PharmaNutra Advances Phase 4 Trial Comparing Sucrosomial® Iron to Ferric Maltol in Iron-Deficient Women

PharmaNutra SpA (IT:PHN) announced an update on their ongoing clinical study.

Study Overview
This phase 4 clinical study, officially titled “A Prospective, Open-Label, Randomized, Interventional Study to Evaluate the Efficacy and Tolerability of Sucrosomial® Iron vs Ferric Maltol in Iron Deficient Women,” aims to compare how well two oral iron products work and how well they are tolerated in women with mild to moderate iron deficiency anemia. The key goal is to see whether PharmaNutra’s Sucrosomial® Iron can match Ferric Maltol in restoring normal hemoglobin levels, while also being easier on the stomach. The study is important because many patients stop taking standard iron due to side effects, so a better tolerated option could unlock wider use in everyday practice.

Intervention/Treatment
The trial tests two daily oral treatments over 12 weeks. The first is Sucrosomial® Iron (Sideral® Forte), a dietary supplement developed by PharmaNutra that delivers 60 mg per day of elemental iron. It is designed to improve absorption and reduce gut discomfort. The second is Ferric Maltol (Feraccru®), a prescription iron drug also given at 60 mg per day. Both are taken as capsules on an empty stomach. The aim is to show that Sucrosomial® Iron offers similar blood results to Ferric Maltol with equal or better tolerability.

Study Design
This is an interventional, randomized, parallel-group study, meaning participants are randomly assigned to one of the two treatments and stay on that treatment for the full 12 weeks. There is no blinding (open-label), so both patients and doctors know which product is being taken. The primary purpose is treatment, not prevention or diagnosis, with a focus on improving anemia and tracking side effects. The randomized and controlled setup should give investors confidence that the results will be robust enough to influence prescribing and product positioning.

Study Timeline
The trial is listed as phase 4 and is currently in “Recruiting” status, indicating active patient enrollment. The study was first submitted on December 17, 2025, which marks the formal start of its regulatory record. The latest update on the protocol was submitted on January 30, 2026, showing that the sponsor is actively managing the study and keeping records current. Primary completion and final completion dates are not yet specified in the summary, but investors should assume a typical 1–2 year window from start of recruitment to key readouts, depending on enrollment speed and follow-up.

Market Implications
The update reinforces PharmaNutra’s strategy to strengthen clinical evidence around Sucrosomial® Iron in a real-world anemia population. If the study shows that Sucrosomial® Iron matches Ferric Maltol on efficacy with better tolerability, PharmaNutra could gain stronger backing from doctors and payers, supporting volume growth in both prescription-like and OTC channels. This could be a medium-term positive driver for IT:PHN, especially as iron deficiency remains common in women and is often under-treated due to side effects from standard iron salts. For competitors in oral iron, including Ferric Maltol makers and generic iron supplement producers, stronger data for Sucrosomial® Iron may raise competitive pressure and encourage more evidence-based differentiation. Near term, the study mainly supports sentiment by showing ongoing investment in data; share price impact will likely depend on final results and any subsequent label, guideline, or reimbursement moves.

The study is currently ongoing and recently updated, with further details available on the ClinicalTrials portal.

To learn more about IT:PHN’s potential, visit the PharmaNutra SpA drug pipeline page.