Last reviewed · How we verify
GEPIRONE
EXXUA's antidepressant effect may stem from modulating serotonergic activity via selective agonist activity at 5HT1A receptors.
At a glance
| Generic name | GEPIRONE |
|---|---|
| Sponsor | Fabre Kramer |
| Drug class | gepirone |
| Target | 5HT1A receptors |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2023 |
Mechanism of action
EXXUA is believed to work as an antidepressant by affecting the activity of serotonin in the brain. It does this by acting as a selective agonist at 5HT1A receptors, which helps regulate mood and other functions.
Approved indications
- Major Depressive Disorder
Boxed warnings
- BOXED WARNING WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1 ) ] . EXXUA is not approved for use in pediatric patients [see Use in Specific Populations (8.4) ] WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Increased risk of suicidal thinking and behavior in pediatric and young adult patients taking antidepressants. Closely monitor for worsening and emergence of suicidal thoughts and behaviors ( 5.1 ). EXXUA is not approved for use in pediatric patients ( 8.4 ).
Common side effects
- Dizziness
- Nausea
- Headache
- Feeling Sleepy or Tired
- Insomnia
- Diarrhea
- Upper Respiratory Tract Infection
- Dry Mouth
- Vomiting
- Abdominal Pain
- Dyspepsia
- Increased Appetite
Drug interactions
- Strong CYP3A4 Inhibitors
- Moderate CYP3A4 Inhibitors
- Monoamine Oxidase Inhibitors (MAOIs)
- Drugs that Prolong the QTc Interval
- Strong CYP3A4 Inducers
- Other Serotonergic Drugs
Key clinical trials
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- GEPIRONE CI brief — competitive landscape report
- GEPIRONE updates RSS · CI watch RSS