CGRP: 5 Essentials to Know
Researchers are still searching to uncover the pathology that causes migraines, in hopes that by understanding how they develop, new treatments can interrupt the disease process and prevent migraines from occurring altogether. While the exact ways migraines occur and cause so much disabling pain remains unknown, scientists have identified a new potential target: calcitonin-gene-related peptide (CGRP). Here are five essential facts you need to know about CGRP:
1. A new target
CGRP is a small protein that acts as a neurotransmitter (a chemical messenger) that is found throughout the brain and body and is highly prevalent in the trigeminal system, the sensory nerves that supply the head and neck. Researchers discovered CGRP is found in high levels in migraine sufferers during an attack, providing a new target for pharmaceutical drugs to focus on. To target CGRP, pharmaceutical researchers have developed monoclonal antibodies, a type of biologic therapy that targets and neutralizes either CGRP or its receptors.1,2
2. Five products under investigation
There are currently five anti-CGRP treatments in development. Four have been submitted to the Food and Drug Administration (FDA), and the fifth is in phase III clinical trials. Phase III clinical trials study a particular treatment in large numbers of patients (typically more than 300) to determine the effectiveness of a drug, as well as understand any potential side effects. Once Phase III clinical trials are completed, a pharmaceutical company can apply for drug approval with the FDA.1,3 The five anti-CGRP products in development are:
- Aimovig (Erenumab), co-developed by Novartis and Amgen - Approved on May 17, 2018
- Eptinezumab (ALD403), developed by Alder Biopharmaceuticals
- Emgality (Galcanezumab), developed by Eli Lilly - Approved on Semptember 27, 2018
- Fremanezumab (TEV-48125), developed by Teva1 - Approved on September 14, 2018
- Ubrogepant, developed by Allergan - Approved on December 23, 2019
3. Promising results
All of the anti-CGRP drugs in development have shown promising results in earlier studies. As an example, 30% of patients receiving ALD403 had a 75% reduction in the number of days they experienced migraines over the course of a 12-week study. All of the anti-CGRP products are injectable – some are injected subcutaneously (under the skin) and others are injected intravenously (into a vein). ALD403 is delivered intravenously, and one injection can reduce migraine days for six months. And so far, the anti-CGRP drugs seem to be well tolerated, causing fewer side effects than other migraine treatments, like triptans. However, additional research is needed to understand any potential long-term adverse effects.1
4. Anticipated timing for availability
The phase III clinical trials have to be completed and the data must be analyzed before any application to the FDA can be made. Four of the anti-CGRP products have been submitted to the FDA. Ubrogepant is still in phase III clinical trials. Researchers are optimistic that we may see a new anti-CGRP product by the second half of 2018.1
5. Participate in clinical trial research
While the clinical trial process is long and expensive, it is crucial for identifying effective and safe treatments. Many trials fail or are delayed because they do not have enough participants. Several of the anti-CGRP products under investigation are still recruiting participants. If you are interested in being a part of the research and receiving one of these new treatment options for preventing migraine, you can find a clinical trial at ClinicalTrials.gov. Search using one of the product names listed above to find which trials are still recruiting.
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