Ubrogepant History and Updates

63 events · 2016 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: June 18, 2026.

FDA Approvals

Label Revisions

Trial Milestones

Pivotal Publications

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-17Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Ubrogepant since 2016, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (3)

2023

Pivotal publicationUbrogepant Phase 3 Trial Published for Migraine Prodrome Treatment· Jan 1, 2023

2019

Pivotal publicationUbrogepant Migraine Treatment Study Results Published in NEJM· Jan 1, 2019
Pivotal publicationUbrogepant Reduces Migraine Pain and Most Bothersome Symptom vs Placebo· Jan 1, 2019

Upcoming & expected milestones

Primary completionMay 31, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT05125302

Study to Assess Adverse Events and Disease Activity of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Children and Adolescen

Primary completionJun 30, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT06417775

Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine

Primary completionJan 31, 2028· ClinicalTrials.gov

Phase 3 primary completion: NCT05127954

Long-term Extension Study to Assess Safety and Tolerability of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Pediatric Part

Past events

2026

Primary completionMay 31, 2026· ClinicalTrials.gov

Primary completion: NCT06212661

Migraine Medication Effects on Urinary Symptoms

Primary completionMay 31, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT05125302

Study to Assess Adverse Events and Disease Activity of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Children and Adolescen

2025

Primary completionJul 11, 2025· ClinicalTrials.gov

Phase 1 primary completion: NCT06578585

A Trial Investigating Lu AG09222 With Ubrogepant in Participants With Migraine

FDA approval (supplemental)Jun 5, 2025· FDA

FDA approved supplemental application for Ubrelvy (ubrogepant) — Labeling (NDA 211765 S-12)

Sponsor: ABBVIE. Class: Labeling.

FDA approval (supplemental)Mar 21, 2025· FDA

FDA approved supplemental application for Ubrelvy (ubrogepant) — Labeling (NDA 211765 S-13)

Sponsor: ABBVIE. Class: Labeling.

2024

Results postedOct 8, 2024· ClinicalTrials.gov

Trial results posted: NCT05264129

Study to Assess Adverse Events When Ubrogepant Tablets in Combination With Atogepant Tablets Are Used to Treat Adult Participants With Migra

Primary completionSep 30, 2024· ClinicalTrials.gov

Phase 4 primary completion: NCT05503082

Ubrogepant treatmeNt in mIgraine Patients Utilizing mOnoclonal aNtibodies

Trial startedSep 13, 2024· ClinicalTrials.gov

Phase 1 trial started: NCT06578585

A Trial Investigating Lu AG09222 With Ubrogepant in Participants With Migraine

Trial startedSep 10, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06417775

Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine

Trial registeredAug 29, 2024· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06578585

A Trial Investigating Lu AG09222 With Ubrogepant in Participants With Migraine

Trial registeredMay 16, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06417775

Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine

Primary completionApr 15, 2024· ClinicalTrials.gov

Phase 4 primary completion: NCT05214001

Evaluation of the Efficacy of Almotriptan and Ubrogepant for the Acute Treatment of Migraine

Trial startedApr 5, 2024· ClinicalTrials.gov

Trial started: NCT06212661

Migraine Medication Effects on Urinary Symptoms

Primary completionFeb 22, 2024· ClinicalTrials.gov

Phase 1 primary completion: NCT05892757

Study to Assess Adverse Events and Compare How Oral Ubrogepant and Oral Atogepant Moves Through the Body of Healthy Female Adult Volunteers

Trial registeredJan 19, 2024· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06212661

Migraine Medication Effects on Urinary Symptoms

2023

Trial startedJul 11, 2023· ClinicalTrials.gov

Phase 1 trial started: NCT05892757

Study to Assess Adverse Events and Compare How Oral Ubrogepant and Oral Atogepant Moves Through the Body of Healthy Female Adult Volunteers

Trial registeredJun 7, 2023· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05892757

Study to Assess Adverse Events and Compare How Oral Ubrogepant and Oral Atogepant Moves Through the Body of Healthy Female Adult Volunteers

Results postedMay 31, 2023· ClinicalTrials.gov

Trial results posted: NCT04492020

Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants

Primary completionApr 4, 2023· ClinicalTrials.gov

Phase 4 primary completion: NCT05264129

Study to Assess Adverse Events When Ubrogepant Tablets in Combination With Atogepant Tablets Are Used to Treat Adult Participants With Migra

Primary completionMar 15, 2023· ClinicalTrials.gov

NA primary completion: NCT05654298

Influence of Ubrogepant and Sumatriptan on the Dermal Blood Flow Response to Histamine, Cinnamaldehyde and Capsaicin

FDA approval (supplemental)Feb 17, 2023· FDA

FDA approved supplemental application for Ubrelvy (ubrogepant) — Labeling (NDA 211765 S-7)

Sponsor: ABBVIE. Class: Labeling.

Pivotal publicationJan 1, 2023· PubMed

Ubrogepant for the treatment of migraine attacks during the prodrome: a phase 3, multicentre, randomised, double-blind, placebo-controlled, crossover trial in t (Lancet)

UBR Prodrome — Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants

2022

Trial registeredDec 16, 2022· ClinicalTrials.gov

NA trial registered on ClinicalTrials.gov: NCT05654298

Influence of Ubrogepant and Sumatriptan on the Dermal Blood Flow Response to Histamine, Cinnamaldehyde and Capsaicin

Trial startedSep 6, 2022· ClinicalTrials.gov

Phase 4 trial started: NCT05503082

Ubrogepant treatmeNt in mIgraine Patients Utilizing mOnoclonal aNtibodies

Trial registeredAug 16, 2022· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT05503082

Ubrogepant treatmeNt in mIgraine Patients Utilizing mOnoclonal aNtibodies

Trial startedJun 30, 2022· ClinicalTrials.gov

Phase 4 trial started: NCT05214001

Evaluation of the Efficacy of Almotriptan and Ubrogepant for the Acute Treatment of Migraine

Primary completionApr 19, 2022· ClinicalTrials.gov

Phase 3 primary completion: NCT04492020

Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants

Trial startedMar 15, 2022· ClinicalTrials.gov

NA trial started: NCT05654298

Influence of Ubrogepant and Sumatriptan on the Dermal Blood Flow Response to Histamine, Cinnamaldehyde and Capsaicin

Trial startedMar 7, 2022· ClinicalTrials.gov

Phase 4 trial started: NCT05264129

Study to Assess Adverse Events When Ubrogepant Tablets in Combination With Atogepant Tablets Are Used to Treat Adult Participants With Migra

Trial registeredMar 3, 2022· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT05264129

Study to Assess Adverse Events When Ubrogepant Tablets in Combination With Atogepant Tablets Are Used to Treat Adult Participants With Migra

Trial registeredJan 28, 2022· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT05214001

Evaluation of the Efficacy of Almotriptan and Ubrogepant for the Acute Treatment of Migraine

Trial startedJan 14, 2022· ClinicalTrials.gov

Phase 3 trial started: NCT05127954

Long-term Extension Study to Assess Safety and Tolerability of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Pediatric Part

Trial startedJan 13, 2022· ClinicalTrials.gov

Phase 3 trial started: NCT05125302

Study to Assess Adverse Events and Disease Activity of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Children and Adolescen

2021

Trial registeredNov 19, 2021· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05127954

Long-term Extension Study to Assess Safety and Tolerability of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Pediatric Part

Trial registeredNov 18, 2021· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05125302

Study to Assess Adverse Events and Disease Activity of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Children and Adolescen

Primary completionJun 18, 2021· ClinicalTrials.gov

Phase 1 primary completion: NCT04818515

Study To Assess Adverse Events and Drug to Drug Interaction of Oral Tablet Atogepant and Ubrogepant in Adult Participants With a History of

Trial registeredMar 26, 2021· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT04818515

Study To Assess Adverse Events and Drug to Drug Interaction of Oral Tablet Atogepant and Ubrogepant in Adult Participants With a History of

Trial startedMar 17, 2021· ClinicalTrials.gov

Phase 1 trial started: NCT04818515

Study To Assess Adverse Events and Drug to Drug Interaction of Oral Tablet Atogepant and Ubrogepant in Adult Participants With a History of

Results postedMar 10, 2021· ClinicalTrials.gov

Trial results posted: NCT04179474

Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine

FDA approval (supplemental)Mar 3, 2021· FDA

FDA approved supplemental application for Ubrelvy (ubrogepant) — Labeling (NDA 211765 S-2)

Sponsor: ABBVIE. Class: Labeling.

2020

Trial startedAug 21, 2020· ClinicalTrials.gov

Phase 3 trial started: NCT04492020

Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants

Trial registeredJul 30, 2020· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT04492020

Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants

2019

Primary completionDec 23, 2019· ClinicalTrials.gov

Phase 1 primary completion: NCT04179474

Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine

FDA approvalDec 23, 2019· FDA

FDA approved Ubrelvy (ubrogepant) (NDA 211765)

Sponsor: ABBVIE. Class: Type 1 - New Molecular Entity.

Trial registeredNov 27, 2019· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT04179474

Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine

Trial startedSep 26, 2019· ClinicalTrials.gov

Phase 1 trial started: NCT04179474

Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine

Results postedAug 28, 2019· ClinicalTrials.gov

Trial results posted: NCT02873221

An Extension Study to Evaluate the Long-Term Safety and Tolerability of Ubrogepant in the Treatment of Migraine

Results postedJan 29, 2019· ClinicalTrials.gov

Trial results posted: NCT02867709

Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine

Results postedJan 3, 2019· ClinicalTrials.gov

Trial results posted: NCT02828020

Efficacy, Safety, and Tolerability Study of Oral Ubrogepant in the Acute Treatment of Migraine

Pivotal publicationJan 1, 2019· PubMed

Ubrogepant for the Treatment of Migraine. (N Engl J Med)

ACHIEVE I — Efficacy, Safety, and Tolerability Study of Oral Ubrogepant in the Acute Treatment of Migraine

Pivotal publicationJan 1, 2019· PubMed

Effect of Ubrogepant vs Placebo on Pain and the Most Bothersome Associated Symptom in the Acute Treatment of Migraine: The ACHIEVE II Randomized Clinical Trial. (JAMA)

ACHIEVE II — Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine

2018

Primary completionAug 2, 2018· ClinicalTrials.gov

Phase 3 primary completion: NCT02873221

An Extension Study to Evaluate the Long-Term Safety and Tolerability of Ubrogepant in the Treatment of Migraine

Primary completionJan 25, 2018· ClinicalTrials.gov

Phase 3 primary completion: NCT02867709

Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine

2017

Primary completionDec 13, 2017· ClinicalTrials.gov

Phase 3 primary completion: NCT02828020

Efficacy, Safety, and Tolerability Study of Oral Ubrogepant in the Acute Treatment of Migraine

2016

Trial startedSep 13, 2016· ClinicalTrials.gov

Phase 3 trial started: NCT02873221

An Extension Study to Evaluate the Long-Term Safety and Tolerability of Ubrogepant in the Treatment of Migraine

Trial startedAug 26, 2016· ClinicalTrials.gov

Phase 3 trial started: NCT02867709

Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine

Trial registeredAug 19, 2016· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT02873221

An Extension Study to Evaluate the Long-Term Safety and Tolerability of Ubrogepant in the Treatment of Migraine

Trial registeredAug 16, 2016· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT02867709

Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine

Trial startedJul 22, 2016· ClinicalTrials.gov

Phase 3 trial started: NCT02828020

Efficacy, Safety, and Tolerability Study of Oral Ubrogepant in the Acute Treatment of Migraine

Trial registeredJul 11, 2016· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT02828020

Efficacy, Safety, and Tolerability Study of Oral Ubrogepant in the Acute Treatment of Migraine

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.