What Hyloris Pharmaceuticals does

Hyloris Pharmaceuticals NV/SA is a Belgian specialty pharmaceutical company founded in 2012 and headquartered in Liège, listed on Euronext Brussels (HYL) since June 2020. The company's strategy is to reinvent existing approved medications through reformulation, repurposing, and select new chemical entities, primarily leveraging the FDA's 505(b)(2) regulatory pathway (or equivalents), which reduces clinical burden and development cost versus de novo drug discovery. Proprietary formulation platforms span ready-to-use intravenous formulations, taste-masked oral liquids, and extended-release oral delivery systems, with patent and application coverage extending into the 2035–2046 range.\n\nThe commercial portfolio currently comprises four royalty-generating assets — Maxigesic IV (a fixed-dose paracetamol/ibuprofen IV for post-operative pain, partnered worldwide with AFT Pharmaceuticals and commercialized by Hikma in the US as Combogesic IV), Sotalol IV (AltaThera, US), Podofilox Gel (Padagis, US, launched December 2023), and Tranexamic Acid RTU (Avenacy, US launch H1 2026). Beyond these, the disclosed pipeline numbers 28 announced candidates (more than 30 product candidates in total) across hospital acute care, swallow-impaired populations (pediatric, geriatric, immunocompromised), women's health and urology, orphan/rare diseases (Wilson's disease, AML, LVAD-associated right heart failure), and specialty therapeutic areas; the pipeline is structured into Mavericks (high-clinical-evidence), Core Drivers (near-term revenue catalysts), and Promising Seeds (early-stage).\n\nHyloris operates an asset-light, partner-driven commercialization model: it retains development and regulatory ownership while licensing out or partnering distribution with established pharma players (AFT Pharmaceuticals, Hikma, AltaThera, Padagis, Avenacy, Orion, Rosemont, Grand Life Sciences, Huons, Kuvatris, Purna Female Healthcare, Vaneltix, Wake Forest, ArborMed, RedHill). Revenue mechanics are licensing royalties, milestones (e.g., up to $60M from the RedHill RHB-102 deal), and license/collaboration fees, supplemented by episodic non-dilutive grants from the Walloon Region; the company is EBITDA-negative and reinvests into pipeline expansion through both organic R&D and in-licensing/acquisitions.\n

Name

Hyloris Pharmaceuticals

Legal name

Hyloris Pharmaceuticals NV/SA

Website

https://hyloris.com

Company type

Public

Founded year

2012

Operating status

Operating

Headcount range

11–50 employees

Short description

Hyloris Pharmaceuticals is a Belgian specialty pharma that develops reformulated, repurposed, and select NCE medicines using the FDA 505(b)(2) pathway, commercializing them globally through licensing partners across hospital, women's health, rare disease, and orphan indications.

Ownership category

akta.pro rank

Product category

Specialty Pharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Cardiology & Vascular Specialty Pharmaceuticals (HLAIACAG)

akta.pro secondary industries

Cardiometabolic Pharmaceuticals (Cardiovascular/Diabetes/Obesity) (HLAIAAAE), Gastroenterology & Hepatology Pharmaceuticals (HLAIAAAI), Generic ANDA/Regulatory Affairs & Submissions (HLAIABAJ)

Keywords

• Reformulated pharmaceuticals
• Specialty pharmaceutical development
• 505(b)(2) regulatory pathway
• Intravenous drug formulations
• Pharmaceutical licensing partnerships

Headquarters

HQ city

Liège

HQ country

Belgium

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Royalty Income from Partnered Products: Three partnered commercial-stage products generate royalty income: Sotalol IV (FDA-approved, commercialized by AltaThera in US), Maxigesic IV (licensed in 100+ countries, marketed in 30+ countries), and Podofilox Gel (FDA approved, launched by Padagis in December 2023). Tranexamic Acid IV RTU also recently approved in US with launch planned for first half 2026.
2. Milestone Payments: Up to $60 million in potential milestone payments plus royalties from licensing RHB-102 (Bekinda) to Hyloris from RedHill Biopharma, demonstrating potential for additional milestone-based revenue from product acquisitions.
3. Equity Financing: The company raised EUR 15.0 million in April 2022 through private placement to fund development of new product candidates and accelerate in-house R&D activities. Additional non-dilutive funding of EUR 1 million received from Walloon Region for HY-083 development.

Pricing tiers

Go-to-market motion1 record

Distribution channels6 records

Marketing channels5 records

Core offering

Hyloris Pharmaceuticals is a specialty pharmaceutical company that develops reformulated, repurposed, and new chemical entity (NCE) medicines primarily using the FDA's 505(b)(2) regulatory pathway. Its proprietary portfolio spans more than 30 products including ready-to-use (RTU) intravenous formulations, taste-masked oral liquids, extended-release oral formulations, and novel drug delivery systems across hospital/acute care, women's health, cardiology, and rare diseases. Four commercial products (Maxigesic IV, Sotalol IV, Podofilox Gel, and Tranexamic Acid RTU) generate royalty income through pharmaceutical partners worldwide.

Product overview

Hyloris Pharmaceuticals is a specialty pharma company with a broad portfolio of reformulated, repurposed, and new chemical entity (NCE) medicines organized across three strategic focus groups: Mavericks (high-potential products with clinical evidence), Core Drivers (catalyst products building near-term recurring revenue), and Promising Seeds (early-stage products pending clinical validation). The company has 4 commercial products delivering royalty income: Maxigesic IV (non-opioid post-operative pain), Sotalol IV (atrial fibrillation), Podofilox Gel (HPV warts), and Tranexamic Acid RTU (bleeding). Beyond the 28 publicly announced products, Hyloris has initiated additional early-stage development activities, bringing the total pipeline to more than 30 products. The development strategy primarily leverages the FDA's 505(b)(2) pathway for reformulated pharmaceuticals where safety and efficacy have already been established.

Differentiator

Problem solved

Functional benefit

Brands

• Maxigesic IV: Differentiated proprietary intravenous fixed-dose combination of paracetamol and ibuprofen for post-operative pain treatment, partnered worldwide with AFT Pharmaceuticals
• Sotalol IV
• XTRAZA
• Alenura

Products and services

• Maxigesic IV Proprietary intravenous fixed-dose combination of 1,000 mg paracetamol and 300 mg ibuprofen for effective, opioid-sparing treatment of acute pain in hospital settings. Partnered worldwide with AFT Pharmaceuticals (excluding Australia and New Zealand); commercialized in the U.S. by Hikma under the trade name Combogesic IV. Licensed in 100+ countries, approved in 50+ countries, marketed in 30+ countries.
• Sotalol IV Intravenous formulation of the established antiarrhythmic sotalol developed to enable safe and efficient initiation of sotalol therapy in patients with atrial fibrillation or ventricular arrhythmias. FDA-approved and commercialized in the U.S. by AltaThera for treatment of documented life-threatening ventricular arrhythmias and maintenance of normal sinus rhythm.
• Podofilox Gel 0.5% podofilox topical gel; the first generic equivalent to Condylox gel in the U.S., developed for treatment of external genital and perianal warts caused by HPV. Launched by Padagis in the U.S. in December 2023.
• Tranexamic Acid RTU Ready-to-use intravenous formulation of tranexamic acid designed to eliminate the need for reconstitution and dilution prior to administration. FDA-approved in June 2025; exclusive US commercialization partner is Avenacy, with U.S. launch planned for H1 2026; partnered with Orion for European markets.
• HY-094 (Next-Generation IV Iron) Next-generation intravenous iron product candidate and new chemical entity (NCE) for treatment of iron deficiency anemia in adults. Co-developed with AFT Pharmaceuticals for global commercialization and partnered with Grand Life Sciences Group for China. Has completed Phase 2b development and is advancing toward Phase 3 clinical trials. Proprietary IP with exclusive global human-use license secured.
• Milrinone ER Proprietary extended-release oral formulation of milrinone for treatment of right heart failure in patients with left ventricular assist devices (LVAD), providing steady-state exposure for long-term use. FDA Orphan Drug Designation received for LVAD-associated RHF indication; priority patent application filed in 2025 with expected expiry in 2046.
• Miconazole DB (Miconazole-Domiphen Bromide) Dual-action vaginal cream combining miconazole with domiphen bromide for treatment of vulvovaginal candidiasis (VVC) and bacterial vaginosis (BV). Dose-finding Phase 2 study in VVC completed. Intellectual property protection through 2038, 2044, and 2045. Developed in partnership with Purna Female Healthcare.
• Suramin IV Standardized intravenous formulation for Human African Trypanosomiasis (sleeping sickness). In Phase 3 development. May qualify for FDA Priority Review Voucher (HAT is on FDA's tropical diseases list). Phase 2 study on Autism Spectrum Disorder completed. Developed in partnership with Kuvatris Therapeutics.
• Alenura Ready-to-use intravesical therapy combining alkalinized lidocaine with heparin for adults with interstitial cystitis/bladder pain syndrome (IC/BPS) acute pain flares. Currently in Phase 2 clinical development in partnership with Vaneltix. Multiple patents and applications with maximum expiry in 2038.
• TXA Oromucosal Solution (XTRAZA) Proprietary tranexamic acid oral rinse designed for dental procedures in patients taking anticoagulants. Randomized, double-blind, multicenter, placebo-controlled Phase 3 trial ongoing with results expected in 2026. U.S. patents granted and pending; expected expiry in 2039. Partnered with Colonis Pharma (UK), Huons Co., Ltd. (South Korea), and AFT Pharmaceuticals in various territories.
• Metolazone IV First injectable formulation of metolazone designed for hospital use in patients with acute decompensated heart failure and severe fluid overload. Registration batches initiated, clinical completion anticipated in 2026. Patents and pending applications including lyophilized formulation protection; expiry 2044.
• Valacyclovir Oral Suspension Differentiated valacyclovir powder for oral suspension designed for patients who have difficulty swallowing tablets. NDA submitted to FDA, Complete Response Letter received due to manufacturing-site issues at the third-party manufacturer; launch timing may shift to 2027. Proprietary formulation protected by U.S. patents expiring 2035 and 2036 and pending applications expected to extend to 2045.
• Atomoxetine Oral Liquid Reformulated easy-to-dose version of atomoxetine for ADHD treatment designed for patients who struggle to swallow capsules. NDA filed with FDA in early 2026 by commercial partner Rosemont Pharmaceuticals. Multiple patents and pending applications providing potential protection through 2044.
• Ondansetron ER Once-daily extended-release oral formulation of ondansetron combining immediate-release and extended-release components for nausea and vomiting associated with chemotherapy, radiotherapy, and post-operative recovery. Acquired from RedHill Biopharma alongside the licensing of RHB-102 (Bekinda).
• Dofetilide IV Differentiated intravenous formulation of dofetilide for treatment of atrial fibrillation and atrial flutter. Pivotal clinical trial completed successfully; U.S. regulatory submission expected Q2 2026. Patents granted with expiry dates between 2039 and 2043, including one-day loading approaches.
• Phosphate Oral Liquid (HY-088) Oral liquid phosphate product (HY-088) designed to improve treatment of hypophosphatemia through a standardized ready-to-use formulation. First European regulatory filing planned for late H1 2026. Pending patent applications with expected expiry in 2045 and 2046.
• Pantoprazole IV RTU Differentiated, ready-to-use IV pantoprazole product designed to replace current lyophilized formulations. Partnership with Orion for European markets announced January 2026. Pending U.S. and international patent applications; expected expiry 2045.
• HY-074 (IV Antiplatelet for Acute Coronary Syndrome) Novel intravenous formulation of a widely used oral antiplatelet therapy for acute coronary syndrome. Registration batches produced; pivotal clinical trial planned for 2026. Patent applications filed with maximum expected expiry in 2043–2044.
• Aspirin IV Intravenous formulation of acetylsalicylic acid designed to provide rapid and reliable antiplatelet activity in acute coronary syndrome. Pivotal study completed successfully with FDA alignment on regulatory pathway; submission planned for 2026. Multiple U.S. patents on aspirin compositions with expiry 2038-2039.
• Fusidic Acid Topical Cream Topical antibiotic cream containing 2% fusidic acid; generic equivalent to Fucidin cream for treatment of bacterial skin infections. Regulatory submission in Canada expected in 2026.
• HY-083 (Idiopathic Rhinitis Intranasal Spray) Potential first-in-class proprietary intranasal spray based on TRPV1 agonist mechanism for treatment of idiopathic rhinitis. Backed by EUR 1 million in non-dilutive funding from the Walloon Region (non-refundable grant plus recoverable cash advance).
• HY-106 Methanobactin (Wilson's Disease) Novel copper-selective chelator based on methanobactin for treatment of Wilson's disease (a rare inherited metabolic disorder characterized by toxic copper accumulation). First-in-human study planned for 2026. European and Turkish rights licensed from ArborMed.
• HY-086 / PTX-252 (AML Adjunctive Therapy) Differentiated NCE adjunctive therapy for acute myeloid leukemia (AML) and small cell lung cancer (SCLC). FDA Orphan Drug Designation obtained for AML; Phase 1 preparations underway.
• RHB-102 (Bekinda) License Licensed RHB-102 (Bekinda) from RedHill Biopharma for up to $60 million in potential milestone payments plus royalties, targeting GLP-1/GIP receptor agonist therapy-associated GI side effects and oncology support indications.

Quantifiable outcome

• Maxigesic IV licensed in more than 100 countries, approved in over 50 countries, marketed in more than 30 countries
• +2 more outcomes

Named customers10 records

Segments4 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

18 partnerships are on record, tiered flagship, core and minor.

• RedHill BiopharmaflagshipStrategic or Co-development Partner · 27 April 2026Licensed RHB-102 (Bekinda) from RedHill for up to $60 million in potential milestone payments plus royalties. Also acquired Ondansetron ER (extended-release oral ondansetron) product, broadening pipeline into GI/nausea indications. RedHill also reports $4 million investment from Cumberland Pharmaceuticals for 30% stake in Talicia Holdings Inc.
• OrionflagshipStrategic or Co-development Partner · 19 January 2026Strategic partnership for RTU Pantoprazole IV in European markets. Orion is a significant European pharmaceutical company with established commercialization capabilities across the region. Target launch as of 2028.
• ArborMedcoreStrategic or Co-development Partner · 30 December 2025Licensed European and Turkish rights to next-generation Wilson's disease candidate (HY-106 Methanobactin) from ArborMed. Wilson's disease is a rare inherited metabolic disorder characterized by toxic copper accumulation.
• Rosemont PharmaceuticalscoreChannel Partner/ Reseller/ Distributor · 29 December 2025Partnership for Atomoxetine Oral Solution in the US market. Also partnered for Valacyclovir Oral Suspension in US. Atomoxetine NDA filed with US FDA in early 2026.
• Wake Forest UniversitycoreStrategic or Co-development Partner · 12 December 2025Collaboration to develop a therapy for a rare skin disorder. This partnership focuses on an exclusive license option for an innovative topical therapy for a rare genetic skin disorder, with potential to qualify for Orphan Drug Designation.
• OrioncoreChannel Partner/ Reseller/ Distributor · 28 October 2025Partnership to bring Tranexamic Acid RTU to key European markets. This complements the January 2026 partnership for Pantoprazole IV RTU.
• Grand Life Sciences GroupcoreChannel Partner/ Reseller/ Distributor · 27 October 2025Partnership for HY-094 (next-generation IV iron product) in China. HY-094 is a new chemical entity for treatment of iron deficiency anemia, currently advancing toward Phase 3 after completing Phase 2b development.
• Huons Co., Ltd.minorChannel Partner/ Reseller/ Distributor · 22 August 2025Exclusive licensing agreement for XTRAZA in South Korea. XTRAZA is a proprietary tranexamic acid oral rinse designed for dental procedures in patients taking anticoagulants.
• Kuvatris TherapeuticscoreStrategic or Co-development Partner · 23 June 2025Partnership to advance Suramin IV development for Human African Trypanosomiasis (sleeping sickness). Since HAT is on FDA's tropical diseases list, approval could qualify for Priority Review Voucher.
• QliniQminorChannel Partner/ Reseller/ Distributor · 13 May 2025Partnership for Valacyclovir Oral Suspension covering the Netherlands. Combined with AFT partnership for Valacyclovir in Australia, New Zealand, and Canada.
• Colonis PharmaminorChannel Partner/ Reseller/ Distributor · 3 February 2025Partnership for XTRAZA (tranexamic acid oral rinse) in the United Kingdom for prevention and treatment of bleeding in patients on anticoagulant therapy undergoing dental procedures.
• AvenacycoreChannel Partner/ Reseller/ Distributor · 26 December 2024Exclusive US commercialization partner for Tranexamic Acid Ready-to-Use (RTU) IV formulation. FDA approval received in June 2025; US launch planned for first half 2026.
• Purna Female HealthcarecoreStrategic or Co-development Partner · 30 January 2024Partnership to develop Miconazole-Domiphen Bromide vaginal cream for vulvovaginal candidiasis (VVC) and bacterial vaginosis (BV). Positive Phase 2 trial results announced in January 2024.
• PadagiscoreChannel Partner/ Reseller/ Distributor · 4 December 2023Padagis launched Podofilox Gel (first generic equivalent to Condylox gel) in the US market in December 2023 for treatment of external genital and perianal warts caused by HPV.
• AFT PharmaceuticalsflagshipStrategic or Co-development Partner · 31 March 2022AFT Pharmaceuticals is a key strategic partner for Maxigesic IV worldwide (excluding Australia and New Zealand). Also co-develops HY-094 (IV iron product for iron deficiency anemia) for global commercialization. Additionally partnered for XTRAZA (tranexamic acid oral rinse) and Valacyclovir in various territories. Maxigesic IV is licensed in 100+ countries, approved in 50+ countries, and marketed in 30+ countries through this partnership network.
• Hikma PharmaceuticalscoreChannel Partner/ Reseller/ Distributor · 31 March 2022Hikma commercializes Maxigesic IV in the United States under the registered trade name Combogesic IV. This is a key commercial partnership for the US market, one of the world's largest pharmaceutical markets.
• AltaTheracoreChannel Partner/ Reseller/ Distributor · 31 March 2022AltaThera commercializes Sotalol IV in the US market. Sotalol IV is FDA-approved for treatment of documented life-threatening ventricular arrhythmias and maintenance of normal sinus rhythm in atrial fibrillation patients.
• VaneltixcoreStrategic or Co-development Partner · 17 October 2021Strategic partnership for Alenura treatment of acute pain in interstitial cystitis. Alenura is a ready-to-use intravesical therapy combining alkalinized lidocaine with heparin for adults with IC/BPS pain flares.

Scale indicators7 records

Recent moves8 records

Expansion highlights6 records

Direct peers

• Lannett: U.S. specialty generic pharmaceutical company focused on oral solids, topicals, and specialty formulations. Similar to Hyloris in pipeline breadth vs. headcount and focus on niche reformulated products.
• Padagis: U.S. specialty generics company (formerly Perrigo's generics unit) commercializing topical, oral, and injectable generics. Direct peer given commercial partnership on Podofilox Gel and overlapping focus on value-added generics and specialty pharmaceutical products.
• AFT Pharmaceuticals: Specialty pharmaceutical company headquartered in New Zealand focused on reformulated and repurposed medicines with global commercialization partnerships. Direct comparable to Hyloris in product strategy and partnership-driven GTM; Hyloris's flagship Maxigesic IV is co-developed with AFT.
• ANI Pharmaceuticals: U.S. specialty pharmaceutical company focused on niche generics, 505(b)(2) products, and contract manufacturing. Closely comparable to Hyloris in reformulation focus, small headcount relative to pipeline breadth, and specialty-pharma commercial model.
• Amneal Pharmaceuticals: U.S.-based specialty generics and specialty pharma company operating across injectables, oral solids, and biosimilars. Comparable to Hyloris for its 505(b)(2) and complex generics expertise, broad pipeline diversification, and reliance on U.S. commercialization partnerships.

Broad incumbents

• Hikma Pharmaceuticals: Large multinational specialty pharmaceutical company with broad generics, injectables, and branded pharma portfolio. Comparable to Hyloris as a U.S. commercial partner on Combogesic IV and for overlapping injectable/specialty strategy at greater scale.
• Mallinckrodt: Global specialty pharmaceutical company with branded and specialty generics franchises, including hospital injectables and reformulated products. Comparable to Hyloris's hospital/acute-care injectable focus.
• Endo International: U.S. specialty pharmaceutical company with focus on sterile injectables, generic pharmaceuticals, and specialty branded products. Overlaps with Hyloris's injectable formulation focus and reformulation-driven pipeline model.
• Lupin Pharmaceuticals: India-based global pharmaceutical company with significant specialty generics, complex injectables, and biosimilars portfolio. Comparable to Hyloris for complex generics/specialty strategy at greater geographic scale.

Regional players

• Theramex: European-based specialty pharmaceutical company focused on women's health and other specialty therapeutic areas. Comparable to Hyloris's women's health and specialty therapeutic area strategy, primarily serving European markets.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/hyloris-pharmaceuticals

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Subsidiaries3 records

Funding overview

Funding rounds3 records

Investors4 records

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

M&A

Investments1 record

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

Frequently asked questions about Hyloris Pharmaceuticals