Evidence map›Paper›PMID 40968480›Full record

ArticleBritish journal of clinical pharmacology2026

Absolute bioavailability and intravenous pharmacokinetics of N-acetyl-D-mannosamine in humans.

Tahlia R Meola, Guy Ludbrook, Gianfranco Fornasini, Olga Pavlova, Sumit Jain, Allan M Evans, Stephanie E Reuter

Abstract read
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. Trial
  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.

Tahlia R MeolaUniSA Clinical & Health Sciences, University of South Australia, Adelaide, SA, Australia.ORCID https://orcid.org/0000-0002-7827-6256
Guy LudbrookPARC Clinical Research, Adelaide, SA, Australia.
Gianfranco FornasiniLeadiant Biosciences, Inc., Rockville, MD, USA.
Olga PavlovaLeadiant Biosciences, Inc., Rockville, MD, USA.
Sumit JainLeadiant Biosciences, Inc., Rockville, MD, USA.
Allan M EvansUniSA Clinical & Health Sciences, University of South Australia, Adelaide, SA, Australia.
Stephanie E ReuterUniSA Clinical & Health Sciences, University of South Australia, Adelaide, SA, Australia.ORCID https://orcid.org/0000-0003-3888-7287

Funding

Leadiant Biosciences Inc
6 · The paper itself

Abstract

aimsN-acetyl-D-mannosamine monohydrate (ManNAc) is a naturally occurring monosaccharide that has attracted considerable attention for its potential in treating GNE myopathy, a rare autosomal recessive muscle disorder. Despite its promise as an oral treatment, the absolute bioavailability of oral ManNAc has not been determined and there has been no evaluation of the ManNAc pharmacokinetics following intravenous administration in humans. The aim of this study was to investigate the pharmacokinetics of intravenous ManNAc and to characterize its absolute bioavailability following a single oral dose.

methodsIn this single-centre, open-label, crossover study, six healthy adult males were administered ManNAc as a single oral dose (1000 mg) and intravenous dose (100 mg). Blood samples were collected over a 48 h period after dose administration for the quantification of plasma ManNAc concentrations. Non-compartmental pharmacokinetic analysis was performed using baseline-corrected plasma concentration-time data.

resultsAfter intravenous dosing, the mean plasma clearance of ManNAc was 10.1 ± 1.94 L/h, volume of distribution was 24.1 ± 4.98 L and elimination half-life was 1.67 ± 0.251 h. The mean absolute bioavailability of oral ManNAc at a dose of 1000 mg was 4.01 ± 1.82%. Deconvolution analysis revealed a zero-order absorption rate of about 10 mg per hour in the initial 3 h after dosing.

conclusionsThe low oral bioavailability of ManNAc is likely due to poor absorption (rather than first-pass hepatic extraction) due to its high polarity. In addition, zero-order absorption explains why the systemic exposure to ManNAc does not increase proportionally with dose.

Indexed as

HexosaminesAdministration, IntravenousAdministration, OralAdultBiological AvailabilityCross-Over StudiesHalf-LifeHealthy VolunteersHumansMaleMiddle AgedYoung AdultHexosaminesN-acetylmannosaminebioavailabilityN‐acetyl‐D‐mannosamine monohydrateN‐acetylneuraminic acidoral absorptionpharmacokinetics

Identifiers

PMID40968480
PMCPMC12850572

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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.