Last reviewed · How we verify
ZULRESSO®
At a glance
| Generic name | ZULRESSO® |
|---|---|
| Also known as | Allopregnanolone, Brexanolone, SAGE-547 |
| Sponsor | Supernus Pharmaceuticals, Inc. |
| Drug class | Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator |
| Target | GABA-A receptor alpha-1/beta-2/gamma-2 |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
Approved indications
- Postpartum depression
Common side effects
Key clinical trials
- A Study to Assess the Safety and Efficacy of Oral LPCN 1154A in Women With Severe PPD (PHASE3)
- Study on Allopregnanolone and Depression in Perimenopausal Women (PHASE4)
- Facilitation of Extinction Retention and Reconsolidation Blockade by IV Allopregnanolone in PTSD. (PHASE2)
- National Pregnancy Registry for Psychiatric Medications
- A Study With SAGE-547 for Super-Refractory Status Epilepticus (PHASE3)
- A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B) (PHASE3)
- Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress Disorder (PHASE1)
- A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD) (PHASE3)
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 |
|---|---|
| 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:
- ZULRESSO® CI brief — competitive landscape report
- ZULRESSO® updates RSS · CI watch RSS
- Supernus Pharmaceuticals, Inc. portfolio CI