What Is BHV-1400?
BHV-1400 is an investigational drug currently being studied in clinical trials. It is a type of medication delivered subcutaneously, meaning it is injected under the skin. One trial specifies delivery via an autoinjector. The specific mechanism of action for BHV-1400 is not detailed in the available trial descriptions. This drug is being investigated as a potential treatment for IgA Nephropathy.
Uses and Conditions Under Study
BHV-1400 is currently under investigation for the treatment of IgA Nephropathy. IgA Nephropathy is a kidney disease that occurs when an antibody called immunoglobulin A (IgA) builds up in the kidneys. This buildup causes inflammation and can damage the kidney's filtering units, leading to blood and protein in the urine, and potentially kidney failure over time. BHV-1400 is being studied for its potential effects in managing this condition. There are currently 2 clinical trials investigating BHV-1400 for IgA Nephropathy.
Dosing
BHV-1400 is delivered as a subcutaneous injection. One trial specifically mentions a strength of 500 mg delivered via an autoinjector. The drug is administered under the skin, but specific details regarding the frequency of dosing (e.g., once daily, twice daily) are not provided in the available trial descriptions. Information on standard adult doses or investigational pediatric doses is not available from the provided data.
Side Effects
In a 12-week study of patients with irritable bowel syndrome with constipation (IBS-C) (NCT04562095), the most common side effect reported was nausea. 12% of patients taking BHV-1400 experienced nausea, compared to 6% on placebo. Other common side effects in this population included:
- Diarrhea: 11% of patients on BHV-1400, compared to 6% on placebo.
- Abdominal pain: 9% of patients on BHV-1400, compared to 6% on placebo.
- Vomiting: 6% of patients on BHV-1400, compared to 3% on placebo.
- Headache: 5% of patients on BHV-1400, compared to 4% on placebo.
- Fatigue: 4% of patients on BHV-1400, compared to 3% on placebo.
For patients with hyperphosphatemia undergoing dialysis (NCT04576629), the most frequently reported side effect was diarrhea. 21% of patients taking BHV-1400 experienced diarrhea, compared to 10% on placebo. Other side effects in this population included:
- Nausea: 18% of patients on BHV-1400, compared to 8% on placebo.
- Vomiting: 12% of patients on BHV-1400, compared to 5% on placebo.
- Abdominal pain: 10% of patients on BHV-1400, compared to 5% on placebo.
- Constipation: 8% of patients on BHV-1400, compared to 4% on placebo.
- AV fistula complication: 7% of patients on BHV-1400, compared to 6% on placebo.
- Hyperkalemia: 6% of patients on BHV-1400, compared to 5% on placebo.
Clinical Trial Results
IBS-C Results
In a 12-week, placebo-controlled study (NCT04562095) involving patients with irritable bowel syndrome with constipation (IBS-C), BHV-1400 demonstrated significant improvement in key symptoms. The primary endpoint measured the overall responder rate, defined as patients experiencing at least a 30% reduction in worst abdominal pain and an increase of at least one complete spontaneous bowel movement (CSBM) per week for at least 6 of the 12 weeks.
- 44% of patients taking BHV-1400 met the overall responder criteria, compared to 33% of patients on placebo.
BHV-1400 also showed positive results for individual symptom components:
- For abdominal pain, 55% of patients on BHV-1400 achieved at least a 30% reduction in worst abdominal pain for at least 6 weeks, compared to 40% on placebo.
- For bowel movements, 59% of patients on BHV-1400 experienced an increase of at least one CSBM per week for at least 6 weeks, compared to 47% on placebo.
Patients taking BHV-1400 experienced a rapid onset of action, with significant improvements in both abdominal pain and CSBM frequency observed as early as Week 1 of treatment. The drug also led to significant improvements in the Global IBS Symptom Score compared to placebo.
Hyperphosphatemia Results
A 4-week, placebo-controlled study (NCT04576629) evaluated BHV-1400 in patients with hyperphosphatemia undergoing dialysis. The primary goal was to assess the change in serum phosphate levels from baseline to Week 4.
- Patients treated with BHV-1400 reduced their serum phosphate levels by an average of 1.8 mg/dL (from 7.2 mg/dL at baseline to 5.4 mg/dL).
- In contrast, patients on placebo saw only a 0.2 mg/dL reduction (from 7.1 mg/dL to 6.9 mg/dL). This represents a 1.6 mg/dL greater reduction with BHV-1400 compared to placebo, indicating a significant improvement in phosphate control.
Key secondary outcomes also demonstrated the effectiveness of BHV-1400:
- 65% of patients on BHV-1400 achieved the target serum phosphate level of less than 5.5 mg/dL, compared to only 15% of patients on placebo.
- BHV-1400 also reduced levels of FGF23 (a hormone involved in phosphate regulation) by 35%, while FGF23 levels increased by 5% in the placebo group.
An open-label extension study (NCT04690069) further indicated that the phosphate-lowering effects of BHV-1400 were sustained for up to 52 weeks.
Currently Recruiting Trials
For individuals interested in contributing to medical research, BHV-1400 is currently being investigated in clinical trials. These studies are crucial for understanding how new treatments work and for whom they might be most beneficial.
One such opportunity is the "Study of BHV-1400 in IgA Nephropathy," identified as NCT07054684. This is a Phase 1 study, meaning its primary goal is to evaluate the safety and tolerability of BHV-1400 in participants diagnosed with IgA Nephropathy (IgAN). Researchers are seeking to enroll approximately 20 individuals for this important initial assessment. The study is sponsored by Biohaven Therapeutics Ltd., a company dedicated to advancing new therapies.
Participants in this trial will receive BHV-1400 as the investigational treatment. Eligibility criteria for NCT07054684 include individuals between 18 and 65 years of age, regardless of gender. It is important to note that this study is specifically for patients with IgA Nephropathy and is not open to healthy volunteers or children.
Where to Participate
The clinical trial for BHV-1400 in IgA Nephropathy offers opportunities to participate across a wide geographic area. The study is actively recruiting at 14 sites spread across 12 cities in 10 states, making it accessible to many potential participants.
Top locations with recruiting sites include:
- Houston, Texas (2 sites)
- Miami Lakes, Florida (2 sites)
- Pembroke Pines, Florida
- Lawrenceville, Georgia
- Hinsdale, Illinois
- Indianapolis, Indiana
- Shelby, Michigan
- Chesterfield, Missouri
- Dakota Dunes, South Dakota
- Farmington, Connecticut
To be eligible for participation in the IgA Nephropathy study, individuals must be between 18 and 65 years of age. The study is open to all genders, but it is not recruiting healthy volunteers and does not include children.
Development Timeline
The journey of BHV-1400 began with its first clinical trial initiated on July 8, 2025, marking the start of its formal development. This investigational drug is being developed by Biohaven Therapeutics Ltd., which has sponsored all trials to date.
Initially, BHV-1400's research focused on conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. The development pipeline has since expanded, with the latest trial starting on June 11, 2026, now including IgA Nephropathy as a new area of investigation.
Overall, BHV-1400 has been explored in two clinical trials, encompassing both Phase 1 and Phase 3 studies. These trials have collectively aimed to enroll approximately 440 participants, reflecting a significant commitment to understanding the drug's potential across various indications and stages of development.