NCT06967259 is a Phase 1 clinical trial of ENA-001 in Respiratory Depression, sponsored by Enalare Therapeutics Inc..

Who is sponsoring NCT06967259?

NCT06967259 is sponsored by Enalare Therapeutics Inc..

What drugs are being tested in NCT06967259?

Interventions in NCT06967259: ENA-001, Placebo Comparator.

What condition does NCT06967259 study?

NCT06967259 studies Respiratory Depression.

Is NCT06967259 still recruiting?

NCT06967259 is currently active, enrolled. Last updated 30 December 2025.

Last reviewed 2025-12-30 · How we verify

NCT06967259

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

ENA-001 for Opioid Induced Respiratory Depression

Active, enrolled Phase 1 Last updated 30 December 2025

What this trial tests

Phase 1 trial testing ENA-001 in Respiratory Depression in 36 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

14 May 2025

Primary endpoint
30 July 2026

30 December 2026

Quick facts

Lead sponsor	Enalare Therapeutics Inc.
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	treatment
Enrollment	36
Start date	14 May 2025
Primary completion	30 July 2026
Estimated completion	30 December 2026
Sites	2 locations across United States

Drugs / interventions tested

ENA-001 — full drug profile →
Placebo Comparator

Conditions studied

Respiratory Depression — all drugs for Respiratory Depression →

Sponsor

Enalare Therapeutics Inc. — full company profile →

Who can join

Adults 18 to 55, any sex, with Respiratory Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a Phase I clinical trial to assess the safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) profiles with single intravenous (IV) and intramuscular (IM) doses of ENA-001.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of ENA-001

Trials testing the same drug.

NCT06137638 — ENA-001 for Post Operative Respiratory Depression (PORD) · Phase 2 · not yet recruiting

Other recruiting trials for Respiratory Depression

Currently open trials in the same condition.

NCT07166614 — Dexmedetomidine vs Propofol in High-Risk ERCP Patients · NA · recruiting
NCT06823661 — Transcutaneous Electrical Stimulation for Apnea Detected by Capnography · NA · recruiting
NCT06777758 — Comparison of Remimazolam and Propofol in Endoscopic Examinations and Treatments · Phase 4 · recruiting
NCT06772961 — Effect of Percutaneous Electrical Acupoint Stimulation on the Improvement of Incidence of Adverse Respiratory Events · NA · recruiting
NCT06374589 — Closed-Loop O2 Use During High Flow Oxygen Treatment of Critical Care Adult Patients (CLOUDHFOT) · NA · recruiting

Other Enalare Therapeutics Inc. trials

Trials by the same sponsor.

NCT06137638 — ENA-001 for Post Operative Respiratory Depression (PORD) · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06967259 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Enalare Therapeutics Inc.
Last refreshed: 30 December 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06967259.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing