Approval Probability
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LY3451838 · 2 trials · 2 indications
Migraine Headache Day is a calendar day on which a migraine or probable migraine headache occurs. Per International Headache Society \[IHS\] International Classification of Headache Disorders version 3 \[ICHD-3\], migraine is defined as a headache, with or without aura, of \>=30 minutes duration with both of the following required features (A) At least 2 of the following headache characteristics: Unilateral location; Pulsatile quality; Moderate or severe pain intensity; Aggravation by or causing avoidance of routine physical activity (B) During headache at least 1 of the following: Nausea and/or vomiting; Photophobia and phonophobia. Least square mean was assessed using Bayesian Mixed Model Analysis with baseline number of monthly migraine headache days as a covariate.
A summary of other non-serious Adverse Events (AE's), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.
A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
| Arm | Type | Description |
|---|---|---|
| 1500 milligrams (mg) LY3451838 | EXPERIMENTAL | Participants received a single intravenous (IV) dose of 1500 mg LY3451838. |
| Placebo | PLACEBO_COMPARATOR | Participants received a single IV dose of placebo. |
| 25 milligram (mg) LY3451838 Part A | EXPERIMENTAL | 25 mg LY3451838 single dose administered intravenously (IV) |
| 75 mg LY3451838 Part A | EXPERIMENTAL | 75 mg LY3451838 single dose administered IV. |
| 250 mg LY3451838 Part A | EXPERIMENTAL | 250 mg LY3451838 single dose administered IV. |
| 500 mg LY3451838 Part A | EXPERIMENTAL | 500 mg LY3451838 single dose administered IV. |
| 1000 mg LY3451838 Part A | EXPERIMENTAL | 1000 mg LY3451838 single dose administered IV. |
| 1500 mg LY3451838 Part A | EXPERIMENTAL | 1500 mg LY3451838 single dose administered IV. |
| 250 mg LY3451838 Part B | EXPERIMENTAL | 250 mg LY3451838 single dose administered subcutaneously (SC). |
| Name | Type | Description |
|---|---|---|
| LY3451838 | DRUG | Administered IV |
| Placebo | DRUG | Administered IV |
Inclusion Criteria: * Must have a diagnosis of migraine with a history of migraine headaches of at least 1 year prior, and migraine onset prior to age 50. * Have completed at least 80% of required daily diary entries during the start of the study. * Have documentation of previous failure of 2 to 4 ...
| 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 |
LY3451838 is an investigational small molecule being studied for use in healthy participants and in participants with migraine. It is currently in clinical development by Eli Lilly and Company and has not been approved by the FDA.
LY3451838 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY.
LY3451838 has completed a Phase 1 trial in healthy participants and a Phase 2 trial in participants with migraine. Both trials are completed, and the drug remains investigational.
LY3451838 has been studied in two completed clinical trials. NCT03692949 was a Phase 1 study in healthy participants in Singapore, and NCT04498910 was a Phase 2 study in participants with migraine in the United States.
LY3451838 is the primary name used for this investigational drug in clinical trials. No alternative names have been reported for this compound.