How the Migraine Drug Ubrogepant Is Processed and Eliminated by the Body | Research

The takeaway

A mass balance study in healthy men shows 92.4% of ubrogepant is recovered, primarily through feces, with extensive hepatic metabolism.

92.4% recovered
Nearly complete drug recovery with extensive hepatic metabolism in healthy men

What the researchers found

Mean total radioactivity recovery was 92.4% after a single 50 mg oral dose of [14C]-ubrogepant, with the drug undergoing extensive hepatic metabolism.

Why it matters

Understanding how migraine drugs are metabolized helps predict drug interactions, guide dosing in liver or kidney disease, and optimize treatment safety.

How the study worked

Mass balance and metabolism study using [14C]-labeled ubrogepant (50 mg, ~200 µCi) in 6 healthy male adults, tracking radioactivity recovery and metabolite identification.

What this study cannot tell us

Small sample (6 males only). Single-dose study — may not reflect steady-state metabolism. Healthy volunteers may not represent migraine patient population.

How to read the evidence

Phase 1 pharmacokinetic study — standard regulatory study design with small but adequate sample for mass balance.

When this study was published

Published in 2026; characterizes an already-approved migraine drug.

The bigger picture

This pharmacokinetic data supports the safe clinical use of CGRP antagonists for migraine and informs development of next-generation migraine treatments.

Questions still open

Does hepatic metabolism of ubrogepant create any pharmacologically active metabolites?
How does liver disease affect ubrogepant clearance?

Common questions

What is ubrogepant?

Ubrogepant (brand name Ubrelvy) is a CGRP receptor antagonist taken as a pill to treat acute migraine attacks. It works by blocking the pain-signaling peptide CGRP.

Why study how a drug is eliminated?

Mass balance studies show how the body processes and eliminates a drug, helping doctors predict drug interactions, adjust doses for patients with liver or kidney problems, and ensure safe use.

Read the original research

A Human Mass Balance and Metabolism Study of [14C]-Ubrogepant in Healthy Male Adults.

Clinical pharmacology in drug development, 15(1), e70010

View on PubMed ↗Publisher’s paper ↗

Citation

Boinpally, Ramesh R; Rowe, Joshua; Chandrasekar, Pushpa; White, Rebecca B; Marcantonio, Eugene E; Trainor, Nicole; Liang, Yuexia; Maciolek, Cheri; Small, James H; Houle, Robert; Hafey, Michael J; Xie, Huizhi; Yabut, Jocelyn; Fandozzi, Christine. (2026). A Human Mass Balance and Metabolism Study of [14C]-Ubrogepant in Healthy Male Adults.. Clinical pharmacology in drug development, 15(1), e70010. https://doi.org/10.1002/cpdd.70010