Evidence map›Paper›PMID 40641004›Full record

ArticleJournal of clinical pharmacology2025

Pharmacokinetics and Safety of Fezolinetant in Women with Hepatic or Renal Impairment.

Megumi Iwai, Xuegong Wang, Melanie Patton, Lauren Benner, Nakyo Heo, Jace C Nielsen, Anna Spence, Thomas C Marbury, Jiayin Huang

Abstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Journal of clinical pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Megumi IwaiAstellas Pharma Global Development, Inc., Northbrook, IL, USA.ORCID 0009-0009-4323-8266
Xuegong WangAstellas Pharma Global Development, Inc., Northbrook, IL, USA.ORCID 0000-0003-3771-0762
Melanie PattonAstellas Pharma Global Development, Inc., Northbrook, IL, USA.ORCID 0009-0004-4921-1535
Lauren BennerAstellas Pharma Global Development, Inc., Northbrook, IL, USA.ORCID 0009-0002-4718-8023
Nakyo HeoAstellas Pharma Global Development, Inc., Northbrook, IL, USA.
Jace C NielsenAstellas Pharma Global Development, Inc., Northbrook, IL, USA.ORCID 0009-0009-4950-7957
Anna SpenceAstellas Pharma Global Development, Inc., Northbrook, IL, USA.ORCID 0009-0009-8221-2894
Thomas C MarburyOrlando Clinical Research Center, Orlando, FL, USA.ORCID 0000-0002-6416-3314
Jiayin HuangAstellas Pharma Global Development, Inc., Northbrook, IL, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The neurokinin 3 receptor antagonist fezolinetant is an approved treatment for vasomotor symptoms due to menopause. The impacts of hepatic and renal impairment on the pharmacokinetics and safety of a single oral dose of fezolinetant 30 mg were investigated in two independent studies. The studies enrolled healthy women and women with mild or moderate hepatic impairment (defined by Child-Pugh classification) or mild to severe renal impairment (categorized by estimated glomerular filtration rate). Blood samples for fezolinetant and its metabolite, ES259564, were collected predose and up to 96 h postdose. Safety was assessed using treatment-emergent adverse events (TEAEs). Overall, 26 and 27 women were enrolled in the hepatic and renal studies. Fezolinetant exposure (area under the concentration-time curve from time of dosing to infinity [AUC

Indexed as

Liver DiseasesRenal InsufficiencyAdultAgedArea Under CurveFemaleHumansMiddle AgedYoung Adultfezolinetanthepatic impairmentpharmacokineticsrenal impairmentsafety

Identifiers

PMID40641004
PMCPMC12555095

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.