Ubrogepant Evidence: Trial Results and Peer-Reviewed Publications

Hipa.ai Research · Source: PubMed & ClinicalTrials.gov / AACT · Last updated:

The clinical evidence base for Ubrogepant comprises 18 peer-reviewed publications across 12 journals, 6 pivotal-trial primary-outcome rows reported to ClinicalTrials.gov, spanning indications including Migraine Disorders. Most recent publication: Ubrogepant Plasma and Cerebrospinal Fluid Exposures in Participants With a History of Migraine: Findings From a Phase 1b Open-Label Trial., Clin Transl Sci, 2026.

Top peer-reviewed publications

Curated set of pivotal-trial result papers and recent publications in high-tier journals.

  1. 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.
    Lipton RB, Dodick DW, Ailani J, et al. · JAMA · 2019
    PubMed: PMID 31742631 · NCT02867709 (ACHIEVE II) · Migraine Disorders
  2. Efficacy of ubrogepant and atogepant in males and females with migraine: A secondary analysis of randomized clinical trials.
    Goadsby PJ, Jürgens TP, Brand-Schieber E, et al. · Cephalalgia · 2025
    PubMed: PMID 39982105 · NCT02828020 (ACHIEVE I) · Migraine Disorders
  3. Ubrogepant for the Treatment of Migraine.
    Dodick DW, Lipton RB, Ailani J, et al. · N Engl J Med · 2019
    PubMed: PMID 31800988 · NCT02828020 (ACHIEVE I) · Migraine Disorders
  4. Ubrogepant for the treatment of migraine attacks during the prodrome: a phase 3, multicentre, randomised, double-blind, placebo-controlled, crossover trial in the USA.
    Dodick DW, Goadsby PJ, Schwedt TJ, et al. · Lancet · 2023
    PubMed: PMID 37979595 · NCT04492020 (UBR Prodrome) · Migraine Disorders
  5. Ubrogepant Plasma and Cerebrospinal Fluid Exposures in Participants With a History of Migraine: Findings From a Phase 1b Open-Label Trial.
    Boinpally RR, Trugman JM · Clin Transl Sci · 2026
    PubMed: PMID 42012062 · NCT04179474 · Migraine Disorders
  6. Pharmacokinetics of Atogepant in Healthy Lactating Female Participants: Results from a Phase 1 Lactation Study.
    Boinpally RR, Smith JH, De Abreu Ferreira RL, et al. · Neurol Ther · 2025
    PubMed: PMID 40455369 · NCT05892757
  7. Milk and plasma pharmacokinetics of single-dose ubrogepant in healthy lactating women.
    Boinpally RR, Smith JH, Cohen E, et al. · Headache · 2025
    PubMed: PMID 40391560 · NCT05892757
  8. Safety and tolerability of ubrogepant for the acute treatment of migraine in participants taking atogepant for the preventive treatment of episodic migraine: Results from the TANDEM study.
    Ailani J, Lipton RB, Blumenfeld AM, et al. · Headache · 2025
    PubMed: PMID 39569702 · NCT05264129 (TANDEM)

Primary-outcome results across pivotal trials

Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.

TrialIndicationPrimary endpointArmValue
NCT02828020
ACHIEVE I
Migraine DisordersPercentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose
Baseline (Predose) to 2 hours after initial dose
Placebo27.8 percentage of participants
Ubrogepant 100 mg37.7 percentage of participants
Ubrogepant 50 mg38.6 percentage of participants
NCT02828020
ACHIEVE I
Migraine DisordersPercentage of Participants With Pain Freedom at 2 Hours After Initial Dose
Baseline (Predose) to 2 hours after initial dose
Placebo11.8 percentage of participants
Ubrogepant 100 mg21.2 percentage of participants
Ubrogepant 50 mg19.2 percentage of participants
NCT02867709
ACHIEVE II
Migraine DisordersPercentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose
Baseline (Predose) to 2 hours after initial dose
Placebo27.4 percentage of participants
Ubrogepant 25 mg34.1 percentage of participants
Ubrogepant 50 mg38.9 percentage of participants
NCT02867709
ACHIEVE II
Migraine DisordersPercentage of Participants With Pain Freedom at 2 Hours After Initial Dose
Baseline (Predose) to 2 hours after initial dose
Placebo14.3 percentage of participants
Ubrogepant 25 mg20.7 percentage of participants
Ubrogepant 50 mg21.8 percentage of participants
NCT02873221Migraine DisordersPercentage of Participants With at Least 1 Treatment Emergent Adverse Event
56 Weeks
Ubrogepant 100 mg72.6 Percentage of Participants
Ubrogepant 50 mg66.3 Percentage of Participants
Usual Care65 Percentage of Participants
NCT04492020
UBR Prodrome
Migraine DisordersPercentage of Participants Reporting Absence of Headache of Moderate/Severe Intensity Within 24 Hours Post-dose
24 hours after taking double-blind study intervention during the prodrome
Placebo121 Participants
Ubrogepant 100 mg190 Participants

Publications by year

2019–2026: 18 publications.

2019
2
2021
3
2022
4
2023
2
2024
2
2025
4
2026
1

Publications by indication

Migraine Disorders (15)

  • Ubrogepant Plasma and Cerebrospinal Fluid Exposures in Participants With a History of Migraine: Findings From a Phase 1b Open-Label Trial.
    Clin Transl Sci · 2026 · PMID 42012062 · NCT04179474
  • Efficacy of ubrogepant and atogepant in males and females with migraine: A secondary analysis of randomized clinical trials.
    Cephalalgia · 2025 · PMID 39982105 · NCT02828020
  • Characterizing Prodrome (Premonitory Phase) in Migraine: Results From the PRODROME Trial Screening Period.
    Neurol Clin Pract · 2024 · PMID 39399572 · NCT04492020
  • Effect of Ubrogepant on Patient-Reported Outcomes When Administered During the Migraine Prodrome: Results From the Randomized PRODROME Trial.
    Neurology · 2024 · PMID 39197113 · NCT04492020
  • Ubrogepant for the Acute Treatment of Migraine: Pooled Efficacy, Safety, and Tolerability From the ACHIEVE I and ACHIEVE II Phase 3 Randomized Trials.
    Neurol Ther · 2023 · PMID 33608814 · NCT02867709

Publications by journal

Trial-results highlights

In two studies, NCT02828020 (ACHIEVE I) and NCT02867709 (ACHIEVE II), participants with migraine disorders were assessed for treatment outcomes at 2 hours after the initial dose. For absence of their most bothersome migraine-associated symptom, ubrogepant 50 mg was associated with this outcome in 38.6% of participants in NCT02828020 and 38.9% in NCT02867709. Other arms reported:

  • In NCT02828020: ubrogepant 100 mg (37.7%), placebo (27.8%).
  • In NCT02867709: ubrogepant 25 mg (34.1%), placebo (27.4%).

For pain freedom at 2 hours after the initial dose:

  • In NCT02828020: ubrogepant 100 mg was associated with this outcome in 21.2% of participants, ubrogepant 50 mg in 19.2%, and placebo in 11.8%.
  • In NCT02867709: ubrogepant 50 mg was associated with this outcome in 21.8% of participants, ubrogepant 25 mg in 20.7%, and placebo in 14.3%.

In NCT04492020 (UBR Prodrome), participants reported absence of headache of moderate/severe intensity within 24 hours post-dose when taking study intervention during the prodrome. Ubrogepant 100 mg was associated with this outcome in 190 participants, compared to 121 participants in the placebo arm. A long-term safety study, NCT02873221, assessed the percentage of participants with at least 1 treatment emergent adverse event over 56 weeks. This was reported by 72.6% of participants in the ubrogepant 100 mg arm, 66.3% in the ubrogepant 50 mg arm, and 65% in the usual care arm.

All values are sourced from primary registry reporting; individual papers should be consulted for clinical decisions.

All Ubrogepant publications (18)

2026 (1 paper)

  1. Ubrogepant Plasma and Cerebrospinal Fluid Exposures in Participants With a History of Migraine: Findings From a Phase 1b Open-Label Trial.
    Boinpally RR, Trugman JM · Clin Transl Sci · 2026 · Derived
    PubMed: PMID 42012062 · NCT04179474 · Migraine Disorders

2025 (4 papers)

  1. Efficacy of ubrogepant and atogepant in males and females with migraine: A secondary analysis of randomized clinical trials.
    Goadsby PJ, Jürgens TP, Brand-Schieber E, et al. · Cephalalgia · 2025 · Derived
    PubMed: PMID 39982105 · NCT02828020 (ACHIEVE I) · Migraine Disorders
  2. Pharmacokinetics of Atogepant in Healthy Lactating Female Participants: Results from a Phase 1 Lactation Study.
    Boinpally RR, Smith JH, De Abreu Ferreira RL, et al. · Neurol Ther · 2025 · Derived
    PubMed: PMID 40455369 · NCT05892757
  3. Milk and plasma pharmacokinetics of single-dose ubrogepant in healthy lactating women.
    Boinpally RR, Smith JH, Cohen E, et al. · Headache · 2025 · Derived
    PubMed: PMID 40391560 · NCT05892757
  4. Safety and tolerability of ubrogepant for the acute treatment of migraine in participants taking atogepant for the preventive treatment of episodic migraine: Results from the TANDEM study.
    Ailani J, Lipton RB, Blumenfeld AM, et al. · Headache · 2025 · Derived
    PubMed: PMID 39569702 · NCT05264129 (TANDEM)

2024 (2 papers)

  1. Characterizing Prodrome (Premonitory Phase) in Migraine: Results From the PRODROME Trial Screening Period.
    Schwedt TJ, Lipton RB, Goadsby PJ, et al. · Neurol Clin Pract · 2024 · Derived
    PubMed: PMID 39399572 · NCT04492020 (UBR Prodrome) · Migraine Disorders
  2. Effect of Ubrogepant on Patient-Reported Outcomes When Administered During the Migraine Prodrome: Results From the Randomized PRODROME Trial.
    Lipton RB, Harriott AM, Ma JY, et al. · Neurology · 2024 · Derived
    PubMed: PMID 39197113 · NCT04492020 (UBR Prodrome) · Migraine Disorders

2023 (2 papers)

  1. Ubrogepant for the Acute Treatment of Migraine: Pooled Efficacy, Safety, and Tolerability From the ACHIEVE I and ACHIEVE II Phase 3 Randomized Trials.
    Hutchinson S, Dodick DW, Treppendahl C, et al. · Neurol Ther · 2023 · Derived
    PubMed: PMID 33608814 · NCT02867709 (ACHIEVE II) · Migraine Disorders
  2. Ubrogepant for the treatment of migraine attacks during the prodrome: a phase 3, multicentre, randomised, double-blind, placebo-controlled, crossover trial in the USA.
    Dodick DW, Goadsby PJ, Schwedt TJ, et al. · Lancet · 2023 · Derived
    PubMed: PMID 37979595 · NCT04492020 (UBR Prodrome) · Migraine Disorders

2022 (4 papers)

  1. Functionality, satisfaction, and global impression of change with ubrogepant for the acute treatment of migraine in triptan insufficient responders: a post hoc analysis of the ACHIEVE I and ACHIEVE II randomized trials.
    Lipton RB, Singh RBH, Revicki DA, et al. · J Headache Pain · 2022 · Derived
    PubMed: PMID 35468729 · NCT02867709 (ACHIEVE II) · Migraine Disorders
  2. Efficacy of Ubrogepant in the Acute Treatment of Migraine With Mild Pain vs Moderate or Severe Pain.
    Lipton RB, Dodick DW, Goadsby PJ, et al. · Neurology · 2022 · Derived
    PubMed: PMID 35977836 · NCT02873221 · Migraine Disorders
  3. Rimegepant, Ubrogepant, and Lasmiditan in the Acute Treatment of Migraine Examining the Benefit-Risk Profile Using Number Needed to Treat/Harm.
    Johnston KM, Powell L, Popoff E, et al. · Clin J Pain · 2022 · Derived
    PubMed: PMID 36125279 · NCT02828020 (ACHIEVE I) · Migraine Disorders
  4. Ubrogepant Is Safe and Efficacious in Participants Taking Concomitant Preventive Medication for Migraine: A Pooled Analysis of Phase 3 Trials.
    Blumenfeld AM, Knievel K, Manack Adams A, et al. · Adv Ther · 2022 · Derived
    PubMed: PMID 34874514 · NCT02828020 (ACHIEVE I) · Migraine Disorders

2021 (3 papers)

  1. Safety and efficacy of ubrogepant in participants with major cardiovascular risk factors in two single-attack phase 3 randomized trials: ACHIEVE I and II.
    Hutchinson S, Silberstein SD, Blumenfeld AM, et al. · Cephalalgia · 2021 · Derived
    PubMed: PMID 33874756 · NCT02828020 (ACHIEVE I) · Migraine Disorders
  2. Time course of efficacy of ubrogepant for the acute treatment of migraine: Clinical implications.
    Goadsby PJ, Blumenfeld AM, Lipton RB, et al. · Cephalalgia · 2021 · Derived
    PubMed: PMID 33241721 · NCT02867709 (ACHIEVE II) · Migraine Disorders
  3. Ubrogepant, an Acute Treatment for Migraine, Improved Patient-Reported Functional Disability and Satisfaction in 2 Single-Attack Phase 3 Randomized Trials, ACHIEVE I and II.
    Dodick DW, Lipton RB, Ailani J, et al. · Headache · 2021 · Background
    PubMed: PMID 32073660 · NCT05503082 (UNION) · Migraine Disorders

2019 (2 papers)

  1. 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.
    Lipton RB, Dodick DW, Ailani J, et al. · JAMA · 2019 · Derived
    PubMed: PMID 31742631 · NCT02867709 (ACHIEVE II) · Migraine Disorders
  2. Ubrogepant for the Treatment of Migraine.
    Dodick DW, Lipton RB, Ailani J, et al. · N Engl J Med · 2019 · Derived
    PubMed: PMID 31800988 · NCT02828020 (ACHIEVE I) · Migraine Disorders

Sources and methodology

This page summarizes published evidence for general reference and does not constitute medical advice. For clinical decisions, consult the linked primary publications and your healthcare provider. Data sourced from PubMed and the ClinicalTrials.gov / AACT database maintained by the Clinical Trials Transformation Initiative (CTTI).