Transforming Patient Experience

VLS-01 is a proprietary oral transmucosal film formulation of N,N-Dimethyltryptamine (DMT) applied to the buccal surface, being developed for the treatment of people suffering from treatment-resistant depression (TRD).Pharmacologically, VLS-01 is a partial to full agonist of the 5-HT1/2/6/7 sub-receptors and is being developed to potentially offer rapid, robust, and durable efficacy with a favorable safety profile. VLS-01 is designed to fit within the established two-hour interventional psychiatry treatment paradigm, positioning it for integration into existing care models.

Nualtis is developing a buprenorphine/naloxone sublingual film as a generic alternative for the treatment of opioid dependence. Utilizing its VersaFilm® platform, the formulation is designed to deliver reliable dosing and support patient adherence in medication-assisted treatment programs. The program aims to expand access to effective, evidence-based therapies in an established market by providing a high-quality, cost-efficient product.

Rizatriptan is a fast-acting, selective serotonin 5-HT。/1D receptor agonist used for the acute treatment of migraines, with or without aura. By targeting specific receptors in the brain, rizatriptan helps constrict dilated blood vessels and block pain pathways, offering rapid relief from migraine symptoms such as headache, nausea, and light sensitivity.

It is typically well tolerated and is favoured for its quick onset of action compared to other triptans. This molecule is available both as a standard tablet and as an orally disintegrating tablet (ODT), providing flexible administration options.

Rizatriptan represents a well-established therapeutic class with continued relevance in markets seeking fast and effective migraine interventions.

Nualtis is investigating Montelukast oral film as a novel therapeutic approach for Alzheimer’s disease. Preclinical and clinical data support Montelukast’s neuroprotective and anti-inflammatory potential. The company has successfully completed a Phase 2a study, demonstrating safety and feasibility. The oral film format enhances compliance and brain bioavailability. Development is now focused on advancing clinical evaluation and strategic collaborations to position Montelukast as a promising candidate in neurodegeneration.

Nualtis is advancing the development of a tadalafil oral film, leveraging its proprietary VersaFilm® technology to deliver a discreet, convenient, and fast-acting alternative to conventional tablets. The program targets the erectile dysfunction market, where improved patient compliance and differentiated delivery formats create strong commercial potential. The oral film is designed for rapid dissolution without water, providing ease of use and portability.

Nualtis, in collaboration with Karolinska Institutet, is advancing the MONTPARK trial, a Phase 2, multicenter, randomized, double-blind, placebo-controlled study led by Professor Per Svenningsson. The 18-month trial, funded by the Swedish Research Council, is enrolling up to 90 early-to-moderate Parkinson’s patients to evaluate high-dose Montelukast VersaFilm®. The program targets neuroinflammation as a potential disease-modifying pathway, distinguishing it from existing symptomatic therapies. Results from MONTPARK will guide the clinical advancement of Nualtis’ oral film platform in neurodegeneration and position Montelukast as one of the most promising candidates in the global search for disease-modifying Parkinson’s treatments.