Evidence map›Paper›PMID 38550433›Full record

ArticleCureus2024

A Single Ascending-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Novel Respiratory Stimulant ENA-001.

Joseph Pergolizzi, Thomas L Miller, Jeanette Mathews, Robert B Raffa, Robert Colucci, Frank J Diana, Errol Gould

Open access · diamondAbstract read
In one paragraph

Article in Cureus, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.4field-weighted citation impact, top 40% of its field
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

5 citing papers in PubMed, 1 citations in OpenAlex.

  1. Targeting the Carotid Body Function With Big-KPharmacology research & perspectives · 2026
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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 at 1 institution in 1 country.

Joseph PergolizziAnesthesiology, Enalare Therapeutics, Inc., Princeton, USA.
Thomas L MillerClinical Development, Enalare Therapeutics, Inc., Princeton, USA.
Jeanette MathewsResearch and Development Operations, Enalare Therapeutics, Inc., Princeton, USA.
Robert B RaffaSchool of Pharmacy, Temple University (Emeritus), Philadelphia, USA.
Robert ColucciPharmacology, NEMA Research, Inc., Naples, USA.
Frank J DianaPulmonology, Enalare Therapeutics, Inc., Princeton, USA.
Errol GouldMedical Affairs, Enalare Therapeutics, Inc., Princeton, USA.
Therapeutics Clinical Research · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background ENA-001 (formerly known as GAL-021) is a novel, first-in-class respiratory stimulant. Pharmacokinetic and pharmacodynamic properties, plus safety and tolerability, were assessed in a randomized, single-center study of healthy volunteers. Methodology This four-period study was designed to test continuous two-hour intravenous infusion regimens of ENA-001 at doses of 0.96, 1.44, and 1.92 mg/kg/hour versus placebo. Each participant received four infusions with a seven-day minimum washout between them: one infusion each of the three doses of ENA-001 and one placebo. Pharmacokinetic and pharmacodynamic parameters were assessed and adverse events were recorded. Results A total of 17 participants completed the study. ENA-001 was generally safe and well tolerated over the dose range studied (0.96 to 1.92 mg/kg/hour). ENA-001 was able to drive hyperventilation in a dose-dependent manner in healthy participants. Increases in ventilation due to ENA-001 were not associated with like-magnitude blood pressure response. ENA-001-stimulated decreases in ETCO

Indexed as

ena-001gal-021minute ventilationpostoperative respiratory depressionrespiratory depressionrespiratory stimulant

Identifiers

PMID38550433
PMCPMC10977476
OpenAlexW4392191051

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.