Primary completion· ClinicalTrials.gov
A Phase 1b Study of BHV-7000 in Participants With Inherited Erythromelalgia
BHV-7000 History and Updates
27 events · 2023 – present
Synced daily from openFDA and ClinicalTrials.gov. Last sync: .
0
FDA Approvals
0
Label Revisions
27
Trial Milestones
0
Pivotal Publications
Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-05-08Download chart as PNG
This page tracks every FDA action, clinical trial milestone, and major publication for BHV-7000 since 2023, drawn from openFDA, ClinicalTrials.gov, and PubMed.
Upcoming & expected milestones
Primary completion· ClinicalTrials.gov
Long-term Safety and Tolerability of BHV-7000
Primary completion· ClinicalTrials.gov
A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
Past events
2026
Primary completion· ClinicalTrials.gov
Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
Primary completion· ClinicalTrials.gov
Long-term Safety Study of BHV-7000 in Participants With Major Depressive Disorder (MDD)
Primary completion· ClinicalTrials.gov
A Study to Determine if BHV-7000 is Effective and Safe in Adults With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures
Trial started· ClinicalTrials.gov
A Phase 1b Study of BHV-7000 in Participants With Inherited Erythromelalgia
2025
Trial registered· ClinicalTrials.gov
A Phase 1b Study of BHV-7000 in Participants With Inherited Erythromelalgia
Primary completion· ClinicalTrials.gov
Efficacy and Safety Study of BHV-7000 Monotherapy in Major Depression
Primary completion· ClinicalTrials.gov
BHV-7000 Open-Label Extension Bipolar Mania Study
Primary completion· ClinicalTrials.gov
BHV-7000 Acute Treatment of Bipolar Mania
2024
Trial started· ClinicalTrials.gov
Long-term Safety Study of BHV-7000 in Participants With Major Depressive Disorder (MDD)
Trial started· ClinicalTrials.gov
Long-term Safety and Tolerability of BHV-7000
Trial started· ClinicalTrials.gov
BHV-7000 Open-Label Extension Bipolar Mania Study
Trial started· ClinicalTrials.gov
A Study to Determine if BHV-7000 is Effective and Safe in Adults With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures
Trial registered· ClinicalTrials.gov
Long-term Safety and Tolerability of BHV-7000
Trial started· ClinicalTrials.gov
BHV-7000 Acute Treatment of Bipolar Mania
Trial started· ClinicalTrials.gov
Efficacy and Safety Study of BHV-7000 Monotherapy in Major Depression
Trial registered· ClinicalTrials.gov
A Study to Determine if BHV-7000 is Effective and Safe in Adults With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures
Trial registered· ClinicalTrials.gov
BHV-7000 Open-Label Extension Bipolar Mania Study
Trial registered· ClinicalTrials.gov
Long-term Safety Study of BHV-7000 in Participants With Major Depressive Disorder (MDD)
Trial registered· ClinicalTrials.gov
BHV-7000 Acute Treatment of Bipolar Mania
Trial registered· ClinicalTrials.gov
Efficacy and Safety Study of BHV-7000 Monotherapy in Major Depression
Trial started· ClinicalTrials.gov
Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
Trial started· ClinicalTrials.gov
A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
Trial registered· ClinicalTrials.gov
Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
2023
Trial registered· ClinicalTrials.gov
A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
Sources
FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.