atogepant

Trade name: Qulipta

Small moleculeapproved

Approved

Sep 28, 2021

Clinical trial activity

21 trials · 5 clinical orgs · 1 marketing orgs

Phase 1
2
Phase 2
16
Phase 3
17
Phase 4
2

Earliest trial started Sep 1, 2016 (NCT02848326)

Timeline

2010s

  1. Jan 1, 2016

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2018

    Earliest Phase 3 Sponsor(trial)

2020s

  1. Jan 1, 2021

    Earliest Phase 1 Sponsor(trial)

  2. Sep 28, 2021

    AbbVie — Earliest FDA Approval

  3. Sep 28, 2021

    AbbVie — Marketing Organization

  4. Sep 28, 2021

    AbbVie — NDA Secondary Org

  5. Sep 28, 2021

    AbbVie — NDA Organization

Indications

Mechanism of action

Approval history

  • approvedPriority reviewSep 28, 2021

Chemistry & pharmacology

Loading structure…

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
Mol. weight
603.52 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • agn-241689
  • agn-241689

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06972056Phase 4Jul 9, 2025AbbVie, Mayo Clinic, Patient-Centered Outcomes Research Institute, University of Iowa
NCT06810505Phase 3Feb 13, 2025AbbVie
NCT06806293Phase 3Feb 10, 2025AbbVie
NCT06241313Phase 3Mar 25, 2024AbbVie
NCT05748483Phase 3Oct 7, 2023AbbVie
NCT05861427Phase 3Jul 12, 2023AbbVie
NCT05892757Phase 1Jul 11, 2023AbbVie
NCT05707949Phase 3Jun 5, 2023AbbVie
NCT05711394Phase 3May 1, 2023AbbVie
NCT05216263Phase 3Nov 1, 2022Allergan
NCT05264129Phase 4Mar 7, 2022AbbVie
NCT04829747Phase 3Aug 2, 2021Allergan
NCT04818515Phase 1Mar 17, 2021Allergan
NCT04740827Phase 3Mar 5, 2021Allergan
NCT04686136Phase 3Feb 1, 2021Allergan
NCT04437433Phase 3Jun 17, 2020Allergan
NCT03939312Phase 3May 6, 2019Allergan
NCT03855137Phase 3Mar 11, 2019Allergan
NCT03777059Phase 3Dec 14, 2018Allergan
NCT03700320Phase 3Oct 8, 2018Allergan
Showing 20 of 21 trials
Page 1 / 2

Organizations

Research & Development (5)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AllerganFor profit111122016
AbbVieFor profit10932022
Mayo ClinicAcademic/Hospital1112025
Patient-Centered Outcomes Research InstituteAcademic/Hospital1012025
University of IowaAcademic/Hospital1012025
5 organizations
Page 1 / 1

Marketing (4)

OrganizationOrg typeRelationshipDate
AbbVieFor profitMKTGSep 28, 2021
AbbVieFor profitSYNSep 28, 2021
AbbVieFor profitNDA2Sep 28, 2021
AbbVieFor profitNDASep 28, 2021