There are several medications and medical devices coming soon that are in various stages of clinical trials, ranging from pre-clinical through to waiting for FDA approval or clearance. In addition to the trials listed below, there are several clinical trials investigating CGRP inhibitor medications in children and adolescents.
Being Relaunched!
- ELYXYB™: A prescription nonsteroidal anti-inflammatory drug (NSAID) used for the acute treatment of migraine with or without aura in adults. This medication was not available for a while due to the pharmaceutical company deciding not to keep manufacturing it. However, it was bought out by a company called Scilex Holding and will be widely available again sometime in the 1st quarter of 2024 - with some places being able to obtain it already.
Phase II & III Clinical Trials
- Idebenone: An oral tablet which improves energy metabolism similar to CoQ10 and is being investigated for migraine prevention. (Currently in Phase 4 studies in China which are expected to be completed June 2024)
- AXS-07: An oral, rapidly absorbed, tablet consisting of Meloxicam and Rizatriptan for the acute treatment of migraine. (Currently in Phase III Open Label clinical trials to study the safety and efficacy. Expected to be completed December 2023)
- TX360: A device which delivers bupivacaine to the sphenopalatine ganglion for migraine prevention. (Currently in Phase III clinical trials. Expected to be completed March 2024)
- Dysport: An injectable formulation of Botulinum toxin type A. (Currently in Phase III clinical trials for the prevention of chronic and episodic migraine. Expected to be completed January 2026)
- Tricaprilin: An oral drug which has been designed to induce ketosis and improve mitochondrial metabolism, and is currently being investigated for preventive treatment of migraine. (A Phase 2 pilot study was completed July 2022 - no further updates)
- Cannabis: Inhaled cannabis being investigated for acute treatment of migraine. (Currently in Phase 2 clinical trials which are expected to be completed June 2024)
- LY3451838: A PACAP inhibitor which is being investigated for preventive migraine treatment. (Currently finished Phase 2 trials with positive results - we are waiting for more information on Phase 3 trials).
- TNX-1900: An intranasal oxytocin product being studies for migraine prevention for chronic migraine. (Currently finishing Phase 2 studies - expected completion March 2024)
Pre-Clinical & Phase I Clinical Trials
- Psilocybin: Oral psilocybin being investigated for preventive treatment of migraine. (Currently in Phase 1 clinical trials which are expected to be completed December 2023)
- Protease Activated Receptor-2 (PAR-2) Inhibitors: This is a novel class of small molecules which inhibit PAR-2, which generates cellular signals involved in inflammation and pain. Currently in preclinical trials for migraine.
- XC101-D13H: A 5-HT2B/2C receptor antagonist without serotonergic agonist-driven side effects, which is currently being investigated for preventive treatment of migraine. (Phase 1 clinical trial results were presented June 2020 - no further news currently)
Medical Devices in Clinical Trials
- Nocira: an AVPI device for the acute treatment of migraine. It is currently in Phase I interventional clinical trials to evaluate safety and efficacy. The trials are expected to be completed December 2023.
- Pulsante: Sphenopalatine Ganglion Stimulator. This device was FDA cleared April 2021 for the treatment of acute headache pain associated with chronic cluster headache. It is not yet FDA cleared for migraine in the USA, although it has received approval in Europe.
- RELIEV-CM: This study in Australia is an interventional study of Shiratronics' implantable craniofacial nerve stimulation system for migraine prevention. This initial trial is expected to be completed December 2024.
Download the Migraine Treatment Toolbox
Bring it to your next doctor's appointment and ask your doctor which options would be good to add to your personal migraine treatment toolbox.