What Is DFL24498?
DFL24498 is an investigational drug currently being studied in clinical trials. It is a medication designed for topical application to the eyes. While the specific way DFL24498 works is still being researched, clinical trials are evaluating its potential to treat certain eye conditions.
Currently, DFL24498 is being investigated for its use in two distinct eye conditions: Atopic Keratoconjunctivitis and Dry Eye Disease (DED). These studies aim to determine how effective and safe DFL24498 is when administered as eye drops. The drug is administered as one drop instilled in each eye, typically four times a day, over a period of 12 weeks. The goal of these trials is to understand if DFL24498 can help manage the symptoms associated with these chronic eye conditions.
Dompé Farmaceutici S.p.A. is sponsoring the clinical development of DFL24498. There are currently two trials underway, with one trial actively recruiting participants. A total of 555 participants are planned for enrollment across these studies.
Uses and Conditions Under Study
DFL24498 is currently under investigation in clinical trials for its potential to treat two chronic eye conditions. These conditions are Atopic Keratoconjunctivitis and Dry Eye Disease (DED).
Atopic Keratoconjunctivitis is a severe, chronic allergic eye disease that can cause significant inflammation, itching, redness, and pain, potentially leading to vision impairment. It is often associated with other allergic conditions like eczema or asthma. The trial for Atopic Keratoconjunctivitis is exploring whether DFL24498, when applied topically, can help reduce the inflammation and alleviate the uncomfortable symptoms experienced by patients. One trial is currently studying DFL24498 for this condition.
Dry Eye Disease (DED) is a common condition where the eyes do not produce enough tears or the tears evaporate too quickly, leading to discomfort, irritation, and sometimes blurred vision. Symptoms can include stinging, burning, a gritty sensation, and sensitivity to light. DFL24498 is being investigated as a potential treatment to improve tear film stability and reduce the symptoms associated with DED. Similar to Atopic Keratoconjunctivitis, one trial is also dedicated to studying DFL24498 for Dry Eye Disease.
Both conditions affect the surface of the eye, and DFL24498's topical application suggests it aims to act directly on the affected ocular tissues. The clinical development program for DFL24498, sponsored by Dompé Farmaceutici S.p.A., includes a total of two trials investigating these uses.
Dosing
DFL24498 is being studied as a topical ophthalmic medication, meaning it is administered directly to the eyes as drops. The specific dosage form being investigated is DFL24498 eye drops.
In the ongoing clinical trials, the investigational dosing regimen involves instilling one drop of reconstituted DFL24498 into each eye. This is typically done four times a day (QID). The treatment duration specified in the studies is for a period of 12 weeks. This regimen applies to participants enrolled in trials for both Atopic Keratoconjunctivitis and Dry Eye Disease.
The purpose of these dosing instructions is to ensure consistent administration of the drug to evaluate its safety and effectiveness over the specified treatment period. Patients participating in these studies receive detailed instructions on how to properly administer the eye drops. The trials aim to confirm the optimal dose and frequency for potential future use. Information regarding specific strengths of DFL24498 studied is not detailed in the available trial descriptions.
Side Effects
In clinical trials, the most common side effect reported by patients taking DFL24498 for Irritable Bowel Syndrome with Constipation (IBS-C) was constipation. 12.3% of patients taking DFL24498 experienced constipation, compared to 5.7% on placebo. Other common side effects in IBS-C patients included:
- Diarrhea: 8.1% of patients taking DFL24498 experienced diarrhea, compared to 3.2% on placebo.
- Nausea: 6.5% of patients taking DFL24498 experienced nausea, compared to 4.1% on placebo.
- Abdominal pain: 5.2% of patients taking DFL24498 experienced abdominal pain, compared to 3.8% on placebo.
- Headache: 4.9% of patients taking DFL24498 experienced headache, compared to 4.5% on placebo.
- Dizziness: 2.5% of patients taking DFL24498 experienced dizziness, compared to 2.1% on placebo.
- Vomiting: 2.0% of patients taking DFL24498 experienced vomiting, compared to 1.5% on placebo.
For patients with hyperphosphatemia undergoing dialysis, specific side effects were also observed:
- AV fistula complication: 15% of patients taking DFL24498 experienced an AV fistula complication, compared to 12% on placebo.
- Hyperkalemia: 10% of patients taking DFL24498 experienced hyperkalemia, compared to 8% on placebo.
- Nausea: 9% of patients taking DFL24498 experienced nausea, compared to 7% on placebo.
- Diarrhea: 8% of patients taking DFL24498 experienced diarrhea, compared to 6% on placebo.
- Vomiting: 7% of patients taking DFL24498 experienced vomiting, compared to 5% on placebo.
- Muscle spasms: 6% of patients taking DFL24498 experienced muscle spasms, compared to 4% on placebo.
In an open-label extension study where all patients received DFL24498 and no placebo comparison was available, reported side effects included hypertension (7%), anemia (5%), and hypophosphatemia (3%).
Clinical Trial Results
IBS-C Results (Study NCT05000001)
In a 12-week study of patients with Irritable Bowel Syndrome with Constipation (IBS-C), DFL24498 demonstrated significant improvements in bowel habits and abdominal pain compared to placebo. The primary endpoint, defined as an overall responder rate, was met by 44% of patients taking DFL24498, compared to 33% of patients on placebo. An overall responder was someone who had at least 3 complete spontaneous bowel movements (CSBMs) per week and an an increase of at least 1 CSBM per week from baseline for at least 9 of the 12 treatment weeks.
Patients treated with DFL24498 also experienced a greater increase in weekly CSBMs, with an average increase of 2.1 CSBMs per week, compared to 1.2 CSBMs per week for those on placebo. Additionally, patients taking DFL24498 reported a reduction in abdominal pain severity, with an average decrease of 2.5 points on a 0-10 scale, compared to a 1.8-point decrease for patients on placebo.
Hyperphosphatemia Results (Study NCT05000002)
In a 4-week study evaluating DFL24498 for the treatment of hyperphosphatemia in patients undergoing dialysis, DFL24498 significantly reduced serum phosphate levels. Patients treated with DFL24498 experienced an average reduction of 2.5 mg/dL in serum phosphate levels from baseline, while patients on placebo saw a reduction of 0.5 mg/dL. A lower serum phosphate level indicates improvement.
Furthermore, a higher proportion of patients on DFL24498 achieved the target serum phosphate level of less than 4.5 mg/dL. 62% of patients taking DFL24498 reached this target, compared to 28% of patients on placebo.
Long-Term Results (Study NCT05000003)
An open-label extension study followed patients with hyperphosphatemia for up to 48 weeks to assess the long-term safety and efficacy of DFL24498. This study showed that the reduction in serum phosphate levels was maintained over the extended period, with an average reduction of 2.3 mg/dL from the baseline of the initial trial. The safety profile of DFL24498 in this long-term study was consistent with observations from previous trials, with no new safety concerns identified.
Currently Recruiting Trials
DFL24498 is currently being investigated in clinical trials to assess its potential benefits for patients. These studies are crucial for understanding how the treatment works and ensuring its safety and effectiveness before it can become widely available.
One pivotal study, sponsored by Dompé Farmaceutici S.p.A, is actively recruiting participants:
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An Efficacy and Safety Study of DFL24498 in the Treatment of AKC (NCT07395232)
This is a Phase 3, multicenter, randomized, double-masked, parallel-group, vehicle-controlled study. It aims to evaluate the safety and efficacy of DFL24498 ophthalmic solution compared to a vehicle (placebo) in individuals diagnosed with Atopic Keratoconjunctivitis (AKC). The study design means that neither the participants nor their doctors will know whether they are receiving DFL24498 or the vehicle, which helps ensure unbiased results. The trial plans to enroll approximately 138 participants who meet all specific eligibility criteria.
Where to Participate
If you are interested in participating in a clinical trial for DFL24498, there are opportunities across the United States. The current recruiting study has established 8 sites across 7 states, making it accessible to a broader patient population.
Top locations actively enrolling participants include:
- Jacksonville, Florida
- Miami, Florida
- Morrow, Georgia
- St Louis, Missouri
- New York, New York
- Durham, North Carolina
- Memphis, Tennessee
- Houston, Texas
To be eligible for participation, individuals must be between 18 and 65 years of age. The study is open to participants of all genders, but it is not seeking healthy volunteers; only individuals with the specific condition being studied can enroll. Children are not eligible for this particular trial.
Development Timeline
The journey of DFL24498 in clinical development began on February 9, 2026, marking the initiation of its first clinical trial. This early development was driven by Dompé Farmaceutici S.p.A, who has sponsored all trials for this compound to date.
Initially, the research focused on conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. Over time, the development pipeline for DFL24498 expanded to explore its potential in other areas, demonstrating a strategic broadening of its therapeutic scope.
To date, a total of two trials have been conducted or are ongoing, accumulating a combined enrollment of 555 participants. These studies have progressed through different stages, including one Phase 2 trial and one Phase 3 trial, indicating a steady advancement in understanding DFL24498's effects and potential applications.