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Ubrogepant

Phase 3

Migraine | Small molecule | Neurology |AbbVie Inc.|Last Updated: Jun 5, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials5
Total Enrollment3,313
FDA Designations
No designations recorded
Clinical Trials (5)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06417775Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual MigrainePHASE3 RECRUITING 496Sep 10, 2024Sep 1, 2027Jun 2, 2026106 United States, Puerto Rico
NCT05127954Long-term Extension Study to Assess Safety and Tolerability of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Pediatric Participants (Ages 6-17)PHASE3 ENROLLING BY_INVITATION 1,200Jan 14, 2022Jan 1, 2028Jul 20, 2025113 United States, Puerto Rico
NCT05125302Study to Assess Adverse Events and Disease Activity of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Children and Adolescents (Ages 6-17)PHASE3 RECRUITING 1,059Jan 13, 2022May 1, 2027Jun 5, 2026129 United States, Puerto Rico
NCT04492020Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult ParticipantsPHASE3 COMPLETED 518Aug 21, 2020Apr 19, 2022May 31, 202373 United States
NCT04179474Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With MigrainePHASE1 COMPLETED 40Sep 26, 2019Dec 23, 2019Mar 10, 20212 United States
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Study Endpoints
Primary Endpoints
Change From Baseline in Number of Migraine Days Occurring During Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period
Up to approximately 16 Weeks

A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed in the protocol as per eDiary.

Number of Participants With Adverse Events (AEs)
Up to approximately 68 Weeks

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Percentage of Participants with Adverse Events (AEs)
up to 54 weeks

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Percentage of Participants with Potentially Clinically Significant Clinical 12-lead Electrocardiogram (ECG)
Up to 54 Weeks

12-lead resting ECGs will be recorded. Parameters include heart rate, PR interval, QT interval, QRS duration, and QT interval corrected using Fridericia's formula (QTcF).

Percentage of Participants with Potentially Clinically Significant Vital Sign Parameters
Up to 54 Weeks

Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.

Percentage of Participants with Potentially Clinically Significant lab values
Up to 54 Weeks

Percentage of participants with abnormal change in clinical laboratory test results like hematology will be assessed.

Percentage of with Participants with Suicidal Ideation or Suicidal Behavior
Up to 54 Weeks

The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation was classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods \[not plan\] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt).

Percentage of Participants with Change in Menstrual Cycle
Up to 54 Weeks

Female participants who have entered menarche are to be asked for the date of the first and last day of their most recent menstrual period.

Change from baseline in Tanner staging score
Up to 54 Weeks

Tanner's staging is used to assess growth and pubertal development.

Change From baseline in Behavior Rating Inventory of Executive Function (BRIEF 2) questionnaire
up to 54 weeks

The BRIEF 2 is an 86-item questionnaire assessing executive function. It consists of 2 indexes, Behavioral Regulation and Metacognition, which are then used to calculate an overall composite score. Higher scores indicate more executive difficulties

Percentage of participants with Pain Freedom at 2 Hours After the Initial Dose in pediatric participants aged 6 to 17 years
2 hours after initial dose

Pain Freedom is defined as a reduction in headache severity from moderate/severe at baseline to no pain.

Percentage 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

The absence of a headache of moderate/severe intensity will be recorded by the participant in an electronic diary (eDiary) within 24 hours after taking double-blind study intervention during the prodrome in order to determine the attenuation of headache. The absence of moderate or severe headache are derived based on headache record and rescue use.

Part 1: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Time t (AUC0-t) for Ubrogepant Alone and in Combination With Erenumab
Day 1 (Treatment Period 1): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdose; Day 12 (Day 1 of Treatment Period 3): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdose
Part 2: AUC0-t for Ubrogepant Alone and in Combination With Galcanezumab
Day 1 (Treatment Period 1): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdose; Day 12 (Day 1 of Treatment Period 3): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdose
Part 1: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity (AUC0-∞) for Ubrogepant Alone and in Combination With Erenumab
Day 1 (Treatment Period 1): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdose; Day 12 (Day 1 of Treatment Period 3): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdose
Part 2: AUC0-∞ for Ubrogepant Alone and in Combination With Galcanezumab
Day 1 (Treatment Period 1): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdose; Day 12 (Day 1 of Treatment Period 3): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdose
Part 1: Maximum Plasma Drug Concentration (Cmax) for Ubrogepant Alone in Combination With Erenumab
Day 1 (Treatment Period 1): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdose; Day 12 (Day 1 of Treatment Period 3): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdose
Part 2: Cmax for Ubrogepant Alone and in Combination With Galcanezumab
Day 1 (Treatment Period 1): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdose; Day 12 (Day 1 of Treatment Period 3): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdose
Secondary Endpoints
Change From Baseline in Number of Headache Days Occurring During Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period
Up to approximately 16 Weeks
Change From Baseline in Number of Moderate or Severe Headache Days During Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period
Up to approximately 16 Weeks
Change From Baseline in Number of Migraine Days With Moderate or Severe Headache During Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period
Up to approximately 16 Weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Double-Blind Period: UbrogepantEXPERIMENTALParticipants will receive ubrogepant during the double-blind period.
Double-Blind Period: Placebo for UbrogepantEXPERIMENTALParticipants will receive placebo during the double-blind period.
Open-Label Extension Period: UbrogepantEXPERIMENTALEligible participants from Double-Blind period may continue to receive ubrogepant during the open-label extension period.
Ubrogepant Dose A (12 to 17 Years Old)EXPERIMENTALParticipants will receive oral tablets of ubrogepant Dose A for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, at least 2 hours after initial dose for headache of any intensity.
Ubrogepant Dose B (6 to 11 Years Old)EXPERIMENTALParticipants will receive the highest dose of oral tablets of ubrogepant tested in Study 3110-305-002 for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, at least 2 hours after initial dose for headache of any intensity.
PK Cohort: Ubrogepant Dose AEXPERIMENTALParticipants aged 6 to 11 will receive oral tablets of ubrogepant for PK analysis to determine appropriate dose for main study.
PK Cohort: Ubrogepant Dose BEXPERIMENTALParticipants aged 6 to 11 will receive oral tablets of ubrogepant for PK analysis to determine appropriate dose for main study.
Main Study: Children Ubrogepant Low DoseEXPERIMENTALParticipants aged 6 to 11 (after dose selection) will receive oral tablets of low dose ubrogepant for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity.
Main Study: Children Ubrogepant High DoseEXPERIMENTALParticipants aged 6 to 11 (after dose selection) will receive oral tablets of high dose ubrogepant Dose B for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity.
Main Study: Children Ubrogepant PlaceboPLACEBO_COMPARATORParticipants aged 6 to 11 (after dose selection) will receive oral tablets of placebo-matching ubrogepant for qualifying migraine attack. Participants have the option to take a second dose of placebo-matching ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity.
Main Study: Adolescents Ubrogepant Low DoseEXPERIMENTALParticipants aged 12 to 17 will receive oral tablets of ubrogepant low dose for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity.
Main Study: Adolescents Ubrogepant High DoseEXPERIMENTALParticipants aged 12 to 17 will receive oral tablets of ubrogepant high dose or qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity.
Main Study: Adolescents Ubrogepant PlaceboPLACEBO_COMPARATORParticipants aged 12 to 17 will receive oral tablets of placebo-matching ubrogepant for qualifying migraine attack. Participants have the option to take a second dose of placebo-matching ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity.
Treatment Sequence AEXPERIMENTALParticipants randomized to Treatment Sequence A will receive placebo to treat their first qualifying prodrome event and ubrogepant 100 mg to treat their second qualifying prodrome event
Treatment Sequence BEXPERIMENTALParticipants randomized to Treatment Sequence B will receive ubrogepant 100 mg to treat their first qualifying prodrome event and placebo to treat their second qualifying prodrome event
Part 1 (Intervention A then B then D)EXPERIMENTALIntervention A: Single oral dose of ubrogepant 100 mg tablet on Day 1 under fasted conditions; followed by Intervention B: Single subcutaneous (SC) injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
Part 2 (Intervention A then C then D)EXPERIMENTALIntervention A: Single oral dose of ubrogepant 100 mg tablet on Day 1 under fasted conditions; followed by Intervention C: Two SC injections of galcanezumab 120 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
Interventions
NameTypeDescription
UbrogepantDRUGOral Tablets
Placebo for UbrogepantDRUGOral Tablets
Placebo-Matching UbrogepantDRUGOral Tablet
Ubrogepant 100 mgDRUGFor each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours
PlaceboDRUGFor each qualifying prodrome event, 2 compressed tablets containing placebo will be taken orally when the participant is confident that a headache will follow within 1-6 hours
ErenumabDRUGSingle dose subcutaneous (SC) injection of erenumab 140 mg \[Intervention B\].
GalcanezumabDRUG2 SC injections of galcanezumab 120 mg \[Intervention C\].
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites106

Inclusion Criteria: * At least a 1-year history of migraine with or without aura. * Have experienced migraine attacks in at least 2 of 3 perimenstrual periods (PMPs) during the screening period. * Collection of daily eDiary data for 3 perimenstrual periods during the up to 16-week screening period ...

Countries:United StatesPuerto Rico
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Recent Changes (Last 90 Days)
LOWJun 5, 2026NCT05125302lastUpdatePostDate: changed
LOWJun 5, 2026NCT05125302lastUpdatePostDate: changed
LOWJun 5, 2026NCT05125302lastUpdatePostDate: changed
LOWJun 5, 2026NCT05125302lastUpdatePostDate: changed
LOWJun 2, 2026NCT06417775lastUpdatePostDate: changed
LOWJun 2, 2026NCT06417775lastUpdatePostDate: changed
LOWJun 2, 2026NCT06417775lastUpdatePostDate: changed
LOWMay 26, 2026NCT06417775primaryCompletionDate: changed
MEDIUMMay 26, 2026NCT05125302primaryCompletionDate: changed
LOWMay 26, 2026NCT05127954primaryCompletionDate: changed
LOWMay 24, 2026NCT06417775studyFirstPostDate: changed
LOWMay 24, 2026NCT05125302studyFirstPostDate: changed
LOWMay 24, 2026NCT05127954studyFirstPostDate: changed