ENA-001 / Enalare Therap - LARVOL DELTA

ENA-001 for Opioid Induced Respiratory Depression (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Enalare Therapeutics Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Depression • Mood Disorders • Psychiatry

ENA-001 for Opioid Induced Respiratory Depression (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Enalare Therapeutics Inc.

New P1 trial • CNS Disorders • Depression • Mood Disorders • Psychiatry

ENA-001 for Post Operative Respiratory Depression (PORD) (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Enalare Therapeutics Inc. | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • CNS Disorders • Depression • Mood Disorders • Psychiatry

ENA-001 Reverses Xylazine/Fentanyl Combination-Induced Respiratory Depression in Rats: A Qualitative Pilot Study. (PubMed, Cureus) - "Based on the results of this pilot study, the "agnostic" nature of ENA-001 respiratory stimulation appears to extend to XFC-induced overdose. Given the urgent clinical need, additional study seems warranted."

Journal • Preclinical • Addiction (Opioid and Alcohol) • CNS Disorders • Depression • Mood Disorders • Psychiatry

ENA-001 improves ventilation in spontaneously breathing late-preterm lambs; Exploratory study for a novel respiratory stimulant (AAP-NCE 2024) - "In the late-preterm lamb, ENA-001 improved tidal volumes leading to better ventilation in a more stable breathing pattern, without exceeding target blood gas values (i.e., absence of hyperventilation). These exploratory data demonstrate that ENA-001 may be a promising therapy for infants with breathing abnormalities associated with immaturity. Further research is required on dosage and safety."

Prematurity

ENA-001 for Post Operative Respiratory Depression (PORD) (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: NEMA Research, Inc. | Trial completion date: Sep 2025 ➔ Dec 2025 | Initiation date: Mar 2024 ➔ Mar 2025 | Trial primary completion date: Mar 2025 ➔ Dec 2025

Trial completion date • Trial initiation date • Trial primary completion date • CNS Disorders • Depression • Mood Disorders • Psychiatry

ENA-001, an Agnostic Respiratory Stimulant, Reverses Xylazine-Fentanyl Induced Respiratory Depression in Rats (CPDD 2024) - "ENA-001 was able to completely and rapidly (<5 minutes) reverse RD associated with an overdose of xylazine mixed with fentanyl. ENA-001 thus appears to be a promising therapy for such an overdose."

Preclinical • CNS Disorders • Depression • Psychiatry

A Single Ascending-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Novel Respiratory Stimulant ENA-001. (PubMed, Cureus) - "Conclusions The respiratory stimulant ENA-001 demonstrated well-behaved pharmacokinetics following the two-hour infusion. Mean peak plasma concentrations and the mean total systemic exposure values were approximately dose-proportional in the dose range studied."

Journal • PK/PD data • CNS Disorders • Depression • Psychiatry

ENA-001, a BK-Channel Blocker, Stimulates Breathing Without Analeptic Side Effects (SCCM 2024) - "It has been previously reported that ENA-001 increased minute ventilation (MV) in healthy subjects and reduces arterial pCO2 in alfentanil-induced. The data from this study showed that treatment with high dose ENA-001 significantly increased the AHR compared to placebo, both with and without co-administration of clinically relevant plasma concentrations of propofol. ENA-001 did not impact propofol-induced sedation while also maintaining a favorable safety profile. These finding support that ENA-001 is a respiratory stimulant with potential for use in clinical practice, inducing stimulation of MV without antagonizing other drugs."

Adverse events • Anesthesia • Cardiovascular • CNS Disorders • Depression • Psychiatry

Reversal of propofol-induced depression of the hypoxic ventilatory response by BK-channel blocker ENA-001: a randomized controlled trial. (PubMed, Anesthesiology) - "In this pilot study, we demonstrated that ENA-001 restored the hypoxic ventilatory response impaired by propofol. This finding is not only of clinical importance, but also provides mechanistic insights into the peripheral stimulation of breathing with ENA-001 overcoming central depression by propofol."

Journal • Anesthesia • CNS Disorders • Depression • Mood Disorders • Psychiatry

ENA-001 for Post Operative Respiratory Depression (PORD) (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: NEMA Research, Inc.

New P2 trial • CNS Disorders • Depression • Mood Disorders • Psychiatry

Influence Of Bk-channel Blocker Ena-001 On Propofol-induced Depression Of The Hypoxic Ventilatory Response (ASA 2023) - "ENA-001 is able to restore the propofol-impaired HVR increasing patient safety from a blunted HVR. This is also an important mechanistic observation in that that peripheral stimulation of breathing with ENA-001 overcomes central depression by propofol without any signs of ceiling."

Anesthesia • CNS Disorders • Depression • Mood Disorders • Psychiatry