What kaleo does

Kaléo (kaleo, Inc.) is a privately held U.S. pharmaceutical and medical-device company headquartered in Glen Allen, Virginia, that develops and commercializes combination drug-device products, with a focus on auto-injectors for anaphylaxis, opioid overdose, and government medical countermeasures. Founded in 2000, the company operates from a 251–500 employee base and has manufactured more than 13 million devices over its 25-year history, anchored by its flagship AUVI-Q epinephrine auto-injector and a naloxone auto-injector (10 mg) for military and chemical-incident responders.

The technological core is the proprietary Aerio Auto-Injector Platform — a gas-powered, non-coaxial auto-injector offered in three configurations (Aerio Uno single container, Aerio Duo dual container, and Aerio Mix dual chamber for lyophilized or dual-liquid formulations). The platform supports volumes up to 20 mL, viscosity ranges of 1–2,000 cP, electronic voice guidance, environmental adaptability for extreme conditions, and Bluetooth connectivity, and is manufactured on a 100% automated robotic U.S. production line performing 100+ quality checks per device. Kaléo holds approximately 200 issued patents on these technologies and was the first company to achieve the FDA draft guidance standard for 99.999% device reliability.

Kaléo monetizes through direct sales of its commercial auto-injector products (AUVI-Q distributed via traditional pharmaceutical channels and direct-to-consumer e-commerce, with a Patient Assistance Program for eligible patients), U.S. government contracts for medical countermeasures (notably with the Department of Defense JPEO-CBRND on RAD-A and with BARDA on a 2-PAM auto-injector under the CHEMPACK program), and pharmaceutical partnership development on the Aerio platform, which generates development fees, manufacturing fees, and potential licensing royalties. Customer segments span patients with severe allergies (primary), caregivers and parents, healthcare professionals (supported by a dedicated Medical Affairs platform), and government and military end-users.

Name

kaleo

Legal name

kaleo, Inc.

Website

https://kaleo.com/

Company type

Private

Founded year

2005

Operating status

Operating

Headcount range

101–250 employees

Short description

Kaléo is a privately held U.S. pharmaceutical and medical-device company that develops combination drug-device products, anchored by its voice-guided AUVI-Q epinephrine auto-injector and its proprietary Aerio auto-injector platform serving severe-allergy patients, healthcare professionals, and U.S. government medical countermeasure programs.

Ownership category

akta.pro rank

Headquarters

HQ city

Richmond

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B and B2C

Offering type

Hardware or Manufacturing

Cost components

Operations, Supply Chain, Technology or R&D, Personnel, Marketing or Sales, Infrastructure

Revenue model

1. AUVI-Q Auto-Injector Sales: Sales of the AUVI-Q epinephrine auto-injector, the company's flagship product. Available in three weight-based doses (0.3 mg, 0.15 mg, and 0.1 mg) for adults and children weighing 16.5 pounds or more. Distributed through pharmaceutical channels to patients, caregivers, and healthcare providers.
2. Naloxone Auto-Injector: Sales of naloxone auto-injector (10 mg) for military personnel and chemical incident responders. Part of Kaléo's emergency medicine portfolio.
3. Pharmaceutical Partnership Development: Revenue from partnering with pharmaceutical companies to develop custom drug-device combinations using the Aerio platform. Includes development fees, manufacturing fees, and potentially licensing royalties from partner products.
4. Government Medical Countermeasures Contracts: Contracts with U.S. government agencies including BARDA and Department of Defense for medical countermeasures. Includes novel pralidoxime chloride (2-PAM) auto-injector for nerve agent poisoning and RAD-A for chemical threats.

Go-to-market motion3 records

Distribution channels5 records

Marketing channels6 records

Core offering

Kaléo is a pharmaceutical company that develops, manufactures, and commercializes drug-device combination auto-injector products for emergency medicine. Its marketed portfolio includes the AUVI-Q epinephrine auto-injector for anaphylaxis and a 10 mg Naloxone Auto-Injector for opioid overdose. The company also partners with pharmaceutical companies and U.S. government agencies (BARDA, DOD) to develop and supply medical countermeasures built on its proprietary Aerio Auto-Injector Platform.

Product overview

Kaléo is a pharmaceutical company specializing in drug-device combinations and auto-injector innovation. The company operates the Aerio Auto-Injector Platform—a proprietary technology base with three configurable versions (Single Container, Dual Container, Dual Chamber)—that powers its portfolio of marketed auto-injector medicines. Marketed products include AUVI-Q (epinephrine injection, USP), the only voice-guided epinephrine auto-injector available in three weight-based doses, and the Naloxone Auto-Injector 10 mg for opioid overdose emergency treatment. The company also develops medical countermeasures for government agencies including the Department of Defense and BARDA.

Differentiator

Problem solved

Functional benefit

Brands

• AUVI-Q: Voice-guided epinephrine auto-injector available in three weight-based doses (0.3mg, 0.15mg, 0.1mg) designed for every age (7.5kg or more). The only compact epinephrine auto-injector with voice instruction system and automatic needle retraction.
• Aerio
• Naloxone Auto-Injector

Products and services

• AUVI-Q (epinephrine injection, USP) Voice-guided, compact epinephrine auto-injector available in three weight-based doses (0.3 mg, 0.15 mg, 0.1 mg) for the emergency treatment of anaphylaxis in patients weighing 7.5 kg or more. Features automatic needle retraction, audible step-by-step voice instructions, and visual cues to confirm medication delivery. Sold to patients, caregivers, and healthcare providers.
• Naloxone Auto-Injector 10 mg Auto-injector delivering 10 mg naloxone hydrochloride injection for emergency treatment of opioid overdose in military personnel and chemical incident responders. Distributed via dedicated product website and government channels.
• Aerio Auto-Injector Platform Proprietary drug delivery platform powering Kaléo's auto-injector portfolio. Available in three configurations: Single Container (up to 10 mL), Dual Container (up to 20 mL), and Dual Chamber (up to 5 mL lyophilized/dual-liquid). Supports viscosity range of 1–2,000 cP and 18g–29g needle gauges. Licensed/partnered with pharmaceutical companies for custom drug-device combinations.
• Medical Countermeasure Auto-Injector Programs Auto-injector-based medical countermeasures developed under contract with U.S. government agencies (BARDA, DOD/JPEO-CBRND) for nerve agent, chemical, and opioid threats. Includes a novel pralidoxime chloride (2-PAM) auto-injector and the RAD-A reconstitution-based countermeasure. Sold through government procurement.

Quantifiable outcome

• Over 11 million AUVI-Q devices distributed to patients
• +3 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature8 records

Partnerships

Six partnerships are on record, tiered minor and core.

• Just Like You FilmsminorGTM or Marketing Partner · 21 May 2026Kaléo sponsored premiere events for the 'May Contain' docudrama film series exploring lived experiences of children and families navigating food allergies. Premieres held in Kansas City, MO (May 21) and New York City (May 27, 2026).
• Axiom SpaceminorStrategic or Co-development Partner · 1 January 2025AUVI-Q was selected by Axiom Space to support crew members on Axiom Mission 4 (June 25 - July 15, 2025) in the event of an allergic emergency during their space flight.
• U.S. Department of Defense (DOD) - JPEO-CBRNDcoreStrategic or Co-development PartnerPartnership with the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) for medical countermeasures development. RAD-A will be the first of a new generation of medical countermeasures utilizing innovative reconstitution technology expected to extend shelf life and stability under extreme conditions.
• BARDA (Biomedical Advanced Research and Development Authority)coreStrategic or Co-development PartnerPartnership with BARDA for novel pralidoxime chloride (2-PAM) auto-injector development for organophosphate or nerve agent poisoning. Part of the CHEMPACK program to provide communities with effective medical countermeasures.
• Elijah-Alavi FoundationminorGTM or Marketing PartnerFeatured in the 'May Contain' documentary sponsored by Kaléo. Foundation is dedicated to advancing food allergy awareness, advocacy, education, and policy efforts.
• Food Allergy & Anaphylaxis Connection Team (FAACT)minorGTM or Marketing PartnerFAACT's President and CEO Eleanor Garrow-Holding provided testimonial about the importance of voice-guided epinephrine auto-injectors for families managing food allergies.

Scale indicators7 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Pfizer: Through legacy Meridian Medical Technologies (now part of Pfizer), Pfizer manufactured auto-injectors including EpiPen and nerve-agent countermeasures, making it a broad incumbent comparable to Kaléo across both commercial epinephrine and DOD medical countermeasures.
• Becton, Dickinson and Company (BD): Global medical device leader with extensive injectable drug-delivery and combination-product capabilities. BD competes with Kaléo in auto-injector platforms and broader pre-filled syringe/injectable delivery systems for pharmaceutical partners.
• West Pharmaceutical Services: Supplies elastomeric components, pre-filled syringe systems, and drug-delivery platforms used in injectable combination products. Comparable as a pharma-enabling drug-delivery infrastructure partner competing for the same partner-licensing deals.

Direct peers

• Ypsomed: Swiss manufacturer of proprietary auto-injector and pen-injector platforms widely used by pharma partners for self-injection products. Directly comparable to Kaléo's Aerio platform in partner-driven drug-device combination development.
• Emergent BioSolutions: Supplies NARCAN (naloxone) and medical countermeasures for chemical/biological threats, competing with Kaléo across both emergency naloxone delivery and government medical countermeasure contracts (BARDA, DOD).
• Amphastar Pharmaceuticals: Manufactures and markets naloxone-based emergency injectables (including nasal sprays and injectables) and injectable pharmaceuticals, directly competing with Kaléo's Naloxone Auto-Injector in opioid overdose and emergency response markets.
• Viatris (EpiPen): Markets EpiPen, the dominant epinephrine auto-injector and Kaléo's principal direct competitor in the anaphylaxis emergency market. Both companies compete on prescriber relationships, payer access, and patient/caregiver usability.

Emerging players

• Teva Pharmaceutical Industries: Has marketed generic epinephrine auto-injectors in the U.S., competing with Kaléo's AUVI-Q on price and payer access within the same therapeutic segment.
• ARS Pharmaceuticals: Develops neffy, an FDA-approved needle-free intranasal epinephrine spray for anaphylaxis, representing a disruptive alternative delivery format that competes with Kaléo's AUVI-Q auto-injector.
• Adamis Pharmaceuticals (now Eos Biosciences-adjacent / SYMJEPI): Marketed Symjepi, a compact pre-filled syringe epinephrine injector for anaphylaxis, competing in the same emergency allergy segment with a similar compact-form-factor positioning to AUVI-Q.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/kaleopharma
• Facebookfacebook.com/kaleo-pharma-256357007877714

Revenue estimate

Valuation estimate

Number of profiles

Profiles15 records

Funding overview

Funding rounds2 records

Investors2 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 kaleo