Atogepant

Atogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist.

• QULIPTA is indicated for the preventive treatment of migraine in adults. QULIPTA is a calcitonin gene-related peptide receptor antagonist indicated for the preventive treatment of migraine in adults.ICD-10: G43.909

• QULIPTA is contraindicated in patients with a history of hypersensitivity to atogepant or any of the components of QULIPTA. Reactions have included anaphylaxis and dyspnea [see Warnings and Precautions ( 5.1 )] .contraindicated

QULIPTA is taken orally with or without food. ( 2.1 ) For episodic migraine, the recommended dosage is 10 mg, 30 mg, or 60 mg taken once daily. ( 2.1 ) For chronic migraine, the recommended dosage is 60 mg taken once daily. ( 2.1 ) Severe Renal Impairment or End-Stage Renal Disease ( 2.2 , 8.6 ): Episodic migraine: 10 mg once daily. Chronic migraine: Not recommended. 2.1 Recommended Dosage QULIPTA is taken orally with or without food. Episodic Migraine The recommended dosage of QULIPTA for episodic migraine is 10 mg, 30 mg, or 60 mg taken once daily. Chronic Migraine The recommended dosage of QULIPTA for chronic migraine is 60 mg taken once daily. 2.2 Dosage Modification s Dosage modifications and usage recommendations for episodic and chronic migraine with concomitant use of specific drugs and for patients with renal impairment are provided in Table 1. Table 1 : Dos age Modifications for Drug Interactions and for Specific Populations Dosage Modifications Recommended Once Daily Dosage for Episodic Migraine Usage and Recommended Once Daily Dosage for Chronic Migraine Concomitant Drug [see Drug Interactions ( 7 )] Strong CYP3A4 Inhibitors ( 7.1 ) 10 mg 10 mg Strong CYP3A4 Inducers ( 7.2 ) 60 mg a Not recommended Moderate CYP3A4 Inducers ( 7.2 ) 60 mg Not recommended Weak CYP3A4 Inducers ( 7.2 ) 30 mg or 60 mg 60 mg a OATP Inhibitors ( 7.3 ) 10 mg or 30 mg 30 mg Renal Impairment [see Use in Specific Populations ( 8 )] Severe Renal Impairment and End-Stage Renal Disease (CLcr <30 mL/min) ( 8.6 ) 10 mg Not recommended a Coadministration decreases atogepant exposure.

Hypersensitivity Reactions: If a hypersensitivity reaction occurs, discontinue QULIPTA and initiate appropriate therapy. Severe hypersensitivity reactions have included anaphylaxis and dyspnea. These reactions can occur days after administration. ( 5.1 ) Hypertension: New-onset or worsening of pre-existing hypertension may occur. ( 5.2 ) Raynaud’s phenomenon: New-onset or worsening of pre-existing Raynaud’s phenomenon may occur. ( 5.3 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, dyspnea, rash, pruritus, urticaria, and facial edema, have been reported with use of QULIPTA [see Adverse Reactions ( 6.2 )] . Hypersensitivity reactions can occur days after administration. If a hypersensitivity reaction occurs, discontinue QULIPTA and institute appropriate therapy [see Contraindications ( 4 )] . 5. 2 Hyper tension Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including QULIPTA, in the postmarketing setting. Some of the patients who developed new-onset hypertension had risk factors for hypertension. There were cases requiring initiation of pharmacological treatment for hypertension and, in some cases, hospitalization. Hypertension may occur at any time during treatment, but was most frequently reported within 7 days of therapy initiation. QULIPTA was discontinued in many of the reported cases.

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Hypertension [see Warnings and Precautions ( 5.2 )] Raynaud’s Phenomenon [see Warnings and Precautions ( 5.3 )] The most common adverse reactions (at least 4% and greater than placebo) are nausea, constipation, and fatigue/somnolence. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of QULIPTA was evaluated in 2657 patients with migraine who received at least one dose of QULIPTA. Of these, 1225 patients were exposed to QULIPTA for at least 6 months, and 826 patients were exposed for 12 months. In the 12-week, placebo-controlled clinical studies (Studies 1, 2, and 3), 314 patients received at least one dose of QULIPTA 10 mg once daily, 411 patients received at least one dose of QULIPTA 30 mg once daily, 678 patients received at least one dose of QULIPTA 60 mg once daily, and 663 patients received placebo [see Clinical Studies ( 14 ) ] . Approximately 88% were female, 75% were White, 13% were Black, 10% were Asian, and 10% were of Hispanic or Latino ethnicity. The mean age at study entry was 41 years (range 18 to 74 years).

Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 ) Avoid use in patients with severe hepatic impairment. ( 8.7 ) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors outcomes in women who become pregnant while taking QULIPTA. Patients should be encouraged to enroll by calling 1-833-277-0206 or visiting http://empresspregnancyregistry.com . Risk Summary There are no adequate data on the developmental risk associated with the use of QULIPTA in pregnant women. In animal studies, oral administration of atogepant during the period of organogenesis (rats and rabbits) or throughout pregnancy and lactation (rats) resulted in adverse developmental effects (decreased fetal and offspring body weight in rats; increased incidence of fetal structural variations in rabbits) at exposures greater than those used clinically [see Data ] . In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The estimated rate of major birth defects (2.2%-2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine.

Metabolism

Absorption Following oral administration of QULIPTA, atogepant is absorbed with peak plasma concentrations at approximately 1 to 2 hours. Atogepant displays dose-proportional pharmacokinetics up to 170 mg per day (approximately 3 times the highest recommended dosage), with no accumulation.

• Sep 28, 2021NDANDA215206Abbvie

1. 1Migraine1,11118%
2. 2Drug Ineffective76312%
3. 3Headache62210%
4. 4Nausea5839.5%
5. 5Constipation4327.0%
6. 6Fatigue4036.6%
7. 7Dizziness2564.2%
8. 8Therapy Interrupted1923.1%
9. 9Decreased Appetite1692.8%
10. 10Off Label Use1662.7%
11. 11Pain1642.7%
12. 12Vomiting1622.6%
13. 13Therapeutic Product Effect Incomplete1472.4%
14. 14Weight Decreased1382.2%
15. 15Anxiety1352.2%

The 10 most recently updated of 32 ClinicalTrials.gov registrations naming Atogepant as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Assess the Adverse Events and Change in Disease Activity of Oral Atogepant Tablets in Pediatric Participants (6-17 Years of Age) With Episodic Migraine
  Recruiting · Phase 3 · Interventional · 450 enrolled · AbbVie
  NCT05711394updated 2026-06-12
• i-NEED: NEw migrainE Drugs Database
  Recruiting · Observational · 2,641 enrolled · IRCCS San Raffaele Roma
  NCT07103694updated 2026-06-11
• Study of Oral Atogepant Tablets to Assess Change in Disease Activity in Adult Japanese Participants With Episodic Migraine
  Completed · Phase 3 · Interventional · 524 enrolled · AbbVie
  NCT05861427updated 2026-06-11
• A Study of Oral Atogepant Tablets to Assess Adverse Events and Change in Disease Activity To Prevent Migraine in Participants Aged 12 to 17 Years
  Recruiting · Phase 3 · Interventional · 420 enrolled · AbbVie
  NCT06810505updated 2026-06-04
• An Observational Study to Assess Change in Disease Activity When Ubrogepant Tablets Are Combined With Atogepant Tablets to Treat Migraine in Adult Participants
  Completed · Observational · 391 enrolled · AbbVie
  NCT05653986updated 2026-06-03
• Observational Study of Oral Atogepant to Evaluate Real-World Effectiveness in Adult Participants With Migraine
  Active not recruiting · Observational · 1,314 enrolled · AbbVie
  NCT06543914updated 2026-06-01
• Study of Oral Atogepant Tablets to Assess Safety and Efficacy in Adult Participants With Migraine
  Active not recruiting · Phase 3 · Interventional · 1,300 enrolled · AbbVie
  NCT06241313updated 2026-05-27
• Post-Marketing Study to Assess the Safety and Effectiveness of Oral Atogepant in Korean Adult Participants for the Prevention of Chronic or Episodic Migraine
  Recruiting · Observational · 3,000 enrolled · AbbVie
  NCT06603558updated 2026-05-26
• Comparative Effectiveness of Migraine Preventive Medications: The APT Comparison Study
  Recruiting · Phase 4 · Interventional · 1,335 enrolled · Mayo Clinic
  NCT06972056updated 2026-05-22
• Study of Oral Atogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine
  Active not recruiting · Phase 3 · Interventional · 468 enrolled · AbbVie
  NCT06806293updated 2026-05-11

Frequently asked questions

How does Atogepant work?

Atogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist.

What is Atogepant used for?

According to FDA labeling, Atogepant carries indications including: QULIPTA is indicated for the preventive treatment of migraine in adults. QULIPTA is a calcitonin gene-related peptide receptor antagonist indicated for the preventive treatment of migraine in adults.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Atogepant?

Atogepant is classified as Calcitonin gene-related peptide (CGRP) antagonists, Calcitonin Gene-related Peptide Receptor Antagonist, Calcitonin Gene-related Peptide Antagonists, Calcitonin Gene-related Peptide Receptor Antagonists.

What are the brand names for Atogepant?

Atogepant is marketed under brand names including Qulipta.

What are the contraindications for Atogepant?

Atogepant labeling lists contraindications including: QULIPTA is contraindicated in patients with a history of hypersensitivity to atogepant or any of the components of QULIPTA. Reactions have included anaphylaxis and dyspnea [see Warnings and Precautions ( 5.1 )] .. Always consult the full prescribing information and a clinician.