Aquipta
Authorised
This medicine is authorised for use in the European Union
atogepant
MedicineHumanAuthorised
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Aquipta is a medicine used in adults to treat migraine with or without aura (unusual visual or other sensory experience). It is also used to prevent migraines in adults who have migraines at least 4 days a month.
Aquipta contains the active substance atogepant.
Aquipta can only be obtained with a prescription. It is available as tablets to be taken by mouth once a day for the prevention of migraine or as needed for the treatment of migraine.
People using Aquipta to prevent migraine should not use this medicine to treat a migraine as they will already have taken the maximum recommended dose per day.
For more information about using Aquipta, see the package leaflet or contact your doctor or pharmacist.
The exact way that Aquipta works is not fully understood. The active substance in Aquipta, atogepant, attaches to receptors (targets) for proteins called CGRP and amylin-1. These proteins are involved in the development of migraine. By attaching to these receptors, the medicine prevents CGRP and amylin-1 from binding to them. This helps to treat and prevent migraine.
Aquipta was shown to reduce the number of days patients have migraines in two main studies.
In one study involving 882 patients who experienced at least 4 migraines a month, treatment with Aquipta for 12 weeks reduced the number of migraine days from around 8 per month to around 3 to 4 per month, compared with around 5 per month for patients taking placebo (a dummy treatment).
In another study involving 760 patients who experienced at least 15 headache days a month with 8 out of these being migraine days, treatment with Aquipta for 12 weeks reduced migraine days from around 19 per month to around 12 per month, compared with 14 per month for patients taking placebo.
Another study, involving 1,328 adults with a history of migraine, showed that Aquipta was effective at treating acute (sudden-onset) migraines. The study looked at how many people were pain free 2 hours after taking either Aquipta or placebo to treat their first migraine attack. Being pain free was defined as having a reduction in headache severity from moderate or severe migraine pain to no pain. Of the people who took Aquipta, around 24% (146 out of 602) were pain free 2 hours after taking the medicine compared with around 13% (80 out of 612) of those who took placebo.
Studies carried out with Aquipta are described in more detail in the medicine’s assessment reports.
For the full list of side effects and restrictions with Aquipta, see the package leaflet.
The most common side effects with Aquipta when used to prevent migraine (which may affect up to 1 in 10 people) include nausea (feeling sick), constipation, tiredness, somnolence (sleepiness), decreased appetite and decreased weight. When used to treat migraine, the most common side effect with Aquipta (which may affect up to 1 in 10 people) is nausea.
Aquipta can reduce the number of migraine days and is effective in treating acute migraine attacks. Most of the side effects are mild or moderate in severity. The European Medicines Agency therefore decided that Aquipta’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Aquipta have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Aquipta are continuously monitored. Suspected side effects reported with Aquipta are carefully evaluated and any necessary action taken to protect patients.
Aquipta received a marketing authorisation valid throughout the EU on 11 August 2023.
Product information
Latest procedure affecting product information:VR/0000310717
29/05/2026
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Aquipta
- Active substance
- atogepant
- International non-proprietary name (INN) or common name
- atogepant
- Therapeutic area (MeSH)
- Migraine Disorders
- Anatomical therapeutic chemical (ATC) code
- N02CD07
Therapeutic indication
Aquipta is indicated for:
- acute treatment of migraine with or without aura in adults
- prophylaxis of migraine in adults who have at least 4 migraine days per month.
News on Aquipta
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