We add value to pharma through the smart, innovative use of existing medicines — addressing unmet patient needs worldwide.
For patients. For practitioners. And for the future of healthcare.
Our Product Portfolio
Since our inception, we have significantly strengthened our capabilities and skills, expanding our focus towards complex, reformulated and repurposed patented products, thereby moving further up the value chain. By applying our know-how and technological innovations to existing pharmaceuticals, we have built a broad proprietary portfolio of value-added product candidates.
Our pipeline spans 30+ products and product candidates — 28 of which are publicly announced — 25 of which are value-added — and is organized around 3 Strategic Focus Groups for Growth: Mavericks, Core Drivers and Promising Seeds.
The portfolio currently includes 4 commercial products which deliver royalties income and are widely brought to the market thanks to an impressive number of partnerships (Maxigesic® IV, Sotalol IV, Podofilox Gel, Tranexamic Acid IV RTU), 25+ products in development of which 2 pending filings (Atomoxetine and Valacyclovir powder for suspension). Most of our cardiovascular candidates are intended for commercialization through third party sales force, targeting cardiovascular specialists and hospitals in the U.S., while we are also pursuing value-added candidates in other high-value markets beyond the cardiovascular space.
We want to lead in number of 505(b)(2) value-added products.
NCE’s may exist already but are now registered by Hyloris in a territory where it did not exist before.
Mavericks
High-potential products backed by clinical evidence and significant commercial potential
HY-094 has completed Phase 2b development and is advancing toward Phase 3 clinical trials.
For the treatment of iron deficiency anemia in adults.
HY-094 is designed to deliver effective iron replacement with the potential for single-infusion administration, with a favorable tolerability profile.
Proprietary IP (exclusive global human-use license secured).
Ongoing human Phase 1 PK studies.
For the treatment of right heart failure (RHF) in patients with a left ventricular assist device (LVAD).
Milrinone ER is designed to lead to a stable and controlled milrinone effect and has the potential to become the first available oral medication to improve strength of heart function in late-stage heart failure patients. This product is planned to be eligible and convenient for long-term oral therapy and reduce reliance on existing regimens of chronic intravenous pharmacotherapy with all its downsides regarding cost, complexity and safety.
Priority patent application filed in 2025. Expiry when granted: 2046.
This application covers the composition under development.
FDA Orphan Drug Designation.
LVAD-associated RHF indication.
Dose-finding Phase 2 study in VVC completed.
Preparations are underway for an exploratory clinical trial to assess potential efficacy against bacterial strains, including Gardnerella.
Treatment of vulvovaginal candidiasis (VVC) and bacterial vaginosis (BV).
The dual-action candidate combines miconazole’s antifungal activity with domiphen bromide’s antiseptic properties, promoting eradication of both Candida and bacterial pathogens. This differentiated mechanism may help address an important driver of recurrence.
Intellectual property protection through 2038, 2044 and 2045.
The HAT program may also serve as a strategic bridge toward Autism Spectrum Disorder (ASD) as a potential follow-on indication.
Suramin IV for HAT is currently in Phase 3 development.
A Phase 2 study on ASD has been completed.
Suramin IV is being developed for the treatment of Trypanosoma brucei rhodesiense, the acute and rapidly progressing form of Human African Trypanosomiasis.
HAT is a neglected tropical disease, and this specific disease is included on the FDA list of tropical diseases for which a Priority Review Voucher (PRV) may be granted.
Following HAT, ASD could be pursued as an additional indication.
Suramin IV is a standardized intravenous formulation of the long-established standard of care for rhodesiense HAT. Although suramin has been used globally for decades and is recognized by the WHO and CDC, it has never been FDA-approved for any indication in the U.S. By formalizing the regulatory path for this life-saving therapy, the program aims to become the first FDA-approved suramin product in the U.S. while also creating a PRV opportunity.
FDA Orphan Drug Designation.
HAT indication.
Currently in Phase 2 clinical development, including a 4-arm study comparing Alenura™ with its individual components and placebo.
The Independent Data Monitoring Committee (IDMC) recommended continuation of the trial following interim analysis.
Additional studies are ongoing to support an End-of-Phase 2 meeting in H2 2026.
For adults with pain associated with IC/BPS, a condition causing recurring discomfort or pain in the bladder and surrounding pelvic region, believed to result from dysfunction of the inner bladder wall’s glycosaminoglycan layer.
A ready-to-use intravesical therapy designed to provide rapid pain relief while also supporting the bladder’s protective lining, with the potential to deliver both immediate and sustained symptom control during acute IC/BPS flares.
Multiple patents and patent applications (max expiry 2038).
Core Drivers
Catalyst products building a strong recurring revenue base in the near term
Licensed in more than 100 countries, approved in over 50 countries, and marketed in more than 30 countries.In the U.S., the product is commercialized by Hikma under the registered trade name Combogesic® IV.
U.S.: Short-term treatment of mild to moderate pain, or moderate to severe pain as an adjunct to opioids, as well as fever, when intravenous administration is clinically justified.
EU: Short-term symptomatic treatment of acute moderate pain and reduction of fever when intravenous administration is clinically necessary or when other routes of administration are not suitable.
Faster, superior pain relief compared to either drug alone, offering an effective non-opioid alternative to reduce opioid use in hospital post-operative pain management.
Range of patents covering formulations, uses, and methods of manufacturing, including an aqueous paracetamol and ibuprofen IV formulation
(U.S. expiry: July 2035 – Aug 2036) and an improved manufacturing method for paracetamol-based aqueous solutions (U.S. expiry: June 2039).
FDA-approved and commercialized in the U.S. by AltaThera.
Sotalol IV is indicated for the treatment of documented, life-threatening ventricular arrhythmias, including sustained ventricular tachycardia.
It is also indicated to help maintain normal sinus rhythm by delaying recurrence of atrial fibrillation or atrial flutter in highly symptomatic patients who are already in sinus rhythm.
In addition, it may provide a useful intravenous option for patients who are temporarily unable to take oral sotalol.
Sotalol IV is designed to shorten hospital initiation time, reduce overall healthcare resource utilization, and improve treatment efficiency for patients starting sotalol therapy.
IV loading may reduce hospitalization to as little as one day in appropriate patients, while also allowing more controlled management of drug exposure and clinical monitoring.
Protected by formulation patents, including ready-to-use intravenous composition patents, with protection currently referenced through 2034.
The product is a 0.5% podofilox topical gel administered twice daily for 3 consecutive days, followed by a 4-day treatment break, for up to 4 weeks.
FDA approved, commercially available in the U.S.; launched by Padagis in December 2023.
For adult patients, for the topical treatment of external genital and perianal warts caused by certain types of human papillomavirus (HPV).
Provides an effective and convenient topical, non-invasive treatment option for external genital and perianal warts, offering patients a well-established alternative to more invasive procedures.
Granted patent in Belgium covering an improved manufacturing process.
In June 2025, Hyloris’ exclusive U.S. partner received FDA approval of its Abbreviated New Drug Application (ANDA) for an intravenous, ready-to-use (RTU) formulation of tranexamic acid, supplied as 10 mg/mL in 100 mL vials. The U.S. launch is planned for the first half of 2026. In Europe, the product is being developed under a value-added medicine approach, reflecting its meaningful practical and clinical advantages versus concentrated reference medicinal products, and is under registration in several countries.
In patients with hemophilia, for short term use to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.
In practice it is mostly used for prevention and treatment of excessive bleeding.
A ready-to-use intravenous formulation that eliminates the need for reconstitution, offering a convenient, time-saving alternative that may streamline treatment and improve patient outcomes.
Granted U.S. (expiry 2 Dec 2039) and BE (expiry 17 June 2039) patents; Ready-to-Use Tranexamic Acid intravenous solution.
A randomized, double-blind, multicenter, placebo-controlled Phase 3 trial is ongoing to evaluate the efficacy, safety, and tolerability of tranexamic acid oral rinse in preventing oral bleeding in anticoagulated patients undergoing tooth extraction. Approximately 280 patients across Europe and the U.S. are planned for enrollment, with results expected in 2026. Subject to positive outcomes, an FDA submission could follow shortly thereafter.
Prevention and treatment of excessive bleeding in patients on anticoagulant therapy undergoing dental procedures.
Convenient oral rinse that helps control bleeding in patients taking blood thinners, offering a practical, localized alternative to systemic treatment approaches and supporting easier use in dental practice.
U.S. patents granted and pending; current expected expiry in 2039.
and severe fluid overload. It is designed to enable immediate drug delivery and more predictable dosing when oral absorption is impaired or oral administration is not feasible.
Registration batches have been initiated, and clinical completion is anticipated in 2026.
For the treatment of salt and water retention, including oedema associated with congestive heart failure and renal disorders such as nephrotic syndrome or reduced kidney function.
The IV formulation is expected to provide faster onset of action, enable concomitant administration with IV furosemide (the first-line standard of care), and improve treatment reliability in patients with gastrointestinal oedema, nausea, or inability to take oral medication.
It may also support better in-hospital dosing control in acutely ill patients.
Patents and pending patent applications in the U.S. and selected countries, including protection for a lyophilized metolazone formulation for parenteral administration;
Expiry 2044, subject to grant and jurisdiction.
It aims to improve access, dosing accuracy, and adherence across pediatric, geriatric, and immunocompromised populations through a more practical oral presentation.
Hyloris has submitted an NDA to the U.S. FDA. A Complete Response Letter was received following manufacturing-site observations identified during an FDA inspection at the CDMO responsible for the product. No product-specific deficiencies were raised. Hyloris is evaluating next steps with the current CDMO, which is addressing the FDA observations, as well as alternative manufacturing solutions; this may shift launch timing into 2027.
Valacyclovir is indicated for herpes virus infections. Adult patients label uses include cold sores, initial and recurrent genital herpes, suppressive therapy and reduction of transmission of genital herpes, and shingles.
Pediatric patient label uses include cold sores and chickenpox.
Currently, valacyclovir is available in oral solid form. This oral liquid formulation is designed to support treatment of infections such as shingles and chickenpox, particularly in patients who cannot easily swallow solid dosage forms. With taste-masking technology and room-temperature stability, it offers a more patient-friendly alternative to tablets and extemporaneously compounded suspensions, with the potential to improve convenience, dosing precision, and adherence.
Proprietary formulation protected by U.S. patents with expiries in 2035 and 2036, and pending patent applications in key markets with expiry expected in 2045.
Following successful completion of the U.S. clinical trial in summer 2025, the NDA was filed with the U.S. FDA in early 2026 by Hyloris' commercial partner Rosemont Pharmaceuticals. In addition, patient participation in a supporting clinical trial for Europe was completed in Q1 2026 and may support future filings in additional territories once results become available.
Primarily indicated for the treatment of ADHD, especially in patients who benefit from flexible dose titration and an oral liquid presentation.
This taste-masked oral liquid enables precise weight-based dosing and easier titration, supporting adherence and tolerability, particularly in children and adolescents who may not reliably take capsule formulations.
Multiple patents and pending applications provide potential protection through 2044, including claims covering the oral liquid formulation.
Late-stage development.
For the relief of nausea and vomiting associated with chemotherapy (CINV), radiotherapy (RINV), and post-operative recovery.
The formulation combines immediate-release and extended-release delivery to support both rapid symptom control and prolonged antiemetic coverage, with the potential to improve convenience, adherence, and overall treatment experience.
Confidential.
The pivotal clinical trial has been completed successfully, and U.S. regulatory submission is expected in Q2 2026.
A meeting with the FDA held in February 2026 confirmed the proposed regulatory strategy.
Dofetilide IV is intended for the same core indications as oral dofetilide, with added utility for: IV loading to achieve therapeutic concentrations more efficiently, potentially reducing hospital stay associated with initiation, re-titration or re-initiation of therapy, facilitating IV-to-oral transition.
Initiation of oral dofetilide currently requires three or more days of in-hospital monitoring. Dofetilide IV has the potential to reduce this to one day, lowering resource utilization and improving treatment efficiency. Intravenous administration may also allow more controlled management of exposure and safety, including immediate interruption of dosing if QTc prolongation or other adverse effects occur.
Granted patents with expiry dates between 2039 and 2043, with additional pending applications, including protection relating to one-day loading approaches,
aqueous IV dofetilide compositions, and additional uses supporting the dosing and treatment advantages of the IV formulation.
Registration batches have been successfully completed, and the first European regulatory filing is planned for late H1 2026.
For the treatment of hypophosphatemia, a condition characterized by abnormally low phosphate levels in the blood.
Hypophosphatemia may arise in a range of clinical settings, including congenital disorders, malabsorption, or treatment-related causes.
HY-088 is designed to provide accurate, consistent phosphate dosing in a convenient oral liquid format, offering a safer and easier-to-administer alternative to compounded or less standardized treatments, with the potential to improve both patient compliance and treatment reliability.
Pending patent applications in selected countries, with expiry expected in 2045 and 2046.
Currently in reformulation development, with manufacturing batches and supporting clinical activities in preparation.
Hyloris is targeting to launch as of 2028.
For the intravenous treatment of acid-related disorders where IV administration is clinically appropriate including gastroesophageal reflux disease (GERD) in patients with a history of erosive esophagitis and pathological hypersecretory conditions such as Zollinger-Ellison syndrome.
The ready-to-use IV formulation is designed to reduce preparation steps, shorten administration time, and minimize handling complexity versus lyophilized products, with the potential to improve efficiency, reduce error risk and generate cost savings for healthcare providers.
Pending U.S. and international patent applications covering liquid, storage-stable, directly injectable pantoprazole formulations, their uses and manufacturing methods.
Expected expiry: 2045.
Registration batches have been produced by the selected CMO, and a pivotal clinical trial is planned for 2026.
Additional potential indications outside the cardiovascular field are also being explored.
For use in the management of reinfarction risk in acute coronary syndrome and related emergency cardiovascular settings, including situations where rapid antiplatelet treatment is needed and oral administration may not be optimal.
HY-074 is designed to provide faster onset of antiplatelet activity, greater dosing control, and more practical administration in acute care settings, particularly for patients who are nauseous, unconscious, or otherwise unable to take oral medication.
Patent applications filed, with maximum expected expiry in 2043–2044.
Late-stage development, with the pivotal study completed successfully. No serious adverse events were reported, and IV aspirin delivered an equivalent pharmacological response with a faster onset of action than oral aspirin. A meeting with the U.S. FDA confirmed alignment on the proposed regulatory pathway and resolved the remaining key items ahead of the planned submission in 2026.
For adults, to decrease the risk of morbidity and mortality associated with emergency cardiac events, including acute myocardial infarction (AMI) and ischemic stroke.
Aspirin™ is a cornerstone of long-term thrombosis management. In acute settings such as ACS, the IV route delivers immediate antiplatelet effect with faster onset than oral aspirin, and eliminates the intrasubject and inter-subject variability of oral administration that has been consistently documented in the literature.
Multiple U.S. patents on aspirin compositions; expiry 2038-2039. Patents and pending patent applications in selected countries.
Regulatory submission in Canada expected in 2026.
Treatment of bacterial skin infections such as impetigo, erythrasma, and infected skin cuts and burns.
High-barrier generic formulation intended to provide a reliable topical alternative to the reference product, while meeting the quality, stability, and performance requirements for regulatory approval in Canada.
No specific IP or regulatory exclusivity currently assumed.
Promising Seeds
Early-stage products pending clinical validation
The program has progressed to the selection of promising new chemical entity (NCE) candidates.
Multiple compounds have been synthesized, several of which have demonstrated strong potency in specialized laboratory assays.
Idiopathic rhinitis is a form of chronic rhinitis without a clearly identifiable allergic, infectious, or other causal trigger. It is associated with overactivity of nasal sensory pathways, including TRPV1-mediated mechanisms in the nasal mucosa, which may contribute to symptoms such as nasal obstruction, rhinorrhea, and sneezing.
Potential first-in-class proprietary therapy targeting TRPV1 receptors in the nasal mucosa, with the aim of improving nasal function and reducing key symptoms of idiopathic rhinitis, including congestion, rhinorrhea, and sneezing.
Confidential. Hyloris is pursuing a dual-track development strategy involving new chemical entity candidates, which could support NCE-based patent protection if successful.
Initial prototype testing in horses was completed in 2025. Further prototype testing is planned for 2026 to build on these early findings and support continued evaluation and advancement of the program.
Treatment of Equine Gastric Ulcer Syndrome (EGUS).
Long-acting, weight-adjusted injectable formulation with the potential to provide reliable and sustained drug delivery, reduce reliance on daily oral dosing, improve adherence, and potentially shorten treatment duration compared with daily oral therapies.
Confidential.
An exploratory clinical trial may start in 2026 to evaluate initial safety and efficacy.
The active substance has been used systemically for many years in an unrelated indication and has an established safety profile, supporting a more de-risked development approach.
For the treatment of a rare inherited inflammatory skin disorder characterized by recurrent flare-ups, painful skin lesions, and chronic inflammation.
Localized delivery directly to affected skin areas may provide a more effective and better-tolerated treatment approach, with the potential to improve symptom control while reducing systemic exposure.
U.S. patent application covering the method of treatment and topical composition, with expected expiry in 2044.
Potential to qualify for Orphan Drug Designation.
Two promising pre-prototypes are advancing in development.
The objective is to finalize a differentiated formulation that is eligible for patent protection and can progress into clinical validation.
Treatment of Burning Mouth Syndrome (BMS).
BMS is a chronic condition characterized by persistent burning sensations in the mouth without an identifiable cause.
It most commonly affects the tongue, lips, gums, or the entire oral cavity and may be associated with dryness, altered taste, or a metallic sensation.
This novel, locally acting oral formulation is designed to provide targeted symptom relief and address a significant unmet need in a condition for which
no approved treatments currently exist.
Confidential.
Multiple formulation strategies have been explored and evaluated, both in-house and with external technology partners, to identify a differentiated product profile for further development.
For the treatment of Vulvar Lichen Sclerosus (VLS) in adults.
VLS is a chronic inflammatory skin disease that predominantly affects the vulva and perianal regions in women, most commonly postmenopausal.
User-friendly formulation intended to reduce inflammation, relieve itching, and help prevent progression of skin changes, providing long-term symptom control for women with VLS.
Confidential.
Selected compound in early clinical development, with formulation work completed and Phase 1 preparations underway.
The program has received FDA Orphan Drug Designation in AML.
Adjunctive therapy to standard-of-care chemotherapy in acute myeloid leukemia (AML), with additional potential in small cell lung cancer (SCLC).
AML is an aggressive hematologic malignancy, while SCLC is a fast-growing neuroendocrine lung cancer; both are associated with high unmet need.
Potential to improve chemotherapy effectiveness and clinical outcomes by modifying the tumor microenvironment in a way that may enhance response to treatment.
Patents and pending patent applications.
FDA Orphan Drug Designation in AML.
First-in-human study planned for 2026 in healthy volunteers.
Treatment of Wilson’s disease, a rare inherited metabolic disorder characterized by toxic copper accumulation in the body.
Potential future label expansion may include cholestatic liver fibrosis and iron overload.
Highly copper-selective injectable therapy with the potential for intermittent dosing, possibly weeks apart, rather than daily treatment, based on non-clinical data.
Patent application on innovative use.
Potential eligibility for Orphan Drug Designation.
Currently development is on hold, pending partnering discussions.
For chronic anticoagulation, including prevention and treatment of venous thromboembolism, stroke prevention in atrial fibrillation, post-myocardial infarction support, and lifelong anticoagulation in patients with mechanical or bioprosthetic heart valves, including LVAD/RVAD support.
Flexible oral solution designed to support more precise dose titration in patients requiring careful anticoagulation management, with the potential to improve TTR and clinical outcomes. May also provide an important alternative for elderly patients or patients with swallowing difficulties.
Patent applications filed.