Evidence map›Paper›PMID 41151967›Full record

ArticleBritish journal of clinical pharmacology2026

Safety and pharmacokinetics of a novel potent GABA analogue crisugabalin in Chinese subjects with various degrees of renal impairment.

Shibeilei Lin, Ye Wang, Chao Hu, Yanhuan Feng, Xi Tang, Ping Fu, Jia Miao

Abstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in British journal of clinical pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. Article
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

7 authors.

Shibeilei LinClinical Trial Center, West China Hospital, Sichuan University, Chengdu, China.ORCID https://orcid.org/0009-0004-2512-3987
Ye WangClinical Trial Center, West China Hospital, Sichuan University, Chengdu, China.
Chao HuClinical Trial Center, West China Hospital, Sichuan University, Chengdu, China.
Yanhuan FengDepartment of Nephrology, Kidney Research Institute, West China Hospital of Sichuan University, Chengdu, China.
Xi TangDepartment of Nephrology, Kidney Research Institute, West China Hospital of Sichuan University, Chengdu, China.
Ping FuDepartment of Nephrology, Kidney Research Institute, West China Hospital of Sichuan University, Chengdu, China.
Jia MiaoClinical Trial Center, West China Hospital, Sichuan University, Chengdu, China.

Funding

Haisco Pharmaceutical N/A
6 · The paper itself

Abstract

aimsCrisugabalin is a novel calcium channel α2δ subunit ligand and a highly selective oral gamma-aminobutyric acid (GABA) analogue developed for the treatment of diabetic peripheral neuropathic pain (DPNP) and postherpetic neuralgia (PHN). This study investigated pharmacokinetic properties and safety of crisugabalin in subjects with renal impairment.

methodsThis multicenter, nonrandomized, open-label Phase I study investigated the pharmacokinetics and safety of a single oral 20-mg dose of crisugabalin capsule in Chinese subjects with various degrees of renal function, categorized according to the absolute glomerular filtration rate (GFR). A total of 32 subjects (eight subjects per renal function category [normal, mild, moderate, or severe impairment]) were enrolled and completed the study. Blood samples were collected up to 72 h post-dose, along with fractionated urine samples. Active moiety exposures were calculated as the sum of unbound exposures for crisugabalin and its active metabolites.

resultsThe t

conclusionFor patients with GFR < 60 mL/min, dosage adjustments of crisugabalin should be considered. To maintain comparable plasma drug concentrations in patients with impaired renal function, it is recommended that crisugabalin doses be decreased by approximately 50% for every 50% decline in GFR.

Indexed as

gamma-Aminobutyric AcidRenal InsufficiencyAdministration, OralAdultAgedArea Under CurveEast Asian PeopleFemaleGlomerular Filtration RateHalf-LifeHumansMaleMiddle AgedSeverity of Illness Indexgamma-Aminobutyric AcidcrisugabalinGABA analoguepharmacokineticsrenal impairmentsafety

Identifiers

PMID41151967
PMCPMC12930009

What Socratic holds

Textmetadata
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 Socratic graph.