ArticleClinical pharmacology in drug development2021
Single-Dose Pharmacokinetics and Safety of Atogepant in Adults With Hepatic Impairment: Results From an Open-Label, Phase 1 Trial.
Article in Clinical pharmacology in drug development, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.
- Atogepant for Migraine Prevention: A Systematic Review of Efficacy and Safety.Clinical drug investigation · 2022Pooled it
- Efficacy of Atogepant in Chronic Migraine With and Without Acute Medication Overuse in the Randomized, Double-Blind, Phase 3 PROGRESS Trial.Neurology · 2024Trial
- Acute Severe Pancolitis After Initiation of a Calcitonin Gene-Related Peptide Receptor Antagonist: A Case Report.ACG case reports journal · 2026Article
- Exposure-Response Modeling of Monthly Migraine Days for Efficacy of Atogepant in Patients With Episodic or Chronic Migraine.CPT: pharmacometrics & systems pharmacology · 2026Article
- What Do Oral Drugs Really Look Like? Dose Regimen, Pharmacokinetics, and Safety of Recently Approved Small-Molecule Oral Drugs.Journal of medicinal chemistry · 2025Review
- Clinical Pharmacokinetics of Atogepant in Healthy Japanese and White Adults.Neurology and therapy · 2025Article
- Comparison of gepant effects at therapeutic plasma concentrations: connecting pharmacodynamics and pharmacokinetics.The journal of headache and pain · 2024Article
- Migraine: from pathophysiology to treatment.Journal of neurology · 2023Review
- Calcitonin Gene-Related Peptide (CGRP)-Targeted Monoclonal Antibodies and Antagonists in Migraine: Current Evidence and Rationale.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022Review
- New Generation Gepants: Migraine Acute and Preventive Medications.Journal of clinical medicine · 2022Review
- Atogepant: First Approval.Drugs · 2022Review
- Role of Atogepant in the Treatment of Episodic Migraines: Clinical Perspectives and Considerations.Therapeutics and clinical risk management · 2022Review
- Atogepant for the prevention of episodic migraine in adults.SAGE open medicine · 2022Review
- Towards Drug Repurposing in Cancer Cachexia: Potential Targets and Candidates.Pharmaceuticals (Basel, Switzerland) · 2021Review
Corrections and comments
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Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Atogepant is a selective oral calcitonin gene-related peptide receptor antagonist in development for migraine prevention. Here, we report the pharmacokinetics (PK) and safety of single-dose 60 mg atogepant in participants with severe, moderate, or mild hepatic impairment and matched participants with normal hepatic function from an open-label, parallel-group, single-dose phase 1 trial. Thirty-two participants aged 45 to 72 years were enrolled, which included 8 each with severe, moderate, mild, or no hepatic impairment. All participants completed the study. Atogepant was rapidly absorbed (median time to maximum plasma concentration, ∼2 hours) with an apparent terminal elimination half-life of ∼11 hours. Compared with participants with normal hepatic function, the change in maximum plasma concentrations of atogepant were -4%, -12%, and +9% in participants with severe, moderate, or mild hepatic impairment, respectively. Overall systemic exposures to atogepant were 15% to 38% higher in participants with hepatic impairment compared with those with normal hepatic function, but these differences are not expected to be clinically relevant given the established safety profile of atogepant. Only 1 adverse event was reported: mild rhinorrhea in a participant with moderate hepatic impairment. Overall, atogepant was safe and not associated with any clinically relevant change in PK in participants with severe, moderate, or mild hepatic impairment.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.