Top 5 Target	Count

μ opioid receptor(Mu opioid receptor)	2
GLP-1R(Glucagon-like peptide 1 receptor)	1
Opioid receptors	1
PGES(Prostaglandin E synthase)	1
adrenergic receptor(Adrenergic receptors)	1

Drugs associated with Orexo AB

Nalmefene Hydrochloride

Target

Opioid receptors

Mechanism

Opioid receptors antagonists

Active Org.

Tharimmune, Inc. [+8]

Originator Org.

Baxter International, Inc.

Active Indication

Alcoholism [+3]

Inactive Indication

Gambling [+1]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

United States

First Approval Date17 Apr 1995

Naloxone hydrochloride

Target

μ opioid receptor

Mechanism

μ opioid receptor antagonists

Active Org.

Eli Lilly Canada, Inc. [+13]

Originator Org.

Endo Pharmaceuticals, Inc. [+1]

Active Indication

Acute Lymphoblastic Leukemia [+2]

Inactive Indication-

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

United States

First Approval Date13 Apr 1971

Adrenaline

Target

adrenergic receptor

Mechanism

adrenergic receptor agonists

Active Org.

Aquestive Therapeutics, Inc. [+24]

Originator Org.

Medeca Pharma AB

Active Indication

Intermittent asthma [+15]

Inactive Indication-

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

United States

First Approval Date08 Nov 1967

Clinical Trials associated with Orexo AB

CTIS2024-514037-38-00

/ CompletedPhase 1

An open-label, crossover trial in otherwise healthy volunteers with allergic rhinitis to evaluate the relative bioavailability and hemodynamic effects of OX640 nasal epinephrine powder to a marketed epinephrine intramuscular injection

Start Date01 Oct 2024

Sponsor / Collaborator

Orexo AB

NCT04948307

/ CompletedNot Applicable

A Randomized, Open-label, Parallel-group Study to Evaluate the Efficacy of the Digital Therapeutic OXD01 (MODIA™) in Combination With Sublingual Buprenorphine/Naloxone for the Treatment of Opioid Use Disorder

This is an open-label, randomized, parallel-group multicenter study designed to evaluate the efficacy of the digital therapeutic OXD01 (MODIA) combined with sublingual buprenorphine/naloxone standard of care (SL BUP/NAL SOC) background therapy compared to SL BUP/NAL alone to change opioid use patterns in subjects with opioid use disorder (OUD).
Approximately 400 subjects will be randomized. The study will include a screening visit and a randomization visit, followed by 24 weeks of study treatment. Subjects will be scheduled for evaluation visits, which will include a urine drug screen (UDS) and a self-report of drug use, weekly during the first four weeks of treatment, then every other week from weeks 5 through 12, then monthly through week 25. Subjects will also return to the site for only a UDS and a self-report of drug use each week between the evaluation visits.
The primary objective of the study is to determine whether the combination of sublingual (SL) buprenorphine/naloxone (BUP/NAL) standard of care (SOC) background therapy and the digital therapeutic OXD01 is superior to SL BUP/NAL alone to reduce opioid use.

Start Date30 Jun 2021

Sponsor / Collaborator

Orexo AB

NCT02243670

/ CompletedNot Applicable

Feasibility and Validity of Using a Novel Artificial Intelligence Platform to Monitor and Optimize Medication Adherence in Patients Receiving Opioid Replacement Therapy

This study uses an artificial intelligence platform to automatically confirm medication ingestion. The Health Insurance Portability and Accountability Act (HIPAA)-compliant platform can be downloaded as an 'app' onto any smartphone to automate directly observed therapy (Automated DOT®). Real-time patient adherence data are encrypted and automatically sent to a centralized web-based dashboard for use by healthcare professionals or research staff. Unlike Facetime® or Skype®, the system relies on computer vision algorithms to confirm the process of medication administration; no human review is necessary.
The purpose of this study is to evaluate the feasibility and acceptability, and measure the accuracy, of the AiCure platform ("platform") in patients being treated for opioid dependence with Zubsolv® over the course of 12 weeks. The following aims will be tested: 1) to assess the feasibility and acceptability to both participants and study staff in using AiCure to monitor medication adherence; 2) to evaluate the acceptability of using AiCure to optimize care pathways; and 3) to measure the reliability and validity of AiCure in detecting interruptions in treatment. To assess feasibility and acceptability of the platform, we will measure rates of physician satisfaction and user acceptance. Optimization of care pathways will be measured by assessing the sustainability of AiCure use over 12 weeks (retention rates) and measuring illicit opioid use (urine drug screens) compared to historical data. Reliability and validity of AiCure will be measured by comparing AiCure adherence against pharmacokinetic data.
All participants will be requested to take each of their prescribed doses using the app. Participants will be able to download the app onto their own smartphone or will be provisioned a device at the start of the study. The data captured during the medication ingestion process will be automatically encrypted and stored on the participant smartphone and uploaded wirelessly to a cloud-based dashboard. If a participant is non-adherent (missed dose, incorrect dosage) or if suspicious behavior is detected, an automated alert will be sent to study staff via email or SMS to prompt immediate intervention. In addition, all participants will receive treatment as usual.

Start Date01 Aug 2016

Sponsor / Collaborator

AiCure LLC

[+2]

100 Clinical Results associated with Orexo AB

0 Patents (Medical) associated with Orexo AB

Literatures (Medical) associated with Orexo AB

02 Jan 2015·Drug development and industrial pharmacyQ4 · MEDICINE

Pharmaceutical and pharmacokinetic characterization of a novel sublingual buprenorphine/naloxone tablet formulation in healthy volunteers

Q4 · MEDICINE

Article

Author: Hjelmstroem, Peter ; Joensson, Martin ; Fischer, Andreas

CONTEXT:

Bitter taste, as well as dissolve time, presents a significant challenge for the acceptability of formulations for oral transmucosal drug delivery.

OBJECTIVE:

To characterize a novel sublingual tablet formulation of buprenorphine/naloxone with regards to pharmacokinetics, dissolve time and formulation acceptability.

METHODS:

Dry mixing techniques were employed to produce a small and fast dissolving buprenorphine/naloxone sublingual tablet formulation, OX219 (Zubsolv®), using sucralose and menthol as sweetener and flavor to mask the bitter taste of the active ingredients. Two cross-over studies were performed in healthy volunteers to evaluate pharmacokinetics, dissolve time and acceptability of OX219 5.7/1.4 mg tablets compared to the commercially available buprenorphine/naloxone formulations Suboxone® tablets and films (8/2 mg).

RESULTS:

Buprenorphine exposure was equivalent in OX219 and Suboxone tablets. Sublingual dissolve times were significantly shorter for OX219 than for Suboxone tablets and were similar to Suboxone films. The OX219 formulation received significantly higher subjective ratings for taste and overall acceptability than both Suboxone formulations. OX219 was preferred over Suboxone tablet and film formulations by 77.4% and 88.9% of subjects, respectively.

CONCLUSIONS:

A sublingual tablet formulation with an improved acceptability has been successfully developed.

01 Dec 2013·Pharmaceutical development and technologyQ4 · MEDICINE

Evaluation of a sieve classification method for characterization of low-dose interactive mixtures

Q4 · MEDICINE

Article

Author: Susanne Bredenberg ; Anna Dahlgren ; Sofia Mattsson

This study investigated a sieve classification method for evaluating carrier materials and particle size fractions, which could be a valuable tool in the early development of pharmaceutical dosage forms containing low-dose interactive mixtures. When developing new products based on interactive mixtures, it is essential to ensure that the drug particles are successfully deagglomerated and have adhered to the carrier particles. In this study, the effect on the demixing potential (DP) of low-dose interactive mixtures was assessed for various carrier particle sizes and surface textures. The model drug used was sodium salicylate and the tested carriers were lactose, mannitol, and isomalt. The results showed that the lowest DPs, i.e. the most mechanically stable mixtures, were obtained with lactose. Furthermore, for interactive mixtures, small carrier particles and/or a narrow carrier particle size range are essential for obtaining a low DP and high homogeneity. Calculation of the DP provided a reliable estimate of the quality of the low-dose interactive mixtures used in this study.

01 Sep 2013·MutagenesisQ3 · MEDICINE

Highly selective bioactivation of 1- and 2-hydroxy-3-methylcholanthrene to mutagens by individual human and other mammalian sulphotransferases expressed in Salmonella typhimurium

Q3 · MEDICINE

Article

Author: Hansruedi Glatt ; Carrie Tsoi ; Charles N. Falany ; Zachary E. Tibbs ; Stellan Swedmark ; Walter Meinl

The benzylic alcohols 1- and 2-hydroxy-3-methylcholanthrene (OH-MC) are major primary metabolites of the carcinogen 3-methylcholanthrene (MC). We investigated them for mutagenicity in TA1538-derived Salmonella typhimurium strains expressing mammalian sulphotransferases (SULTs). 1-OH-MC was efficiently activated by human (h) SULT1B1 (2400 revertants/nmol), weakly activated by hSULT1C3 and hSULT2A1 (2-9 revertants/nmol), but not activated by the other hSULTs studied (1A2, 1A3, 1C2 and 1E1). Mouse, rat and dog SULT1B1 activated 1-OH-MC (8-100 revertants/nmol) with much lower efficiency than their human orthologue. The other isomer, 2-OH-MC, was activated to a potent mutagen by hSULT1A1 (4000-5400 revertants/nmol), weakly activated by hSULT1A2 or hSULT2A1 (1-12 revertants/nmol), but not activated by the other hSULTs. In contrast to their human orthologue, mouse, rat and dog SULT1A1 did not appreciably activate 2-OH-MC (<1 to 6 revertants/nmol), either. Instead, mouse and rat SULT1B1, unlike their human and canine orthologues, demonstrated some activation of 2-OH-MC (15-100 revertants/nmol). Docking analyses indicated that 1- and 2-OH-MC might bind to the active site of hSULT1A1 and hSULT1B1, but only for (S)-2-OH-MC/hSULT1A1 and (R)-1-OH-MC/hSULT1B1 with an orientation suitable for catalysis. Indeed, 1- and 2-OH-MC were potent inhibitors of the hSULT1A1-mediated sulphation of acetaminophen [concentration inhibiting the enzyme activity by 50% (IC50) 15 and 13nM, respectively]. This inhibition was weak with mouse, rat and dog SULT1A1 (IC50 ≥ 4 µM). Inhibition of the SULT1B1 enzymes was moderate, strongest for 1-OH-MC/hSULT1B1. In conclusion, this study provides examples for high selectivity of bioactivation of promutagens by an individual form of human SULT and for pronounced differences in activation capacity between orthologous SULTs from different mammalian species. These characteristics make the detection and evaluation of such mutagens extremely difficult, in particular as the critical form may even differ for positional isomers, such as 1- and 2-OH-MC. Moreover, the species-dependent differences will complicate the verification of in vitro results in animal studies.

100

News (Medical) associated with Orexo AB

07 Jan 2026

·www.prnewswire.com

Dexcel Pharma USA Acquires US Rights to Zubsolv®

Parsippany, N.J., Jan. 7, 2026 /PRNewswire/ -- Dexcel Pharma USA is excited to announce the successful closing of an Asset Purchase Agreement with Orexo AB to acquire the U.S. rights to Zubsolv® (buprenorphine and naloxone) sublingual tablets and the associated commercial infrastructure. This acquisition is an important milestone in the Company's history, as it provides us with new capabilities to promote branded products. Continue Reading Zubsolv Logo Our CEO, Doug Boothe, added: "Dexcel Pharma is excited to be adding the Zubsolv® product and related commercial capabilities from Orexo into our expanding US operations. This product, together with our proven sales & marketing platform, will enable Dexcel Pharma's strategic growth in the U.S." The Company thanks its employees and third-party advisors, including DLA Piper LLP (US) for their hard work and support in connection with this transaction. We look forward to working with new and existing customers and partners to ensure continued access to this important therapy in the treatment of opioid use disorder. For more information please visit About Dexcel Pharma USA Dexcel Pharma USA is the U.S. subsidiary of Dexcel Pharma. Dexcel Pharma is the largest private pharmaceutical company in Israel, commercializing an extensive portfolio of branded and generic drugs. Our state-of-the-art R&D and manufacturing facilities enable us to develop and manufacture high-quality products while maintaining long-term partnerships across the value chain. SOURCE Dexcel Pharma USA 21% more press release views with Request a Demo

AcquisitionLicense out/in

23 Oct 2025

·orexo.com

Orexo Q3 2025 Interim Report

Unlocking the potential of the AmorphOX® technology Q3 2025 highlights › Total net revenues of SEK 118.7 m (136.5) › EBITDA of SEK -9.8 m (-0.7), including a negative impact from costs associated with LTIP programs of SEK -12.9 m › Net earnings of SEK -29.8 m (-41.9) › US Commercial segment net revenues of SEK 113.9 m (131.0), in local currency USD 12.0 m (12.6) › Cash flow from operating activities of SEK -10.3 m (-13.4), cash and cash equivalents of SEK 105.6 m (114.9) › Earnings per share before dilution and after dilution amounted to SEK -0.86 (-1.21) › Positive in-vivo data showed for a powder-based intranasal GLP-1 agonist medication supported by the AmorphOX® technology › The subsidiary, Orexo US Inc., awarded approx. SEK 75 m (USD 8 m) by BARDA for the development of OX390, an intranasal rescue medication for adulterated overdoses. Pending milestones and deliverables the award is valued up to approx. SEK 480 m (USD 50.9 m). › 2025 financial outlook reiterated. Important events after the end of the period › No important events after the end of the period. SEK m unless otherwise stated 2025 Jul-Sep2024 Jul-Sep2025 Jan-Sep2024 Jan-Sep2024 Jan-DecNet revenues118.7136.5383.2429.7590.0Cost of goods sold-7.1-20.1-36.3-49.7-72.1Operating expenses-132.7-138.1-394.7-422.3-658.2EBIT-21.1-21.7-47.8-42.2-140.3EBIT margin %neg.neg.neg.neg.neg.EBITDA-9.8-0.7-14.020.248.9Earnings per share, before dilution, SEK-0.86-1.21-2.47-2.51-5.89Earnings per share, after dilution, SEK-0.86-1.21-2.47-2.51-5.89Cash flow from operating activities-10.3-13.421.9-38.8-32.6Cash and cash equivalents105.6114.9105.6114.9123.3 CEO Comments in brief Orexo has a strong track record of turning platform technologies into approved medicines. Our sublingual platform enabled multiple FDA-approved products, including Zubsolv® and Abstral®, that generated significant revenues for the company. Building on that success, we are now concentrating resources on the AmorphOX® platform, our next-generation formulation engine designed to unlock proprietary products and expand our pipeline. During the quarter, we reached two key milestones that reinforce the scalability of the AmorphOX platform. The breakthrough with the GLP-1 agonist and the BARDA¹ financing secured for the OX390 project both strengthen the platform and its future potential. I am encouraged by the enthusiasm these developments have generated among our key stakeholders, and by the growing recognition of AmorphOX’s long-term value. From a financial perspective, EBITDA was negative, however, we would have reported positive EBITDA for the quarter absent provisions for social security fees related to the long-term incentive program following the positive share price development in the quarter. Zubsolv demand is stable, but top line sales were impacted by foreign exchange rate headwinds and significantly lower inventory levels with the wholesalers. We expect Zubsolv sales to improve in the fourth quarter consistently with historical seasonal patterns and we maintain our full-year guidance. Uppsala, Sweden, October 23, 2025 Nikolaj Sørensen President and CEO Contact persons interim report Nikolaj Sørensen, President and CEO Fredrik Järrsten, EVP and CFO Lena Wange, IR & Communications Director Tel: +46 18 780 88 00, +1 855 982 7658, E-mail: ir@orexo.com. Presentation On October 23, at 2 pm CEST analysts, investors and media are invited to attend a presentation, incl. a Q&A. Participants may access the event via live webcast or teleconference through the following link: https://investorcaller.com/events/orexo/orexo-q3-report-2025 Prior to the call, presentation material will be available on the website under Investors/Rapport archive.

Financial Statement

17 Oct 2025

·orexo.com

Orexo´s Nomination Committee for the Annual General Meeting 2026

Uppsala, Sweden – October 17, 2025 – The members of the Nomination Committee for the Annual General Meeting (AGM), that takes place on May 7, 2026, have been appointed and comprises of the following members: • Henrik Kjaer Hansen, (Chairman, appointed by Novo Holdings A/S) • Claus Berner Møller, (appointed by The Danish Labour Market Supplementary Pension, ATP) • Stefan Hansson, (private investor) • Friedrich von Bohlen, (Chairman of the Board of Orexo). The appointments have been made in accordance with the rules last approved by Orexo´s AGM. The Nomination Committee represents approximately 34 percent of the number of votes in the company as end of August 2025. Shareholders who want to submit proposals to the Nomination Committee can do this by sending an e-mail to ir@orexo.com (subject “Nomination Committee”) at latest March 2, 2026. Orexo AB (publ.) About Orexo Orexo is a Swedish pharmaceutical company with 30 years of experience developing improved pharmaceuticals based on proprietary formulation technologies that meet large medical needs. On the US market, Orexo provides innovative treatment solutions for patients suffering from opioid use disorder. Products targeting other therapeutic areas are developed and commercialized worldwide with leading partners. Total net sales in 2024 amounted to SEK 590 million, and the number of employees to 110. Orexo is listed on Nasdaq Stockholm's main list and is available as ADRs on OTCQX market (ORXOY) in the US. For more information about Orexo please visit www.orexo.com. You can also follow Orexo on X, LinkedIn, and YouTube.

Executive Change

100 Deals associated with Orexo AB

100 Translational Medicine associated with Orexo AB

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Pipeline

Pipeline Snapshot as of 02 Feb 2026

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Preclinical

Phase 1

Phase 2

Phase 3

NDA/BLA

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Naloxone hydrochloride ( μ opioid receptor )	Opiate Overdose More	NDA/BLA
Sufentanil ( μ opioid receptor )	Cancer Pain More	Phase 3
Vipoglanstat ( PGES )	Endometriosis More	Phase 2
Adrenaline ( adrenergic receptor )	Anaphylaxis More	Phase 1
Nalmefene Hydrochloride ( Opioid receptors )	Opiate Overdose More	Phase 1

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