Trial reportClinical and translational science2021
Atogepant Is Not Associated With Clinically Meaningful Alanine Aminotransferase Elevations in Healthy Adults.
Trial report in Clinical and translational science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06136442 (Atogepant in Real Life in Italy), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Atogepant in Real Life in Italy
Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 36 citations in OpenAlex.
- Atogepant for Migraine Prevention: A Systematic Review of Efficacy and Safety.Clinical drug investigation · 2022Pooled it
- Mass Balance and Metabolism ofClinical and translational science · 2025Article
- Gepants: Key Features of A Potent Therapeutic Option and Considerations in The Latin American Context.Revista de neurologia · 2025Review
- Nociceptive adenosine AInternational journal of oral science · 2024Article
- A Brief Review of Gepants.Current pain and headache reports · 2023Review
- Migraine: from pathophysiology to treatment.Journal of neurology · 2023Review
- Atogepant for the Prevention of Episodic Migraine in Adults: A Systematic Review and Meta-Analysis of Efficacy and Safety.Neurology and therapy · 2022Article
- Gepants - a long way to cure: a narrative review.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2022Review
- Non-coding RNAs associated with autophagy and their regulatory role in cancer therapeutics.Molecular biology reports · 2022Review
- 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
- Role of Atogepant in the Treatment of Episodic Migraines: Clinical Perspectives and Considerations.Therapeutics and clinical risk management · 2022Review
- Atogepant: First Approval.Drugs · 2022Review
- Novel Oral CGRP Receptor Antagonist Atogepant in the Prevention of Migraine.Discoveries (Craiova, Romania)Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Atogepant is a potent, selective, oral calcitonin gene-related peptide (CGRP) receptor antagonist in development for migraine prevention. The chemical structure of atogepant is distinct from previous CGRP receptor antagonists, which were associated with elevated serum alanine aminotransferase (ALT) in clinical trials. Here, we report the safety, tolerability, and pharmacokinetics (PKs) of a once-daily supratherapeutic dose (170 mg) of atogepant for 28 days from a randomized, double-blind, placebo-controlled phase I trial in healthy participants. Overall safety, hepatic safety, and plasma PK parameters were evaluated. Thirty-four participants aged 23-55 years enrolled; 28 (82.4%) completed the study in accordance with the protocol. Multiple doses of 170 mg atogepant for 28 consecutive days were generally well-tolerated. All adverse events (AEs; reported in 87.0% of the atogepant group; 72.7%, placebo) were mild in severity except one serious AE of subarachnoid hemorrhage due to a bicycle accident and not considered related to treatment. There were two discontinuations due to AEs, both with atogepant, one considered possibly related to treatment. Over 28 days of treatment, no participant receiving atogepant had an ALT elevation above 1.5 × upper limit of normal. Change from baseline in serum ALT levels was not different between atogepant and placebo. Atogepant is rapidly absorbed (median time to maximum plasma concentration, ~ 2 hours) with an apparent terminal half-life of ~ 11 hours, and no evidence of accumulation after once-daily dosing. Overall, atogepant at a high oral dose is safe and well-tolerated in healthy participants with no clinically meaningful elevations in ALT.
Indexed as
Identifiers
What OpenQuestion holds
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.