Ireland
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Priya Life Science Compound trial record
Compound · clinical trials

Atogepant clinical trials

Also listed in trial records as Qulipta, AGN-241689, Aquipta
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 8 trials in our Italy, UK, Poland, Japan, USA, Spain, Netherlands, Denmark, Canada, France, Belgium, Sweden, Israel, Portugal, South Korea, China, Germany, Czechia, Taiwan and Switzerland registers that name Atogepant as an intervention. Synced 10 Nov 2026
8Current trials
4Recruiting now
4Lead sponsors
20Country registers
At a glance

Atogepant is named as an intervention in 8 current clinical trials in our Italy, UK, Poland, Japan, USA, Spain, Netherlands, Denmark, Canada, France, Belgium, Sweden, Israel, Portugal, South Korea, China, Germany, Czechia, Taiwan and Switzerland registers. 4 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is AbbVie (5). The most-studied condition is Episodic Migraine.

Where Atogepant is approved

All regulators →

Of the three regulators tracked here, the first to approve Atogepant was the US, on 28 Sep 2021. It is approved in 3 of the 3 regulators tracked here.

USUnited States (FDA)
28 Sep 2021
Qulipta
NDA215206 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
11 Aug 2023
Aquipta
EMA product page
First centralised authorisation
CACanada (Health Canada)
22 Dec 2022
Qulipta
Notice of Compliance 29754
First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

Atogepant patents and exclusivity

Expiry tracker →

Protections still running for marketed products containing Atogepant, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.

US FDA Orange Book Qulipta
  • 9 listed patents; the last listed expires 27 Feb 2043 (US 12350259).
  • Latest patent on the drug substance itself: 28 Sep 2035 (US 8754096).
See the Orange Book listing for NDA 215206

Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.

What health systems spend on Atogepant

All medicines →
ENNHS England
£20.4m
100,505 items dispensed, Sep 2025 to Aug 2026
+301% on the previous 12 months
Net ingredient cost, community prescriptions
USUS Medicaid
$223.9m
194,866 prescriptions in 2025 · Qulipta
+45% on 2024
Amount Medicaid reimbursed, before rebates

From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.

How Atogepant works

All drug targets →
  • Calcitonin gene-related peptide type 1 receptor antagonist Antagonist
    Target: CALCRL calcitonin receptor like receptor
    ✓ In ChEMBL and the Guide to Pharmacology
Other medicines acting on CALCRL

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL3991065, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 9730, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

NICE appraisals of Atogepant

All NICE appraisals →

NICE, which decides whether the NHS in England should fund new medicines, has published 2 technology appraisals of Atogepant. 2 are current, and 2 of these recommend it for at least some patients.

AppraisalNICE recommendationPublishedStatus
Atogepant for treating migraine
NICE TA1172
Optimised30 Jun 2026Current
Atogepant for preventing migraine
NICE TA973
Optimised15 May 2024Current

NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.

Patient leaflets for Atogepant

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

  • IE
    Ireland: 2 products on the HPRA list
    Each product record links to the HPRA, which publishes the leaflet and SmPC.
  • EU
    European Union: Aquipta
    EMA product information: package leaflet and summary of product characteristics in every EU language.
  • UK
    United Kingdom: Search MHRA Products
    Patient information leaflets and SmPCs for UK-licensed products.
  • US
    United States: Search DailyMed
    FDA-approved labels, including patient and medication guides.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Reference identifiers for Atogepant

ChEMBL
CHEMBL3991065
DrugBank
DB16098
PubChem CID
72163100
CAS number
1374248-81-3
FDA UNII
7CRV8RR151
Wikidata
Q76797798
Wikipedia
Atogepant

Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.

Trials by status

  • Recruiting450%
  • Not yet open113%
  • Active, closed225%
  • By invitation113%

Trials by phase

  • Phase 3450%
  • Observational338%
  • Phase 4113%
01

Clinical trials of Atogepant

8 trials
StudyPhaseStatusLead sponsorRegisters
A Study to Assess the Adverse Events and Change in Disease Activity of Oral Atogepant Tablets in Pediatric Participants (6-17 Years of Age) With Episodic Migraine
NCT05711394 · Episodic Migraine
Phase 3 Recruiting AbbVie UK, USA, France, Spain, Italy, Netherlands, Belgium, Sweden, Denmark, Poland, Canada, Japan, Israel
A Study of Oral Atogepant Tablets to Assess Adverse Events and Change in Disease Activity To Prevent Migraine in Participants Aged 12 to 17 Years
NCT06810505 · Chronic Migraine
Phase 3 Recruiting AbbVie UK, USA, Italy, Netherlands, Denmark, Poland, Portugal, Canada, Japan
Post-Marketing Study to Assess the Safety and Effectiveness of Oral Atogepant in Korean Adult Participants for the Prevention of Chronic or Episodic Migraine
NCT06603558 · ClinicalTrials.gov ↗ · Chronic Migraine, Episodic Migraine, Migraine
Observational Recruiting AbbVie South Korea
Neurophysiological and Biomolecular Effects of Atogepant in Episodic Migraine
NCT06882122 · ClinicalTrials.gov ↗ · Migraine Disorder, Episodic Migraine
Observational Recruiting IRCCS National Neurological Institute "C. Mondino" Foundation Italy
Effect of Atogepant on the Vestibulo-Ocular Reflex in Healthy Adults and Adults With Migraine
NCT07826910 · ClinicalTrials.gov ↗ · Migraine Disorders, Brain, Healthy Adult Participants, Vestibulo-Ocular Reflex
Phase 4 Not yet open Konrad Peter Weber Switzerland
Long-term Extension Study to Assess Adverse Events of Oral Atogepant Tablets in Pediatric Participants (6 to 17 Years of Age) With Migraine
NCT05707949 · Migraine Prophylaxis
Phase 3 By invitation AbbVie UK, USA, France, Spain, Italy, Netherlands, Belgium, Sweden, Denmark, Poland, Canada, Japan, Israel
Study of Oral Atogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine
NCT06806293 · Menstrual Migraine (MM)
Phase 3 Active, closed AbbVie UK, China, Germany, Spain, Italy, Poland, Czechia, Portugal, Japan, South Korea, Taiwan
Italian Real-life obServational Study on the effecTiveness, sAfety and Tolerability of Atogepant in Migraine Patients
NCT06414044 · ClinicalTrials.gov ↗ · Migraine, Migraine With Aura, Migraine Without Aura
Observational Active, closed University of Florence Italy

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Atogepant across our data

Ireland · EU · US

The same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.

Licensed in Ireland (HPRA)

2 single-substance products containing Atogepant on the HPRA medicines list.

All 2 Irish products →

Supply shortages

No entry for Atogepant in the EMA, FDA or German BfArM shortage lists we track.

03

Conditions studied with Atogepant

11 conditions
Episodic Migraine3Chronic Migraine3Migraine2Migraine Prophylaxis1Menstrual Migraine (MM)1Migraine Disorder1Migraine With Aura1Migraine Without Aura1Migraine Disorders, Brain1Healthy Adult Participants1Vestibulo-Ocular Reflex1
06

Related compounds

07

Questions about Atogepant trials

How many clinical trials are testing Atogepant?

8 current trials in our Italy, UK, Poland, Japan, USA, Spain, Netherlands, Denmark, Canada, France, Belgium, Sweden, Israel, Portugal, South Korea, China, Germany, Czechia, Taiwan and Switzerland registers name Atogepant (also registered as AGN-241689) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.

Are Atogepant trials recruiting patients?

Yes. 4 of the 8 trials are recruiting: 3 with sites in Italy, 2 with sites in UK, 2 with sites in Poland, 2 with sites in Japan, 2 with sites in USA, 1 with sites in Spain, 2 with sites in Netherlands, 2 with sites in Denmark, 2 with sites in Canada, 1 with sites in France, 1 with sites in Belgium, 1 with sites in Sweden, 1 with sites in Israel, 1 with sites in Portugal and 1 with sites in South Korea. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Atogepant clinical trials?

AbbVie (5), IRCCS National Neurological Institute "C. Mondino" Foundation (1), University of Florence (1) and Konrad Peter Weber (1). The number in brackets is how many trials each organisation leads.

Is Atogepant licensed in Ireland?

Yes. The HPRA medicines list includes 2 single-substance products containing Atogepant, for example AQUIPTA 10 mg tablets (AbbVie Deutschland GmbH & Co. KG). A licence does not mean a product is currently marketed or reimbursed; see each product's record.

Is there a Atogepant shortage?

Not in the lists we track: Atogepant has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Atogepant works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Atogepant works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Atogepant (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.