraine Products have been categorized under various Molecule types such as

  • Oligonucleotide
  • Peptide
  • Small molecule

Discover the latest advancements in Migraine Treatment by visiting our website. Stay informed about how we’re transforming the future of neurology @ Migraine Market Drivers and Barriers, and Future Perspectives

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- ALD403 (Eptinezumab), Ketorolac, Sumatriptan, divalproex sodium, Erenumab, GSK1838262, ALD403 and others.
  • Migraine Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
  • Migraine Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

For a detailed overview of our latest research findings and future plans, read the full details of Migraine Pipeline on our website @ Migraine Emerging Drugs and Companies

Table of Content

  1. Introduction
  2. Executive Summary
  3. Migraine: Overview
  4. Pipeline Therapeutics
  5. Therapeutic Assessment
  6. Migraine– DelveInsight’s Analytical Perspective
  7. Late Stage Products (Pre-Registration)
  8. AXS-07: Axsome Therapeutics
  9. Drug profiles in the detailed report…..
  10. Last Stage Products (Phase III)
  11. STS-101: Satsuma Pharmaceuticals
  12. Drug profiles in the detailed report…..
  13. Mid Stage Products (Phase II)
  14. TNX1900: Tonix Pharmaceuticals
  15. Drug profiles in the detailed report…..
  16. Preclinical and Discovery Stage Products
  17. Drug name: Company Name
  18. Drug profiles in the detailed report…..
  19. Inactive Products
  20. Migraine Key Companies
  21. Migraine Key Products
  22. Migraine – Unmet Needs
  23. Migraine – Market Drivers and Barriers
  24. Migraine – Future Perspectives and Conclusion
  25. Migraine Analyst Views
  26. Migraine Key Companies
  27. Appendix

About Us

DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.

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