Wednesday, October 15, 2025

Migraine Pipeline 2025: Therapies Under Investigation, Clinical Trials Milestones, and FDA Approvals by DelveInsight | GlaxoSmithKline, Merck & Co., Inc., Pfizer, Bausch Health, Amgen, Abbvie Inc

Migraine Pipeline 2025: Therapies Under Investigation, Clinical Trials Milestones, and FDA Approvals by DelveInsight | GlaxoSmithKline, Merck & Co., Inc., Pfizer, Bausch Health, Amgen, Abbvie Inc
(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Migraine pipeline constitutes 30+ key companies continuously working towards developing 30+ Migraine treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

 

Migraine Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Migraine Market.

 

The Migraine Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

 

Some of the key takeaways from the Migraine Pipeline Report:

  • Companies across the globe are diligently working toward developing novel Migraine treatment therapies with a considerable amount of success over the years.

  • Migraine companies working in the treatment market are Axsome Therapeutics, Tonix Pharmaceuticals, Eli Lilly and Company, Satsuma Pharmaceuticals, Pulmatrix, Vaxxinity, Inc., Tonix Pharmaceuticals, Inc, AEON Biopharma, Inc., Axsome Therapeutics, Pfizer, and others, are developing therapies for the Migraine treatment

  • Emerging Migraine therapies in the different phases of clinical trials are- TNX1900, LY3451838, STS-101, PUR-3100, UB-313, TNX-1900, ABP-450, AXS 07, Zavegepant, and others are expected to have a significant impact on the Migraine market in the coming years.

  • In September 2025, ShiraTronics aims to secure FDA approval for its migraine implant by 2027, with an Australian review expected afterward. The ShiraTronics Migraine Therapy System is a fully implantable neuromodulation device designed specifically for head-focused therapy. Unlike previous off-label uses of spinal cord stimulators, it utilizes subcutaneous leads that target the occipital and supraorbital nerves.

  • In September 2025, Click Therapeutics, Inc., a pioneer in Digital Therapeutics™, announced achieving the primary endpoint in the pivotal randomized, double-blind, controlled, decentralized ReMMi-D study (NCT05853900) evaluating CT-132 for migraine prevention. After 12 weeks of treatment, CT-132 demonstrated a statistically significant reduction in monthly migraine days (MMDs) compared to sham treatment (-0.9 MMDs, p=0.005) in the ITT population of 568 participants, with the treatment group experiencing a reduction of -3.04 MMDs by the study's conclusion.

  • In June 2025, Lundbeck’s humanized monoclonal antibody, Vyepti (eptinezumab), successfully achieved both primary and secondary endpoints in the placebo-controlled, randomized Phase IV RESOLUTION trial involving patients with chronic migraine and coexisting medication-overuse headache (MOH), who also received standardized patient education. The study enrolled 608 participants diagnosed with both chronic migraine and MOH, who were randomly assigned to receive either eptinezumab with a brief educational intervention (BEI) or placebo with BEI. The primary objective was to evaluate the reduction in monthly migraine days (MMDs) from baseline during the first four weeks of treatment.

  • In June 2025, AbbVie announced that its Phase III TEMPLE study, comparing the oral CGRP receptor antagonist atogepant to the highest tolerated dose of topiramate for adult migraine, has successfully met its primary endpoint. This double-blind, randomized, head-to-head trial demonstrated that atogepant resulted in fewer treatment discontinuations due to adverse events (AEs) compared to topiramate. The study included participants with a history of four or more migraine days per month.

  • In June 2025, Teva Pharmaceutical released the final results from the PEARL Phase IV trial evaluating Ajovy (fremanezumab), an anti-CGRP monoclonal antibody, for the prevention of chronic and episodic migraine (EM). The pan-European study successfully met both its primary and secondary endpoints. The primary objective was to determine the proportion of patients who achieved a minimum 50% reduction in monthly migraine days (MMD) within six months of initiating fremanezumab therapy.

  • In May 2025, The FDA has approved Satsuma’s dihydroergotamine (DHE) nasal powder, STS101—now marketed as Atzumi—for the acute treatment of migraine, with or without aura, according to a company announcement. However, the company clarified that Atzumi is not approved for migraine prevention or for treating hemiplegic migraine or migraine with brainstem aura.

  • In April 2025, The US Food and Drug Administration (FDA) has approved CT-132 from Click Therapeutics, a first-of-its-kind prescription digital therapeutic designed to help prevent episodic migraine in adults. According to the company’s announcement, this mobile smartphone application combines biological, psychological, and behavioral methods to influence pain perception. Features include a daily lesson program and an eDiary tracker. CT-132 is intended to be used in conjunction with existing acute and preventive migraine treatments.

 

Migraine Overview

Migraine is a neurological disorder characterized by recurring headaches, often on one side of the head, accompanied by other symptoms such as nausea, vomiting, and sensitivity to light and sound. Migraines can occur with or without an aura, which are sensory disturbances like visual changes or tingling sensations that precede the headache. They are triggered by various factors, including stress, hormonal changes, certain foods, or environmental stimuli. While the exact cause is not fully understood, migraines are linked to genetic and environmental factors. Treatment includes pain relief medications, preventive therapies, and lifestyle modifications to reduce frequency and severity.

 

Get a Free Sample PDF Report to know more about Migraine Pipeline Therapeutic Assessment-

https://www.delveinsight.com/report-store/migraine-pipeline-insight

 

Emerging Migraine Drugs Under Different Phases of Clinical Development Include:

  • AXS-07: Axsome Therapeutics

  • TNX1900: Tonix Pharmaceuticals

  • LY3451838: Eli Lilly and Company

  • STS-101: Satsuma Pharmaceuticals

  • PUR-3100: Pulmatrix

  • UB-313: Vaxxinity, Inc.

  • TNX-1900: Tonix Pharmaceuticals, Inc

  • ABP-450: AEON Biopharma, Inc.

  • AXS 07: Axsome Therapeutics

  • Zavegepant: Pfizer

 

Migraine Route of Administration

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 Molecule Type

Migraine Products have been categorized under various Molecule types, such as

  • Oligonucleotide

  • Peptide

  • Small molecule

 

Migraine Pipeline Therapeutics Assessment

  • Migraine Assessment by Product Type

  • Migraine By Stage and Product Type

  • Migraine Assessment by Route of Administration

  • Migraine By Stage and Route of Administration

  • Migraine Assessment by Molecule Type

  • Migraine by Stage and Molecule Type

 

DelveInsight's Migraine Report covers around 30+ products under different phases of clinical development like

  • Late-stage products (Phase III)

  • Mid-stage products (Phase II)

  • Early-stage product (Phase I)

  • Pre-clinical and Discovery stage candidates

  • Discontinued & Inactive candidates

  • Route of Administration

 

Further Migraine product details are provided in the report. Download the Migraine pipeline report to learn more about the emerging Migraine therapies

 

Some of the key companies in the Migraine Therapeutics Market include:

Key companies developing therapies for Migraine are - GlaxoSmithKline, Merck & Co., Inc., Pfizer, Bausch Health, Amgen, Abbvie Inc., AstraZeneca, Eli Lilly and Co., Teva Pharmaceuticals, Novartis AG, Eisai Co., Ltd., Abbott Laboratories, and others.

 

Migraine Pipeline Analysis:

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 key 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.

The report is built using data and information traced from the researcher’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

 

Download Sample PDF Report to know more about Migraine drugs and therapies

 

Migraine Pipeline Market Drivers

  • Increasing prevalence of Migraine, significant progress is being made in the preventative treatment of chronic migraine, growing awareness regarding migraine are some of the important factors that are fueling the Migraine Market.

 

Migraine Pipeline Market Barriers

  • However, lack of proper diagnosis, various side-effects associated with the available drugs and other factors are creating obstacles in the Migraine Market growth.

 

Scope of Migraine Pipeline Drug Insight

  • Coverage: Global

  • Key Migraine Companies: Axsome Therapeutics, Tonix Pharmaceuticals, Eli Lilly and Company, Satsuma Pharmaceuticals, Pulmatrix, Vaxxinity, Inc., Tonix Pharmaceuticals, Inc, AEON Biopharma, Inc., Axsome Therapeutics, Pfizer, and others

  • Key Migraine Therapies: TNX1900, LY3451838, STS-101, PUR-3100, UB-313, TNX-1900, ABP-450, AXS 07, Zavegepant, and others

  • Migraine Therapeutic Assessment: Migraine current marketed and Migraine emerging therapies

  • Migraine Market Dynamics: Migraine market drivers and Migraine market barriers

 

Request for Sample PDF Report for Migraine Pipeline Assessment and clinical trials

 

Table of Contents

1. Migraine Report Introduction

2. Migraine Executive Summary

3. Migraine Overview

4. Migraine- Analytical Perspective In-depth Commercial Assessment

5. Migraine Pipeline Therapeutics

6. Migraine Late Stage Products (Phase II/III)

7. Migraine Mid Stage Products (Phase II)

8. Migraine Early Stage Products (Phase I)

9. Migraine Preclinical Stage Products

10. Migraine Therapeutics Assessment

11. Migraine Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Migraine Key Companies

14. Migraine Key Products

15. Migraine Unmet Needs

16 . Migraine Market Drivers and Barriers

17. Migraine Future Perspectives and Conclusion

18. Migraine Analyst Views

19. Appendix

20. About DelveInsight

 

 

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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