CLINICAL TRIALS PROFILE FOR UBROGEPANT

All Clinical Trials for UBROGEPANT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02828020 ↗	Efficacy, Safety, and Tolerability Study of Oral Ubrogepant in the Acute Treatment of Migraine	Completed	Allergan	Phase 3	2016-07-22	This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (50 and 100 mg) compared to placebo for the acute treatment of a single migraine attack.
NCT02867709 ↗	Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine	Completed	Allergan	Phase 3	2016-08-26	This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (25 and 50 mg) compared to placebo for the acute treatment of a single migraine attack.
NCT02873221 ↗	An Extension Study to Evaluate the Long-Term Safety and Tolerability of Ubrogepant in the Treatment of Migraine	Completed	Allergan	Phase 3	2016-09-13	This study will evaluate the long-term safety and tolerability of intermittent treatment with ubrogepant for the acute treatment of migraine over 1 year.
NCT04179474 ↗	Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine	Completed	Allergan	Phase 1	2019-09-26	This study will evaluate the potential for a pharmacokinetic (PK) interaction and provide safety and tolerability information when ubrogepant and erenumab or ubrogepant and galcanezumab are co-administered.
NCT04492020 ↗	Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants	Recruiting	Allergan	Phase 3	2020-08-21	Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine When Administered During the Prodrome
NCT04818515 ↗	Study To Assess Adverse Events and Drug to Drug Interaction of Oral Tablet Atogepant and Ubrogepant in Adult Participants With a History of Migraine	Completed	Allergan	Phase 1	2021-03-17	Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. This study will assess the drug to drug interaction between atogepant and ubrogepant and assess the safety of atogepant and ubrogepant, when given alone or in combination, in adult participants with migraine. Atogepant is an investigational (unapproved) drug for the preventative treatment of migraine. Ubrogepant is a drug approved for the acute treatment of migraine. Adult participants with a history of migraine will be enrolled. Approximately, 30 participants will be enrolled in the study in multiple sites in the United States. Participants will receive oral tablets of ubrogepant, followed be oral tablets of atogepant, followed by administration of oral tablets of atogepant and ubrogepant in combination. The study duration will be 30 days with a 7 day follow period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, telephone assessments, blood tests, checking for side effects, and clinician-rated assessments.
NCT05125302 ↗	Study to Assess Adverse Events and Disease Activity of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Children and Adolescents (Ages 6-17)	Not yet recruiting	Allergan	Phase 3	2021-11-09	Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. Migraine is extremely common and disabling in children. The purpose of this study is to evaluate how safe and effective ubrogepant is in the acute treatment of migraine in children and adolescents. Ubrogepant is a drug approved for the acute treatment of migraine in adults. Children and adolescents (aged 6-17 years) with a history of migraine will be enrolled. The study will include 2 cohorts of participants - PK Cohort and Main Study (non-PK cohort). Participants aged 6-11 years in the PK Cohort will receive Dose A or Dose B of Ubrogepant for PK analysis to determine dose selection for the main study. In the main study, after dose selection, children aged 6-11 years will be randomized to receive either low or high dose of Ubrogepant or placebo. There is a 1 in 3 chance that a participant will be assigned to placebo. Adolescents aged 12-17 years will be randomized to receive either low or high dose of Ubrogepant or placebo with a 1 in 3 chance of placebo assignment. For qualifying migraine attacks, participants will receive oral tablets of the double-blind study intervention. There will be an option to take a second dose of double-blind study intervention (identical to initial dose), or rescue medication, 2 to 24 hours after the initial dose, for headache of moderate/severe intensity. Around 1059 participants will be enrolled in the study in approximately 120 sites in the United States. The study duration will be up to 6 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Clinical Trial Conditions for UBROGEPANT

Condition Name

Condition Name for UBROGEPANT
Intervention	Trials
Migraine	8
Migraine, With or Without Aura	3
Episodic Migraine	1
Headache, Migraine	1

Condition MeSH

Condition MeSH for UBROGEPANT
Intervention	Trials
Migraine Disorders	13
Migraine without Aura	1
Migraine with Aura	1
Headache	1

Clinical Trial Locations for UBROGEPANT

Trials by Country

Trials by Country for UBROGEPANT
Location	Trials
United States	267
Denmark	1
Puerto Rico	1
Belgium	1

Trials by US State

Trials by US State for UBROGEPANT
Location	Trials
Florida	10
Georgia	9
Texas	9
Missouri	9
Maryland	8

Clinical Trial Progress for UBROGEPANT

Clinical Trial Phase

Clinical Trial Phase for UBROGEPANT
Clinical Trial Phase	Trials
PHASE3	1
PHASE1	1
Phase 4	3

Clinical Trial Status

Clinical Trial Status for UBROGEPANT
Clinical Trial Phase	Trials
Not yet recruiting	6
Completed	5
Recruiting	4

Clinical Trial Sponsors for UBROGEPANT

Sponsor Name

Sponsor Name for UBROGEPANT
Sponsor	Trials
Allergan	9
AbbVie	3
Messoud Ashina, MD	1

Sponsor Type

Sponsor Type for UBROGEPANT
Sponsor	Trials
Industry	13
Other	3

Ubrogepant: Clinical Trials Update, Market Analysis, and 2030 Projection

Last updated: April 28, 2026

What is ubrogepant and where does it sit commercially?

Ubrogepant (Ubrelvy) is an oral CGRP receptor antagonist (gepant) indicated for the acute treatment of migraine with or without aura in adults. It is marketed by AbbVie (following AbbVie’s acquisition/formation structure around Allergan) with co-commercial execution via its partner channels depending on territory.

Core positioning

• Mechanism: Oral CGRP receptor antagonist (acute migraine).
• Use case: Breakthrough/acute attack treatment; not a preventive therapy label.
• Competitive set: Ditans (e.g., lasmiditan), triptans (generic), and other gepants (rimegepant, atogepant is preventive; zavegepant is acute intranasal).

Key market context

• Ubrogepant is one of the leading oral acute non-triptan options. Its category competes against (1) generic triptans on price, (2) another oral gepant rimegepant on class effect, and (3) newer migraine acute agents where approved.

What do the clinical trials landscape and updates show?

A “clinical trials update” for ubrogepant needs two layers: (1) late-stage and pivotal evidence supporting current indications and label expansions, and (2) ongoing studies that broaden usage (population, dosing strategy, combination regimens, additional migraine-related conditions).

Current practical status

• Ubrogepant’s principal clinical footprint remains anchored to acute migraine treatment efficacy and safety.
• Ongoing clinical programs in migraine generally target: refractory populations, use in patients with inadequate response to triptans or NSAIDs, pharmacokinetic and dosing optimization, and comparative or switch studies versus other acute options.
• The class continues to consolidate evidence for real-world-like patient behavior (head-to-head or comparative designs), medication adherence, and reduced discontinuation due to tolerability.

What matters to development ROI

• For acute migraine, pipeline value concentrates in:
  • Label expansion (additional populations and attack settings).
  • Combination or sequential use studies that preserve safety with rescue dosing.
  • Pediatric, geriatric, comorbidity-specific studies where uptake is limited by contraindications in standard therapies.
• For ubrogepant specifically, the “go-forward” question is not whether acute efficacy exists; it is whether the next development steps unlock meaningful market share from triptans and rimegepant or reduce payer friction.

Which trials define the label and switching behavior?

Without publishing a new trial roster in this response (to avoid partial or incorrect trial identification), the actionable lens for ubrogepant’s trial update is the impact on: 1) Attack onset-to-relief window (how quickly benefit appears), 2) Durability (sustained pain freedom without re-dosing), 3) Rescue use and repeat dosing tolerability, 4) Head-to-head or indirect comparative adoption against triptans and rimegepant.

Clinical endpoints that drive payer acceptance

• Pain freedom at 2 hours is the main driver for acute claims.
• Freedom from most bothersome symptom (photophobia, phonophobia, or nausea) supports differentiated utilization when triptans fail due to tolerability.
• Sustained response over 24 hours reduces re-medication, which is critical in US claims data.

What is the market opportunity for ubrogepant by segment?

Ubrogepant sits in a market structured by:

• Acute migraine attack volume
• Treatment preference shifts away from triptans
• Class penetration of gepants in payer formularies
• Patient subgroups that avoid triptans due to contraindications, intolerance, or prior failure

Segment model (practical commercial drivers)

Segment	Adoption limiter	What can unlock share
Triptan-eligible patients	Generic pricing + habits	Convenience, preference, fewer contraindication barriers
Triptan-ineligible patients	Contraindications, adverse effects	Wider label confidence and comorbidity-specific evidence
Patients with nausea/photophobia dominance	Triptan tolerability variability	Gepant tolerability and symptom coverage claims
Patients dissatisfied with prior acute therapy	Prior failure	Fast onset and consistent responder profiles

Pricing and access dynamics

• Acute migraine is cost-sensitive because patients may treat multiple attacks per month.
• Gepants face step edits and prior authorization depending on payer.
• Ubrogepant’s commercial ceiling depends on how quickly formulary access broadens versus rimegepant and versus emerging acute options.

How competitive is ubrogepant vs other acute migraine agents?

Competitive set

• Rimegepant (oral gepant): Direct oral-class competitor for acute use; tends to win where payer prefers a single gepant or where switching creates volume.
• Zavegepant (acute intranasal gepant): Route-of-admin differentiator, used where rapid administration matters and adherence barriers exist.
• Lasmiditan (ditan): CNS side-effect profile limits uptake in some cohorts; competes primarily in specific patient segments.
• Triptans: Remain the baseline for many patients due to generic availability.

Key commercial implication

Ubrogepant’s growth is driven more by payer formulary position and patient switching than by incremental efficacy within the existing labeled acute setting, because most acute options show clinically meaningful pain relief versus placebo and differentiate at the margins.

What is the 2030 projection for ubrogepant and how does it scale?

A defensible projection requires published market sizing and consensus forecasts. In this response, only a structured projection framework is provided without numeric claims.

Projection framework (what to model)

Variable	Why it moves revenue	Direction for ubrogepant
US patient-treated rate (migraine diagnosis treated with acute meds)	Determines addressable attack pool	Gradual expansion with increasing non-triptan adoption
Gepant share within acute therapy	Converts attack volume into gepant utilization	Likely rises as barriers to access fall
Ubrogepant share among gepants	Converts “class” into “brand”	Sensitive to payer preference vs rimegepant and route comparators
Net price	Payer rebates and access rules	Pressured by competition and volume discounts
Persistence and repeat use	Acute attack recurrence	Moderate stabilization after initial adoption

Scenario structure (base/upside/downside)

• Base case: Ubrogepant maintains leading oral gepant position with gradual share gains, offset by price pressure and competitive switching.
• Upside: Broader formulary access, durable safety confidence, and evidence-based expansions increase persistence and reduce PA friction.
• Downside: Rapid payer preference shift to rimegepant or other non-oral modalities; increased generic/triptan substitution in insured populations.

Result

• The projection should be expressed as a revenue and unit trend curve by year, with sensitivity on net price and gepant share. Without cited source forecasts and unit data in this response, providing explicit dollar numbers would create an accuracy gap.

What should investors and R&D teams track next?

Commercial checkpoints

• Formulary decisions in large US commercial and Medicare Part D plans.
• PA criteria tightening or loosening for acute gepants.
• Evidence of switching from rimegepant or triptans in claims data (market share signal).
• Net price changes driven by competitive contracting.

Clinical development checkpoints

• New efficacy/safety readouts targeting:
  • Rapid onset in real-world dosing,
  • Rescue dosing strategies,
  • Broader responder definitions,
  • Expanded populations (including comorbidity-heavy cohorts).

Key Takeaways

• Ubrogepant’s commercial model is built on acute migraine attack treatment with a differentiated safety and tolerability profile relative to triptans.
• The next value inflection is less about proving acute efficacy and more about reducing payer friction and increasing share relative to rimegepant and other acute migraine competitors.
• A 2030 projection must be driven by (1) gepant class share within acute therapy, (2) ubrogepant’s share among gepants, and (3) net pricing under contracting pressure.
• Clinical development value concentrates on label-consistent additions that support adoption (population fit, dosing convenience, rescue strategy clarity).

FAQs

1. Is ubrogepant only for acute migraine attacks?
   Yes, its key label is acute treatment of migraine in adults, with no routine preventive dosing positioning in the core indication framework.

2. How does ubrogepant compare to rimegepant clinically?
   Both are oral gepants for acute migraine. Practical differentiation typically comes from payer access, dosing convenience, and real-world switching patterns rather than a single decisive efficacy gap.

3. What are the biggest commercial risks for ubrogepant?
   Net price compression from competitive contracting, payer preference shifts within gepants, and substitution back to generic triptans in cost-sensitive segments.

4. What clinical evidence most influences adoption?
   Pain freedom and sustained response at clinically relevant timepoints, plus tolerability that supports repeat use across monthly attack patterns.

5. What market drivers could expand ubrogepant’s share by 2030?
   Broader formulary access, reduced prior authorization barriers, and development programs that make switching from triptans or rimegepant easier in payer and prescriber workflows.

References

[1] U.S. Food and Drug Administration. Drug Approval Package: Ubrelvy (ubrogepant). (FDA product labeling and approval history).