Evaluation of the effect of oral sotalol in comparison with oral metoprolol succinate in prevention of atrial fibrillation in patients after coronary artery bypass graft surgery

Start Date22 Dec 2023

Sponsor / Collaborator

Qazvin University of Medical Sciences

NCT05939076 / Not yet recruitingPhase 3IIT

First-line Cryoablation for Early Treatment of Persistent Atrial Fibrillation - a Randomized Study Comparing Early Trigger Isolation Using the Cryoballoon Versus Antiarrhythmic Medication

The goal of this multicentre, prospective, randomized, open, blinded for evaluation of end point (PROBE) controlled parallel-group superiority trial, is to compare the efficacy of antiarrhythmic drug (AAD) therapy and cryoballoon pulmonary vein isolation (PVI) regarding freedom from atrial fibrillation (%) assessed by an implantable cardiac monitor (ICM), ECG tracing or Holter at 12 months in patients with persistent AF. The main question[s] it aims to answer are:
Will first-line cryoballoon ablation for PVI compared to AAD, result in 25 % higher freedom from atrial tachyarrhythmias lasting > 6 minutes at 12 months (primary outcome) excluding three months initial blanking period, in patients with symptomatic and recurrent persistent AF?
Will first-line cryoablation for PVI, compared to AAD result in a superior improvement in health related Quality of Life (HRQoL), AF/AT burden, AF/AT progression and reversion, more reverse atrial remodeling, cognitive function, healthcare utilization with associated costs, better safety, at 12-24-36 months as compared with drug use? Participants will be randomized 1:1 to first-line PVI using the cryoballoon or to first-line antiarrhythmic drug therapy and during 3 years follow-up undergo regular;
Continuous ECG monitoring for assessment of first AF recurrence and AF burden using an implantable cardiac monitor,
Regular echocardiographic exams for reverse atrial remodelling assessment,
HRQoL questionnaires
Assessment of cognitive function
Atrial fibrillation evaluation regarding structured characterisation and AF progression/regression
Assessment of Health care use and costs
Safety

Start Date21 Aug 2023

Sponsor / Collaborator

University of Uppsala

[+2]

NCT05794997 / Active, not recruitingNot ApplicableIIT

Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Propranolol/Carvedilol Versus Atenolol/Bisoprolol/Sotalol

This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication.

Start Date30 Nov 2022

Sponsor / Collaborator

The Brigham & Women's Hospital, Inc.

[+3]

100 Clinical Results associated with Sotalol Hydrochloride

100 Translational Medicine associated with Sotalol Hydrochloride

100 Patents (Medical) associated with Sotalol Hydrochloride

3,509

Literatures (Medical) associated with Sotalol Hydrochloride

01 Mar 2024·Primary care

Arrhythmias and Sudden Cardiac Death

Review

Author: DeCastro, Alexei O ; Bragg, Scott ; Brown, Brandon

Ventricular tachyarrhythmias remain a major cause of sudden cardiac arrest (SCA) that leads to sudden cardiac death (SCD). Primary prevention strategies to prevent SCD include promoting a healthy lifestyle, following United States Preventive Service Task Force recommendations related to cardiovascular disease, and controlling comorbid conditions. For a patient experiencing SCA, early cardiopulmonary resuscitation and defibrillation should be performed. Implantable cardioverter defibrillators are more effective at secondary prevention compared with drug therapy but medications such as amiodarone, beta-blockers, and sotalol may be helpful adjuncts to reduce the risk of SCD or improve a patient's symptoms (eg, palpitations and inappropriate defibrillator shocks).

01 Feb 2024·Heart (British Cardiac Society)

Management of arrhythmogenic right ventricular cardiomyopathy

Review

Author: Elliott, Perry M ; Lambiase, Pier D ; Al-Aidarous, Sayed ; Protonotarios, Alexandros

Arrhythmogenic right ventricular cardiomyopathy (ARVC) is a disease characterised by fibrofatty replacement of the ventricular myocardium due to specific mutations, leading to ventricular arrhythmias and sudden cardiac death. Treating this condition can be challenging due to progressive fibrosis, phenotypic variations and small patient cohorts limiting the feasibility of conducting meaningful clinical trials. Although widely used, the evidence base for anti-arrhythmic drugs is limited. Beta-blockers are theoretically sound, yet their efficacy in reducing arrhythmic risk is not robust. Additionally, the impact of sotalol and amiodarone is inconsistent with studies reporting contradictory results. Emerging evidence suggests that combining flecainide and bisoprolol may be efficacious.Radiofrequency ablation has shown some potential in disrupting ventricular tachycardia circuits, with combined endo and epicardial ablation yielding better results which could be considered at the index procedure. In addition, stereotactic radiotherapy may be a future option that can decrease arrhythmias beyond simple scar formation by altering levels of Nav1.5 channels, Connexin 43 and Wnt signalling, potentially modifying myocardial fibrosis.Future therapies, such as adenoviruses and GSk3b modulation, are still in early-stage research. While implantable cardioverter-defibrillator implantation is a key intervention for reducing arrhythmic death, the risks of inappropriate shocks and device complications must be carefully considered.

01 Feb 2024·Journal of veterinary cardiology : the official journal of the European Society of Veterinary Cardiology

Successful high-resolution three-dimensional electroanatomical mapping and radiofrequency catheter ablation of a posteroseptal accessory pathway in a dog using CARTO 3

Article

Author: Bosmans, T ; Hellemans, A ; Smets, P ; Mampaey, G ; Duytschaever, M ; Van Steenkiste, G ; van Loon, G

A one-year-and-seven-month-old, 28 kg, male castrated crossbreed dog was presented for supraventricular tachycardia causing recurrent episodes of anorexia and lethargy. Sotalol (2.2 mg/kg q12 h) reduced the frequency of symptomatic episodes but did not provide full relief. Three-dimensional electroanatomical mapping was performed at the Ghent University Small Animal Teaching hospital using the CARTO 3. Right atrial activation mapping identified the earliest atrial activation right posteroseptal, near the tricuspid annulus. Fast retrograde ventriculoatrial conduction during tachycardia and extrastimulus testing confirmed the presence of a concealed right posteroseptal accessory pathway. Six radiofrequency catheter ablation applications were delivered, and tachycardia remained uninducible. The dog recovered well from the procedure. Sotalol was stopped three weeks later, and no more clinical signs were noted by the owner. Repeated 24-hour electrocardiography monitoring on day one and at one, three, and 12 months after the procedure showed no recurrence of tachycardia.

News (Medical) associated with Sotalol Hydrochloride

14 Mar 2024

·www.globenewswire.com

Hyloris Reports Full Year Results for 2023 & Provides Business Outlook

Hyloris Reports Full Year Results for 2023 & Provides Business Outlook Total revenue and other income amounted to €4.4 millionStronger growth expected in 2024 of both sales and gross margin, mainly fueled by the recent launch in the U.S. of Maxigesic® IV and Podofilox gel, the global roll out of Maxigesic IV® and commercial dealsIncreased operating R&D expenses while net operating cash outflow remained stable versus 2022Significant R&D progress including clinical and regulatory achievements with multiple NDA submissions expected within the next 15 monthsAttractive commercial deals, including an out-licensing deal for Atomoxetine Oral Liquid in CanadaPromising new product candidates driving innovation, targeting a portfolio of 30 assets by 2025€30.2 million in cash & cash equivalents, no financial debtWebcast on 14 March 2024 at 1PM GMT / 2PM CET/ 9AM EST (Register here) Liège, Belgium – 14 March 2023 – 7AM CET – Regulated Information – Inside Information - Hyloris Pharmaceuticals SA (Euronext Brussels: HYL), a specialty biopharma company committed to addressing unmet medical needs through reinventing existing medications, today announces its financial and operational results for the year ending on 31 December 2023, as well as its business outlook for 2024. Stijn Van Rompay, Chief Executive Officer of Hyloris, commented: “Despite a challenging year for the global healthcare industry, 2023 proved to be a year of significant accomplishment for Hyloris. As a company built on the unique and successful strategy of repurposing and reformulating existing pharmaceuticals, we achieved a major milestone with the U.S. approval of Maxigesic® IV in partnership with AFT Pharmaceuticals, marking a crucial step in delivering this innovative pain management solution to American patients. Additionally, approval was secured for Podofilox gel, the first generic version of Condylox® Gel, expanding access to this medication. Our unwavering commitment to research and development yielded impressive progress across our diverse product pipeline. These advancements solidify our position as a leader in providing solutions to unmet medical needs in the years to come. We are incredibly proud of our team's dedication and resilience throughout this transformative year. Looking ahead to 2024, Hyloris is poised for continued growth and innovation. We plan to significantly bolster our pipeline with the addition of several new product candidates addressing critical unmet medical needs. Recent additions, including treatments for Vulvar Lichen Sclerosus and Burning Mouth Syndrome, demonstrate our commitment to expanding our portfolio and addressing a wider range of patient needs. We remain confident in our ability to continue delivering value to patients, shareholders, and all stakeholders and expect continued growth beyond 2024. Commercial Highlights Maxigesic® IV is a patented, unique combination, intravenous formulation for the treatment of post-operative pain and is currently licensed to partners covering over 100 countries across the globe. During 2023 and early 2024: A marketing authorization was granted by the United States Food and Drug Administration (FDA) in October 2023.Hikma Pharmaceuticals (Hikma), a leading supplier of complex injectable hospital products, has launched the product in the U.S. under the tradename Combogesic® IV. An exclusive license and distribution agreement had previously been signed between Hyloris’ partner AFT Pharmaceuticals (AFT) and Hikma.Additional submissions for marketing authorization were made in 13 countries in the Middle East, Africa, Latin America, and Asia.Additional marketing authorizations have been granted in 8 countries including Poland, South Africa, and Spain. In early 2024, Health Canada granted approval bringing the total number of approvals to 50.Launches occurred in 14 countries including Norway, Singapore, Belgium, The Netherlands, the Czech Republic, and Romania. Imminent launches are expected in several additional countries, bringing the total number of countries where Maxigesic® IV will be available up to more than 30. In the United States, chronic opioid usage in patients following surgery averages around 9%, ranging from 4% to 24% among various specialties. Drug overdoses involving opioids resulted in over 80.000 deaths in the U.S. in 2021. Patients who experienced an opioid overdose accounted for nearly $2 billion in annual hospital costs. Sotalol IV is a patented, intravenous formulation of Sotalol for the treatment of atrial fibrillation, and life-threatening ventricular arrhythmias developed for the U.S. Sotalol IV potentially allows to significantly reduce the length of hospital stay and the overall cost of care and potentially improve patient outcomes. Hyloris is taking further steps targeting to increase product related revenues in the future (see also: Ongoing Legal Proceedings). Podofilox Gel (Product previously referenced as HY-016) In December 2023, our partner Padagis US LLC (Padagis) received marketing authorization for Podofilox gel 0.5% from the FDA. Padagis launched the product in December 2023. It is the first generic for Condylox® Gel in the U.S. Podofilox Gel is an antimycotic drug for the topical treatment of external genital and perianal warts caused by certain types of the Human Papilloma Virus (HPV). Around 1% of the sexually active population in the U.S. presents with genital or perianal warts.1 To date there is a vaccine for HPV but no cure. For the 12 months period ending December 2022, Condylox® Gel had U.S. sales of approximately $9 million according to IQVIA Health. Other Commercial Highlights Tranexamic Acid RTU Additional out-licensing agreements were signed for Tranexamic Acid RTU in 2023. These agreements cover a large European country and several major Asian countries, with a combined population of over 60 million people. Previous agreements have been signed in 2021 for Australia, New-Zealand and Canada. In 2023, our licensing partner for Canada submitted an application for approval by Health Canada. Additional regulatory submissions in the partnered territories are in progress, and more out-licensing agreements are expected going forward. An Abbreviated New Drug Application (ANDA) has been submitted to the U.S. FDA. Tranexamic acid injection is an established antifibrinolytic agent used in emergency situations with major hemorrhages and is also used as a prophylactic agent in surgeries. Hyloris is developing a ready-to-use (RTU) formulation for infusion. Atomoxetine Oral Liquid An out-licensing agreement was signed with Kye Pharmaceuticals (Kye) in October 2023. Kye will exclusively commercialize the product in Canada where atomoxetine is currently not available as an oral liquid formulation. The introduction of an oral liquid formulation in the ADHD (Attention Deficit Hyperactivity Disorder) medication category has historically led to significant market share gains2. This suggests a strong potential for Atomoxetine Oral Liquid in Canada, where an estimated 1.8 million people (or 4-6% of adults and 5-7% of children) are diagnosed with ADHD3. ADHD is a chronic condition, with symptoms persisting into adulthood for 60-80% of patients4. Under the terms of the agreement, Hyloris will be eligible to receive attractive sales-related milestone payments (totaling up to USD 7.5 million), and a substantial share of the generated revenue. New Pipeline Product Candidates Our business development team leverages its expertise in existing products, real-world data, and a vast network to identify unmet medical needs. This includes collaborating with healthcare professionals, patient groups, insurers (payors), and industry partners. In 2023 over 87 opportunities were screened and 3 product candidates will meet our investment criteria of €7 million5 in 7 years or less. For product candidates which Hyloris intends to out-license, the strategic goal is to capture a substantial part of the net product margin realized by our commercial partners. Hyloris aims to achieve this by partnering these assets close to regulatory submission, except in countries where additional local clinical trials are required. In general, we will prioritize in-market product sales or profit-based participation over (upfront) milestone payments. We aim to increase our product portfolio to 30 assets by 2025, with a focus on accelerating pipeline growth in the near future. HY-091, a novel topical treatment candidate for Vulvar Lichen Sclerosus (VLS) was announced in January 2024. VLS is a chronic inflammatory condition affecting an estimated 3% of women, causing severe pain, itching, and discomfort, significantly impacting their quality of life. HY-091 is being developed as a convenient and user-friendly treatment specifically designed to target these VLS symptoms. Hyloris has partnered with AFT for co-development, registration, and worldwide commercialization. HY-090, a promising new treatment candidate for Burning Mouth Syndrome (BMS) was announced in December 2023. BMS is a chronic condition affecting millions, primarily postmenopausal women, causing a burning, tingling, or scalding sensation in the mouth for months at a time. While the mouth appears healthy, sufferers may also experience dry mouth or taste alterations, the exact cause of BMS remains unknown. Studies suggest that 0.7% to 5% of individuals in the U.S. might be affected6. Hyloris has partnered with AFT to co-develop and commercialize the product worldwide. HY-088 was announced in January 2023. This novel, proprietary oral formulation will be administered to patients with hypophosphatemia – a condition where the blood level of phosphorus is lower than 2.5mg/dL. Patients can develop hypophosphatemia from either a genetic abnormality (such as Cushing Syndrome or osteomalacia) or an acquired condition (like long-term use of diuretics or phosphate binders). It is estimated hypophosphatemia affects around 5% of hospitalized patients, and a subpopulation needs direct treatment during and/or after their hospital stay. Treatment protocols for patients deficient in phosphate are well-established and have proven useful in other situations of bone mineral imbalance. Oral administration is the preferred way of treating hypophosphatemia, although in most countries no approved drugs exist. Currently, physicians mostly rely on compounded drugs which have, by definition, not been submitted for regulatory scrutiny regarding safety, efficacy, and quality. R&D Update Throughout 2023, Hyloris achieved significant advancements across the entire R&D portfolio, propelling the 18 product candidates and 3 high-barrier generics closer to commercialization. Key milestones were met for multiple programs, and discussions with regulatory agencies and partners are underway to solidify development plans. As a result, Hyloris anticipates submitting multiple INDs (Investigational New Drug applications) and NDAs (New Drug Applications) throughout 2024 and early 2025. Enhanced Capabilities Drive Efficiency Further bolstering our R&D efforts, Hyloris officially opened its new and improved R&D lab at the Montlegia Science Park in June 2023. This on-site facility allows Hyloris to perform drug formulation and analytical activities in-house, streamlining processes and optimizing resource allocation for the expanding pipeline. Cardiovascular Portfolio Hyloris is actively engaged in advancing a comprehensive portfolio dedicated to addressing a wide range of conditions within the largest global treatment category – cardiovascular care. These products are currently progressing through or towards clinical trials, with the aim of significantly enhancing the quality of life for patients. Main highlights for 2023 and selected expected milestones for 2024 include: Aspirin IV: Registration batches have been manufactured and the stability study is ongoing. An NDA submission is planned for the U.S. as soon as all necessary data has been collected. Aspirin IV is an intravenous (IV) formulation of acetylsalicylic acid (ASA) to be used in an emergency setting. Aspirin is not available in the U.S. as an IV product. Currently, most patients suspected of having an emergency cardiovascular event (such as a myocardial infarction or stroke) are immediately given oral aspirin to decrease their risk of morbidity and mortality. Milrinone: The optimization of the extended-release formulation for alcohol resistance marked a significant development milestone. Preparations for a pilot pharmacokinetic (PK) study are in progress. Oral milrinone is being developed as a novel, extended-release formulation offering convenient oral dosing for a selected population of end-stage heart failure (HF) patients who have Left Ventricular Assist Devices (LVADs). HY-074: All non-clinical studies were completed in 2023. A patent application was filed through the Patent Cooperation Treaty (PCT) which allows an applicant to seek patent protection in several different countries – including the U.S. Hyloris is targeting an IND submission for Q2 2024 for the PK bridging study expected to start at the end of 2024. HY-074 is an intravenous formulation of current standard of care treatment for acute coronary syndrome (ACS) to offer faster onset of action, more convenient administration, and dosage control. It is currently available in oral form, which should allow for an optimal switching strategy from the oral form to an IV in a hospital setting. Dofetilide IV: Registration batches have been manufactured and the stability study is ongoing. A CRO has been selected for the required clinical study. An NDA submission is planned for the U.S. as soon as all necessary data has been collected. A pivotal clinical study to support regulatory submission for Dofetilide IV is nearing completion, with results expected by Q3 2024. Additional U.S. patent applications have been filed to bolster the drug's intellectual property protection. Other Value-Added Programs Hyloris, in collaboration with its development partners, is achieving consistent progress on all stages of our value-added programs. Main highlights for 2023 and expected milestones for 2024 include: Tranexamic Acid Oral Mouth Rinse (previously HY-004): A Type A meeting with the FDA resulted in alignment on the phase 3 study protocol. The phase 3 trial began in November 2023, enrolling the first patient in early 2024. Completion of enrollment (Last Patient Last Visit - LPLV) is expected by year-end, with study results anticipated in the first half of 2025. This rinse targets patients on blood thinners (anticoagulant therapies) undergoing dental procedures with a high risk of excessive bleeding. Additionally, Hyloris intends to explore the effectiveness in a wider range of related oral surgery procedures, encompassing both patients with and without bleeding disorders who could benefit from a localized treatment to reduce blood clotting. Miconazole/Domiphen Bromide: Hyloris is co-developing Miconazole/Domiphen Bromide (MCZ/DB) with Purna Female Healthcare, a topical cream combining miconazole and domiphen bromide. This innovative treatment targets Recurrent Vulvovaginal Candidiasis (rVVC), a chronic and often debilitating vaginal yeast infection affecting nearly 1 in 10 women throughout their lives. The Phase 2 clinical trial, completed in late 2023 (Q4), showed promising results. The low-dose group exhibited evidence of delayed disease recurrence at day 29. These findings will be used to design the next clinical trial, scheduled to begin by year-end 2024. MCZ/DB presents a strong scientific and commercial potential for addressing rVVC. AlenuraTM: Hyloris is co-developing Alenura™ with Vaneltix. It is a first-in-class drug candidate designed to bring immediate pain relief to patients suffering from interstitial cystitis/bladder pain syndrome (IC/BPS). This chronic condition affects at least 6 million people in the U.S. alone. Alenura™ stands out for its innovative dual mode-of-action. It combines a new, alkalinized form of lidocaine for fast pain relief with heparin to potentially aid in the regeneration of the bladder lining. This unique approach holds promise for providing both immediate symptom relief and long-term benefits for IC/BPS patients. June 2023 marked a significant milestone with the enrollment of the first patient in the Phase 2 clinical trial of Alenura™. This pivotal study will compare the effectiveness of Alenura™ against its individual components (lidocaine and heparin) as well as a placebo. PTX-252: PTX-252 is a novel chelating agent in development for the treatment of Acute Myeloid Leukemia (AML). This product candidate incorporates a novel molecular entity that is a derivative of a known established molecule. This advancement was followed by positive news: Hyloris' co-development partner, Pleco, secured Orphan Drug Designation from the FDA for PTX-252 specifically for AML. PTX-252's potential lies in its ability to potentially improve the effectiveness of existing chemotherapy for AML patients. This is particularly significant as AML affects approximately 160,000 people globally. Previous research suggests a correlation between high levels of toxic metals and lower survival rates in AML patients. A Pre-Investigational New Drug (PIND) meeting with the FDA is planned. Valacyclovir: A successful study demonstrating bioequivalence was completed in 2023. An additional pivotal study can be expected to start and close in H1 of 2024. Registration batches have been manufactured to demonstrate pharmaceutical quality of the product and robustness of the manufacturing process. Hyloris is developing a liquid formulation of valacyclovir which is currently only available in oral solid form. Valayclovir is an antiviral drug commonly used to treat the Herpes Simplex Viruses (HSV) that cause cold sores, genital herpes, chicken pox, and shingles. Management & Board changes The total headcount of the Company grew to 42 people, with several key recruitments occurring over the summer. To enhance the development activities, only limited additional hiring is required. Both the C-level executives and all board members remained in their respective positions, providing continuity in the company's leadership. Business Outlook With 18 reformulated and repurposed molecules, and 3 high-barrier generics, several clinical trials are expected to start and/or finish within 2024. The Company is actively accelerating the growth of its product pipeline, aiming to reach 30 product candidates by 2025. The company is expecting several clinical and regulatory achievements in the next 15 months. Several clinical studies will be initiated or completed. The Company is anticipating multiple NDA submissions to the U.S. FDA and other regulatory agencies. Webcast Details The Company will host a webcast conducted in English to present its 2023 annual results and 2024 Business Outlook, followed by a live Q&A session. The webcast will start on March 14th 2024 at 2PM CET / 1PM GMT / 9AM EST. To join the webcast, please register at the following link: Hyloris: 2023 Full Year Results, Outlook for 2024, and Q&A For those unable to join via webcast, please find dial in information below: Phone Conference ID: 598 167 742# Belgium: +32 4 290 22 87France: +33 1 73 24 00 56Netherlands: +31 20 708 1382Switzerland: +41 43 434 66 31United Kingdom: +44 20 7660 8327United States: +1 347 378 4531Japan: +81 3 4540 5088 Financial Highlights 2023 Year ended 31 December (in € thousand)20232022 Restated*VarianceTotal Revenues and Other income4,4062,38685%Revenues2,8141,951*44%Other operating income1,5924357266%Operating expenses(20,642)(14,024)47%Cost of sales(93)(94)(1%)Research and development expenses(14,749)(10,272)44%General and administration expenses(5,653)(3,517)61%Share of result of equity-accounted investees, net of tax(147)(130)13%Other operating expenses-(12) Operating result (EBIT)(16,236)(11,638)*40%Net financial result474(127)-473%Income Taxes-(4) Profit/(Loss) for the period(15,762)(11,770)*34%Net operating cash flow(12,726)(12,499)82%Other investment-10,000 Cash and cash equivalents30,19633,457-10%Total cash and Other investment30,19643,457 *See Note: Restatement of the year 2022 and Press Release dated 14th of March 2024 related to restatement for additional information on HY-038 and HY-088. Total Revenue and Other Income In 2023, total revenue and other income increased to €4,406 thousand compared to €2,386 thousand in 2022, which is 85% higher compared to last year. The strong growth is mainly driven by increase of royalties of the 3 early-stage commercialized products, services provided to external partners and non-dilutive funding which we received from a US State Government and the Walloon region in Belgium. Results The Company realized a net loss of €15,762 thousand in 2023, compared to a net loss of €11,770 thousand last year. The net loss is mainly resulting from the increase in R&D expenditure and G&A expenses for supporting the development of the Company. R&D expenditure during 2023 amounted to €14,749 thousand, compared to €10,272 thousand in 2022. The increase was mainly driven by the progressive shift from early to late-stage development of several product candidates as well as the increased headcount of the research and development team leading to additional costs. General and administrative expenses increased to €5,653 thousand in 2023 versus €3,517 thousand in 2022, mainly driven by higher legal costs related to the AltaThera’s litigation compared to last year. The net financial income in 2023 was €474 thousand compared to a net financial loss of €127 thousand in 2022. The positive evolution of the financial result is mainly due to the impact of an active cash management strategy in a context of high short term interest rates both in EURO and USD. As a result, net losses in 2023 increased to €15,762 thousand versus €11,770 thousand in the same period of 2022. Balance Sheet The Company’s non-current assets mainly consist of (1) investments in joint ventures of € 3,801 thousand, (2) intangible assets of €3,828 thousand including capitalized development, purchased assets and in-licensing costs, versus €3,600 thousand in 2022, (3) Right of use assets related to the leasing of the office, lab and cars, (4) shares in Pleco of €1,000 thousand, (5) a prepayment of future royalties to a third party of $700 thousand and (6) a tax credit. Hyloris does not capitalize research and development expenses until the filing for a marketing authorization for the applicable product candidate. Research and development expenditures incurred during the period were accounted for as operating expenses. When an intangible asset is acquired and capitalized, the amortization begins when the asset is available for commercialization. The Company’s current assets mainly consist of €30,196 thousand in cash and cash equivalents on total assets of €47.61 million, and trade and other receivables of €4.1 million. The increase in Right-of-use assets and borrowings is due to the start of the lease for the new lab. The Company received an advance payment related to a government grant from the Walloon region. €43 thousand of this advance is a financial liability and €37 thousand is part of Trade and other liabilities. Cash Position and cash flow The Company maintains its strong cash position, with a current cash and cash equivalents totaled €30,196 thousand at the end of 2023, compared to €43,457 thousand at the end of 2022 (which includes a deposit for an amount of €10 million which has been reclassified to Other investment in 2022). Net cash outflow generated from operating activities was €12,726 thousand in 2023, compared to a net operating cash outflow of €12,499 thousand in 2022. The stable net operating cash outflow is attributed to an internal control system implemented to oversee expenditure and cash flow, which includes effective management of working capital. CONSOLIDATED STATEMENT OF FINANCIAL POSITION FOR THE YEAR ENDED DECEMBER 31 ASSETS (in thousands of euros) 31-Dec-23 31-Dec-22 Restated* Non-current assets12,33611,063 Intangible assets3,8283,607 Property, plant and equipment429176 Right-of-use assets1,724885 Equity accounted investments3,8013,948 Other investment, including derivatives1,0001,000 Trade and other receivables1.5541.447 Current assets35,27649,801 Trade and other receivables4,1004,127 Other investment, including derivatives49910,4699 Prepayments4811,748 Cash and cash equivalents30,19633,4579 TOTAL ASSETS47,61260,864 EQUITY AND LIABILITIES(in thousands of euros) 31-Dec-23 31-Dec-22 Restated* Equity 38.82254.045 Share capital140140 Share premium121,513121,513 Retained earnings, excluding profit (loss) for the reporting period(65,246)(53,476) Result of the period, profit (loss) for the reporting period(15,762)(11,770) Share based payment2.1611,621 Cost of Capital(4,460)(4,460) Other reserves476476 Non-current liabilities1.8531,047 Borrowings1,510747 Other financial liabilities344300 Current liabilities6,9375,772 Borrowings241138 Other financial liabilities3,2003,212 Trade and other liabilities3,4962,422 Current tax liabilities-- TOTAL EQUITY AND LIABILITIES47,61260,864 CONSOLIDATED STATEMENT OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME FOR THE YEAR ENDED DECEMBER 31 in € thousands20232022 restated*VarianceRevenue 2,8141,95147%Other operating income1,5924353252%Operating income4,4062,38685%Cost of sales(93)(94)(1%)Research and development expenses(14,749)(10,272)1044%Selling, general and administrative expenses(5,653)(3,517)61%Share of result of equity-accounted investees, net of tax(147)(130)13%Other operating expenses-(12) Operating expenses(20,642)(14,024)47%Operating profit/(loss) (EBIT)(16,236)(11,638)40%Financial income86746686%Financial expenses(393)(594)-34%Profit/(loss) before taxes(15,762)(11,766)34%Income taxes-(4) PROFIT/(LOSS) FOR THE PERIOD(15,762)(11,770)34% CONSOLIDATED STATEMENT OF CHANGES IN EQUITY FOR THE YEAR ENDED DECEMBER 31 2023 (in thousands of euros) Attributable to equity holders of the CompanyTotal EquityShare capital Share premium Other reservesRetained earnings Share-based payment reserveCost of CapitalOther reservesBalance at December 31, 2021129103,6932,391(3,827)476(54,805)48,056Private Placement Via an Accelerated Bookbuild Offering514,995 (634) 14,366Equity Transaction via Transaction Warrants 62,826(1,329) 1,3292,832Share-based payments 560 560Total comprehensive income (11,770)(11,770)Balance at December 31, 2022140121,5131,622(4,460)476(65,246)54,045Share-based payments 539 539Total comprehensive income (15,762)(15,762)Balance at December 31, 2023140121,5132,161(4,460)476(81,008)38,822 CONSOLIDATED STATEMENT OF CASH FLOWS FOR THE YEAR ENDED DECEMBER 31 2023 in € thousands20232022 Restated* CASH FLOW FROM OPERATING ACTIVITIES Net result(15,762)(11,770) Adjustments to reconcile net loss to net cash provided by operating activities: Depreciation, amortisation and impairments349196 Share-based payment expense539560 Derivatives financial instruments(52)52 Interest income on deposits and current accounts-164 Net finance result(474)- Change in fair value of financial assets311- Loss on derecognition of shareholders loans-486 Equity transaction costs-29 Share of profit of equity-accounted investees, net of tax147130 Losses on disposal of PPE-16 Other non-cash adjustments(17)16 Changes in working capital: Trade and other receivables(293)(921) Other investment, including derivatives(31)4 Prepayments1,268(650) Trade and Other liabilities1,236(468) Cash generated from operations(12,779)(12,157) Interest paid527 Income Taxes paid-(349) Net cash generated from operating activities(12,726)(12,499) CASH FLOW FROM INVESTING ACTIVITIES Interest received403 Purchases of property, plant and equipment(298)(101) Purchases of Intangible assets(425)(638) Acquisition of Other Investments(0)(500) Loans made to third parties- (655) Deposits10,000(10,000) Discontinued operations Net cash provided by/(used in) investing activities9,654(11,894) CASH FLOW FROM FINANCING ACTIVITIES Reimbursements of borrowings and other financial liabilities(12)(7,376) Proceeds from borrowings and other financial liabilities44- Reimbursements of lease liabilities(222)(79) Modifications/terminations Right of Use Assets2- Proceeds from Private Placement via Accelerated Book Building- 14,337 Proceeds from Execution Transactions Warrants-2,832 Interests paid-(1,877) Net cash provided by/(used in) financing activities(188)7,838 NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS(3,261)(16,555) CASH AND CASH EQUIVALENTS at beginning of year33,45750,012 CASH AND CASH EQUIVALENTS at end of year, calculated30,19633,457* RESTATEMENT OF THE YEAR 2022 and HALF-YEAR 2023 Accounting treatment of the transactions with Qliniq Hyloris initially recognized (a) €1 million in revenue in 2022 from the divestment of HY-038, and (b) € 1 million in R&D expenses and € 0,2 million in intangible assets in H1 2023 for the purchase of HY-088. A reassessment determined that both transactions qualify as a non-monetary exchange because negotiations and valuations occurred simultaneously. Due to the development stage of the products exchanged, the fair value of neither the asset received, nor the asset given up can be reliably determined. As a result of this reassessment, the restated financials for 2022 will reverse the €1 million revenue from the divestment of HY-038. This adjustment will also affect the half-year 2023 financial statements, resulting in a reversal of €1 million in R&D expenses for HY-088. These expenses are offset against the €1 million received by Hyloris for HY-038. (See Press Release dated 14th of March 2024 on the restatement for more information) The following tables summarize the impact of the restatement on the consolidated financial statements. Consolidated statement of financial position Per 31 December 2022(in € thousands) Impact of correction of errorAs previously reportedAdjustmentAs restatedCurrent assets50.801-1.00049.801Trade and other receivables5.127-1.0004.127Total assets61.864-1.00060.864 Equity55.045-1.00054.045Result of the period(10.770)-1.000(11.770)Total equity and liabilities61.864-1.00060.864 Consolidated statement of profit or loss and other comprehensive income For the year ended 31 December 2022(in € thousands) Impact of correction of errorAs previously reportedAdjustmentAs restatedRevenues2.951-1.0001.951Gross profit2.857-1.0001.857Operating profit/(loss) (EBIT)(10.638)-1.000(11.638)Profit (loss) before taxes(10.766)-1.000(11.766)PROFIT (LOSS) FOR THE PERIOD(10.770)-1.000(11.770)TOTAL COMPREHENSIVE INCOME FOR THE PERIOD(10.770)-1.000(11.770)For the year ended 31 December 2022(in €) Impact of correction of errorAs previously reportedAdjustmentAs restatedBasic/diluted earnings/(loss) per share(0.380)(0.035)(0.435) Consolidated statement of cash flows Even though there was an actual cash inflow of EUR 1 million from the out-licensing of HY-038 and a cash outflow of EUR 1.2 million resulting from the in-licensing of HY-088, the transactions are presented in the consolidated statement of cash flows for the year ended per December 31, 2023 (i.e., EUR 200k prepaid expenses), as this most faithfully presents the substance of the transactions. There is no impact on the consolidated statement of cash flows for the year ended per December 31, 2022, as no cash inflow occurred yet. Audit Report The statutory auditor, KPMG Bedrijfsrevisoren - Réviseurs d’Entreprises, represented by Olivier Declercq, has informed us that the audit procedures were not yet completed. ONGOING LEGAL PROCEEDINGS In August 2022, AltaThera Pharmaceuticals LLC filed a complaint before the District Court for the Northern District of Illinois against Academic Pharmaceuticals Inc, Dr. Somberg and Hyloris Pharmaceuticals, for (a.o.) alleged misappropriation of AltaThera’s trade secrets and confidential information, improper inventorship, and breach of contract, which seeks (punitive) damages and termination of the agreement whereby Hyloris licenses Sotalol IV to AltaThera (the “Litigation”). Hyloris moved to dismiss the complaint for improper service of process and lack of jurisdiction. Further, in November 2022, Hyloris initiated an arbitration against AltaThera for breach of the same licensing agreement between Hyloris and AltaThera in relation to Sotalol IV, including the failure of AltaThera to use commercially reasonable efforts in selling Sotalol IV as required under the licensing agreement, which seeks damages and termination of the licensing agreement (the “Arbitration”). AltaThera responded and counter-demanded, reasserting its claims from the Litigation. At the end of August 2023, all parties agreed to stipulate to the dismissal of the Litigation and to consolidate the Litigation and the Arbitration before the American Arbitration Association (“AAA”) in New York. Hyloris contests the claims asserted by AltaThera and, based upon Hyloris’ assessment of the documents and expert reports put forward to date by AltaThera to support its claims, Hyloris is of the view that there is no convincing evidence supporting AltaThera’s claims for liability or damages. On the other hand, Hyloris believes strongly in the merits of its claims against AltaThera, and that its position is well supported by its expert reports and other documents and evidence submitted to the arbitration panel. Arbitration hearings are scheduled in April 2024 with a final decision expected by the end of H1 2024. Hyloris remains fully confident about the outcome of this litigation in its favor. Hyloris however cannot guarantee that the outcome of the litigation, even if in its favor, may not have a negative impact on future sales of Sotalol IV. About Hyloris Pharmaceuticals SA Hyloris is a specialty biopharma company focused on innovating, reinventing, and optimizing existing medications to address important healthcare needs and deliver relevant improvements for patients, healthcare professionals and payors. The Company’s development strategy primarily focuses on leveraging established regulatory pathways, such as the FDA’s 505(b)2 pathway in the U.S or equivalent regulatory frameworks in other regions which are specifically designed for pharmaceuticals for which safety and efficacy of the molecule have already been established. This approach can reduce the clinical burden required for market entry, and significantly shorten the development timelines, leading to reduced costs and risks. Hyloris has built a broad, patented portfolio of 18 reformulated and repurposed value-added medicines that have the potential to offer significant advantages over existing alternatives. Two products are currently in early phases of commercialization in collaboration with commercial partners: Sotalol IV for the treatment of atrial fibrillation, and Maxigesic® IV, a non-opioid post-operative pain treatment. In addition to its core strategic focus, the Company has 1 approved high barrier generic product launched in the U.S. and 2 high barrier generic products in development. Hyloris is based in Liège, Belgium. For more information, visit www.hyloris.com and follow-us on LinkedIn. For more information, contact Hyloris Pharmaceuticals:Stijn Van Rompay, CEOstijn.vanrompay@hyloris.com+32 (0)4 346 02 07Jean-Luc Vandebroek, CFOjean-luc.vandebroek@hyloris.com+32 (0)478 27 68 42Jessica McHarguejessica.mchargue@hyloris.com+1 919 451 4740 Disclaimer and forward-looking statements Hyloris means “high yield, lower risk”, which relates to the 505(b)(2) regulatory pathway for product approval on which the Company focuses, but in no way relates or applies to an investment in the Shares. Certain statements in this press release are “forward-looking statements.” These forward-looking statements can be identified using forward-looking terminology, including the words "believes", "estimates," "anticipates", "expects", "intends", "may", "will", "plans", "continue", "ongoing", "potential", "predict", "project", "target", "seek" or "should", and include statements the Company makes concerning the intended results of its strategy. These statements relate to future events or the Company’s future financial performance and involve known and unknown risks, uncertainties, and other factors, many of which are beyond the Company’s control, that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. The Company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law. 1 https://www.aafp.org/pubs/afp/issues/2010/1115/p1209.html2 IQVIA3 https://caddac.ca/about-adhd/4 https://journals.sagepub.com/doi/10.1177/10600280135106995 Not adjusted for inflation6 Based on combination of different sources: population-based study, clinical based study and key opinion leaders' estimation7 Reclassification of the withholding tax on R&D salaries. (payroll tax rebates)8 Reclassification of the loan to third-party from Operating to Investing activities in the Cash flow statement9 Reclassification of deposit from Cash and cash equivalents to Other investment including derivatives for an amount of €10 million in 202210 Reclassification of the withholding tax on R&D salaries. (payroll tax rebates) for an amount of €120k Attachment 20240314 Full Year Results 2023 ENG

Clinical ResultLicense out/inDrug ApprovalPhase 2Phase 3

14 Mar 2024

·www.globenewswire.com

Communication at the request of the FSMA on the transactions with Qliniq

Communication at the request of the FSMA on the transactions with Qliniq Revision of 2022 and half-year of 2023 (HY 2023) financial statements following a correction of a non-cash error in the accounting treatment of the transactions with Qliniq announced on 20 January 2023HY-088 and HY-038 considered as a non-monetary exchange under IAS 38.45 in 2023No impact on the cash flow and cash position Liège, Belgium – 14 March 2023 – 07:00AM CET – Regulated Information – Inside informaition - Hyloris Pharmaceuticals SA (Euronext Brussels: HYL), a specialty biopharma company committed to addressing unmet medical needs through reinventing existing medications, today announces it has issued a restatement of fiscal year 2022 and half year 2023 results. Following discussions with the Belgian Financial Services and Markets Authority (FSMA) and Hyloris‘ statutory auditor, the Board of Directors has revised the financial statements due to the correction of a non-cash accounting error regarding the divestment of HY-038 and acquisition of HY-088. Clarification on the press release of 20 January 2023 on the transactions with Qliniq On 20 January 2023 Hyloris announced that the global rights of the ongoing development of HY-088 was licensed-in from a Dutch company, Qliniq, who maintained the rights to commercialize the product candidate in its home country, and a selected number of Middle Eastern and developing countries. In the same press release, Hyloris announced that it had divested HY-038 to the same company, Qliniq, for a price of EUR 1 million. As detailed in the 2022 Annual Report, HY-038 falls under the category of high-barrier generics and thus lies beyond Hyloris’ core portfolio of assets. Limited development activities had occurred for HY-038 since the IPO and the product was no longer under development at the time of the closing of the transaction with Qliniq. Hyloris encountered challenges in identifying a suitable Contract Manufacturing Organization (CMO) capable of producing HY-038 at a desired cost. The transaction price of € 1 million was received on 16 February 2023. HY-088 is a ready-to-administer oral liquid formulation designed for addressing hypophosphatemia. Presently, physicians utilize compounded products for treating this condition, which have not undergone regulatory evaluation regarding their safety, effectiveness, and quality. At the time of the transaction, QliniQ held no exclusive rights to develop the oral liquid formulation and had not initiated any significant development activities on HY-088. It is expected that Hyloris will submit HY-088 for registration in the course of 2025. The transaction price of €1.2 million (including €200 thousand designated as prepaid expenses), was paid by Hyloris on 13 February 2023. QliniQ is a Dutch company which develops and in-licenses drugs and medical supplies in various therapeutic domains and commercializes these in the Netherlands. QliniQ nurtures cooperation and long-lasting business relationships with international companies as part of its successful market approach. At December 31, 2022, Qliniq had a balance sheet total of € 0.8 million, a cash balance of € 0.2 million and 2 FTE’s. Qliniq’s shareholders have previously successfully developed several pharmaceutical companies. Accounting treatment of the transactions with Qliniq Hyloris initially recognized (a) €1 million in revenue in 2022 from the divestment of HY-038, and (b) € 1 million in R&D expenses and € 0,2 million in intangible assets in H1 2023 for the purchase of HY-088. A reassessment determined that both transactions qualify as a non-monetary exchange because negotiations and valuations occurred simultaneously. Due to the development stage of the products exchanged, the fair value of neither the asset received, nor the asset given up can be reliably determined. As a result of this reassessment, the restated financials for 2022 will reverse the €1 million revenue from the divestment of HY-038. This adjustment will also affect the half-year 2023 financial statements, resulting in a reversal of €1 million in R&D expenses for HY-088. These expenses are offset against the €1 million received by Hyloris for HY-038. The following tables summarize the impact of the restatement on the consolidated financial statements. Consolidated statement of financial position Per 31 December 2022(in € thousands) Impact of Restatement As previously reported Adjustment As restated Current assets 50.801 -1.000 49.801 Trade and other receivables 5.127 -1.000 4.127 Total assets 61.864 -1.000 60.864 Equity 55.045 -1.000 54.045 Result of the period (10.770) -1.000 (11.770) Total equity and liabilities 61.864 -1.000 60.864 Consolidated statement of profit or loss and other comprehensive income For the year ended 31 December 2022(in € thousands) Impact of Restatement As previously reported Adjustment As restated Revenues 2.951 -1.000 1.951 Gross profit 2.857 -1.000 1.857 Operating profit/(loss) (EBIT) (10.638) -1.000 (11.638) Profit (loss) before taxes (10.766) -1.000 (11.766) PROFIT (LOSS) FOR THE PERIOD (10.770) -1.000 (11.770) TOTAL COMPREHENSIVE INCOME FOR THE PERIOD (10.770) -1.000 (11.770) For the year ended 31 December 2022(in €) Impact of Restatement As previously reported Adjustment As restated Basic/diluted earnings/(loss) per share (0.380) (0.035) (0.435) Consolidated statement of cash flows Even though there was an actual cash inflow of € 1 million from the divestment of HY-038 and a cash outflow of € 1.2 million resulting from the in-licensing of HY-088, the transactions are presented in the net consolidated cash flow statement for the year ended per December 31, 2023 (i.e., € 200k prepaid expenses), as this most faithfully presents the substance of the transactions. There is no impact on the consolidated statement of cash flows for the year ended on December 31, 2022, as there is no cash impact. About Hyloris Pharmaceuticals SA Hyloris is a specialty biopharma company focused on innovating, reinventing, and optimizing existing medications to address important healthcare needs and deliver relevant improvements for patients, healthcare professionals and payors. The Company’s development strategy primarily focuses on leveraging established regulatory pathways, such as the FDA’s 505(b)2 pathway in the U.S or equivalent regulatory frameworks in other regions which are specifically designed for pharmaceuticals for which safety and efficacy of the molecule have already been established. This approach can reduce the clinical burden required for market entry, and significantly shorten the development timelines, leading to reduced costs and risks. Hyloris has built a broad, patented portfolio of 18 reformulated and repurposed value-added medicines that have the potential to offer significant advantages over existing alternatives. Two products are currently in early phases of commercialization in collaboration with commercial partners: Sotalol IV for the treatment of atrial fibrillation, and Maxigesic® IV, a non-opioid post-operative pain treatment. In addition to its core strategic focus, the Company has 1 approved high barrier generic product launched in the U.S. and 2 high barrier generic products in development. Hyloris is based in Liège, Belgium. For more information, visit www.hyloris.com and follow-us on LinkedIn. For more information, contact Hyloris Pharmaceuticals:Stijn Van Rompay, CEOstijn.vanrompay@hyloris.com+32 (0)4 346 02 07Jean-Luc Vandebroek, CFOjean-luc.vandebroek@hyloris.com+32 (0)478 27 68 42Jessica McHarguejessica.mchargue@hyloris.com+1 919 451 4740 Disclaimer and forward-looking statements Hyloris means “high yield, lower risk”, which relates to the 505(b)(2) regulatory pathway for product approval on which the Company focuses, but in no way relates or applies to an investment in the Shares. Certain statements in this press release are “forward-looking statements.” These forward-looking statements can be identified using forward-looking terminology, including the words "believes", "estimates," "anticipates", "expects", "intends", "may", "will", "plans", "continue", "ongoing", "potential", "predict", "project", "target", "seek" or "should", and include statements the Company makes concerning the intended results of its strategy. These statements relate to future events or the Company’s future financial performance and involve known and unknown risks, uncertainties, and other factors, many of which are beyond the Company’s control, that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. The Company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law. Attachment 20240314 Restatement of FY22 ENG

AcquisitionFinancial Statement

29 Feb 2024

·www.globenewswire.com

Hyloris Announces Launch of Maxigesic® IV in the U.S. and approval In Canada

Hyloris Announces Launch of Maxigesic® IV in the U.S. and approval In Canada Maxigesic® IV, a Potent Non-opioid Painkiller, Marketed in the U.S. under the Tradename Combogesic® IV Maxigesic® IV approved in Canada 27 February 2024, 06:00 PM CET – Non-regulated information – Hyloris Pharmaceuticals SA (Euronext Brussels: HYL), a specialty biopharma company committed to addressing unmet medical needs through reinventing existing medications, today announces that Hikma Pharmaceuticals (Hikma) has launched Maxigesic® IV in the U.S. under the tradename Combogesic® IV. Stijn Van Rompay, Chief Executive Officer of Hyloris, commented: “I am delighted with the rapid marketing launch by our partner Hikma Pharmaceuticals, a leading supplier of injectable medicines globally. The initial feedback from the market is encouraging. Combogesic® IV represents a significant innovation in pain management, offers effective pain relief and importantly provides clinicians a valuable alternative to opioid analgesics.” Hyloris is entitled to a milestone payment of USD 1,1 million, in addition to the USD 1 million that became due upon product manufacturing, which occurred in December 2023. Maxigesic® IV has recently been granted marketing authorization by Health Canada. Canada1 is facing a significant public health crisis related to opioid use with debilitating consequences for individuals, families, and communities. 22 Canadians die on average each day from apparent opioid toxicity. Between 2022 and 2023, health systems have seen an 11% year over year increase in the number of opioid-related hospitalizations. Beyond the human toll, the opioid crisis has significantly impacted Canada's economy, costing an estimated CAD 3,5 billion across healthcare, law enforcement, and lost productivity. Stijn Van Rompay added: “When launched, it will fill the critical need for post-surgical pain management between inadequate non-steroidal anti-inflammatory drugs (NSAIDs) and habit-forming opioids.” The opioid pandemic in the U.S. is a critical healthcare issue, with chronic opioid use after surgery being one of the most common post-operative complications2. The devastating consequences are reflected in the prevalence of new chronic opioid use post-surgery in the U.S. In the past 2 decades, prescription opioid usage in the U.S. contributed to over 600,000 deaths related to opioid overdoses, with the annual death toll rising tenfold between 1999 and 2021. In 2021 alone approximately 80,000 deaths were attributed to opioid overdoses, with nearly involving prescription opioids. The economic impact is also substantial, as patients requiring medical attention related to opioid abuse contribute around USD 11 billion in added costs to the U.S. healthcare system annually, constituting 1% of all hospital costs. Maxigesic® IV is a unique combination of 1000mg paracetamol with 300mg ibuprofen solution for infusion (in a 100 ml bottle) for use post-operatively. Results from a randomised, double-blind, placebo-controlled Phase 3 trial in 276 patients following bunion surgery demonstrated that Maxigesic® IV was well-tolerated and had a faster onset of action and offered higher pain relief compared to Ibuprofen IV or Paracetamol IV alone in the same doses. Moreover, the superior analgesic effect of Maxigesic® IV was supported by a range of secondary endpoints, including reduced opioid consumption compared to the Paracetamol IV and Ibuprofen IV treatment groups (p-value Maxigesic® IV is, to date, licensed in over 100 countries, approved in over 40 countries and marketed in over 20 countries. Hyloris is a specialty biopharma company focused on innovating, reinventing, and optimizing existing medications to address important healthcare needs and deliver relevant improvements for patients, healthcare professionals and payors. The Company’s development strategy primarily focuses on leveraging established regulatory pathways, such as the FDA’s 505(b)2 pathway in the U.S or equivalent regulatory frameworks in other regions which are specifically designed for pharmaceuticals for which safety and efficacy of the molecule have already been established. This approach can reduce the clinical burden required for market entry, and significantly shorten the development timelines, leading to reduced costs and risks. Hyloris has built a broad, patented portfolio of 18 reformulated and repurposed value-added medicines that have the potential to offer significant advantages over existing alternatives. Two products are currently in early phases of commercialization in collaboration with commercial partners: Sotalol IV for the treatment of atrial fibrillation, and Maxigesic® IV, a non-opioid post-operative pain treatment. In addition to its core strategic focus, the Company has 1 approved high barrier generic product launched in the U.S. and 2 high barrier generic products in development. Hyloris is based in Liège, Belgium. For more information, visit www.hyloris.com and follow-us on LinkedIn. 1 https://health-infobase.canada.ca/substance-related-harms/opioids-stimulants/ https://pubmed.ncbi.nlm.nih.gov/33279425/ 2 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7990836/ https://jamanetwork.com/journals/jamasurgery/fullarticle/2618383 The content above comes from the network. if any infringement, please contact us to modify.

Drug ApprovalClinical Result

100 Deals associated with Sotalol Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D01026	Sotalol Hydrochloride	C07AA07	DB00489

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Tachycardia, Ventricular	JP	Sandoz AG	30 Sep 1998
Ventricular Fibrillation	JP	Sandoz AG	30 Sep 1998
Atrial Fibrillation	US	Legacy Pharma LP	30 Oct 1992
Atrial Flutter	US	Legacy Pharma LP	30 Oct 1992
Ventricular Arrhythmia	US	Legacy Pharma LP	30 Oct 1992
Arrhythmias, Cardiac	-	Covis Pharma Holdings BV	01 Jan 1973

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESC2023	Not Applicable	Atrial Fibrillation	-	Sotalol-treated patients	wczzdutlbh(ykfoabbwob) = fqtxpjmrje ulwpbcixsg (bskyvkqqdi )	-	18 Apr 2023
NCT00773201 (Pubmed \| J Biol Chem)	Phase 1	-	990	Sotalol 80mg	dcrpjxfxbz(nqgfnjoozk) = etxclyajov paqyrucqql (sajavakrxr )	-	01 Jan 2017
NCT01576042 (CALYPSO, CTgov)	Not Applicable	Tachycardia, Ventricular	27	Biosense Webster's NAVI-STAR Thermo-Cool (Catheter Ablation)	tvkuppohqm(xxkgzhyxdh) = yxfmwwodpi wgnewrfadf (hijpzxolkm, omejathkuw - wmaappivyk) View more	-	25 Sep 2014
				amiodarone+sotalol (Antiarrhythmic Medication)	tvkuppohqm(xxkgzhyxdh) = yswvimnilv wgnewrfadf (hijpzxolkm, sqmzfmooak - fhykanksgy) View more
NCT00408200 (CTgov)	Not Applicable	Atrial Fibrillation \| Atrial arrhythmia	110	Radiofrequency catheter ablation (AAD:NO)	rnjzzawkda(fzlpygnfdf) = pdzjdwmvqe fgjnwdasvz (ukqjdbmumd, hzqgqmnlug - hwedlgvdsy) View more	-	07 Mar 2013
				Radiofrequency catheter ablation+propafenone+flecainide+dofetilide+sotalol (AAD:YES)	rnjzzawkda(fzlpygnfdf) = ivmizogzac fgjnwdasvz (ukqjdbmumd, dqcfsykrup - jvuvnxkrqg) View more
NCT00578617 (CTgov)	Not Applicable	Atrial Fibrillation	60	Ablation Therapy	klivfnracj(dtudqwfkdd) = yovvobkpzx castnxacpm (nndtelkqpb, cluvvzuodw - qlvbeudzxd) View more	-	04 Jan 2013
NCT00257959 (OPTIC, Pubmed \| J Coll Physicians Surg Pak)	Phase 4	Shock	412	Beta-blocker alone	nmlerwjktq(lyighvlgub): HR = 0.61 (95% CI, 0.37 - 1.01), P-Value = 0.055 View more	Positive	11 Jan 2006
				Sotalol alone

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis