What Is BHV-7000?
BHV-7000 is an investigational drug currently being studied in clinical trials for various neurological and psychiatric conditions. It is designed to be taken orally once daily. The development of BHV-7000 is sponsored by Biohaven Therapeutics Ltd.
This medication is under investigation for its potential use in conditions such as Focal Epilepsy, Bipolar Disorder, Major Depressive Disorder, Familial Erythromelalgia, and Generalized Epilepsy. There are a total of 9 clinical trials involving BHV-7000, with the first trial initiated on 2023-11-15. These trials have enrolled a combined total of 2,409 participants. As of now, 4 trials are actively recruiting new participants, while 3 trials have been completed.
Uses and Conditions Under Study
BHV-7000 is being investigated for its potential to treat several neurological and psychiatric conditions. These include different forms of epilepsy, mood disorders, and a rare pain disorder.
- Epilepsy: BHV-7000 is being studied for both Focal Epilepsy and Generalized Epilepsy. Focal epilepsy involves seizures that originate in one area of the brain, while generalized epilepsy affects both sides of the brain. A total of 4 trials are investigating BHV-7000 for these types of epilepsy (3 for Focal Epilepsy, 1 for Generalized Epilepsy).
- Mood Disorders: The drug is also under investigation for Bipolar Disorder and Major Depressive Disorder. Bipolar disorder is characterized by significant mood swings, including emotional highs (mania or hypomania) and lows (depression). Major depressive disorder involves persistent feelings of sadness and loss of interest. There are 4 trials exploring BHV-7000 for these mood disorders (2 for Bipolar Disorder, 2 for Major Depressive Disorder).
- Familial Erythromelalgia: BHV-7000 is being studied in 1 trial for Familial Erythromelalgia. This is a rare genetic disorder characterized by episodes of severe burning pain, warmth, and redness in the extremities.
Dosing
BHV-7000 is being studied as an oral medication. Clinical trials have investigated various strengths of the drug. Participants in these studies have typically taken the investigational product once daily.
The dosage forms studied include:
- BHV-7000 25 mg (as Part A in some studies)
- BHV-7000 50 mg (also as Part A in some studies)
- BHV-7000 75 mg (also as Part B in some studies)
Specific trial descriptions indicate that dosages of 50 mg and 75 mg once daily have been administered. For instance, some studies specify participants taking BHV-7000 75 mg once daily, including one trial where this regimen was followed for 21 days. Other trials have explored BHV-7000 50 mg once daily. The exact dosage and duration of treatment can vary depending on the specific clinical trial and the condition being investigated.
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Side Effects
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Clinical Trial Results
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Currently Recruiting Trials
Several clinical trials are actively seeking participants to evaluate BHV-7000, an investigational medicine. These studies aim to understand its potential benefits and safety across different conditions, primarily focusing on neurological disorders.
One ongoing Phase 1b study, NCT07262268, is exploring BHV-7000 in individuals with Inherited Erythromelalgia (IEM). This study, sponsored by Biohaven Therapeutics Ltd., seeks to determine if BHV-7000 can help reduce chronic pain in participants who have a specific genetic mutation in the SCN9A gene. It plans to enroll 5 participants.
For adults living with refractory focal onset epilepsy, there are multiple opportunities to participate. A Phase 2 study, NCT06443463, is focused on the long-term safety and tolerability of BHV-7000. This Biohaven Therapeutics Ltd. trial is designed to enroll 660 participants and is evaluating dosages of 50 mg and 75 mg.
Two additional studies, both Phase 2/Phase 3 trials, are investigating the effectiveness and safety of BHV-7000 for refractory focal onset epilepsy. Study NCT06309966, also sponsored by Biohaven Therapeutics Ltd., aims to enroll 390 participants and is testing 50 mg and 75 mg dosages. Similarly, study NCT06132893, also from Biohaven Therapeutics Ltd., is enrolling another 390 participants. This trial explores dosages of 25 mg and 50 mg in Part A, and 75 mg in Part B, to assess the drug's efficacy and safety profile.
Where to Participate
Clinical trials for BHV-7000 are currently active across a wide geographic area, offering opportunities for participation in many communities. These studies are being conducted at 122 sites located in 96 cities across 33 states.
Some of the cities with the highest number of participating sites include:
- Miami, Florida (8 sites)
- Phoenix, Arizona (8 sites)
- Houston, Texas (6 sites)
- Orlando, Florida (6 sites)
- New York, New York (5 sites)
- San Antonio, Texas (4 sites)
- Dallas, Texas (4 sites)
- Pittsburgh, Pennsylvania (4 sites)
- New Orleans, Louisiana (4 sites)
- Baton Rouge, Louisiana (4 sites)
Eligibility criteria for these trials generally require participants to be between 18 and 75 years of age. All genders are welcome to participate, but these studies are not open to healthy volunteers or children.
Development Timeline
The development journey of BHV-7000 began with its first clinical trial on November 15, 2023, and is projected to continue with ongoing studies until at least December 3, 2025. This investigational drug is being developed by Biohaven Therapeutics Ltd., which has sponsored all 9 clinical trials to date.
Initially, BHV-7000 was explored for conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. Over time, the research expanded to include new therapeutic areas, demonstrating a growing understanding of the drug's potential. The development pipeline broadened to investigate its effects in Major Depressive Disorder, Familial Erythromelalgia, and Generalized Epilepsy.
Across all trials, a total of 2,409 participants have been involved. The studies have progressed through various phases, including one Phase 1 trial, four Phase 2 trials, and four Phase 2/Phase 3 trials, marking significant steps in evaluating BHV-7000's safety and effectiveness for a range of challenging conditions.