NDAORALTABLET, EXTENDED RELEASE
Approved
Sep 2023
Lifecycle
Peak
Competitive Pressure
8/100
Data completeness
4/8 — Partial
EXXUA (gepirone) by Fabre-Kramer Pharmaceuticals is 5ht1a receptors. Approved for major depressive disorder (mdd) in adults ( ). First approved in 2023.
Drug data last refreshed 34m ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EXXUA (gepirone) is an oral extended-release tablet approved in September 2023 for major depressive disorder (MDD) in adults. It works as a selective 5-HT1A receptor agonist, a novel mechanism distinct from SSRIs. This represents the first new chemical entity in this receptor class approved for depression in decades.
Growth3.8 years to LOE
Early-stage product in growth phase with significant commercial opportunity; teams are ramping up launch infrastructure and field presence.
Mechanism of Action
5HT1A receptors.
Indications (1)
Why This Matters for Your Career
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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.