What Orexo does

Orexo AB (publ.) is a Swedish specialty pharmaceutical company headquartered in Uppsala that develops improved pharmaceutical treatments using proprietary drug delivery technology, in particular its AmorphOX powder-based platform. Founded in 1995 and listed on Nasdaq Stockholm (ORX) with ADRs on OTCQX (ORXOY), Orexo historically operated a US commercial subsidiary that sold Zubsolv (buprenorphine/naloxone) for opioid use disorder until divesting US rights to Dexcel Pharma USA in December 2025 for $91 million, a transaction that fundamentally repositioned the business.

AmorphOX is the company's core technology asset: a powder-based delivery system that stabilizes amorphous materials — including peptides, proteins, and vaccines — across extreme temperature ranges (-20°C to 70-80°C), eliminating cold-chain requirements and enabling intranasal or oral administration with high bioavailability. The platform underpins an active development pipeline including OX640 (nasal epinephrine for anaphylaxis, entering pivotal studies Q4 2026), OX390 (intranasal atipamezole for reversing xylazine/medetomidine overdoses, preclinical with FDA Type C meeting planned and BARDA support), OX472 (oral semaglutide, patent filed), Izipry (high-dose naloxone rescue medication, NDA resubmission planned Q3 2026 after a Complete Response Letter), and an AmorphOX-based intranasal vaccine program with Abera Bioscience. Orexo has also commercialized Abstral (breakthrough cancer pain), Edluar (insomnia), and Diabact UBT (H. pylori diagnosis) through partners such as Viatris.

Orexo's business model has materially shifted from internalized US commercialization toward a partnership-driven R&D and licensing model. The company now generates minimal product revenue (SEK 5.0 million in Q1 2026 from continuing operations, versus SEK 26.0 million for FY2025), supplemented by non-dilutive government funding (BARDA $8 million for OX390, contract number 75A50125C00010), planned milestone payments from partners, and the strategic intent to monetize AmorphOX through platform out-licensing to other pharmaceutical developers. Customers span patients with opioid use disorder, anaphylaxis, and overdose emergencies; US government agencies (BARDA/HHS) for medical countermeasures; and pharmaceutical partners licensing the AmorphOX technology for their own development programs. The Novo Holdings A/S ownership position since 2010 provides additional capital backing.

Name

Orexo

Legal name

Orexo AB (publ.)

Website

https://orexo.com

Company type

Public

Founded year

1995

Operating status

Operating

Headcount range

101–250 employees

Short description

Orexo AB is a Swedish specialty pharmaceutical company developing treatments via its proprietary AmorphOX powder-based drug delivery platform, targeting opioid use disorder, anaphylaxis, and emerging overdose threats through R&D partnerships and platform licensing.

Ownership category

akta.pro rank

Product category

Specialty Pharmaceuticals

NAICS

Medicinal and Botanical Manufacturing (325411)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Nasal Drug Delivery Devices (Sprays/Powder Devices) (HLAHAIAK)

akta.pro secondary industries

DTx/SaMD Regulatory, Quality & Compliance Software (QMS/ISO/FDA) (HLACANAN), Pain Relief & Anti-Inflammatory (Analgesics) (HLAIADAA)

Keywords

• Powder drug delivery
• Sublingual pharmaceuticals
• Intranasal medications
• Rescue medications
• Specialty pharmaceuticals

Headquarters

HQ city

Uppsala

HQ country

Sweden

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Product Sales (discontinued US commercial operations): Orexo historically generated revenue from direct sales of Zubsolv in the US market through its commercial subsidiary Orexo US Inc. These commercial operations were divested to Dexcel Pharma USA in December 2025. Going forward, the company earns minimal product revenues (SEK 5.0m in Q1 2026) from residual activities.
2. R&D Partnerships and BARDA Contract Revenue: Following the Zubsolv divestment, Orexo is focused on R&D partnerships and BARDA funding. The OX390 program is developed in partnership with BARDA (US Department of Health and Human Services). BARDA awarded USD 8 million for OX390 development. Revenue is project-based from federal funding.
3. Zubsolv US Divestment Proceeds: Orexo received SEK 91 million from Dexcel Pharma USA for the sale of US rights to Zubsolv in December 2025, providing near-term cash and removing US commercial costs.
4. Partnering and Licensing (future): Orexo's strategy involves advancing proprietary development programs toward defined value inflection points with the objective of attracting partnerships for continued development and commercialization. The company also makes AmorphOX technology available to other pharmaceutical companies for use in their own development programs.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels4 records

Core offering

Orexo is a Swedish pharmaceutical company that develops and commercializes improved treatments using its proprietary AmorphOX powder-based drug delivery platform, which stabilizes amorphous materials including peptides and biologics to enable rapid intranasal and sublingal absorption. The company's portfolio spans commercialized specialty products (Zubsolv, Abstral, Edluar, Diabact UBT), digital therapeutics (Deprexis, MODIA, Vorvida) and a development pipeline including OX640 nasal epinephrine, OX390 xylazine/medetomidine antidote, OX472 semaglutide, Izipry high-dose naloxone, and intranasal vaccines.

Product overview

Orexo is a Swedish pharmaceutical company focused on drug delivery technology and pharmaceutical product development. The company operates primarily through its proprietary AmorphOX platform, a powder-based drug delivery technology that stabilizes amorphous materials including peptides and biologics, enabling rapid absorption and improved bioavailability. Orexo's product portfolio spans commercialized products (Edluar for insomnia, Abstral for breakthrough cancer pain, Diabact for H. pylori diagnosis), divested products (Zubsolv for opioid use disorder, divested to Dexcel Pharma USA in December 2025), digital therapeutics (Deprexis for depression, MODIA and Vorvida for substance use disorders licensed from GAIA AG), and a development pipeline including OX640 (nasal epinephrine for anaphylaxis), OX390 (antidote for xylazine/medetomidine overdoses with BARDA partnership), OX472 (semaglutide formulations), and Izipry (high-dose naloxone rescue medication). Following the Zubsolv divestment, Orexo has strategically pivoted toward R&D with a focus on advancing its AmorphOX-based pipeline programs.

Differentiator

Problem solved

Functional benefit

Brands

• AmorphOX: Proprietary powder-based drug delivery technology that stabilizes amorphous materials including peptides and biologics, designed for strong bioavailability and next-generation drug development.

Products and services

• AmorphOX Proprietary powder-based drug delivery technology platform that stabilizes amorphous materials including peptides and biologics, designed to support strong bioavailability and rapid absorption. Made available to pharmaceutical partners for use in their own development programs covering small molecules, peptides, proteins, and vaccines.
• Zubsolv Buprenorphine/naloxone sublingual tablet for treatment of opioid use disorder. US commercial rights divested to Dexcel Pharma USA in December 2025 for SEK 91 million; retained in other markets.
• Abstral Sublingual fentanyl product for treatment of breakthrough cancer pain. Approved in first market in 2008 and commercialized worldwide through partners.
• Edluar Sublingual zolpidem product for treatment of insomnia. Approved in 2009 and commercialized by Viatris on multiple markets.
• Diabact UBT Urea breath test product for diagnosing Helicobacter pylori infection. First market approval received in 2000 and commercialized worldwide through partners.
• OX640 Powder-based nasal epinephrine medication for treatment of severe allergic reactions and anaphylaxis using AmorphOX technology. Designed to provide rapid delivery with strong temperature stability and is being advanced toward pivotal clinical studies.
• OX390 Emergency intranasal powder treatment containing atipamezole to reverse overdoses involving xylazine and medetomidine (alpha-2 agonists). Developed in partnership with BARDA for community-based use by first responders and laypersons.
• OX472 AmorphOX-based exploratory program developing semaglutide formulations via nasal and oral delivery routes, with formulation development initiated for semaglutide tablets.
• Izipry High-dose naloxone rescue medication for opioid overdoses using AmorphOX-based formulation. NDA resubmission planned for Q3 2026 with intended commercialization through partnering strategy.
• OX-MPI Vaccine Powder-based intranasal vaccine formulated with AmorphOX technology, developed in collaboration with Abera Bioscience. Demonstrated positive data from in-vivo study in 2025.
• Deprexis Scientifically proven digital support program for depression developed by partner GAIA AG. Multiple clinical trials have demonstrated its efficacy.
• MODIA Digital support program for the treatment of opioid use disorder developed in partnership with GAIA AG, designed to support patients with OUD alongside medication-based treatment.
• Vorvida Scientifically proven digital therapy for alcohol misuse including alcohol use disorder. Orexo acquired US rights from GAIA AG.

Quantifiable outcome

• Zubsolv US gross sales exceeded USD 1 billion since 2013 launch
• +4 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Five partnerships are on record, tiered minor and core.

• Royal Swedish Academy of Engineering Sciences (IVA)minorOthers · 6 March 2026The Royal Swedish Academy of Engineering Sciences (IVA) in Stockholm served as the venue for Orexo's R&D Day on March 24, 2026, where the company presented its updated strategy following the Zubsolv divestment, focusing on AmorphOX and pipeline programs.
• Dexcel Pharma USAcoreChannel Partner/ Reseller/ Distributor · 22 December 2025Dexcel Pharma USA acquired all US rights to Zubsolv and the associated commercial infrastructure (sales force, distribution, inventory) through an Asset Purchase Agreement. The transaction closed on January 2, 2026, with Dexcel assuming full responsibility for US commercialization of Zubsolv for opioid use disorder.
• BARDA (Biomedical Advanced Research and Development Authority)coreStrategic or Co-development Partner · 29 September 2025BARDA, part of the US Department of Health and Human Services (HHS) Administration for Strategic Preparedness and Response, awarded Orexo US Inc. USD 8 million to support the development of OX390 as a medical countermeasure against threats from xylazine and medetomidine. OX390 is being developed as a rapidly acting intranasal powder using AmorphOX technology. BARDA funding is under contract number 75A50125C00010. The program aims to address the rising threat of alpha-2 agonist adulterants in the US illicit drug supply.
• GAIA AGcoreStrategic or Co-development Partner · 29 September 2025GAIA AG is a world leader in digital therapeutics. Orexo partnered with GAIA AG in 2019 to develop MODIA, a digital support program for opioid use disorder. Orexo also acquired US rights for Vorvida, a digital therapy for alcohol misuse including AUD, and owns US rights for Deprexis, a digital therapy for depression developed by GAIA. In 2024, US commercial rights to Deprexis were returned to GAIA AG. Orexo is exploring business development opportunities with GAIA for remaining digital therapeutic assets.
• Abera BioscienceminorStrategic or Co-development Partner · 29 September 2025Collaboration with Abera Bioscience for the development of a powder-based intranasal vaccine formulated with AmorphOX technology. Positive data obtained from an in-vivo study demonstrating viability of the approach in 2025.

Scale indicators9 records

Recent moves6 records

Expansion highlights6 records

Others

• Mundipharma (Dexcel Pharma related): Global specialty pharma network; comparable as the broader commercialization/distribution backdrop behind Dexcel Pharma USA, which now owns US Zubsolv rights. Indirectly connected as Orexo's US commercialization counterparty going forward.

Direct peers

• Amphastar Pharmaceuticals: Specialty pharmaceutical company focused on injectable, inhalation, and intranasal products including epinephrine and naloxone - directly comparable product overlap with OX640 and Izipry. Comparable size and commercialization approach via specialty channels.
• Halozyme Therapeutics: Biotech whose ENHANZE drug delivery platform enables subcutaneous delivery of biologics via proprietary enzyme technology and licenses it broadly to large pharma. Highly comparable business model: a single proprietary delivery platform driving partnership/licensing revenue across multiple partners.
• Acorda Therapeutics: Smaller specialty pharmaceutical company with a mix of legacy commercial products and pipeline assets, similar size range and surgical focus on US specialty commercialization prior to Orexo's Zubsolv divestment.
• Hovione: Specialty CDMO and drug delivery company with deep expertise in particle engineering, amorphous solid dispersions, and nasal/inhaled formulations - directly comparable to AmorphOX's amorphous stabilization approach for small molecules and peptides.
• Emergent BioSolutions: Specialty biopharmaceutical company focused on medical countermeasures and rescue products including NARCAN (naloxone nasal spray) and other emergency-use pharmaceuticals. Direct overlap with Orexo's rescue-medicine focus (OX390, Izipry, OX640) and BARDA-style government procurement exposure.
• Camurus: Swedish specialty pharmaceutical company based in Lund with a proprietary drug delivery technology (FluidCrystal) used to formulate long-acting injectables and other formulations. Highly comparable to Orexo: similar Swedish origin, comparable size and headcount, advanced drug delivery platform, focus on specialty therapeutics and partnerships, public listing.
• Collegium Pharmaceutical: Specialty pharmaceutical company focused on responsible pain management including opioid and ADHD products; comparable to Orexo's specialty-pharma model, comparable size, and overlap with Zubsolv's opioid use disorder space prior to divestment.

Emerging players

• ARS Pharmaceuticals: Specialty pharma focused on intranasal epinephrine (Neffy, FDA-approved 2024) - direct head-to-head comparable for OX640 in the needle-free epinephrine segment. Like Orexo, targets the same underserved population with a nasal product.

Broad incumbents

• Catalent: Global leading contract development and manufacturing organization (CDMO) with extensive drug delivery capabilities including oral, inhalation, and nasal formulation services. Comparable to Orexo as a drug delivery technology/partnering organization serving pharma companies across multiple dosage forms.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/orexoabpubl
• YouTubeyoutube.com/channel/UCTWbzCkLowUlRocCqxesbjw
• LinkedInlinkedin.com/company/65006

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Subsidiaries1 record

Funding overview

Funding rounds5 records

Investors7 records

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

M&A2 records

Investments

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

Frequently asked questions about Orexo