Evidence map›Paper›PMID 41215526›Full record

Trial reportClinical and translational science2025

Valbenazine Sprinkle: An Alternative Formulation of Valbenazine for Oral Administration in Patients With Dysphagia.

Nagdeep Giri, Roland Jimenez, Linda Rees, Alexander Mar, Ali Bristow, Mello Hebert, Jessica Maynard-Scott, Hui Zhang, Satjit Brar

Abstract readRandomized Controlled TrialClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical and translational science, 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. Trial
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.

Nagdeep GiriNeurocrine Biosciences, Inc., San Diego, California, USA.ORCID 0009-0002-0397-0865
Roland JimenezNeurocrine Biosciences, Inc., San Diego, California, USA.
Linda ReesNeurocrine Biosciences, Inc., San Diego, California, USA.
Alexander MarNeurocrine Biosciences, Inc., San Diego, California, USA.
Ali BristowNeurocrine Biosciences, Inc., San Diego, California, USA.
Mello HebertNeurocrine Biosciences, Inc., San Diego, California, USA.
Jessica Maynard-ScottNeurocrine Biosciences, Inc., San Diego, California, USA.
Hui ZhangNeurocrine Biosciences, Inc., San Diego, California, USA.
Satjit BrarNeurocrine Biosciences, Inc., San Diego, California, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Valbenazine is a vesicular monoamine transporter 2 (VMAT2) inhibitor approved for the treatment of tardive dyskinesia and Huntington's chorea. Dysphagia, pill aversion, and fear of swallowing are common in patients with these conditions. A new valbenazine sprinkle capsule, to be swallowed whole or the granule contents sprinkled onto soft food, was developed and approved based on the studies presented here. Study 1 evaluated the stability of valbenazine granules in soft foods. Recovery of valbenazine granules within 2 h after addition to applesauce, pudding, and yogurt was 95.6%-100.2%, indicating acceptable stability. Study 2 was a randomized, open-label, 2-cohort, phase 1 study in healthy volunteers. Plasma concentrations of valbenazine and its active metabolite, [+]-α-dihydrotetrabenazine ([+]-α-HTBZ) were measured serially after a single dose under various conditions. Cohort 1 evaluated bioequivalence between the sprinkle capsule and the original capsule with compacted powder (reference). Pharmacokinetics of valbenazine and [+]-α-HTBZ were similar between the whole sprinkle capsule and reference. When granules were sprinkled on applesauce, a lower valbenazine C

Indexed as

Deglutition DisordersTetrabenazineValineAdministration, OralAdultCapsulesFemaleHealthy VolunteersHumansMaleMiddle AgedTherapeutic EquivalencyVesicular Monoamine Transport ProteinsYoung AdultCapsulesdihydrotetrabenazineSLC18A2 protein, humanTetrabenazinevalbenazineValineVesicular Monoamine Transport ProteinscapsulesdysphagiaHuntington's disease choreaoral administrationtardive dyskinesiavalbenazine

Identifiers

PMID41215526
PMCPMC12602462

What OpenQuestion holds

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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.