NDAORALTABLET, EXTENDED RELEASE
Approved
Sep 2023
Lifecycle
Growth
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 5h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EXXUA (gepirone) is an oral, extended-release 5-HT1A receptor agonist approved in September 2023 for major depressive disorder (MDD) in adults. It represents a novel mechanism of action distinct from traditional SSRIs, targeting serotonin 1A receptors to enhance serotonergic neurotransmission. This is Fabre-Kramer Pharmaceuticals' first major CNS launch in the competitive antidepressant market.
Growth4.2 years to LOE
Early-stage growth product with significant commercial opportunity; expect expanding commercial team investment and field force buildout over next 2-3 years.
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.