ubrogepant

Trade name: Ubrelvy

Small moleculeapproved

Approved

Dec 23, 2019

Ubrogepant, a small molecule drug, is being developed by Merck & Co for the treatment of migraine. The calcitonin gene-related peptide receptor (CGRP) antagonist is administered orally as a film coated tablet. Ubrogepant is a competitive antagonist with high affinity, potency, and selectivity for the human CGRP receptor. In the four clinical studies (ACHIEVE I, ACHIEVE II, UBR-MD-04 and 3110-105-002) ubrogepant demonstrated efficacy, safety and tolerability in the acute treatment of migraine among a broad patient population, including those who had an insufficient response to a triptan or those patients in whom triptans were contraindicated, as well as in patients who had moderate to severe CV risk profile. — NCATS

Clinical trial activity

17 trials · 6 clinical orgs · 3 marketing orgs

Phase 1
4
Phase 2
9
Phase 3
7
Phase 4
3

Earliest trial started Jul 1, 2012 (NCT01613248)

Timeline

2010s

  1. Jan 1, 2012

    Allergan — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2016

    Allergan — Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 2019

    Allergan — Earliest Phase 1 Sponsor(trial)

  4. Dec 23, 2019

    Allergan — Earliest FDA Approval

  5. Dec 23, 2019

    Allergan — Marketing Organization

  6. Dec 23, 2019

    Allergan — NDA Organization

  7. Dec 23, 2019

    AbbVie — Marketing Organization

  8. Dec 23, 2019

    AbbVie — NDA Secondary Org

2020s

  1. May 28, 2025

    Aurobindo Pharma — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedDec 23, 2019

Chemistry & pharmacology

Loading structure…

SMILES

C[C@@H]1[C@@H](C[C@H](NC(=O)C2=CN=C3C[C@]4(CC3=C2)C(=O)NC5=NC=CC=C45)C(=O)N1CC(F)(F)F)C6=CC=CC=C6
Mol. weight
549.5436 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

  • 1',2',5,7-tetrahydro-n-((3s,5s,6r)-6-methyl-2-oxo-5-phenyl-1-(2,2,2-trifluoroethyl)-3-piperidinyl)-2'-oxo-, (6s)- spiro(6h-cyclopenta(b)pyridine-6,3'-(3h)pyrrolo(2,3-b)pyridine)-3-carboxamide
  • mk-1602
  • mk-1602
  • mk-1602
  • mk-1602
  • ubrogepant
  • ubrogepant
  • ubrogepant
  • ubrogepant

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06578585Phase 1Sep 13, 2024Lundbeck
NCT06417775Phase 3Sep 10, 2024AbbVie
NCT05892757Phase 1Jul 11, 2023AbbVie
NCT05503082Phase 4Aug 31, 2022AbbVie, Chicago Headache Center
NCT05214001Phase 4Jun 30, 2022University of Copenhagen
NCT05654298N/AMar 15, 2022Katholieke Universiteit Leuven
NCT05264129Phase 4Mar 7, 2022AbbVie
NCT05127954Phase 3Nov 12, 2021Allergan
NCT05125302Phase 3Nov 9, 2021Allergan
NCT04818515Phase 1Mar 17, 2021Allergan
NCT04492020Phase 3Aug 21, 2020Allergan
NCT04179474Phase 1Sep 26, 2019Allergan
NCT02873221Phase 3Sep 13, 2016Allergan
NCT02867709Phase 3Aug 26, 2016Allergan
NCT02828020Phase 3Jul 22, 2016Allergan
NCT01657370Phase 2Aug 1, 2012Allergan
NCT01613248Phase 2Jul 1, 2012Allergan
Showing 17 of 17 trials
Page 1 / 1

Organizations

Research & Development (6)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AllerganFor profit101032012
AbbVieFor profit4332022
Chicago Headache CenterAcademic/Hospital1112022
Katholieke Universiteit LeuvenAcademic/Hospital1112022
LundbeckFor profit1112024
University of CopenhagenAcademic/Hospital1112022
6 organizations
Page 1 / 1

Marketing (5)

OrganizationOrg typeRelationshipDate
AbbVieFor profitMKTGDec 23, 2019
AbbVieFor profitNDA2Dec 23, 2019
AllerganFor profitMKTGDec 23, 2019
AllerganFor profitNDADec 23, 2019
Aurobindo PharmaFor profitMKTGMay 28, 2025