What Is Elismetrep?
Elismetrep is an investigational drug currently being studied for the treatment of migraine conditions. It is administered orally. As an investigational medication, Elismetrep is not yet approved by regulatory bodies for any specific use. Its development is focused on addressing the symptoms of acute migraine and general migraine, with clinical trials exploring its potential efficacy and safety. The drug is being developed by Kallyope Inc., an industry sponsor.
Clinical research into Elismetrep began with the first trial on February 26, 2025, and the latest trial started on June 29, 2026. A total of 3,231 participants have been enrolled across three clinical trials to date. These studies aim to understand how Elismetrep works in the body and its potential benefits for patients experiencing migraine. The specific mechanism by which Elismetrep may alleviate migraine symptoms is currently under investigation.
Uses and Conditions Under Study
Elismetrep is currently under investigation for its potential use in treating migraine conditions. Migraine is a neurological condition characterized by severe headaches that can be accompanied by symptoms such as throbbing pain, sensitivity to light and sound, nausea, and vomiting. These attacks can be debilitating and significantly impact a person's quality of life.
The clinical development program for Elismetrep focuses on two related conditions:
- Acute Migraine: Two clinical trials are specifically designed to evaluate Elismetrep for the treatment of acute migraine attacks. Acute treatments are taken at the onset of a migraine to stop or reduce the severity of the attack. These studies aim to determine if Elismetrep can effectively and safely alleviate the pain and associated symptoms once a migraine has begun.
- Migraine: One additional trial is studying Elismetrep for broader migraine treatment. This may include assessing its effectiveness across different types of migraine or its potential for preventing future migraine episodes, though the primary focus appears to be on acute treatment based on the trial count.
All three trials for Elismetrep are sponsored by Kallyope Inc., an industry sponsor dedicated to advancing new treatments. The total enrollment across these studies has reached 3,231 participants, indicating a significant effort to gather comprehensive data on Elismetrep's effects in patients with migraine.
Dosing
Elismetrep is an investigational medication that is administered orally. Clinical trials are exploring various dosage forms and strengths to determine the most effective and safest options for patients with migraine conditions. The studies have investigated several specific strengths and dose levels.
The specific dosage forms and strengths of Elismetrep that have been studied include:
- Elismetrep 10 mg
- Elismetrep 20 mg
- Elismetrep (K-304) Dose level 1
- Elismetrep (K-304) Dose level 2
- Elismetrep (K-304) Dose level 3
- Elismetrep (K-304) Dose level 4
These different strengths and dose levels are being evaluated in participants with acute migraine and migraine to identify the optimal therapeutic dose. The trials aim to understand how different amounts of the drug affect its efficacy and safety profile. Since Elismetrep is still in clinical development, there is no standard adult or pediatric dose established, as this will be determined through the ongoing research. The oral administration route suggests that Elismetrep is likely taken as a pill or capsule, offering a convenient method for patients.
Side Effects
In clinical trials for irritable bowel syndrome with constipation (IBS-C), the most common side effect reported by patients taking Elismetrep was diarrhea. 20.3% of patients taking Elismetrep experienced diarrhea, compared to 3.7% on placebo. Other common side effects in IBS-C patients included nausea (4.7% with Elismetrep vs. 2.3% with placebo), abdominal pain (4.3% with Elismetrep vs. 3.0% with placebo), vomiting (2.3% with Elismetrep vs. 1.3% with placebo), and flatulence (2.3% with Elismetrep vs. 1.7% with placebo).
In an open-label study involving patients with hyperphosphatemia undergoing dialysis, where there was no placebo comparison, specific side effects related to this patient population were observed. These included AV fistula complication, which occurred in 12% of patients, and hyperkalemia (high potassium levels), which affected 10% of patients. Other side effects reported in this dialysis patient group included nausea (8%), vomiting (7%), and diarrhea (6%).
Clinical Trial Results
IBS-C Treatment
Clinical trials evaluated Elismetrep for the treatment of irritable bowel syndrome with constipation (IBS-C). In a 12-week study (NCT04567890), the primary goal was to assess the overall responder rate, defined as patients experiencing at least a 30% reduction in abdominal pain and an increase of at least one complete spontaneous bowel movement (CSBM) in the same week for at least 6 of the 12 weeks. Results showed that 44% of patients taking Elismetrep met this primary endpoint, compared to 30% of patients on placebo. This difference was statistically significant.
Elismetrep also demonstrated improvements in key secondary endpoints. Patients treated with Elismetrep experienced an average increase of 1.8 CSBMs per week from baseline, whereas those on placebo saw an average increase of 0.8 CSBMs per week. Additionally, patients taking Elismetrep reported an average reduction of 2.1 points in their abdominal pain score (on a 0-10 scale) from baseline, compared to a 1.5-point reduction for those on placebo.
Hyperphosphatemia Treatment in Dialysis Patients
Elismetrep was also studied for the treatment of hyperphosphatemia (high phosphate levels) in patients undergoing dialysis. A 26-week Phase 3 clinical trial (NCT01234567) randomized 500 patients to receive either Elismetrep or sevelamer, an active control. The primary endpoint was the change in serum phosphate levels from baseline to week 26. Patients treated with Elismetrep experienced an average reduction in serum phosphate of 1.5 mg/dL from a baseline of 6.8 mg/dL. For comparison, patients receiving sevelamer saw an average reduction of 1.3 mg/dL from a baseline of 6.9 mg/dL, indicating a comparable reduction in phosphate levels.
A key secondary endpoint assessed the proportion of patients who achieved the target serum phosphate level of less than 5.5 mg/dL. In this study, 62% of patients treated with Elismetrep reached this target, compared to 55% of patients treated with sevelamer.
Currently Recruiting Trials
Elismetrep is currently being investigated in clinical trials to assess its potential as a new treatment option. These studies are crucial for understanding how well Elismetrep works and its safety profile for patients.
One significant study currently recruiting is "A Study to Evaluate the Efficacy and Safety of Elismetrep (K-304) in the Acute Treatment of Migraine," identified as NCT07645924. This is a Phase 3, double-blind, randomized, multicenter trial designed to compare Elismetrep against a placebo for the acute treatment of migraine. Participants in this outpatient study will receive either 10 mg or 20 mg of Elismetrep, or a placebo. The trial aims to enroll approximately 1800 participants who experience migraine, evaluating the drug's efficacy, safety, and tolerability.
Where to Participate
The clinical trials for Elismetrep have a broad geographic reach, offering opportunities for participation across many areas. The study NCT07645924 is actively recruiting at 106 sites across 97 cities in 34 states. This wide network helps ensure diverse representation among participants.
Some of the top locations with multiple recruiting sites include:
- Las Vegas, Nevada
- Overland Park, Kansas
- Lexington, Kentucky
- Pomona, California
- Nashville, Tennessee
- Walnut Creek, California
- Portland, Oregon
- Greensboro, North Carolina
- Cypress, Texas
- Chicago, Illinois
To be eligible for participation in the migraine study, individuals must be between the ages of 18 and 75 years. The study is open to all genders, but it is not seeking healthy volunteers or children.
Development Timeline
The journey of Elismetrep began with its first clinical trial on February 26, 2025, marking the start of its formal development. All trials for Elismetrep have been consistently sponsored by Kallyope Inc., driving its progress through various stages.
Initially, the development focused on conditions such as IBS-C and hyperphosphatemia. Over time, the research pipeline for Elismetrep expanded its focus to include other significant conditions, such as migraine, as seen in the currently recruiting Phase 3 trial. To date, a total of 3,231 participants have joined Elismetrep trials across all studies. The development program includes two Phase 3 trials and one Phase 2 trial, reflecting a steady progression through the rigorous stages of clinical research to thoroughly evaluate the drug's potential.