Ubrelvy

(Ubrogepant)

ApprovedSmall molecule

Ubrelvy is a small molecule that works as a CGRP Receptor Antagonist.[2] It is being used across 1 indication, with its most advanced program in Approved.[1]

Ubrelvy is one of 39 small molecule programs targeting Migraine. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

MigraineCompleted

MigraineApproved

Completed

Competition

Competitive Landscape

102 competitors in Migraine

#DrugCompanyPhaseTrials

Zonegran

AAzurity Pharmaceuticals

Phase 3

3 2

Effient

CCosette Pharmaceuticals, Inc.

Phase 3

1 3

Ubrelvy

AbbVie

Approved

10 4

Triptans

Pfizer

Phase 3

2 5

Aspirin /d

TThe First Affiliated Hospital with Nanjing Medical University

Phase 3

1 6

Flunarizine

AAspartes Pharmaceuticals, Inc.

Phase 3

9 7

BAT7104

Teva

Phase 3

1 8

Tizanidine Hydrochloride

EElan Pharmaceuticals

Phase 3

1 9

Bayer Aspirin

Bayer

Preclinical

2 10

Cervidil

Pfizer

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 3Recruiting

Migraine

NCT05125302

Q4 2027

Phase 3Active, not recruiting

Migraine

NCT06417775

Clinical

Trials by Indication[1]

Migraine10 trials

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

Completed· AbbVie logo

AbbVie·Phase 3·NCT02873221·1,254 enrolled

A Trial Investigating Lu AG09222 With Ubrogepant in Participants With Migraine

Completed· Lundbeck logo

Lundbeck·Phase 1·NCT06578585·43 enrolled

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

Completed· AbbVie logo

AbbVie·Phase 3·NCT02867709·1,686 enrolled

Show 7 more trials

Long-term Extension Study to Assess Safety and Tolerability of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Pediatric Participants (Ages 6-17)

Enrolling by invitation· AbbVie logo

AbbVie·Phase 3·NCT05127954·1,200 enrolled

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

Completed· AbbVie logo

AbbVie·Phase 4·NCT05264129·263 enrolled

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

Completed· AbbVie logo

AbbVie·Phase 3·NCT04492020·518 enrolled

Ubrogepant treatmeNt in mIgraine Patients Utilizing mOnoclonal aNtibodies

Active, not recruiting·—·Phase 4·NCT05503082·164 enrolled

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

Completed· AbbVie logo

AbbVie·Phase 3·NCT02828020·1,672 enrolled

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Single-attack Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura in Children and Adolescents (Ages 6-17)

Recruiting· AbbVie logo

AbbVie·Phase 3·NCT05125302·1,059 enrolled

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Ubrogepant for the Preventive Treatment of Menstrual Migraine With an Open-Label Extension

Active, not recruiting· AbbVie logo

AbbVie·Phase 3·NCT06417775·496 enrolled

Adverse Events2 trials

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

Completed· AbbVie logo

AbbVie·Phase 1·NCT05892757·24 enrolled

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· AbbVie logo

AbbVie·Phase 1·NCT04818515·26 enrolled

ALD1 trial

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

Completed·UUniversitaire Ziekenhuizen KU Leuven·N/A·NCT05654298·20 enrolled

Interaction1 trial

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

Completed· AbbVie logo

AbbVie·Phase 1·NCT04179474·40 enrolled

Overactive Bladder1 trial

Migraine Medication Effects on Urinary Symptoms

Enrolling by invitation·TThe Cleveland Clinic··NCT06212661·200 enrolled

1 more indication

Unspecified1 trial

A Two-Part, Phase 1, Open-Label, Randomized Study to Evaluate the Relative Bioavailability (Versus Immediate Release Tablet) and Food Effect of a New Orally Disintegrating Tablet Formulation of Ubrogepant in Healthy Volunteers

Active, not recruiting· AbbVie logo

AbbVie·Phase 1·NCT07680686·52 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 23, 2019

UBRELVY

NDA NDA211765

Dec 23, 2019

UBRELVY

NDA NDA211765

Mar 3, 2021

UBRELVY

NDA NDA211765

Feb 17, 2023

UBRELVY

NDA NDA211765

Mar 21, 2025

UBRELVY

NDA NDA211765

Jun 5, 2025

UBRELVY

NDA NDA211765

Sources

References

[1]
ClinicalTrials.gov — 16 trial records for Ubrogepant. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ubrogepant compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Ubrogepant. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA211765). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Ubrelvy. U.S. Food & Drug Administration.
[6]
SEC EDGAR — AbbVie company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: CGRP Receptor Antagonist[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: AbbVie

Patent Landscape[5]

Patent Cliff

Nov 10, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9499545Nov 10, 2031

9833448Nov 10, 2031

8754096Jul 19, 2032

8912210Dec 23, 2033

12310953Jan 30, 2035

11 more patents

12458632Jan 30, 2035

12168004Jan 30, 2035

11925709Jan 30, 2035

12458633Jan 30, 2035

10117836Jan 30, 2035

12220408Jan 30, 2035

12329750Dec 22, 2041

12194030Dec 22, 2041

11857542Dec 22, 2041

12070450Dec 22, 2041

11717515Dec 22, 2041

Ubrelvy

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q4 2027

Trials by Indication[1]

Migraine10 trials

Adverse Events2 trials

ALD1 trial

Interaction1 trial

Overactive Bladder1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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