What Enalare Therapeutics does

Enalare Therapeutics is a privately held, clinical-stage biopharmaceutical company developing novel therapies for acute respiratory and critical care conditions. The company's lead drug candidate, ENA-001, is a patent-protected new chemical entity that functions as a BK-channel blocker (big potassium channel blocker) and acts as an agnostic respiratory stimulant — meaning it stimulates breathing without being limited to a specific drug class. Enalare is advancing ENA-001 in both intramuscular (IM) and intravenous (IV) formulations against three target indications: drug overdose (including opioid and polysubstance scenarios), post-operative respiratory depression, and apnea of prematurity. The candidate has demonstrated proof-of-concept in reversing propofol-induced respiratory depression in randomized clinical studies, and in September 2024 the FDA cleared initiation of the first US Phase 1 study.

The underlying technology is differentiated by its mechanism of action. ENA-001's BK-channel blockade provides respiratory stimulation without opioid antagonist properties, avoiding precipitated withdrawal or reversal of analgesia — addressing limitations of existing therapies such as naloxone, flumazenil, and doxapram, which are narrow in scope (single drug class) or carry significant side effects. The intellectual property estate has been deliberately expanded: a new US patent granted in November 2024 extends exclusivity to 2043, with global exclusivity through 2042 from earlier filings. The compound has received FDA Orphan Drug Designation and Rare Pediatric Disease Designation for apnea of prematurity.

Enalare is pre-revenue and its commercial model is still being constructed. Development has been substantially financed through non-dilutive government funding — BARDA (up to $55.8M total potential support across the 2021 award, the September 2022 expansion, and the September 2024 supplement), NIH/NIDA grants (up to $5.3M total), and a single $25M equity investment from Eagle Pharmaceuticals in August 2022, which carries an option for Eagle to acquire the remaining shares. Upon regulatory approval, the company expects to commercialize via direct sales to hospital pharmacies, emergency departments, anesthesiology/critical care units, neonatal intensive care units, and government procurement channels for medical-countermeasure stockpiling. The Eagle Pharmaceuticals option creates a defined potential acquisition exit that could accelerate commercial scale-up.

Name

Enalare Therapeutics

Legal name

Enalare Therapeutics Inc.

Website

https://enalare.com

Company type

Private

Founded year

2020

Operating status

Operating

Headcount range

1–10 employees

Short description

Enalare Therapeutics is a clinical-stage biopharmaceutical company developing ENA-001, a patent-protected BK-channel blocker that acts as an agnostic respiratory stimulant to treat drug overdose, post-operative respiratory depression, and apnea of prematurity.

Ownership category

akta.pro rank

Product category

Respiratory Therapeutics

NAICS

Pharmaceutical and Medicine Manufacturing (32541)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Pulmonology & Allergy Specialty Pharmaceuticals (HLAIACAF)

Keywords

• Respiratory stimulant therapeutics
• Acute respiratory depression
• Biopharmaceutical drug development
• Opioid overdose treatment
• Apnea of prematurity

Headquarters

HQ city

Naples

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales

Revenue model

1. Pharmaceutical Product Sales: Pre-revenue clinical-stage biopharmaceutical company. Expected to generate revenue through sales of ENA-001 upon regulatory approval, targeting hospital pharmacies, emergency medical services, and healthcare providers for treatment of drug overdose, post-operative respiratory depression, and apnea of prematurity.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Enalare Therapeutics develops ENA-001, a patent-protected new chemical entity that acts as an agnostic respiratory stimulant by blocking big potassium (BK) channels to treat acute respiratory depression. The compound is being advanced in intramuscular and intravenous formulations for drug overdose (including polysubstance), post-operative respiratory depression, and apnea of prematurity, with FDA Orphan Drug and Rare Pediatric Disease Designations in hand. The company is pre-revenue and intends to commercialize through hospital and government channels upon regulatory approval.

Product overview

Enalare Therapeutics is a clinical-stage biopharmaceutical company developing ENA-001, a novel respiratory stimulant drug candidate, as its core product. ENA-001 is a patent-protected new chemical entity designed to address acute respiratory depression through a novel mechanism of action. The company is advancing ENA-001 through clinical development in multiple formulations (intramuscular and intravenous) for applications in drug overdose treatment, post-operative respiratory depression, and apnea of prematurity.

Differentiator

Problem solved

Functional benefit

Products and services

• ENA-001 Patent-protected new chemical entity (NCE) respiratory stimulant designed to treat acute respiratory depression from multiple causes including drug overdose (opioid, non-opioid, polysubstance), post-operative respiratory depression, and apnea of prematurity. Available in intramuscular (IM) and intravenous (IV) formulations. Targets hospitals, emergency medical services, anesthesiology/critical care departments, and neonatal intensive care units.

Quantifiable outcome

• Demonstrated safety and efficacy in reversing propofol-induced depression of hypoxic ventilatory response in randomized controlled trial
• +2 more outcomes

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Partnerships

Two partnerships are on record, tiered major.

• Leiden University Medical CentermajorStrategic or Co-development Partner · 15 February 2024Clinical studies for ENA-001 conducted under direction of Dr. Albert Dahan at Leiden University Medical Center in the Netherlands. Dr. Dahan is a renowned global leader in breathing control mechanisms and serves on Enalare's Scientific Advisory Board.
• NEMA Research, Inc.majorStrategic or Co-development Partner · 8 March 2023NEMA Research, Inc. is Enalare's research partner organization, with whom the company was nominated for a Citeline Award for Best Clinical Partnership of the Year in 2023. NEMA Research conducted clinical studies including the propofol-induced respiratory depression study.

Scale indicators6 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Jazz Pharmaceuticals: Specialty pharmaceutical company with respiratory portfolio (Sunosi for narcolepsy, formerly a competitive respiratory stimulant). Comparable as a larger specialty pharma with respiratory/critical care franchise and orphan drug commercialization experience.
• Emergent BioSolutions: Major BARDA contractor and biodefense medical countermeasure developer that owns Narcan (acquired via Adapt Pharma). Comparable as a fellow BARDA-funded company with established medical countermeasure commercial infrastructure for mass casualty respiratory events.
• Mallinckrodt Pharmaceuticals: Specialty pharmaceutical company with significant respiratory franchise and history in neonatal care. Comparable as a larger specialty pharma with neonatology and respiratory product portfolios that would overlap with ENA-001's apnea of prematurity and post-operative indications.
• Theravance Biopharma: Specialty pharmaceutical company focused on respiratory diseases (Yupelri for COPD) and CNS therapeutics. Comparable as a respiratory-focused specialty pharma with commercial-stage product in adjacent respiratory indications.
• SIGA Technologies: Specialty pharmaceutical company funded by BARDA for medical countermeasure development (TPOXX for smallpox). Comparable as a small-cap government-contract-dependent pharma with similar BARDA partnership model for countermeasure development.
• Hikma Pharmaceuticals: Global specialty pharmaceutical company producing respiratory and injectable products including generic naloxone. Comparable as a supplier of respiratory pharmaceuticals including opioid overdose reversal products to government and hospital channels.

Direct peers

• AcelRx Pharmaceuticals: Specialty pharmaceutical company developing non-opioid pain and respiratory therapies (Dsuvia). Comparable as a small-cap clinical-stage pharma focused on addressing opioid-related and acute care respiratory/critical care indications.
• Opiant Pharmaceuticals: Developed opioid overdose reversal therapies including nasal naloxone (OPVEE) before being acquired by Indivior in 2023. Directly comparable as a clinical-stage company focused on respiratory depression from opioid overdose with differentiated formulation strategies.

Others

• Eagle Pharmaceuticals: Specialty pharmaceutical company and Enalare's existing equity investor with option to acquire remaining shares. Comparable as the strategic investor/partner and potential acquirer with respiratory and injectable product expertise relevant to ENA-001 commercialization.

Emerging players

• Zogenix (now UCB): Previously a small-cap specialty pharma focused on rare CNS disorders with FDA orphan and rare pediatric designations (Fintepla for Dravet syndrome). Comparable as a clinical-to-commercial-stage rare disease pharma with relevant regulatory strategy expertise for orphan/pediatric designations.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/enalare-therapeutics-inc

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Funding overview

Funding rounds8 records

Investors4 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Enalare Therapeutics