NDASUBCUTANEOUSSOLUTION
Approved
May 2025
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
1
Data completeness
5/8 — Partial
BREKIYA (AUTOINJECTOR) (dihydroergotamine mesylate) by Baxter is 5-ht 1dα and 5-ht 1dβ receptors. First approved in 2025.
Drug data last refreshed 40m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BREKIYA is a subcutaneous autoinjector formulation of dihydroergotamine mesylate, a selective 5-HT1D receptor agonist approved by the FDA in May 2025 for acute migraine treatment. The drug works by binding to 5-HT1Dα and 5-HT1Dβ receptors to provide rapid symptom relief during migraine attacks. This self-injection format represents a modernization of an established ergot alkaloid mechanism with improved patient convenience.
Growth12.7 years to LOE
Recently launched product in a mature indication with no direct branded competitors creates opportunity for rapid market penetration and team expansion.
Mechanism of Action
5-HT 1Dα and 5-HT 1Dβ receptors. The therapeutic activity of dihydroergotamine in migraine is generally attributed to the agonist effects at 5-HT 1D receptors.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
Pharmacodynamic Study to Compare Acute Effects of Dihydroergotamine Mesylate (DHE) on Pulmonary Arterial Pressure
Started Mar 2010
24 enrolled
Healthy
Career Relevance
BREKIYA represents a rare opportunity to build a new brand franchise in an established therapeutic area with limited recent competition, offering visibility, autonomy, and rapid impact for early-career professionals. The 12.7-year patent exclusivity window provides career stability and the potential to manage a product across multiple commercial lifecycle phases.
Brand Manager
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.