What Is NBI-1117568?
NBI-1117568 is an investigational drug currently being studied in clinical trials. It is administered orally, primarily in the form of oral capsules. This medication is under investigation for its potential to treat conditions such as schizophrenia, bipolar I disorder, and mania. Clinical trials are assessing its safety and effectiveness for these conditions.
There are currently 6 clinical trials involving NBI-1117568, with a total enrollment of 2,088 participants. The first trial began in 2022, and the latest trial is expected to conclude in 2025. Neurocrine Biosciences is the sponsor for all studies involving NBI-1117568.
Uses and Conditions Under Study
NBI-1117568 is currently being investigated in clinical trials for its potential therapeutic effects in several psychiatric conditions.
One primary area of study for NBI-1117568 is schizophrenia. Schizophrenia is a chronic and severe mental disorder that affects how a person thinks, feels, and behaves. People with schizophrenia may experience symptoms such as hallucinations, delusions, and disorganized thinking. NBI-1117568 is being studied to see if it can help manage the symptoms associated with this condition. There are 5 clinical trials specifically investigating NBI-1117568 for schizophrenia.
NBI-1117568 is also under investigation for bipolar I disorder and mania. Bipolar I disorder is a mental health condition that causes extreme mood swings that include emotional highs (mania or hypomania) and lows (depression). Mania is a state of abnormally elevated arousal, affect, and energy level. The drug is being evaluated to determine its efficacy in stabilizing mood and reducing manic episodes in individuals with these conditions. There is 1 clinical trial studying NBI-1117568 for bipolar I disorder and 1 trial for mania.
Dosing
NBI-1117568 is administered orally, primarily in the form of oral capsules. The specific dosage and schedule for NBI-1117568 are determined by the design of each clinical trial and are specified in the arm descriptions for participants.
Clinical studies have explored various investigational dosage forms and levels of NBI-1117568. These include:
- NBI-1117568 (general formulation)
- Dose Level A
- Dose Level B
- Dose Level C
- Dose Level D
These different dose levels are being investigated to determine the most effective and safest amount of the drug for treating the conditions under study, such as schizophrenia and bipolar I disorder. The precise dosing schedule, including how often the medication is taken, is part of the ongoing research to optimize its therapeutic benefits. Patients participating in these trials receive detailed instructions regarding their specific dosing regimen.
Side Effects
In a clinical trial for irritable bowel syndrome with constipation (IBS-C) (NCT05006611), the most common side effect reported by patients taking NBI-1117568 was diarrhea. 12.7% of patients taking NBI-1117568 experienced diarrhea, compared to 3.0% on placebo. Other common side effects included:
- Nausea: 5.9% of patients taking NBI-1117568 experienced nausea, compared to 3.0% on placebo.
- Abdominal pain: 4.3% of patients taking NBI-1117568 experienced abdominal pain, compared to 3.0% on placebo.
- Headache: 3.3% of patients taking NBI-1117568 experienced headache, compared to 3.0% on placebo.
- Upper respiratory tract infection: 3.3% of patients taking NBI-1117568 experienced an upper respiratory tract infection, compared to 3.0% on placebo.
- Vomiting: 2.3% of patients taking NBI-1117568 experienced vomiting, compared to 1.0% on placebo.
In a separate clinical trial involving patients with hyperphosphatemia on dialysis (NCT04840398), the most common side effects were also gastrointestinal, but with higher frequencies:
- Diarrhea: 20.0% of patients taking NBI-1117568 experienced diarrhea, compared to 10.0% on placebo.
- Nausea: 15.0% of patients taking NBI-1117568 experienced nausea, compared to 5.0% on placebo.
- Vomiting: 15.0% of patients taking NBI-1117568 experienced vomiting, compared to 5.0% on placebo.
- Abdominal pain: 10.0% of patients taking NBI-1117568 experienced abdominal pain, compared to 5.0% on placebo.
- Hyperkalemia (high potassium levels): 10.0% of patients taking NBI-1117568 experienced hyperkalemia, compared to 0.0% on placebo.
- AV fistula complication (issues with the vascular access used for dialysis): 10.0% of patients taking NBI-1117568 experienced an AV fistula complication, compared to 0.0% on placebo.
Clinical Trial Results
IBS-C Trial Results
A 12-week, Phase 2b clinical trial (NCT05006611) evaluated the effectiveness of NBI-1117568 in 607 patients with irritable bowel syndrome with constipation (IBS-C). The primary goal was to determine the percentage of "Overall Responders," defined as patients who experienced at least a 30% reduction in weekly worst abdominal pain and an increase of at least one complete spontaneous bowel movement (CSBM) per week for at least 6 out of 12 weeks.
- Overall Responder Rate: 44% of patients taking NBI-1117568 met the criteria for an overall response, compared to 33% of patients taking placebo. This represents an 11% difference between the groups.
- Abdominal Pain Response: 52% of patients taking NBI-1117568 reported at least a 30% reduction in weekly worst abdominal pain for at least 6 out of 12 weeks, compared to 40% on placebo.
- CSBM Frequency: Patients taking NBI-1117568 experienced an average increase of 1.2 CSBMs per week from baseline, while those on placebo saw an increase of 0.6 CSBMs per week.
Hyperphosphatemia Trial Results
A 28-day, Phase 2 clinical trial (NCT04840398) assessed NBI-1117568 in 20 patients with hyperphosphatemia (high phosphate levels) who were undergoing dialysis. The primary goal was to measure the change in serum phosphate levels from baseline to Day 28.
- Phosphate Level Reduction: Patients taking NBI-1117568 experienced a significant reduction in serum phosphate levels, decreasing by an average of 1.5 mg/dL. Patients on placebo had a much smaller reduction of 0.3 mg/dL. A reduction in phosphate levels indicates improvement.
- Achieving Target Levels: 70% of patients treated with NBI-1117568 achieved the target serum phosphate level of less than 4.5 mg/dL, compared to only 10% of patients on placebo.
- FGF23 Levels: NBI-1117568 also reduced fibroblast growth factor 23 (FGF23) levels by 25% from baseline, while placebo showed no change. High FGF23 levels are associated with cardiovascular disease in dialysis patients.
Currently Recruiting Trials
Neurocrine Biosciences is actively seeking participants for several clinical trials evaluating NBI-1117568, an investigational medication. These studies aim to understand how NBI-1117568 may help individuals with certain mental health conditions. Participating in a clinical trial contributes to medical research and could help advance new treatment options.
One ongoing Phase 2 study, NCT07288320, is assessing the efficacy, safety, and pharmacokinetics of NBI-1117568 in adults diagnosed with Bipolar I Disorder who are currently experiencing a manic episode. This trial aims to determine if NBI-1117568 can effectively improve manic symptoms. It plans to enroll approximately 150 participants.
For individuals with schizophrenia, there are multiple Phase 3 trials underway. Study NCT07227818 is evaluating NBI-1117568's effectiveness in preventing the relapse of schizophrenia symptoms in adults who have shown a stable response to previous treatment. This study is targeting 560 participants.
Two additional Phase 3 studies, NCT07105098 and NCT06963034, are focused on inpatient adults with schizophrenia. Both trials are designed to evaluate whether NBI-1117568 can improve behavioral and psychological symptoms associated with the condition. Each of these studies aims to enroll 284 participants.
Finally, a long-term Phase 3 study, NCT07114874, is investigating the long-term safety profile of NBI-1117568 in adults with schizophrenia. This trial is designed for approximately 600 participants.
Where to Participate
Clinical trials for NBI-1117568 are currently recruiting participants across a wide geographic area, making it accessible to many individuals. Studies are active at 3 sites, spanning 47 cities in 16 states across the United States. If you are interested in participating, you might find a study location near you.
Top recruiting locations include:
- Atlanta, Georgia (6 sites)
- New York, New York (4 sites)
- Garden Grove, California (4 sites)
- Miami, Florida (3 sites)
- Gaithersburg, Maryland (3 sites)
- Hollywood, Florida (3 sites)
- Marlton, New Jersey (3 sites)
- San Diego, California (3 sites)
- Torrance, California (2 sites)
- West Hills, California (2 sites)
Eligibility criteria for these trials generally require participants to be between 18 to 65 years of age. All genders are welcome to participate. It is important to note that these studies are not seeking healthy volunteers or children.
Development Timeline
The journey of NBI-1117568 in clinical development began with its first trial on September 19, 2022. Neurocrine Biosciences has been the sole sponsor, driving the research and development of this investigational drug. Initially, NBI-1117568 was explored for conditions such as IBS-C and hyperphosphatemia, demonstrating an early broad interest in its potential applications.
Over time, the development pipeline for NBI-1117568 expanded significantly, focusing on mental health conditions. The program now includes studies for Bipolar I Disorder with current mania and schizophrenia. This expansion reflects a strategic shift towards addressing significant unmet needs in these areas.
To date, a total of six clinical trials have been initiated for NBI-1117568, with a combined enrollment target of 2,088 participants. The majority of these studies are in advanced stages, with four trials being Phase 3 and two in Phase 2. This progression indicates a robust and active development program, aiming to thoroughly evaluate the efficacy and safety of NBI-1117568. The latest trial is projected to conclude by December 17, 2025.