Brand Name

Qulipta

Generic Name
Atogepant
View Brand Information
FDA approval date: September 30, 2021
Classification: Calcitonin Gene-related Peptide Receptor Antagonist
Form: Tablet

What is Qulipta (Atogepant)?

Migraines can be more than just headaches; they can disrupt work, relationships, and daily life. Many people living with chronic migraines struggle to find lasting relief despite trying multiple medications. Qulipta (generic name: atogepant) offers a modern option designed specifically to prevent migraine attacks before they start, helping patients regain control of their days.

Qulipta belongs to a newer class of medicines known as calcitonin gene-related peptide (CGRP) receptor antagonists. Unlike older migraine treatments that focus on easing pain after it begins, Qulipta works by targeting one of the key pathways involved in migraine development. Approved by the U.S. Food and Drug Administration (FDA) in 2021, it represents an important advance for people seeking reliable, preventive migraine care.

What does Qulipta do?

Qulipta is prescribed to help prevent episodic or chronic migraine attacks in adults. Rather than treating pain during a migraine, it reduces the frequency and intensity of attacks over time.

In clinical studies, patients taking Qulipta experienced significantly fewer monthly migraine days compared to those taking a placebo (FDA, 2023). Many reported being able to engage more fully in daily activities, work, and social life without the constant fear of the next migraine episode.

Qulipta’s benefits include:

  • Fewer migraine days per month
  • Less reliance on rescue pain medications
  • Improved quality of life and functional performance

Because it is taken once daily by mouth, Qulipta offers a convenient option for those who prefer an oral preventive treatment rather than injections or infusions used with some other CGRP drugs.

How does Qulipta work?

Qulipta targets the calcitonin gene-related peptide (CGRP) receptor, a critical signaling pathway linked to migraine attacks. CGRP is a natural protein in the brain that causes blood vessels to widen and triggers inflammation during migraines.

By blocking the CGRP receptor, Qulipta helps prevent the chain reaction that leads to migraine pain and sensitivity to light, sound, and movement. In simple terms, it stops the migraine process before it begins.

Clinically, this mechanism is significant because it allows for targeted prevention without constricting blood vessels, a limitation seen with older migraine medications like triptans. This makes Qulipta suitable for patients who cannot tolerate those older therapies or have cardiovascular concerns.

Qulipta side effects

Most people tolerate Qulipta well, but as with any medication, side effects can occur. These are generally mild and tend to lessen as the body adjusts.

Common side effects include:

  • Nausea
  • Constipation
  • Fatigue or sleepiness
  • Decreased appetite

Less common effects may include:

  • Weight loss
  • Dry mouth
  • Muscle weakness

Serious side effects are rare, but patients should seek immediate medical attention if they notice signs of allergic reaction such as rash, swelling, or difficulty breathing.

People with severe liver disease should discuss safety and dosing options with their doctor, as Qulipta is processed by the liver. Women who are pregnant or breastfeeding should also consult their healthcare provider before starting treatment.

Qulipta does not appear to cause dependency or withdrawal symptoms, and it has not been linked to medication overuse headache, a problem sometimes seen with frequent use of pain relievers.

Qulipta dosage

Qulipta is taken by mouth once daily, with or without food. It comes in tablet form, which makes it easy to integrate into a daily routine.

The exact dosage depends on individual factors such as migraine frequency, other medications being used, and overall health. Your doctor will choose the most appropriate strength for you and may adjust it over time based on your response.

While Qulipta does not require intensive lab monitoring, your healthcare provider may:

  • Review liver function periodically to ensure safe metabolism of the drug.
  • Assess migraine frequency and symptom severity to evaluate treatment response.
  • Discuss potential drug interactions, especially with medications affecting liver enzymes.

Patients should take the medication at the same time each day for best results and avoid skipping doses, as consistent use is key to migraine prevention.

Does Qulipta have a generic version?

As of 2025, Qulipta (atogepant) does not have an FDA-approved generic version. It is currently available only as the brand-name product marketed by AbbVie.

Because it is a relatively new medication, it may take several years before generic formulations become available. Patients concerned about cost can discuss insurance coverage, patient-assistance programs, or rebate options with their healthcare provider or pharmacist.

All future FDA-approved generics, when available, will be required to meet the same standards of safety, quality, and effectiveness as the brand-name version.

Conclusion

Qulipta offers a modern and effective approach to prevent migraine attacks, helping people live with fewer disruptions and greater consistency in their daily lives. By targeting the CGRP pathway, a major driver of migraine activity, it works at the source rather than simply masking pain.

Most patients find it convenient and well tolerated, with a manageable side-effect profile. As with all preventive therapies, the full benefits often appear after consistent use over several weeks, so staying in close contact with your healthcare provider is essential.

When prescribed and monitored by a qualified professional, Qulipta can play a key role in reducing migraine burden, restoring daily functionality and improving overall quality of life for people affected by this chronic condition.

References

  1. U.S. Food and Drug Administration (FDA). (2023). Qulipta (atogepant) prescribing information. Retrieved from https://www.fda.gov
  2. Mayo Clinic. (2024). Atogepant (oral route) – Description and brand names. Retrieved from https://www.mayoclinic.org
  3. National Institutes of Health (NIH). (2023). Calcitonin gene-related peptide and migraine mechanisms. Retrieved from https://www.ncbi.nlm.nih.gov
  4. MedlinePlus. (2024). Atogepant medication overview. Retrieved from https://medlineplus.gov

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Brand Information

Qulipta (Atogepant)
1INDICATIONS AND USAGE
QULIPTA is indicated for the preventive treatment of migraine in adults.
2DOSAGE FORMS AND STRENGTHS
QULIPTA 10 mg is supplied as white to off-white, round biconvex tablets debossed with “A” and “10” on one side.
QULIPTA 30 mg is supplied as white to off-white, oval biconvex tablets debossed with “A30” on one side.
QULIPTA 60 mg is supplied as white to off-white, oval biconvex tablets debossed with “A60” on one side.
3CONTRAINDICATIONS
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
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
  • Hypersensitivity Reactions
  • Hypertension
  • Raynaud’s Phenomenon
4.1Clinical 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
The most common adverse reactions (incidence at least 4% and greater than placebo) are nausea, constipation, and fatigue/somnolence. 
Table 2 summarizes the adverse reactions that occurred during Studies 1, 2, and 3.
* 10 mg and 30 mg incidence from Studies 1 and 2; 60 mg pooled incidence from Studies 1, 2, and 3.
The adverse reactions that most commonly led to discontinuation of QULIPTA in these studies were nausea (0.6%), constipation (0.5%), and fatigue/somnolence (0.2%).
Liver Enzyme Elevations
In Study 1, Study 2, and Study 3, the rate of transaminase elevations over 3 times the upper limit of normal was similar between patients treated with QULIPTA (0.9%) and those treated with placebo (1.2%). However, there were cases with transaminase elevations over 3 times the upper limit of normal that were temporally associated with QULIPTA treatment; these were asymptomatic and resolved within 8 weeks of discontinuation. There were no cases of severe liver injury or jaundice.
Decreases in Body Weight
In Study 1, Study 2, and Study 3, the proportion of patients with a weight decrease of at least 7% at any point was 2.5% for placebo, 3.8% for QULIPTA 10 mg, 3.2% for QULIPTA 30 mg, and 5.3% for QULIPTA 60 mg.
4.2Postmarketing Experience
The following adverse reactions have been identified during post approval use of QULIPTA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure.
Immune System Disorders: Hypersensitivity (e.g., anaphylaxis, dyspnea, rash, pruritus, urticaria, facial edema) [see Contraindications (4) and Warnings and Precautions (5.1)]
Vascular Disorders: Hypertension [see Warnings and Precautions (5.2)], Raynaud’s phenomenon [see Warnings and Precautions (5.3)]
5DESCRIPTION
The active ingredient of QULIPTA is atogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist. The chemical name of atogepant is (3’
The active ingredient of TRADENAME is atogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist. The chemical name of atogepant is (S)-N-((3S,5S,6R)-6-methyl-2-oxo-1-(2,2,2-trifluoroethyl)-5-(2,3,6-trifluorophenyl)piperidin-3-yl)-2'-oxo-1',2',5,7-tetrahydrospiro[cyclopenta[b]pyridine-6,3'-pyrrolo[2,3-b]pyridine]-3-carboxamide and has the following structural formula:
The molecular formula is C
QULIPTA is available as tablets for oral administration containing 10 mg, 30 mg, or 60 mg atogepant. The inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, polyvinylpyrrolidone vinyl acetate copolymer, sodium chloride, sodium stearyl fumarate, and vitamin E polyethylene glycol succinate.
6PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
Hypersensitivity Reactions
Inform patients about the signs and symptoms of hypersensitivity reactions and that these reactions can occur with QULIPTA. Advise patients to discontinue QULIPTA and seek immediate medical attention if they experience any symptoms of a hypersensitivity reaction
Hypertension
Inform patients that hypertension can develop or pre-existing hypertension can worsen with QULIPTA, and that they should contact their healthcare providers if they experience elevation in their blood pressure
Raynaud’s Phenomenon
Inform patients that Raynaud’s phenomenon can develop or worsen with QULIPTA. Advise patients to discontinue QULIPTA and contact their healthcare provider if they experience signs or symptoms of Raynaud’s phenomenon
Drug Interactions
Inform patients that QULIPTA may interact with certain other drugs, and that dosage modifications of QULIPTA may be recommended when used with some other drugs. Advise patients to report to their healthcare provider the use of any other prescription medications, over-the-counter medications, herbal products, or grapefruit juice 
Pregnancy
Advise patients to notify their healthcare provider if they become pregnant during treatment or plan to become pregnant
Lactation
Inform patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed
Manufactured for:
© 2025 AbbVie. All rights reserved.

QULIPTA and its design are trademarks of Allergan Pharmaceuticals International Limited, an AbbVie company.
20096809 September 2025
7PRINCIPAL DISPLAY PANEL
NDC 0074-
PRINCIPAL DISPLAY PANEL
NDC 0074-7095-30
Rx Only
QULIPTA®
(atogepant) tablets
10 mg

Contains 30 Tablets
8PRINCIPAL DISPLAY PANEL
NDC 0074-
PRINCIPAL DISPLAY PANEL
NDC 0074-7096-30
Rx Only
QULIPTA®
(atogepant) tablets

30 mg
Contains 30 Tablets
9PRINCIPAL DISPLAY PANEL
NDC 0074-
PRINCIPAL DISPLAY PANEL
NDC 0074-7094-30
Rx Only
QULIPTA®
(atogepant) tablets

60 mg
Contains 30 Tablets