Enalare Therapeutics


Clinical-stage biopharmaceutical company developing a novel new-chemical-entity respiratory stimulant for treatment of acute respiratory depression across settings including drug overdose, postoperative respiratory depression, and apnea of prematurity. Activities described on the site include discovery and development of a lead NCE, preclinical toxicology, clinical studies (including randomized controlled trials), regulatory interactions (FDA designations), patent filings, and partnerships with government and industry funders.

Industries

Biopharma
Biotechnology
Pharmaceutical
Pharmaceutical Manufacturing

Nr. of Employees

small (1-50)

Enalare Therapeutics

Princeton, New Jersey, United States


Patents

Large-conductance potassium channel modulators, compositions thereof, methods of manufacturing thereof, and methods of use thereof

US-12721850-B2

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Methods and pharmaceutical compositions to treat drug overdose

US-12544369-B2

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Methods of treating respiratory depression modulated by a non-opioid agent

US-12138267-B2

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Products

Lead respiratory stimulant candidate — clinical-stage NCE (parenteral formulations)

Patent-protected small-molecule respiratory stimulant NCE in clinical development intended to reverse pharmacologically induced respiratory depression; clinical data include randomized controlled study demonstrating reversal of propofol-induced depression of the hypoxic ventilatory response. Development includes IV and IM formulations and regulatory filings.

ENA-001

Our lead drug candidate, ENA-001, is a patent-protected new chemical entity (NCE) beginning additional clinical trials, holding the potential to dramatically improve the lives of those impacted by several life-threatening conditions.


Services

Engagement with industry and government partners for funding, licensing, and co-development of respiratory stimulant therapeutics.

Expertise Areas

  • Acute respiratory depression therapeutics
  • Clinical trial management (early-phase)
  • Respiratory physiology and clinical pharmacology
  • Preclinical toxicology and IND-enabling studies
  • Show More (4)

Key Technologies

  • BK-channel modulation
  • New chemical entity (NCE) development
  • Intravenous and intramuscular formulation development
  • Clinical respiratory monitoring (capnography, pulse oximetry)
  • Show More (3)

News & Updates

Company presentations and poster sessions at conferences including PAINWeek, ASA, AAP, ASRA, CPDD, and others from 2021–2025.

Randomized controlled trial publication reporting reversal of propofol-induced depression of hypoxic ventilatory response by the lead BK-channel blocking respiratory stimulant candidate.

Announcement of supplemental BARDA funding expanding a prior contract to support development of the lead respiratory stimulant candidate.

Announcement of U.S. FDA orphan drug designation for the lead compound for treatment of apnea of prematurity.

Awards and supplemental contracts from BARDA to support preclinical, clinical, manufacturing, and regulatory development activities.

Grant funding from the NIH National Institute on Drug Abuse to support further development of the respiratory stimulant candidate.

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