Atogepant

{{Short description|Chemical compound}} {{Use American English|date=September 2021}} {{Use dmy dates|date=August 2023}} {{cs1 config |name-list-style=vanc |display-authors=6}} {{Infobox drug | image = Atogepant.svg | image_class = skin-invert-image | width = | alt = | caption =

| pronounce = | tradename = Qulipta, Aquipta | Drugs.com = {{drugs.com|monograph|atogepant}} | MedlinePlus = a621052 | DailyMedID = Atogepant | pregnancy_AU = B3 | pregnancy_AU_comment = <ref name="Aquipta APMDS" /> | pregnancy_category= | routes_of_administration = By mouth | class = | ATCvet = | ATC_prefix = N02 | ATC_suffix = CD07 | ATC_supplemental =

| legal_AU = S4 | legal_AU_comment = <ref name="Aquipta APMDS">{{cite web | title=Aquipta APMDS | website=Therapeutic Goods Administration (TGA) | date=20 December 2023 | url=https://www.tga.gov.au/resources/auspmd/aquipta | access-date=7 March 2024 | archive-date=2 January 2024 | archive-url=https://web.archive.org/web/20240102015343/https://www.tga.gov.au/resources/auspmd/aquipta | url-status=live }}</ref> | legal_BR =  | legal_BR_comment = | legal_CA = Rx-only | legal_CA_comment = <ref>{{cite web | title=Summary Basis of Decision for Qulipta | website=Health Canada | date=20 April 2023 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1684957849549 | access-date=20 August 2023 | archive-date=20 August 2023 | archive-url=https://web.archive.org/web/20230820191658/https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1684957849549 | url-status=live }}</ref><ref>{{cite web | title=Details for: Qulipta | website=Health Canada | date=24 March 2023 | url=https://dhpp.hpfb-dgpsa.ca/dhpp/resource/102287 | access-date=20 August 2023}}</ref> | legal_DE =  | legal_DE_comment = | legal_NZ =  | legal_NZ_comment = | legal_UK =  | legal_UK_comment = | legal_US = Rx-only | legal_US_comment = <ref name="Qulipta FDA label" /> | legal_EU = Rx-only | legal_EU_comment = <ref name="Aquipta EPAR">{{cite web | title=Aquipta EPAR | publisher=European Medicines Agency (EMA) | date=25 August 2023 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/aquipta | access-date=25 August 2023 | archive-date=25 August 2023 | archive-url=https://web.archive.org/web/20230825212457/https://www.ema.europa.eu/en/medicines/human/EPAR/aquipta | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref><ref>{{cite web | title=Aquipta Product information | website=Union Register of medicinal products | date=14 August 2023 | url= https://ec.europa.eu/health/documents/community-register/html/h1750.htm | access-date=25 August 2023 | archive-date=25 August 2023 | archive-url=https://web.archive.org/web/20230825212748/https://ec.europa.eu/health/documents/community-register/html/h1750.htm | url-status=live }}</ref> | legal_UN =  | legal_UN_comment = | legal_status =

| IUPAC_name = (3''S'')-''N''-[(3''S'',5''S'',6''R'')-6-methyl-2-oxo-1-(2,2,2-trifluoroethyl)-5-(2,3,6-trifluorophenyl)piperidin-3-yl]-2-oxospiro[1''H''-pyrrolo[2,3-b]pyridine-3,6'-5,7-dihydrocyclopenta[b]pyridine]-3'-carboxamide | C=29 | H=23 | F=6 | N=5 | O=3 | SMILES = C[C@@H]1[C@H](c2c(F)ccc(F)c2F)C[C@H](NC(=O)c2cnc3c(c2)C[C@@]2(C3)C(=O)Nc3ncccc32)C(=O)N1CC(F)(F)F | StdInChI_Ref = | StdInChI = 1S/C29H23F6N5O3/c1-13-16(22-18(30)4-5-19(31)23(22)32)8-20(26(42)40(13)12-29(33,34)35)38-25(41)15-7-14-9-28(10-21(14)37-11-15)17-3-2-6-36-24(17)39-27(28)43/h2-7,11,13,16,20H,8-10,12H2,1H3,(H,38,41)(H,36,39,43)/t13-,16-,20+,28+/m1/s1 | StdInChI_comment = | StdInChIKey_Ref = | StdInChIKey = QIVUCLWGARAQIO-OLIXTKCUSA-N | density = | density_notes = | melting_point = | melting_high = | melting_notes = | boiling_point = | boiling_notes = | solubility = | sol_units = | specific_rotation = }}

'''Atogepant''', sold under the brand name '''Qulipta''' among others, is a medication used to prevent migraines.<ref name="Qulipta FDA label" /><ref name="Aquipta EPAR" /> It is a gepant, a calcitonin gene-related peptide receptor antagonist administered orally.<ref name="Qulipta FDA label">{{cite web | title=Qulipta- atogepant tablet | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8c8ab8f4-32bd-497a-befa-70c8a51d8d52 | access-date=31 October 2021 | archive-date=1 November 2021 | archive-url=https://web.archive.org/web/20211101041111/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8c8ab8f4-32bd-497a-befa-70c8a51d8d52 | url-status=live }}</ref><ref name="Moreno-Ajona_2020">{{cite journal | vauthors = Moreno-Ajona D, Pérez-Rodríguez A, Goadsby PJ | title = Gepants, calcitonin-gene-related peptide receptor antagonists: what could be their role in migraine treatment? | journal = Current Opinion in Neurology | volume = 33 | issue = 3 | pages = 309–315 | date = June 2020 | pmid = 32251023 | doi = 10.1097/WCO.0000000000000806 | s2cid = 215408433 }}</ref>

The most common side effects include nausea, constipation, tiredness, somnolence (sleepiness), decreased appetite, and decreased weight.<ref name="Aquipta EPAR" />

Atogepant was approved for medical use in the United States in September 2021,<ref name="Qulipta FDA label" /><ref>{{cite press release | title=FDA Approves Qulipta (atogepant), the First and Only Oral CGRP Receptor Antagonist Specifically Developed for the Preventive Treatment of Migraine | website=AbbVie | via=PR Newswire | date=28 September 2021 | url=https://www.prnewswire.com/news-releases/fda-approves-qulipta-atogepant-the-first-and-only-oral-cgrp-receptor-antagonist-specifically-developed-for-the-preventive-treatment-of-migraine-301387297.html | access-date=29 September 2021 | archive-date=28 September 2021 | archive-url=https://web.archive.org/web/20210928233843/https://www.prnewswire.com/news-releases/fda-approves-qulipta-atogepant-the-first-and-only-oral-cgrp-receptor-antagonist-specifically-developed-for-the-preventive-treatment-of-migraine-301387297.html | url-status=live }}</ref> and in the European Union in August 2023.<ref name="Aquipta EPAR" /><ref>{{cite press release | title=AbbVie Announces European Commission Approval of Aquipta (atogepant) for the Preventive Treatment of Migraine in Adults | publisher=AbbVie | via=PR Newswire | date=17 August 2023 | url=https://www.prnewswire.com/news-releases/abbvie-announces-european-commission-approval-of-aquipta-atogepant-for-the-preventive-treatment-of-migraine-in-adults-301903027.html | access-date=25 August 2023 | archive-date=24 August 2023 | archive-url=https://web.archive.org/web/20230824082847/https://www.prnewswire.com/news-releases/abbvie-announces-european-commission-approval-of-aquipta-atogepant-for-the-preventive-treatment-of-migraine-in-adults-301903027.html | url-status=live }}</ref>

== Medical uses == Atogepant is indicated for the preventive treatment of episodic migraine in adults.<ref name="Qulipta FDA label" /><ref name="Aquipta EPAR" />

In the European Union, atogepant (Aquipta) is indicated for prophylaxis (prevention) of migraine in adults who have at least four migraine days per month.<ref name="Aquipta EPAR" />

== History == Atogepant was developed by the biopharmaceutical company AbbVie.<ref>{{Cite web |last=Cornall |first=Jim |date=2023-06-26 |title=AbbVie takes step forward in Europe with migraine drug |url=https://www.labiotech.eu/trends-news/abbvie-step-forward-migraine-drug/ |access-date=2024-07-26 |website=Labiotech.eu |language=en-US}}</ref> The benefits and side effects of atogepant were evaluated in two clinical trials of 1,562 participants with a history of migraine headaches occurring on 4 to 14 days per month.<ref name="Qulipta FDA snapshot">{{cite web | title=Drug Trials Snapshots: Qulipta | website=U.S. Food and Drug Administration | date=28 September 2021 | url=https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-qulipta | access-date=10 September 2023 | archive-date=25 August 2023 | archive-url=https://web.archive.org/web/20230825214123/https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-qulipta | url-status=dead }} {{PD-notice}}</ref> The two trials to show the benefits were designed similarly.<ref name="Qulipta FDA snapshot" /> Trials 1 and 2 assigned participants to one of several doses of atogepant or placebo daily for three months.<ref name="Qulipta FDA snapshot" /> Neither the participants nor the health care providers knew which treatment was being given until after the trial was completed.<ref name="Qulipta FDA snapshot" /> The benefit of atogepant was assessed based on the change from baseline in the number of migraine days per month to the last month of the three-month treatment period, comparing participants in the atogepant and placebo groups.<ref name="Qulipta FDA snapshot" /> The trials were conducted at over 100 sites in the United States.<ref name="Qulipta FDA snapshot" /> The safety of atogepant was evaluated in 1,958 participants with migraine who received at least one dose of atogepant; therefore, the number of participants representing efficacy findings may differ from the number of participants representing safety findings due to different pools of study participants analyzed for efficacy and safety.<ref name="Qulipta FDA snapshot" />

The UK’s National Institute for Health and Care Excellence has issued draft guidance recommending atogepant for preventing episodic and chronic migraine in NHS patients. It's approved for those experiencing at least 4 migraine days per month after failing 3 prior treatments. Atogepant costs £463 monthly but includes a confidential discount.<ref>{{Cite report |url=https://onlinelibrary.wiley.com/do/10.1002/psb.0010155/abs/ |title=NICE recommends atogepant for preventing episodic and chronic migraine in final draft guidance |date=2024-04-11 |doi=10.1002/psb.0010155 |language=en|url-access=subscription }}</ref>

== Research == Atogepant demonstrated efficacy in two phase 3 trials (ADVANCE and PROGRESS) by significantly reducing monthly migraine days, acute medication use, and improving quality of life in patients with episodic and chronic migraine over 12 weeks compared to placebo.<ref>{{Cite report |url=https://onlinelibrary.wiley.com/do/10.1002/psb.0010155/abs/ |title=NICE recommends atogepant for preventing episodic and chronic migraine in final draft guidance |date=2024-04-11 |doi=10.1002/psb.0010155 |language=en|url-access=subscription }}</ref> Common side effects included nausea, constipation, and fatigue/somnolence.

A study presented at the 2023 meeting for the American Academy of Neurology also showed that atogepant may help prevent migraines in patients who have had no prior success with other preventative drugs.<ref>{{Cite web |title=Study Shows Atogepant Prevents Migraine In Difficult Cases |url=https://www.painmedicinenews.com/Clinical-Pain-Medicine/Article/08-23/Atogepant-Prevents-Migraine/71109 |access-date=2024-07-26 |website=Pain Medicine News}}</ref>

==References== {{Reflist}}

Category:Drugs developed by AbbVie Category:Antimigraine drugs Category:Calcitonin gene-related peptide receptor antagonists Category:Carboxamides Category:Organofluorides Category:Piperidines Category:Pyridines Category:Pyrroles Category:Spiro compounds Category:Trifluoroethyl compounds