Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BHV-2100 · 1 trial · 1 indication
Pain levels are assessed on a 4-point scale (none, mild, moderate, severe) using the electronic diary (eDiary). Pain freedom is defined as pain level of none. Coprimary endpoints will be tested hierarachically by dose
MBS is reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) is assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Freedom from MBS is defined as MBS reported at onset that was absent post-dose. Coprimary endpoints will be tested hierarachically by dose
| Arm | Type | Description |
|---|---|---|
| BHV-2100 75 mg | EXPERIMENTAL | - |
| BHV-2100 150 mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| BHV-2100 | DRUG | BHV-2100 75mg |
| Placebo | DRUG | matching placebo |
Key Inclusion Criteria: Participants with at least 1 year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition,19 including the following: 1. 2-8 migraine headache attacks of moderate or severe inten...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 13 | PHASE3 | Atogepant |
| Pfizer Inc. | PFE | 9 | PHASE3 | Rimegepant |
| Eli Lilly and Company | LLY | 2 | PHASE3 | Galcanezumab |
| Amgen Inc. | AMGN | 2 | PHASE3 | Erenumab Dose 1 |
| Ki Health Partners. LLC | RVNC | 1 | - | Daxibotulinumtonix A |
BHV-2100 is an investigational small molecule being developed for the acute treatment of migraine. It is currently in clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with migraine to evaluate its efficacy and safety.
BHV-2100 is being developed by Biohaven Ltd., a biopharmaceutical company. Biohaven is conducting clinical trials to evaluate the drug's potential as an acute treatment for migraine. The company is listed on the New York Stock Exchange under the ticker symbol BHVN.
BHV-2100 is in Phase 2 clinical development. A Phase 2 trial of the drug for the acute treatment of migraine has been completed. The drug is investigational and has not yet received regulatory approval for any use.
BHV-2100 has been studied in a Phase 2 clinical trial with the identifier NCT06603623, titled "Efficacy and Safety Trial of BHV-2100 for the Acute Treatment of Migraine." The trial was completed and enrolled 647 participants in the United States.
BHV-2100 is not FDA approved. It is an investigational drug currently in clinical development for the acute treatment of migraine. The Phase 2 trial has been completed, but the drug has not yet received marketing authorization from regulatory authorities.